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The Rotating Hook Knife is a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.

The Ethicon Endo Surgery® (EES) Rotating Hook Knife is a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. The device consists of a flexible wire cable and hook knife electrode, which can be extended and rotated from the flexible outer shaft using two handle control knobs. When connected to an electrosurgical generator and activated, the hook knife delivers a monopolar electrical current to the surgical site. This device passes through endoscopes having a 2.8 mm or larger working channel. This device is supplied sterile for single-patient use.

The provided document is a 510(k) summary for the Ethicon Endo Surgery® Rotating Hook Knife. It describes the device, its intended use, and its technological characteristics compared to a predicate device. The document also lists the performance data submitted to demonstrate compliance with various safety standards.

However, the document does not contain information about acceptance criteria for a study proving device performance, nor details of a specific study meeting said criteria in the format usually associated with clinical validation of AI/ML or diagnostic devices. Instead, it details bench testing performed to demonstrate that the device performs as intended and complies with several international standards related to medical electrical equipment, biocompatibility, and electromagnetic compatibility.

Therefore, I cannot extract the information required in your request about acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Based on the information provided, here's what can be stated about the performance data:

1. A table of acceptance criteria and the reported device performance:
   Not provided in the document. The document lists the standards the device was tested against, but not specific acceptance criteria within those standards or a table of measured performance against those criteria.

2. Sample size used for the test set and the data provenance:
   Not specified. The document mentions "bench testing," but does not detail sample sizes, or data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. The performance data described is "bench testing" against engineering and safety standards, not a study requiring expert-established ground truth.

4. Adjudication method for the test set:
   Not applicable. The performance data described is "bench testing," not a study requiring adjudication.

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:
   Not applicable. This is not an AI/ML device or a diagnostic device where MRMC studies would typically be performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is a physical electrosurgical instrument, not an algorithm.

7. The type of ground truth used:
   Not applicable in the context of clinical/diagnostic AI studies. For bench testing, the "ground truth" would be the specifications and requirements outlined in the listed international standards (e.g., IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, IEC 60601-1-2, ISO 10993-1).

8. The sample size for the training set:
   Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:
   Not applicable. This is not an AI/ML device.

Summary of Performance Data from Document:

The document states:

• "Bench testing was performed to demonstrate that the EES device performs as intended."
• "The patient contact portions of the device have been evaluated for biocompatibility and comply with the requirements of ISO 10993-1."
• "The device was tested to demonstrate compliance with the following standards:"
  • Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
  • Medical Electrical Equipment - Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment, IEC 60601-2-2, 2006/07/01
  • Medical Electrical Equipment - Part 2-18: Particular Requirements for the Safety of Endoscopic Equipment, IEC 60601-2-18, 1996/08/01
  • Medical Electrical Equipment Part 1-2: General Requirements for Safety: Electromagnetic Compatibility, IEC 60601-1-2 (2004)

This indicates that the "study" for performance consisted of engineering bench tests against recognized international safety and performance standards for electrosurgical and endoscopic devices, and biocompatibility. Specific numerical acceptance criteria or performance metrics beyond "compliance" are not detailed in this summary.

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