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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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ProgenaMatrix™ is indicated for dry and exuding partial and full thickness wounds such as: pressure (stage I-IV) and venous stasis ulcers caused by mixed vascular etiologies, diabetic ulcers, donor sites and grafts, first and second degree burns, superficial injuries, cuts, abrasions and surgical wounds.

ProgenaMatrix™ is not intended to be used on third degree burns.

ProgenaMatrix™ is a clear keratin matrix derived from human hair designed to assist wound healing by facilitating a moist wound healing environment. It is packaged in a sterile, moisture-proof, peel-open pouch containing water and propylene glycol.

The provided text is a 510(k) summary for the ProgenaMatrix™ device, a wound dressing. This document confirms the device's substantial equivalence to predicate devices based on non-clinical and biocompatibility testing, rather than a clinical study evaluating its performance in relation to acceptance criteria for diagnostic efficacy. Therefore, it does not contain the information required to populate most of the requested fields.

Here's a breakdown of what can and cannot be extracted:

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

The document does not specify quantitative acceptance criteria or device performance measurements in the context of diagnostic accuracy, as it is not a diagnostic device. It lists mechanical properties, biocompatibility tests, and clinical tests (patch and prick tests) that were conducted to demonstrate substantial equivalence to a predicate device.

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. The document describes non-clinical and biocompatibility testing, not a clinical study with a "test set" in the diagnostic sense.

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. Ground truth establishment by experts is not described for this type of device submission.

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

Not applicable. This is not a study requiring adjudication of diagnostic findings.

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 a wound dressing, not an AI-assisted diagnostic device.

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

Not applicable. This is a wound dressing, not an algorithm.

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

Not applicable. The "ground truth" here refers to established scientific methods for evaluating material properties, biocompatibility, and safety, not diagnostic categories.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of device.

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

Not applicable.

Summary of available information (based on the provided text):

The document indicates that the ProgenaMatrix™ device underwent Non-Clinical Testing and Biocompatibility Testing to demonstrate substantial equivalence to its predicate device. This testing focused on material properties and safety.

Non-Clinical Testing evaluated:

• Tensile Strength
• Moisture Vapor Transmission Rate
• Water Transmission Rate
• Degradation Potential
• Manufacturing Residuals
• Viral Inactivation
• Protein Characterization
• Removal of Contaminants

Biocompatibility Testing included:

• Cytotoxicity
• Sensitization
• Irritation
• Acute Toxicity
• Subacute & Subchronic Toxicity (Implantation Endpoint Assessment)
• Endotoxin Testing
• Pyrogenicity
• Toxicological Risk Assessment
• Chronic Toxicity
• Genotoxicity
• Carcinogenicity

Clinical Testing (mentioned in the non-clinical testing section, which is unusual phrasing) involved:

• Repeat Insult Patch Test
• Skin Prick Test

The conclusions state that the device "has the same intended use, principles of operation and substantially equivalent technological characteristics as Keratec Wound Dressing... While ProgenaMatrix™ differs from the predicate device in the source of keratin protein (human vs. sheep), both devices share the same mode of action in that they assist in providing a moist wound healing environment." It concludes the device is "substantially equivalent with respect to safety and effectiveness to the predicate and reference devices and does not raise different questions of safety and effectiveness."

However, specific quantitative acceptance criteria or detailed results for these tests are not provided in the summary. The document focuses on the types of tests performed to establish equivalence for regulatory clearance, not detailed performance metrics against specific acceptance thresholds in the way a diagnostic study would.

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