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Intended for use in Endoscopic Saphenous Vein harvesting procedures.

The Henke Sass Wolf Saphenous Vein Laparoscope is identical in terms of materials and modes of construction, optical performance and safety to the existing line of HSW 5mm Laparoscopes, differing only in working length and angle of view. The materials and basic design are identical. For the purpose of saphenous vein harvesting, a standard 5mm laparoscope is modified to extend the working length to 300mm. The laparoscope in used in conjunction with Ethicon's Endo-Surgery cannula system to provide a complete visualization system. These laparoscopes were designed to be inserted in the Ethicon sheath to help view the surgical area. To facilitate this, the laparoscope working length was modified. These laparoscopes are reusable and employed in conjunction with other cleared devices, to form a complete system.

This document is a 510(k) premarket notification for a medical device called the "Henke Sass Wolf Saphenous Vein Laparoscope." It's primarily focused on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria for an AI-powered device.

Therefore, many of the requested sections about AI-specific criteria, studies, and ground truth are not applicable to this document. I will extract the information that is present concerning safety and effectiveness testing.

Acceptance Criteria and Study for the Henke Sass Wolf Saphenous Vein Laparoscope

This submission is for a conventional medical device, a laparoscope, and not an AI-powered device. As such, the "acceptance criteria" and "device performance" are related to established safety and performance standards for such physical medical instruments, rather than AI model metrics. The study focuses on demonstrating compliance with these standards and substantial equivalence to existing devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated in terms of a "test set" as would be used for AI/software. The testing mentioned (Electrical Safety, Electromedical System) would involve testing of physical device prototypes or production samples. The substantial equivalence argument relies on comparison to known predicate devices already on the market.
• Data Provenance: Not applicable in the context of data for an AI model.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as this is a submission for a physical medical device, not an AI or diagnostic application that would require expert-established ground truth on a test set of data.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, this type of study is typically done for diagnostic imaging or AI systems where human reader performance is a key metric. This is a surgical instrument.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable, as this is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" here is compliance with established safety standards (EN 60601-1-1, EN 601-2-10) and physical attributes (materials, construction, optical performance, safety) matching a known, legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI or machine learning device.

9. How the Ground Truth for the Training Set was Established

Not applicable.

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