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The Miromatrix Biological Mesh TW is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

The Miromatrix Biological Mesh TW is an implantable, animal-sourced, acellular surgical mesh that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting mesh is comprised primarily of collagen type I. The Miromatrix Biological Mesh TW provides a scaffold during tissue repair and is designed to be an interface between the tendon and tendon sheath or the surrounding tissues. The Miromatrix Biological Mesh TW is designed for placement under, around or over the injured tendon. The device is terminally sterilized by electron beam irradiation in its packaging and is hydrated, moist and flexible when its packaging is opened. The mesh is available in sizes ranging from 1 cm x 2 cm to 10 cm x 20 cm, and may be trimmed or cut as required before being sutured to the surgical site.

The provided text is a 510(k) premarket notification letter and a 510(k) summary for a medical device called the "Miromatrix Biological Mesh TW." This document is used by the FDA to determine substantial equivalence to a legally marketed predicate device, not to prove that a device meets specific acceptance criteria through a clinical or algorithmic performance study in the way an AI/ML medical device would.

Therefore, many of the requested details, such as:

• Acceptance criteria (in the context of an AI/ML study)
• Study that proves the device meets acceptance criteria (in the context of an AI/ML study)
• Sample sizes for test sets, data provenance
• Number of experts and their qualifications for ground truth
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for training set
• How ground truth for the training set was established

are not applicable to the information provided in this document.

This document describes a surgical mesh product, which is a physical implant, not a software algorithm or an AI/ML medical device. The "performance data" mentioned refers to bench testing (tensile strength, suture pullout strength) and animal studies (tissue attachment, healing response) conducted to demonstrate the physical and biological performance of the mesh, not the performance of an AI algorithm.

The core of this 510(k) submission is to demonstrate substantial equivalence to a predicate device based on:

• Identical Indications for Use.
• Similar Technological Characteristics (design, materials, performance). The key point here is that if there are differences, they must not raise new questions of safety and effectiveness.

Here's a summary of the information that is present in the document, framed in the context of device approval, though not directly corresponding to AI/ML acceptance criteria:

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

• Acceptance Goal (Substantial Equivalence): The Miromatrix Biological Mesh TW must perform comparably to the predicate device (Integra Tendon Wrap™ Tendon Protector) in terms of safety and effectiveness for its intended use, and any differences in technological characteristics must not raise new questions of safety or effectiveness.
• Performance Metrics (from animal/bench testing):
  • Tensile Strength & Suture Pullout Strength: The Miromatrix Biological Mesh TW was shown to have higher tensile and suture pullout strength than the predicate device. The conclusion states these differences "do not have any impact on safety and effectiveness, and therefore, on substantial equivalence."
  • Tissue Attachment (animal study): After 4 and 10 weeks, the average tissue attachment was comparable between the Miromatrix Biological Mesh TW and the predicate device in an Achilles tendon defect model.
  • Healing Response (animal study): The healing response at 4 and 10 weeks was also comparable.
  • Biocompatibility: Established based on the identical material (porcine liver tissue) to a previously cleared reference device (Miromatrix Biological Mesh, K134033). No new biocompatibility testing was required.
  • Shelf Life: Shelf life testing was performed to establish the proposed shelf life.

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

• No specific "test set" in the AI/ML sense. The document mentions "bench and animal data."
  • Animal study: A "4 and 10-week partial Achilles tendon defect model" was used. The specific number of animals is not provided.
  • Bench testing: Performed for tensile and suture pullout strength. The number of samples tested is not provided.
• Data Provenance: Not specified, but generally, studies for FDA submissions are expected to follow good laboratory practices.

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 in this context would refer to the validated physical and biological properties of the mesh and the animal model outcomes, which are measured or observed by scientific/technical personnel, not "experts" establishing a diagnostic "ground truth."

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

• Not applicable. This methodology is for assessing subjective human interpretation, not for objective measurements or animal study outcomes.

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 relates to AI assistance for human interpretation, which is not relevant to a surgical mesh.

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

• Not applicable. This is for AI algorithms.

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

• No "ground truth" in the AI/ML sense. The "truth" is established by direct measurement of physical properties (e.g., tensile strength) and observation of biological responses in animal models (e.g., tissue attachment, healing response) according to established scientific methods.

8. The sample size for the training set

• Not applicable. There is no "training set" for a physical device in this context.

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

• Not applicable. See point 8.

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The Miromatrix Biological Mesh is intended to be implanted to reinforce soft tissue and is also intended for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.

The Miromatrix Biological Mesh is an implantable, animal-sourced, acellular surgical mesh that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting mesh is comprised primarily of collagen type I. The device is intended to function as a surgical mesh for soft tissue repair while providing a scaffold for tissue incorporation. The device is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened. The mesh is available in sizes ranging from 1 cm x 2 cm to 20 cm x 30 cm, and may be trimmed or cut as required before being sutured to the surgical site.

The provided text is a 510(k) summary for the Miromatrix Biological Mesh, which is a surgical mesh. This document describes the device, its intended use, and its substantial equivalence to a predicate device. It primarily focuses on a labeling change rather than a new medical AI device or diagnostic algorithm.

