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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 Fiber System is a single use device intended to be used for reinforcement of the rotator cuff, following or during repair by suture or suture anchors, where weakness exists in the soft tissue.

The Fiber Locker System is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the repair.

The FiberLocker System is comprised of two components: (1) the FiberLocker Implant (SpeedPatch PET) and (2) an instrument (FiberLocker Instrument) for fixation of said implant. The implant, a needled textile felt is made out of polyester staple fibers and is non-degradable. The FiberLocker Instrument, a surgical micro-stapling or felting device, is a sterile, single use device designed for the fixation of medical felt patches in soft tissue.

The provided FDA 510(k) summary (K241219) for the FiberLocker System does not contain any information about acceptance criteria or a study design for evaluating software or AI performance.

This document describes a medical device called the "FiberLocker System," which is a surgical mesh primarily intended for rotator cuff reinforcement. The performance data presented focuses on the physical and biological characteristics of the implant and its fixation instrument, primarily through bench testing and animal studies.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for AI/software performance. The provided text does not describe an AI or software component for which such criteria and studies would be relevant.

Here's a breakdown of why this information is not present in the document:

1. Nature of the Device: The FiberLocker System is a physical medical device (surgical mesh and instrument), not a software or AI-driven diagnostic or treatment tool.
2. Type of Performance Data: The "Performance Data" section details mechanical properties (tensile strength, suture pull-out, tear testing, corrosion), biocompatibility, and fixation performance in an ex-vivo animal model. These are standard tests for physical implants and surgical instruments.
3. Animal Studies: The animal study described assesses the biological response and biomechanical equivalence of the FiberLocker Implant compared to a predicate device, which is typical for implantable materials.
4. No Mention of Software/AI: The entire document focuses on the hardware aspects of the device. There is no mention of an algorithm, image analysis, diagnostic capabilities, or any form of artificial intelligence.

If this document were for an AI/software device, I would look for keywords like:

• Accuracy, sensitivity, specificity, AUC
• Ground truth, expert consensus, pathology
• Training set, test set, validation set
• Reader study, MRMC study
• FROC, ROC curves
• Algorithm performance, decision support

Since these terms and concepts are entirely absent, it confirms that the provided text does not relate to an AI-enabled medical device performance study.

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The Integrity Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

The Integrity Implant is a partially resorbable mesh. The Integrity Implant is designed to provide an augmentation layer over an injured tendon. The patch is comprised of a knitted porous mesh of resorbable Hyaff multifilament fibers and non-resorbable poly(ethylene terephthalate) [PET] multifilament fibers. The patch is provided sterile, for single use only, in a variety of sizes in a thermoformed tray with peelable lid and outer polymer packaging. The device is an easy-to-handle, pliable, nonfriable, porous patch in both the dry and hydrated state.

The Integrity Implant will be made available in 2 sizes:

• 20mm X 25mm
• 25mm X 30mm

The mechanism of action of the Integrity Implant is to function as a protective layer by keeping damaged tendon physically separated from surrounding tissues during healing. It is not intended to replace substantial loss of tendon. Over the course of 4-6 months, the device will be mostly resorbed by the body.

The patch will be used in a surgical environment by a board-certified surgeon. It will be implanted using a standard open or arthroscopic access surgical procedure. It will be fixated at one end to the bone via fixation anchor and at the other end to the repaired tendon via suture or fixation anchor.

The provided document is a 510(k) summary for the Integrity™ Implant, a medical device for managing and protecting tendon injuries. It is a premarket notification to the FDA, demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail format typical of AI/ML device submissions. Instead, it focuses on demonstrating substantial equivalence to a predicate device through various performance tests. The performance data is presented as evidence that the subject device performs comparably to the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

• Animal Study (Test Set):

  • Sample Size: Forty-seven (47) skeletally mature sheep were enrolled.
  • Data Provenance: The study used an adult bilateral infraspinatus model in sheep, making it prospective animal data. The country of origin of the animal study is not specified in this document.

• No human clinical studies were conducted for this 510(k) submission, so there is no human test set data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• For the animal study, the document mentions "gross dissections and harvest," "blood work and distant organ pathology," "radiographic endpoints," and "histology results."
• While these imply expert analysis (e.g., veterinary pathologists, radiologists, histotechnologists/pathologists), the document does not explicitly state the number of experts, their qualifications, or how ground truth was established for the animal study. It only reports the findings (e.g., "Blood work and distant organ pathology were normal," "Histology results from the current study demonstrated...").

4. Adjudication Method for the Test Set:

• The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the animal study. It's typical for animal study results to be interpreted by a single or a small team of experts (e.g., a veterinary pathologist), but this detail is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This device is a surgical implant, not an imaging analysis AI device that would typically involve human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• No standalone (algorithm only) performance study was done. This device is a physical implant; there is no AI algorithm being evaluated for standalone performance.

7. The Type of Ground Truth Used:

• For the animal study, the "ground truth" was established through a combination of:
  • Direct Observation: Gross macroscopic appearance during dissection.
  • Imaging: Radiographic changes based on AP and lateral radiographs and Micro-Computed Tomography, 3T MRI scanning.
  • Biomechanical Testing: Tensile testing of the repaired rotator cuff.
  • Histopathology: Histological responses.
  • These are all objective biological and physical measurements from the animal model.

8. The Sample Size for the Training Set:

• This submission is for a physical medical device (implant), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning model development. The performance data is generated through bench and animal testing.

9. How the Ground Truth for the Training Set Was Established:

• As there is no AI/ML algorithm with a training set, this question is not applicable.

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