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The New Device is intended for the same use as the Predicate Devices. All of these devices are intended for use in either minimally invasive or open surgical procedures. The indications statement for the New Device and the Predicate Devices is the same. All of these devices are used for approximating tissue and affixing surgical mesh to tissue.

The Ethicon Endo-Surgery Endoscopic Articulating Multifeed Stapler with Reload Unit is a sterile, single patient-use multi-fire stapler that articulates on a rotating shaft and is intended for use in minimally invasive or open surgical procedures. The device is composed of two primary sections: (1) a reloadable cartridge and (2) a shaft/handle portion. The ETHICON Endoscopic Multifeed Stapler is a sterile, single patient-use multi-fire stapler which provides titanium or stainless steel staples.

The provided text is a 510(k) summary for a medical device (surgical stapler) and explicitly states: "Pre-clinical and Clinical data were deemed unnecessary for support of this premarket notification." Therefore, the document does not contain information regarding acceptance criteria, device performance, or any studies as requested.

• 1. A table of acceptance criteria and the reported device performance: Not available. The submission states that pre-clinical and clinical data were not required. The device is considered substantially equivalent to a predicate device, implying its performance is expected to be similar, but no specific performance metrics or acceptance criteria are provided.
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available. No test set or study data is mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not available. No ground truth establishment is described.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available. No test set or adjudication 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 available. This device is a surgical stapler, not an AI-assisted diagnostic tool, so an MRMC study is not relevant and not discussed.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available. This is a mechanical surgical device, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available. No ground truth is mentioned.
• 8. The sample size for the training set: Not available. No training set is mentioned.
• 9. How the ground truth for the training set was established: Not available. No ground truth for a training set is mentioned.

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