EXAMPLE:All[Product Name]configurations covered under this clinical evaluation are considered equivalent and the data presented may include various device configurations, when applicable.Literature sources frequently do not state the specific device configurations used, which precludes any sub-analysis within the clinical evaluation for specific designs within a product line.All[Product Name]device configurations have the same or similar clinical, technical, and biological characteristics.Some specifications are designed to vary by device, but are consistent across product lines.Consequently, all product lines are expected to have comparable functionality when used as directed under the instructions for use.Selection of specific product lines is at the discretion of the attending physician based on the clinical application and patient anatomy, and is generally based on physician preference in particular procedures.Therefore, equivalence has been established across product lines for[Product Name].The clinical evaluation will be based on clinical data sources for any device configuration and conclusions will be applicable across all configurations, unless noted otherwise.EXAMPLE:Clinical, technical, and biological criteria to establish device equivalency is provided in Table 4-1.Table 4-1:Equivalence Table for[Product Name]and[Equivalent Device]
EXAMPLE:All[Product Name]configurations covered under this clinical evaluation are considered equivalent and the data presented may include various device configurations, when applicable.<br>Literature sources frequently do not state the specific device configurations used, which precludes any sub-analysis within the clinical evaluation for specific designs within a product line.<br>All[Product Name]device configurations have the same or similar clinical, technical, and biological characteristics.<br>Some specifications are designed to vary by device, but are consistent across product lines.<br>Consequently, all product lines are expected to have comparable functionality when used as directed under the instructions for use.<br>Selection of specific product lines is at the discretion of the attending physician based on the clinical application and patient anatomy, and is generally based on physician preference in particular procedures.<br>Therefore, equivalence has been established across product lines for[Product Name].<br>The clinical evaluation will be based on clinical data sources for any device configuration and conclusions will be applicable across all configurations, unless noted otherwise.<br>EXAMPLE:Clinical, technical, and biological criteria to establish device equivalency is provided in Table 4-1.<br>Table 4-1:Equivalence Table for[Product Name]and[Equivalent Device]
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