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The Coring Morcellator is used during laparoscopic surgery for the removal of a non-malignant fibroid tumor or other tissue within the peritoneal cavity.

The Coring Morcellator is used during laparoscopic surgery for the removal of a non-malignant fibroid tumor or other tissue within the peritoneal cavity. This device will be made from stainless steel. Stainless steel is widely accepted in the medical field, therefore, biocompatibility is assured.

The provided text is a 510(k) summary for a "Coring Morcellator" from 1996. It explicitly states that the device's substantial equivalence is based on its "indications for use, materials and physical construction to predicate device" and that it "meets the requirements for section 510(k) substantial equivalence."

This type of submission does not typically include the kind of performance studies, acceptance criteria, ground truth establishment, or sample size details that are common for AI/ML or more complex diagnostic devices today. The 510(k) process for a device like this in 1996 primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than rigorous statistical performance evaluation against specific criteria.

Therefore, most of the requested information cannot be found in the provided text.

Here's a breakdown of what can and cannot be inferred from the document based on the request:

1. Table of acceptance criteria and the reported device performance:

• Cannot be provided. The document does not specify any quantitative acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy, precision, etc.) for the Coring Morcellator. The basis for acceptance is substantial equivalence to predicate devices in terms of intended use, materials, and physical construction.

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

• Cannot be provided. No test set or data provenance is mentioned as this was not a data-driven device or study in the sense of AI/ML performance.

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

• Cannot be provided. Ground truth establishment by experts for performance data is not applicable to this type of device submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Cannot be provided. Not applicable.

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:

• Cannot be provided. This is a surgical device, not an AI-assisted diagnostic tool. MRMC studies are not relevant here.

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

• Cannot be provided. This is a surgical instrument, not an algorithm. Standalone performance as understood in AI/ML is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Cannot be provided. Ground truth as a concept for performance evaluation is not relevant to this type of device submission. The "ground truth" for a surgical instrument's safety and effectiveness is largely based on historical clinical use of similar devices, material safety, and manufacturing quality.

8. The sample size for the training set:

• Cannot be provided. There is no "training set" as this device is not an AI/ML algorithm.

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

• Cannot be provided. Not applicable.

Summary based on the document:

The provided 510(k) summary focuses on demonstrating substantial equivalence. The "acceptance criteria" can be inferred as meeting the criteria for substantial equivalence to legally marketed predicate devices, specifically the Sorring Metobiance (SEMM-Set) and the Birtcher Endoscopic Corkscrew, based on:

• Indications for Use: Removal of non-malignant fibroid tumors or other tissue during laparoscopic surgery.
• Materials: Stainless steel (with a statement about assured biocompatibility due to widespread use in medical field).
• Physical Construction: Similar design and manufacturing processes.
• Manufacturing, Packaging, and Sterilization: Similar to already marketed devices by Cook OB/GYN.

The "study that proves the device meets the acceptance criteria" is implicitly the 510(k) submission itself, where Cook OB/GYN asserts and provides documentation to support the claim of substantial equivalence based on the above points, rather than presenting a performance study with quantitative metrics against defined acceptance criteria.

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