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The STR GRAFT is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.

The STR GRAFT is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.

The STR GRAFT is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures used to repair the tear, and sutures or bone anchors, used to attach the tissue to bone, provide mechanical strength for the tendon repair.

The STR GRAFT is a bioresorbable, three-dimensionally (3-D) braided construct made of poly-L-lactic-acid (PLLA) fiber. The STR GRAFT is available in rectangular and square sizes of 23 mm x 12 mm, 23 mm x 23 mm x 40 mm, and 23 mm x 60 mm; all STR GRAFT devices are approximately 1.0 mm thick; with the thickness comprised of three layers of 3-D braided fiber bundles. The STR GRAFT is supplied sterile (EtO) and is single-use only.

The provided text describes a 510(k) submission for a surgical mesh device, the STR GRAFT. It outlines the device's characteristics, intended use, and claims of substantial equivalence to predicate devices, supported by various performance tests. However, it does not describe or include an acceptance criterion table for overall device performance, nor does it detail a study that explicitly proves the device meets such criteria in terms of clinical effectiveness.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is the primary pathway for 510(k) clearances. This pathway often relies on showing that the new device has similar technological characteristics and performance to existing devices, rather than conducting new clinical trials to establish de novo safety and effectiveness with pre-defined acceptance criteria.

Therefore, many of the requested elements for a study proving device performance against acceptance criteria cannot be extracted from this document, as such a study and acceptance criteria are not presented in the context of a clinical performance evaluation.

Here's a breakdown of what can and cannot be derived from the provided text, addressing your specific points:

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

• Cannot be provided. The document does not present an overall acceptance criteria table for the device's clinical performance. It mentions performance data derived from mechanical and biocompatibility testing against standards (ASTM, ISO), and an in-vivo animal model. These are used to support substantial equivalence, not to meet a specific, pre-defined set of clinical acceptance criteria for safety and effectiveness.

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

• Cannot be fully provided for a human clinical "test set." The document mentions "a 12 week ovine model of rotator cuff repair was performed." This is an animal study, not a human clinical test set.
  • Sample size for animal model: Not specified (e.g., how many sheep were used).
  • Provenance: An ovine model (sheep). No country of origin is mentioned for this specific animal study data within the document. It's likely considered pre-clinical or non-clinical data.
  • Retrospective or prospective: Animal studies for device evaluation are typically prospective, but this is not explicitly stated.

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. Since there's no human clinical "test set" or ground truth based on expert consensus described for overall device performance, this information is not available. The animal model likely involved veterinarians or animal researchers, but their number and qualifications are not provided.

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

• Not applicable. No human clinical test set with an 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

• No. This document describes a surgical mesh, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance is relevant or discussed.

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

• Not applicable. This document describes a surgical mesh, not an algorithm.

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

• For the animal model: The "ground truth" would be based on surgical observations, histological examination of tissues, mechanical testing of the repaired tendons, and other animal study endpoints relevant to rotator cuff repair in the ovine model. The document broadly states "results of physical, mechanical, in-vivo, and biocompatibility testing indicate that the STR GRAFT possesses appropriate physical and mechanical characteristics." This implies outcomes data from the animal model.

8. The sample size for the training set

• Not applicable. This pertains to machine learning models. The STR GRAFT is a medical device (surgical mesh), not an AI algorithm.

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

• Not applicable. As above, this pertains to machine learning models.

Summary of available "Performance Data" from the document:

The "Performance Data" section (G) details the types of tests conducted to support substantial equivalence:

• Mechanical Testing: Performed per ASTM Standards F-2150-07, D3787-07, D2261-07a, D882-10, F2392-04, F1877-05, D4032-08, and D6767-11. The document notes these methods were "modified as appropriate regarding the length and width of the STR GRAFT."
• Biocompatibility Testing: Performed per ISO Standards 10993-3, -5, -7, -10, and -11.
• In-vivo Testing: A "12 week ovine model of rotator cuff repair was performed."

The conclusion states that these tests, along with material selection and design features, support the determination of substantial equivalence to predicate devices, implying that the device performs similarly and safely enough to existing devices on the market. It does not establish explicit clinical acceptance criteria or report performance against them in a human study.

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