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The SuturePatch Tissue Reinforcement is intended for the management and protection of soft tissue injuries. The SuturePatch Tissue Reinforcement is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement 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. The SuturePatch Tissue Reinforcement device reinforces and protects healing soft tissues.

The SuturePatch Tissue Reinforcement device is not intended to replace normal body structure or provide the full mechanical strength to support 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 bone, provide mechanical strength for the repair.

The Arthrex SuturePatch Tissue Reinforcement device is a non-absorbable, permanent, implantable orthopedic surgical mesh intended for the reinforcement of soft tissue/tendon repair. It is manufactured from embroidered polyester yarns with integral reinforcements across its width and around its perimeter to provide improved stability and high suture retention strength. The SuturePatch is available in rectangular and trapezoidal patterns and configurable sizes. Sutures passed through soft tissue can also be passed throughout the SuturePatch with needles or suture passer.

This document is a 510(k) clearance letter for a medical device called "SuturePatch Tissue Reinforcement." It does NOT describe an AI/ML device or its acceptance criteria and a study proving it meets them. The text provided is wholly unrelated to AI/ML.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document is for a physical surgical mesh and details its regulatory clearance, not the performance of an AI/ML algorithm.

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The Surgcraft Surgical Mesh is intended for the reinforcement of the soft tissues which are repaired by suture or suture anchors during rotator cuff repair surgery. The mesh is not intended to replace normal body structure or provide full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchor systems used to attach the tissue to the bone, provide mechanical strength for tendon repair.

The Surgicraft Surgical Mesh System consists of a series of specialized shapes of surgical mesh made from commercially available polyester suture fibers. All sizes incorporate regions of reinforced holes to assist secure anchoring of the mesh to tissue. The devices are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The provided text is a 510(k) summary for the Surgicraft Surgical Mesh System. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria, performance metrics, or study details in the way requested by the prompt.

Instead, it lists types of tests performed (biocompatibility and mechanical testing) without providing the results or the acceptance criteria for those tests. It explicitly states "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act applicable to this device" and "Clinical Testing Not applicable to this device."

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided document.

Here's what can be extracted based on the document:

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

• Cannot be provided. The document lists types of tests performed (Biocompatibility, Dynamic Tensile Fatigue, Static Tensile, Burst Strength, Suture Attachment Strength, Screw Pullout Strength, Tear Resistance, Screw Resistance) but does not provide specific acceptance criteria or reported performance values for these tests. It concludes "substantially equivalent" rather than reporting specific performance against criteria.

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

• Cannot be provided. The document does not specify sample sizes for any of the non-clinical tests. Data provenance (country of origin, retrospective/prospective) is also not mentioned.

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 device is a surgical mesh, not an AI/diagnostic device that would require ground truth established by experts for a test set. Clinical testing was deemed "not applicable."

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

• Not applicable. See point 3.

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-assisted diagnostic device. Clinical testing was deemed "not applicable" and no human reader studies were conducted.

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

• Not applicable. This is not an algorithm or AI device.

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

• Not applicable. For the non-clinical tests, the "ground truth" would be the measured physical properties or biological responses compared against established standards or predicate device properties, but specific details are not provided.

8. The sample size for the training set

• Not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

• Not applicable. See point 8.

Summary of available information regarding compliance/testing:

• Study Type: Non-clinical testing only (Biocompatibility and Mechanical Testing). Clinical testing was explicitly stated as "Not applicable to this device."
• Biocompatibility Testing: Conducted according to ISO 10993 and Directive 93/42/EC, EN ISO 1099-1 FDA. Specific tests included:
  • Sensitization extract (0.9% sodium chloride)
  • Sensitization extract (sesame oil)
  • Genotoxicity (dimethyl sulfoxide extract)
  • Genotoxicity (0.9% sodium chloride extract)
  • Muscle Implantation study - 4 weeks
  • Cytotoxicity (according to EN ISO 10993-5, -12, EN ISO 9363-1, LM SOP 4-06-01)
  • Chemical Analysis (characterization of organic leachables, according to EN ISO 10993-1, -12, -18, LM P 8-01, LM SOP 9-01-01)
• Mechanical Testing: Included:
  • Dynamic Tensile Fatigue
  • Static Tensile
  • Burst Strength
  • Suture Attachment Strength
  • Screw Pullout Strength
  • Tear Resistance
  • Screw Resistance
• Conclusion: Based on engineering drawings, labeling, laboratory and mechanical testing, the device was found to be "substantially equivalent" to its predicate devices in terms of design, materials, indications for use, and other characteristics.

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