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CuffPatch™ surgical mesh is intended for the reinforcement of soft tissues repaired by sutures or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons.

CuffPatch™ surgical mesh is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. CuffPatch™ surgical mesh reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.

CuffPatch™ consists of laminated sheets of porcine intestinal collagen matrix is primarily Type I porcine collagen, and is free of cells and cell remnants. The product is supplied sterile in doublelayered peelable packaging.

The provided text describes a 510(k) summary for a medical device called CuffPatch™ Surgical Mesh. It does not contain information about acceptance criteria for a study or a study that proves the device meets such criteria in the way typically expected for an AI/ML device.

Instead, the document details the device's intended use, classification, description, and claims of substantial equivalence to legally marketed predicate devices. The "Performance Data" section briefly states that "Evaluation of the device's materials, physical and performance characteristics revealed that CuffPatch™ is substantially equivalent to the predicate devices, and is suitable for its intended clinical applications." This indicates an assessment was made, but the specific acceptance criteria and the detailed study results are not provided.

Therefore, most of the requested information cannot be extracted from this document, as it outlines a regulatory submission based on substantial equivalence, not a detailed performance study with explicit acceptance criteria.

However, I can extract what is implied about the performance assessment rather than explicit acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

• FortaFlex™ Surgical Mesh (CuffPatch™), K020049 and K011025
• Restore® Orthobiologic Soft Tissue Implant, K031969 |
  | - Materials | Evaluation of the device's materials revealed substantial equivalence. CuffPatch™ consists of laminated sheets of porcine intestinal collagen matrix (primarily Type I porcine collagen, free of cells and cell remnants). This is similar to predicate devices which are also surgical meshes. |
  | - Design | Evaluation of the device's design revealed substantial equivalence. |
  | - Physical characteristics | Evaluation of the device's physical characteristics revealed substantial equivalence. |
  | - Performance characteristics | Evaluation of the device's performance characteristics revealed substantial equivalence. The device's intended use is for reinforcement of soft tissues during tendon repair and provides a resorbable scaffold. This is similar to predicate devices. The document explicitly states it "is suitable for its intended clinical applications." |
  | - Biological attributes | Evaluation of the device's biological attributes revealed substantial equivalence. The device is a resorbable scaffold replaced by the patient's own soft tissue. |
  | Secondary (Suitability for Intended Use): Function as intended. | The device's "Evaluation... revealed that CuffPatch™ is substantially equivalent to the predicate devices, and is suitable for its intended clinical applications."
  Intended Use: Reinforcement of soft tissues repaired by sutures or suture anchors, during various tendon repair surgeries. It reinforces soft tissue and provides a resorbable scaffold. It is not intended to replace normal body structure or provide full mechanical strength; sutures provide biomechanical strength. |

Given the nature of the document as a 510(k) summary for a conventional medical device (surgical mesh), it does not address AI/ML-specific testing methodologies. Therefore, the following points cannot be answered:

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

• Not applicable/Not provided. The document describes a "Performance Data" section but does not detail a study involving test sets in the context of data-driven performance.

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/Not provided. No ground truth establishment by experts for a test set is mentioned.

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

• Not applicable/Not provided.

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/Not provided. This is a conventional medical device, not an AI/ML diagnostic tool.

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

• Not applicable/Not provided. This is a conventional medical device.

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

• Not applicable/Not provided. The performance assessment was based on comparing material, physical, performance, and biological characteristics to existing predicate devices, rather than a clinical ground truth in the context of an AI/ML model.

8. The sample size for the training set

• Not applicable/Not provided. No training set is relevant for this conventional device.

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

• Not applicable/Not provided. No training set is relevant for this conventional device.

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