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The Stryker Saphenous Vein Harvest Laparoscope is substantially equivalent to the Snowden Pencer Saphenous Vein Endoscope in intended use and is compatible for use with the Ethicon Subcu-Retractor for this purpose.

The Stryker Saphenous Vein Harvest Laparoscope is identical in terms of materials and modes of construction, optical performance and safety to the existing line of Stryker 5mm Laparoscopes, differing only in working length. Materials of construction coming into patient contact, including structural components and cannula components which are of stainless steel, plated brass, and anodized aluminum, joined with adhesives and braze alloys, are demonstrated to be bio-compatible per the Tripartite scheme, and/or ISO 10993 and G95-1. The optical system consisting of optical glass, adhesives and coated brass components for spacing and mounting, and light transmission fibers are identical to those currently used in Stryker cleared laparoscopes. Stryker Saphenous Vein Harvest laparoscopes are reusable, and sold non-sterile, and are validated for cleanability, disinfection and re-sterilization. Sterilization methods include 100% EtO, Cidex® and Steris® processes. Those endoscopes labeled as "Autoclavable" will be validated for durability, cleanability, and sterilizability under specified cycles per appropriate AAMI guidelines.

This document is a 510(k) premarket notification for a medical device, the Stryker Saphenous Vein Harvest Laparoscope. It is a declaration of substantial equivalence to existing devices and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way you've outlined for an AI/CAD system.

The provided text focuses on:

• Device Identification: Name, classification, sponsor.
• Substantial Equivalence Claim: The primary purpose of a 510(k) submission. It argues that the new device is "substantially equivalent" to legally marketed predicate devices (existing Stryker laparoscopes and the Snowden Pencer Saphenous Vein Endoscope).
• Justification for Equivalence: This includes comparing materials, construction, optical performance, safety, intended use, and compatibility with other devices.
• Biocompatibility: Statements about material biocompatibility per specific schemes and standards.
• Sterilization: Validation for cleanability, disinfection, and re-sterilization methods.

Therefore, I cannot extract the information requested in your numbered list from this document. This typically applies to performance studies for novel devices or AI/CAD systems, which are not detailed in this particular type of regulatory submission for a rigid endoscope.

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