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The ESHV (Endoscopic Subfascial Harvesting of Veins) instrument set is used for minimally invasive preparation and harvesting of the veins for use in cardiac and vascular surgical procedures. The intervention takes place under sterile conditions.

The Veins dissector (stripper) is used for the blunt preparation of tubular structures. specifically for the free-preparation of vessels, e.g. the vein saphena magma.

The ESDP (Endoscopic Subfascial Discision of Perforating Veins) instrument set is used for minimally invasive visualization, diagnostic, and therapeutic procedures of subfascial veins in the lower extremities, e.g. the saphenous vein. The intervention takes place under sterile conditions.

The Instruments for endoscopic subfascial Harvesting of Veins (ESHV) and Endoscopic Subfascial Discision of Perforating Beins (ESDP) consists of operating telescopes, endoscopic operating tubes, laser guide, hook knife, various monopolar and bipolar grasping forceps and scissors, and veins dissector (stripper).

Here's an analysis of the provided information regarding the acceptance criteria and study for the device:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, there are no specific, quantifiable acceptance criteria or performance metrics reported for the device. The submission explicitly states:

The document concludes with a general statement on design and testing for safety and effectiveness, but this doesn't constitute quantifiable performance data against predefined criteria.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not applicable. No test set was used for performance evaluation, as "performance data not generated" and "no clinical tests performed."
• Data Provenance: Not applicable, as no data was generated or used for performance evaluation.

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

• Number of Experts: Not applicable. No ground truth was established as no test set or performance evaluation was conducted.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No. The document explicitly states "No clinical tests performed" and "Performance data not generated." This device is from 1998, well before the widespread use and regulatory expectation of AI-assisted device studies.

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

• Standalone Performance: No. The document explicitly states "No clinical tests performed" and "Performance data not generated." This device is not an AI algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable. No ground truth was established as no test set or performance evaluation was conducted.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Ground Truth Establishment: Not applicable. This device is not an AI/ML algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

Based on the provided 510(k) summary, there was no study conducted to explicitly prove the device meets pre-defined acceptance criteria through performance data or clinical trials. The submission relies on demonstrating substantial equivalence to existing predicate devices.

The document states:

• "Performance data not generated."
• "No clinical tests performed."
• "These devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manual." (This is a general statement from the manufacturer, not indicative of a specific study proving it.)
• "The submitted devices are substantially equivalent to existing pre-enactment and 510(k) devices sold by Richard Wolf and competitors."

The FDA's letter concurs with the substantial equivalence claim, allowing the device to be marketed. This means the device was cleared because it was deemed as safe and effective as a legally marketed predicate device, primarily based on its technological characteristics and intended use, rather than new performance data or clinical studies generated for this specific submission.

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