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The single use ANDORATE® Suction Valve is used to control the suction function of an endoscope during the endoscopic procedure.

The single use ANDORATE® Biopsy Valve is used to cover the biopsy/suction channel of endoscope. The biopsy valve provides access for endoscopic device passage and exchange and minimizes leakage of biomaterial from the biopsy port through the endoscopic procedure.

The subject devices are intended for single-use and are supplied sterile. The suction valve is designed to be attached to the suction port of the bronchoscope and the biopsy valve is designed to be attached to the biopsy port of the bronchoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the bronchoscopic image while biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The suction valve and biopsy valve kit is compatible with Olympus® 160/180/190/260/290 Series Bronchoscopes.

The provided text is a 510(k) Summary for medical device clearance, specifically concerning the ANDORATE® Suction Valve and ANDORATE® Biopsy Valve. It outlines the safety and effectiveness information for these devices and compares them to a predicate device.

However, the document does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and the study proving the device meets those criteria, particularly in the context of an AI/algorithm-driven device.

The request asks for details like:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, and how training ground truth was established.

The provided document describes physical medical devices (valves for bronchoscopes), not an AI/algorithm. Therefore, concepts like "AI assistance," "human readers," "effect size of human readers improve with AI," "standalone algorithm performance," and "training/test sets for an algorithm" are not applicable to the information given.

The document does mention "Performance Test" in Section 9, stating:
"The bench testing was performed to support substantial equivalence on both the subject device and the predicate device. The following bench testing was performed - endoscope compatibility test, suction flow, vacuum leak, water leak test, pressing force test and fatigue test for suction valve and endoscope compatibility, vacuum leak and squeegee leak test for biopsy valve. The performance data demonstrated that the subject devices met established specifications."

While this section indicates that performance tests were done and met specifications, it does not provide the acceptance criteria or the specific performance results in a quantitative manner. It also does not involve human readers, AI, or traditional "ground truth" as it would apply to a diagnostic algorithm.

Conclusion based on the provided text:

The provided document is for physical medical devices (valves), not an AI/algorithm. Therefore, most of the requested information (related to AI performance, human reader studies, training/test sets for AI, ground truth establishment for AI) is not present and not applicable to this submission.

The document states that bench testing was performed and the devices met established specifications. However, the specific quantitative acceptance criteria and the reported performance values are not detailed in this summary.

To answer your request based only on the provided text:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly detailed in quantitative terms within the summary, but implied that each test (endoscope compatibility, suction flow, vacuum leak, water leak, pressing force, fatigue, squeegee leak) had "established specifications."
   • Reported Device Performance: The document summarily states: "The performance data demonstrated that the subject devices met established specifications." No specific quantitative results are provided.

2. Sample sized used for the test set and the data provenance: Not applicable to this type of device testing as described. The testing is bench testing on physical units.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/diagnostic algorithms is not relevant here.

4. Adjudication method for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable. This is not an algorithm.

7. The type of ground truth used: Not applicable. The "ground truth" for these physical devices would be their ability to perform their mechanical functions according to engineering specifications.

8. The sample size for the training set: Not applicable (not an AI/ML algorithm).

9. How the ground truth for the training set was established: Not applicable (not an AI/ML algorithm).

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