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Cutting and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures where instruments are introduced into the body through a cannula.

The Microline ACCUSHEAR Laparoscopic Surgical Instruments are a line of nonsterile, reusable 5 mm diameter instruments used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula. The device is used with monopolar electrosurgical generators.

This is a 510(k) premarket notification for a medical device (ACCUSHEAR Laparoscopic Surgical Instruments), not an AI/ML medical device. Therefore, the concept of "acceptance criteria" and "study proving device meets acceptance criteria" as it applies to AI/ML performance metrics and studies is not directly applicable in the same way.

However, based on the provided text, I can infer the "acceptance criteria" for this device from the perspective of substantial equivalence to a predicate device, and the "study" is the information provided in the 510(k) submission itself that demonstrates this equivalence.

Here's how I can interpret and answer your request in the context of this specific regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

For a traditional medical device 510(k), the "acceptance criteria" is typically demonstrating substantial equivalence to a legally marketed predicate device. The "performance" is that the new device performs as safely and effectively as the predicate, with no new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance

This is not applicable for this type of device and submission. There is no "test set" in the context of an AI/ML device relying on data. The submission relies on a comparison of the device's design and intended use to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable. There is no ground truth, test set, or expert review in this sense for a traditional surgical instrument 510(k). The "ground truth" is established by the existing regulatory clearance and safe market history of the predicate devices.

4. Adjudication method for the test set

This is not applicable. There is no test set or adjudication method for this type of submission.

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

This is not applicable. This is not an AI/ML device, and no MRMC study would be performed.

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

This is not applicable. This is not an AI/ML device.

7. The type of ground truth used

For a traditional 510(k) like this, the "ground truth" (if you can call it that) is the demonstration of substantial equivalence to a legally marketed device that has already established its safety and effectiveness. This is based on:

• Predicate Device History: The predicate devices ("Re-New" K962119 and "Selec-Tip" K980758) have already been cleared by the FDA, implying their safety and effectiveness have been appropriately assessed.
• Design Rationale: The manufacturer's rationale that the minor modification to the shaft and handpiece connection does not affect safety or effectiveness.

8. The sample size for the training set

This is not applicable. This is not an AI/ML device, and there is no training set.

9. How the ground truth for the training set was established

This is not applicable. There is no training set for this type of device.

In Summary for this Specific Device:

The "study" proving the device meets "acceptance criteria" for a 510(k) is the submission itself, which articulates:

• The device's description and intended use.
• The identification of predicate devices with established safety and effectiveness.
• A detailed comparison demonstrating that the new device is substantially equivalent to the predicate, particularly highlighting that any modifications are minor and do not introduce new safety or effectiveness concerns.

The FDA's review of this submission and subsequent clearance (K982984) serves as the "proof" that the device meets the regulatory acceptance criteria for market entry via the 510(k) pathway.

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