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The SubQ It!™ Bioabsorbable Skin Closure System is intended for use in humans for abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation.

The SubQ It!" Bioabsorbable Skin Closure System comprises bioabsorbable fasteners made of 82/18 L-lactide/Glycolide copolymer, a well-established material for resorbable medical devices. The fasteners have two legs with barbed tips (4.3mm long, 0.88mm diameter and spaced 2.75mm center-to-center). The fasteners are inserted using the SubQ It!" Stapler.

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria in the typical format of a medical device submission. Instead, it describes an administrative change related to the reclassification of surgical staplers and provides a 510(k) summary for the "SubQ It!™ Bioabsorbable Skin Closure System."

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than explicitly detailing acceptance criteria for a new device and a study to prove conformance. Substantial equivalence means that the device is as safe and effective as a legally marketed device (predicate device).

However, I can extract the information provided that is most relevant to the requested categories.

Here's a breakdown based on the provided text, using the closest available information:

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

The document doesn't provide a table of explicit acceptance criteria with numerical targets. Instead, the "performance" is demonstrated by showing "no significant differences" to the predicate device in a comparative animal study. The "criteria" are implicitly tied to the performance of the predicate device.

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

• Sample Size (Animal Study): Not explicitly stated as a number of animals or incisions, but it refers to "7cm long incisions in a GLP compliant porcine animal model for 90 days." For "other information" (implied additional testing), it mentions "1 cm and 2 cm incisions in a GLP compliant porcine animal model."
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies were conducted in a "GLP compliant porcine animal model," implying an established research setting. The nature is prospective with controlled animal studies.

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

This information is not provided in the document. For animal studies, "ground truth" (e.g., wound healing assessment) would typically be established by veterinary pathologists or clinical researchers, but no details are given.

4. Adjudication method for the test set:

This information is not provided in the document.

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. The device is a surgical stapler, not an AI-based diagnostic or imaging device that would typically involve human readers. Therefore, an MRMC study and AI assistance effect size are irrelevant in this context.

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

This is not applicable. The device is a physical surgical stapler, not an algorithm.

7. The type of ground truth used:

• Animal Model Outcomes: Observation of wound healing, tissue approximation, and potentially histological analysis in the porcine model over 90 days. The "not significant differences" suggest a comparison of these biological outcomes.
• Bench Test Results: Mechanical properties, integrity, etc.

8. The sample size for the training set:

This is not applicable. The device is a physical product, not a machine learning algorithm that requires a training set.

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

This is not applicable for the same reason as point 8.

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