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Surgimatix ProxiFast Absorbable Staples are intended for use in abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subcuticular closure of skin with an approximate thickness of 1 to 5 mm where an absorbable tissue fastener is desired for temporary tissue approximation.

The device is not indicated for use in shallow or very small incisions, and is not indicated for final closure of the terminal 2 cm of incisions.

The ProxiFast Absorbable Staple is an absorbable staple for subcuticular skin closure. The staple is made of polydioxanone, and consists of a main body that is 19.35 mm in length, with an obround loop at either end, each of which measure 2.74 by 4.72 mm. The staple is formed into an s-shape the size of 10.3 mm x 17.3 mm prior to deployment, and forms a helical configuration when placed into the subcuticular skin. The Proxifast Absorbable staples are used in conjunction with a manual surgical stapler from Surgimatix, Inc. (Note: The Surgimatix manual surgical stapler is a Class I exempt device pursuant to 21 CFR 878.4800 and is not the subject of this submission).

The provided text describes a 510(k) summary for the ProxiFast™ Absorbable Staple, which sought to establish substantial equivalence to a predicate device. The information details the device's characteristics, indications for use, and performance data, but it does not include specific acceptance criteria for a device, nor does it detail a study designed to prove the device meets such criteria in the format requested.

The document primarily focuses on demonstrating substantial equivalence based on:

• Indications for Use: Comparing the intended use to the predicate device.
• Technological Characteristics: Highlighting similarities in material (both absorbable polymers with similar strength and absorption profiles), sterilization methods, and general physical attributes.
• Performance Data: General statements about mechanical, biocompatibility, and preclinical data.

There is no mention of a standalone algorithm or AI, multi-reader multi-case studies, ground truth establishment for a test set, or training set details as pertinent to AI/ML device evaluations. This document is for a physical medical device (an absorbable staple), not a diagnostic or AI-driven software device.

Therefore, for the specific questions regarding acceptance criteria and performance study details usually associated with diagnostic or AI/ML devices, the information is not present in this 510(k) summary.

However, extracting the information that is available about the "study" for this physical device, we can answer some aspects:

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

The submission does not explicitly state quantitative "acceptance criteria" for performance that can be presented in a table alongside reported device performance. Instead, it makes comparative statements relative to the predicate device regarding key performance aspects.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "preclinical data, including a chronic animal study" and "functional and deployment testing in tissue," and "mechanical testing following deployment in tissue."

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The "chronic animal study" implies prospective data from an animal model. "Testing in tissue" could refer to ex-vivo or in-vivo human/animal tissue, but details are not provided.

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)

This concept is not applicable to the performance data described for this physical device. The "ground truth" for a mechanical device is typically established through direct physical measurement and observation of its function, rather than expert interpretation of data.

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

Not applicable. This concept relates to human expert review of images or data, which is not described here.

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. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

For mechanical performance aspects, "ground truth" would be objective measurements (e.g., tensile strength, deployment characteristics) and observations in animal models for in-vivo performance (e.g., tissue approximation, absorption profile, chronic tissue response). Biocompatibility is based on standardized testing.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. There is no training set for this physical device.

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