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The Arthrex BioSuture is intended for soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs, including those with allograft tissues, are used for repair.

The proposed Arthrex BioSuture is a braided construct made of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester and coated with collagen coating. The proposed suture is braided flat with round ends and may be available in precut lengths in straight and loop configurations. The Arthrex BioSuture is packaged sterile for single use. The Arthrex BioSuture is a line extension to the Arthrex Bio-Suture consisting of a new size.

The provided document is a 510(k) summary for the Arthrex BioSuture, a surgical suture. It details the device's indications for use, technological characteristics, and conformity to established standards through performance testing. However, the document does not describe a study involving an AI/ML device, human readers, or any of the specific criteria typically associated with such studies (e.g., sample size for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, or training set details).

This document focuses on demonstrating substantial equivalence to predicate devices for a physical medical device (suture) through mechanical testing and comparison of attributes.

Therefore, most of the requested information regarding AI/ML device acceptance criteria and studies cannot be extracted from this document.

Here's an attempt to answer the questions based only on the provided text, highlighting what is present and what is absent:

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

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

• Sample Size: Not specified. The document only states "representative samples" for the Bacterial Endotoxins Test and generally mentions "mechanical testing."
• Data Provenance: Not specified.

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 applicable. This is not an AI/ML study involving human expert ground truth. The "ground truth" here is based on physical material properties and established industry standards for sutures.

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

• Not applicable. This is not an AI/ML study involving human expert ground truth adjudication.

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, an MRMC comparative effectiveness study was not done. This document describes a submission for a surgical suture, not an AI/ML device that assists human readers.

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

• Not applicable. This document is for a physical medical device (suture), not an algorithm.

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

• The "ground truth" or reference for comparison described in this document is based on:
  • Established physical and mechanical properties of surgical sutures: Primarily tensile strength (straight pull, knot pull) as defined by internal acceptance criteria and implicitly compared to predicate devices.
  • Regulatory standards: Specifically pyrogen limits as outlined in ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14.
  • Characteristics of legally marketed predicate devices: For demonstrating substantial equivalence in design, materials, manufacturing, and performance.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device that requires a training set.

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The Arthrex BioSuture is intended for soft tissue approximation and or ligation. These sutures may be incorporated, as componens, into surgeries where constructs, including those with allograft tissues, are used for repair.

The Arthrex Bio-Suture is a dyed or non-dyed braided polyester suture construct coated with type 1 bovine collagen. The suture construct is made of UHMWPE and polyester braided over a UHMWPE core. The suture tape construct is a flat suture construct composed of UHMWPE and polyester yarns braided over a FiberWire suture core and UHMWPE yarns. Arthrex Bio-Suture strands that are dyed black are made of nylon. The suture ends are stiffened with cyanoacrylate. The Arthrex Bio-Suture will be supplied in pre-cut lengths with or without various swaged needles. The Arthrex Bio-Suture constructs meet USP standards for suture, except for diameter.

This looks like a 510(k) submission for a medical device (suture) and not an AI/ML product. The document describes a special 510(k) "to extend the shelf-life of the Arthrex BioSuture." Therefore, many of the requested fields for AI/ML performance evaluation (such as sample size for training/test sets, expert ground truth, MRMC studies, etc.) are not applicable here.

However, I can extract information relevant to the device's acceptance criteria and the study that indicates it meets those criteria for its extended shelf-life.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

• Device Name: Arthrex BioSuture
• Purpose of Submission: Extend the shelf-life of the Arthrex BioSuture.
• Methodology to demonstrate extended shelf-life: Real-time stability testing.
• Parameters evaluated in stability testing: Ultimate Load and Anchor Pullout strength.
• Result: The real-time stability testing data demonstrates that the extended shelf life does not affect the performance of the device for Ultimate Load and Anchor Pullout. This indicates the device continues to meet its pre-defined performance requirements (acceptance criteria) even with the extended shelf-life.
• General Performance Statement: The Arthrex Bio-Suture constructs meet USP standards for suture, except for diameter, implying these standards are the baseline acceptance criteria for the device's physical properties.

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

• Test Set Sample Size: Not explicitly stated for the shelf-life study. The document refers to "real-time stability testing data" for Ultimate Load and Anchor Pullout, which would involve a sample of sutures tested over time.
• Data Provenance: Not specified, but generally, such stability testing would be conducted by the manufacturer (Arthrex, Inc.) in a controlled laboratory environment. Retrospective/Prospective is not applicable in the context of stability testing; it's an ongoing process.

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

• Not applicable. This is not an AI/ML diagnostic or prognostic device that requires expert ground truth for classification. The "ground truth" for suture performance is based on established engineering and material science standards (e.g., tensile strength, pullout force) measured objectively, not by expert interpretation.

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

• Not applicable. This is not an AI/ML diagnostic or prognostic device that requires adjudication of expert opinions.

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, nor does it involve human readers/interpretation.

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 consensus, pathology, outcomes data, etc.)

• The "ground truth" for the performance of the Arthrex BioSuture (including the extended shelf-life) is based on objective physical and mechanical measurements derived from established engineering and material science testing protocols, compared against recognized industry standards (specifically USP standards for sutures). It's not a "ground truth" in the sense of clinical diagnoses or pathology.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device and does not involve a training set.

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

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

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