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Simultaneous cutting and cauterization of soft tissue during surgery.

Starion's Cautery Forceps and Battery Pack Power Supply are single use devices that are intended for the simultaneous cutting and coagulation of soft tissue during surgery, to be used in essentially all major surgical disciplines. Starion's Cautery Forceps are substantially equivalent in terms of intended use, principles of operation, basic technological characteristics and target population of surgical disciplines. The principle of operation is that heat is conducted to the tissue via a small heater located at the tip of a hand-held, surgical instrument to provide cutting/cauterization.

This document is a 510(k) summary for a medical device (Cautery Forceps and Battery Pack Power Supply) and an FDA clearance letter. It does not contain a study that proves the device meets acceptance criteria. Instead, it states that the device is "substantially equivalent" to existing predicate devices based on intended use, principles of operation, basic technological characteristics, and target population.

Therefore, I cannot provide the requested table and study details as they are not present in the provided text. The 510(k) process in this context relies on demonstrating equivalence rather than conducting a new performance study with specific acceptance criteria that are then proven.

To directly answer your request based on the absence of this information in the provided text:

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

• Not provided in the document. The document asserts substantial equivalence to predicate devices, but does not present specific performance metrics or acceptance criteria for the new device.

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

• Not applicable/Not provided. No explicit "test set" or performance study data is described. The clearance is based on comparison to predicate devices, not on a new performance study with a specific data set.

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

• Not applicable/Not provided. No explicit "ground truth" establishment for a performance study is mentioned.

4. Adjudication method for the test set

• Not applicable/Not provided.

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

• No. This document describes a thermal cautery device, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study with AI assistance is not relevant or mentioned.

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

• No. This is a physical medical device, not a software algorithm.

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

• Not applicable/Not provided.

8. The sample size for the training set

• Not applicable/Not provided. This is not an AI/machine learning device.

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

• Not applicable/Not provided.

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