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A clip like device intended to connect internal tissues to aid in healing. These clips are intended to be used in accordance with the many of surgeon judgement.

The MSC Ligating Clip is substantially equivalent in function and intended use to the Edward Weck and Company Hemoclip Ligating Clip and the Ethicon Ligaclip. Specifically: the MSC Ligating Clip is exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices mentioned above. The packaging methods and packaging materials are exactly the same, respectively.

This document is a 510(k) premarket notification for the Micro Stamping Corporation (MSC) Ligating Clip. It focuses on establishing substantial equivalence to existing devices rather than presenting detailed performance studies or specific acceptance criteria with numerical performance targets. Therefore, the requested information cannot be fully extracted as it is not present in the provided text.

Here is an attempt to address your request based on the available information, with specific notes on what is not provided:

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

Missing Information: There are no specific numerical acceptance criteria (e.g., tensile strength, closure force, biocompatibility test results with thresholds) or quantitative performance data presented in the document. The substantial equivalence argument is based on qualitative similarity to predicate devices.

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

Not provided. This document does not describe a performance study with a test set. The submission is a 510(k) premarket notification claiming substantial equivalence.

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

Not applicable/Not provided. As no specific performance study with a test set is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication method for the test set

Not applicable/Not provided. No test set or adjudication method is described.

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/Not provided. This device is a ligating clip, not an AI-based diagnostic or assistive device. Therefore, an MRMC study related to human readers and AI is irrelevant and not mentioned.

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

Not applicable/Not provided. This is a medical device (a ligating clip), not an algorithm or software. "Standalone performance" in this context is not relevant. The device's performance would be assessed through bench testing and potentially animal or human clinical data (though none are detailed in this specific document for the substantial equivalence claim).

7. The type of ground truth used

Not applicable/Not provided. Since this is a 510(k) based on substantial equivalence to predicate devices, the "ground truth" is largely established by stating the similarities to devices already legally marketed and presumed safe and effective. There is no mention of pathology, outcomes data, or expert consensus used as ground truth for a novel performance study.

8. The sample size for the training set

Not applicable/Not provided. This is not an AI/machine learning device, so the concept of a "training set" is not relevant.

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

Not applicable/Not provided. As above, no training set for an algorithm is involved.

Summary of what the document does provide regarding "proof" of meeting criteria:

The "study that proves the device meets the acceptance criteria" in this context is the substantive equivalence comparison detailed in the "Summary of Safety and Effectiveness." The proof is in the assertion that the MSC Ligating Clip is "substantially equivalent in function and intended use" to legally marketed predicate devices like the Edward Weck and Company Hemoclip Ligating Clip and the Ethicon Ligaclip. This equivalence is justified by stating:

• "exactly similar in functional design"
• "performs the same functions"
• "has the same intended use"
• "packaging methods and packaging materials are exactly the same"

This type of submission relies on the established safety and effectiveness of the predicate devices as evidence that the new device, being substantially similar, also meets those standards. It does not typically involve new, extensive performance studies with quantitative acceptance criteria detailed within the 510(k) summary itself, unless the differences from the predicate device warrant new data.

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