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ProPatch® is indicated for implantation to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and reconstructive procedures.

ProPatch® is indicated for the reinforcement, where weakness exists, of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including, but not limited to: reinforcement of rotator cuff, patellar, Achilles, biceps, quadricens, or other tendons.

ProPatch Soft Tissue Repair Matrix (ProPatch) is a surgical mesh manufactured from bovine pericardium. Decellularized tissues undergo chemical microbial reduction and viral inactivation processes, are inspected for freedom from defects, packaged, and terminally sterilized via gamma radiation.

ProPatch is comprised of a single tissue layer, nominally 0.6 mm thick, and is provided as a sterile and non-pyrogenic product that is fully hydrated and ready for use without the need for rinsing or rehydration prior to implantation.

The provided document K110581 is a 510(k) summary for the ProPatch® Soft Tissue Repair Matrix. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria and performance metrics for a new, innovative device. Therefore, the information requested might not be fully present in the context of this specific document.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of acceptance criteria and the reported device performance

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

The document does not specify the sample sizes used for the testing, nor does it provide information about the data provenance (e.g., country of origin, retrospective or prospective nature of the data). The testing described is in-vitro biomechanical testing and decellularization efficiency assessment, not clinical study data involving patients.

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)

This is not applicable as the document describes a 510(k) submission for a surgical mesh, which relies on demonstrating substantial equivalence through laboratory testing rather than expert-derived ground truth for diagnostic accuracy.

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

This is not applicable as the document describes a 510(k) submission for a surgical mesh, focusing on physical and biological properties. There is no mention of adjudication methods, which are typically relevant for diagnostic studies involving human assessment.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic devices, which is not the nature of the ProPatch® Soft Tissue Repair Matrix.

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

A standalone performance assessment was not done. This concept is applicable to AI algorithms, not a physical medical device like a surgical mesh. The "performance" here refers to the device's biomechanical and de-cellularization properties as compared to a predicate, not an algorithm's output.

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

The "ground truth" in this context is the established properties of the predicate device. The studies aimed to demonstrate that the new device's properties (tensile, tear, bursting, suture retention, and decellularization) are substantially equivalent to those of the predicate device. This is based on objective, quantifiable laboratory measurements.

8. The sample size for the training set

This is not applicable. The ProPatch® Soft Tissue Repair Matrix is a physical surgical mesh, not an artificial intelligence or machine learning model that requires a training set.

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

This is not applicable for the same reason as point 8.

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ProPatch® is indicated for implantation to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement, and reconstructive procedures.

ProPatch is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including, but not limited to: reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

Non-Joint Related Repair

ProPatch is indicated for implantation to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and reconstructive procedures.

Joint Related Repair

ProPatch is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including, but not limited to: reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

ProPatch Soft Tissue Repair Matrix (ProPatch) is a surgical mesh manufactured from decellularized bovine pericardium. Decellularized tissues undergo chemical microbial and viral inactivation processes, are inspected for freedom from defects, packaged, and terminally sterilized via gamma radiation.

ProPatch is comprised of a single layer, nominally 0.6 mm thick, and is provided as a sterile and non-pyrogenic product that is fully hydrated and ready for use without the need for rinsing or rehydration prior to implantation.

The provided document describes a 510(k) submission for the "ProPatch® Soft Tissue Repair Matrix" and specifically states that no new studies were performed to prove the device meets acceptance criteria. Instead, this submission is for minor changes to the Instructions for Use and a manufacturing change, and the device's equivalence to a previously cleared predicate device (K061892) is asserted based on identical indicated uses and technological characteristics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a new study is not applicable to this particular 510(k) submission.

Here's an explanation based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. The document does not describe new performance or acceptance criteria for this 510(k) submission. It relies on the prior clearance of the 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. No new test set or data are 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. No new ground truth establishment is described.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No new test set adjudication 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: Not applicable. This device is a surgical mesh, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical mesh; it is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this submission. The original predicate device's clearance would have relied on appropriate testing for surgical mesh, likely including mechanical properties, biocompatibility, and potentially animal or clinical data, which would have established its "ground truth" for safety and effectiveness.
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
• 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device requiring a training set.

Summary based on the document:

This 510(k) submission (K101587) for the ProPatch® Soft Tissue Repair Matrix is a "Special 510(k)" or similar submission for minor changes (Instructions for Use and minor manufacturing change) to an already cleared device. The manufacturer asserts equivalence to the predicate device K061892 based on "identical indicated uses and technological characteristics." Therefore, this document does not contain information about new studies proving the device meets acceptance criteria, as its substantial equivalence is based on the previously cleared device.

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ProPatch™ Soft Tissue Repair Matrix is indication to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floration of the reinforcement, and reconstructive procedures.

ProPatch™ Soft Tissue Repair Matiz is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendone repair surgery including reinforcement of solt used as them soft includes, biceps, quadriceps, or other tendons.

ProPatch™ Soft Tissue Repair Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendor to 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. ProPatch™ Soft Tissue Repair Matrix reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.

ProPatch™ Soft Tissue Repair Matrix is an acelluar bovine pericardia based surgical mesh. Product configurations consist of a 7 cm round and a 5 x 8 cm oval shapes, and configurations from 1 x 1 cm to 9 x 19 cm. Each surgical mesh is packaged ready to use within a clear peel-away inter pouch, and a foil laminte peelaway outer pouch. The packaged product is supplied sterile and non-pyrogenic.

The provided text describes a 510(k) premarket notification for the ProPatch™ Soft Tissue Repair Matrix. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial with acceptance criteria for device performance in the way an AI/ML device would. Therefore, much of the requested information (like expert qualifications, adjudication methods, MRMC studies, sample sizes for training/test sets, and ground truth establishment for AI/ML models) is not applicable to this submission.

However, I can extract information related to the device's physical performance and biocompatibility testing which serves a similar role to "acceptance criteria" for a medical device that reinforces soft tissues.

Here's a summary of the available information:

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

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated as this is a device for physical reinforcement, not an AI/ML diagnostic. The testing involved mechanical and biocompatibility assessments, which would have their own sample sizes (e.g., number of samples for tensile testing, number of animals for biocompatibility). These are not detailed in the summary.
• Data Provenance: Not applicable in the context of country of origin for patient data. The provenance relates to laboratory testing of the material.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. Ground truth, in the AI/ML sense, is not relevant here. The "ground truth" for this device is established by physical measurement standards and established biocompatibility testing protocols, not by expert interpretation of patient data.

4. Adjudication method for the test set:

• Not Applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of data, which is not the nature of this submission. The tests performed are objective physical and chemical tests.

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 physical medical device (surgical mesh), not an AI/ML diagnostic or assistance tool; therefore, MRMC studies are irrelevant.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• For Mechanical/Biomechanical performance: The "ground truth" is based on established engineering principles and standards for material strength, stiffness, tear resistance, suture retention, and burst strength. The compliance is assessed against the "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (revision: 03/02/1999)."
• For Biocompatibility: The "ground truth" is based on established biological safety principles and testing protocols (e.g., ISO 10993 series), specifically stating "Intramuscular implants of the device were found to be non-irritating relative to the product control article."

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device; therefore, there is no "training set."

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

• Not Applicable. This is not an AI/ML device.

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