Therefore, the requested information regarding acceptance criteria and performance studies for an AI/diagnostic algorithm cannot be extracted from this document. The document describes a biological mesh and a change to its instructions for use (allowing quilting of multiple meshes). The "performance data" mentioned (Section 7) refers to a risk analysis and verification/validation activities related to the quilting of the mesh, not to the performance of an AI or algorithmic medical device in a clinical setting.

Specifically, there is no mention of:

• A table of acceptance criteria and reported device performance for an AI/diagnostic algorithm.
• Sample sizes for test sets, data provenance, or training sets for an AI.
• Number of experts, their qualifications, or adjudication methods for establishing ground truth for an AI.
• Multi-reader multi-case (MRMC) comparative effectiveness studies for AI.
• Standalone performance studies for an AI algorithm.
• Types of ground truth for an AI (pathology, outcomes data, etc.).

The "acceptance criteria" referred to in the document are about the quilted mesh meeting pre-determined acceptance criteria for the individual cleared mesh (a physical biological product), not for an AI.

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The Miromatrix Biological Mesh RS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.

The Miromatrix Biological Mesh RS is an implantable, animal-sourced, acellular surgical mesh that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting mesh is comprised primarily of collagen type I. The device is intended to function as a surgical mesh for soft tissue repair while providing a scaffold for tissue incorporation. The device is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened. The mesh is available in sizes ranging from 1 cm x 2 cm to 20 cm x 30 cm, and may be trimmed or cut as required before being sutured to the surgical site.

This document is a 510(k) premarket notification for the Miromatrix Biological Mesh RS, declaring its substantial equivalence to a previously cleared predicate device, the Miromatrix Biological Mesh (K134033). As such, it does not describe a study involving acceptance criteria and device performance in the typical sense of a rigorous clinical or standalone performance study for an AI/device algorithm.

Instead, the core of this submission is to demonstrate that the new device (Miromatrix Biological Mesh RS) is substantially equivalent to a legally marketed predicate device (Miromatrix Biological Mesh, K134033). This means that the acceptance criteria are implicitly met by demonstrating sameness or very similar characteristics and performance to the predicate device, which has already been deemed safe and effective.

Here's an breakdown based on the provided text, addressing your questions where applicable, and noting where information is not present due to the nature of a 510(k) substantial equivalence submission for a physical medical device (not an AI algorithm):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly defined as numerical thresholds in this document for a "new" device performance study. Instead, the "acceptance criteria" are effectively that the new device (Miromatrix Biological Mesh RS) is identical in materials and design and has similar indications for use and the same intended use as the predicate device (Miromatrix Biological Mesh, K134033). The "reported device performance" is essentially the equivalence shown in the comparison table.

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

• Sample Size: Not applicable. This is not a study assessing performance on a test set of data. It's a regulatory submission demonstrating equivalence of a physical medical device to an existing one.
• Data Provenance: Not applicable.

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

• Not applicable. This is not an AI/algorithm submission requiring expert-established ground truth.

4. Adjudication Method for the Test Set

• Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. This is not an AI algorithm.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not applicable. This is not an AI algorithm.

7. Type of Ground Truth Used

• Not applicable in the context of an AI algorithm. For this physical device, the "ground truth" for its safety and effectiveness is established by the prior clearance of the predicate device (K134033) and the demonstration that the subject device is essentially the same.

8. Sample Size for the Training Set

• Not applicable. This is not an AI algorithm.

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

• Not applicable. This is not an AI algorithm.

In summary: The provided text is a 510(k) premarket notification for a physical medical device (surgical mesh), not an AI algorithm. The core of such a submission is to argue that a new device is "substantially equivalent" to an already cleared predicate device. Therefore, the questions related to studies, test sets, training sets, ground truth, and expert adjudication, which are typical for AI/algorithm performance evaluations, are not addressed in this type of document. The "acceptance criteria" here are met by the demonstration of material, design, and functional similarity to the predicate device.

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The Miromatrix Biological Mesh is intended to be implanted to reinforce soft tissue.

The Miromatrix Biological Mesh is an implantable, animal-sourced, acellular surgical mesh that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting mesh is comprised primarily of collagen type I. The device is intended to function as a surgical mesh for soft tissue repair while providing a scaffold for tissue incorporation. The Miromatrix Biological Mesh is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened. The mesh is available in sizes ranging from 1 cm x 2 cm to 20 cm x 30 cm, and may be trimmed or cut as required before being sutured to the surgical site.

Acceptance Criteria and Study for Miromatrix Biological Mesh

This document describes the acceptance criteria and the study performed to demonstrate the substantial equivalence of the Miromatrix Biological Mesh.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Miromatrix Biological Mesh were established by comparing its performance to a predicate device (K980431, SurgiSIS Surgical Mesh) based on recommendations in the "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh," dated March 2, 1999." The device met these criteria by demonstrating comparable safety and mechanical properties.

Summary of Substantial Equivalence: Based on the indications for use, technological characteristics, and performance test results, the Miromatrix Biological Mesh was determined to be substantially equivalent to the predicate device.

2. Sample Size and Data Provenance

• Sample Size for Test Set: The document does not explicitly state the exact sample sizes for each test (e.g., number of samples for tensile strength, number of animals in the rat study).
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a new device, the studies are inherently prospective.

3. Number, Qualifications, and Adjudication Methods of Experts

These sections are not applicable as the provided document describes the regulatory submission for a medical device (surgical mesh), not an AI/algorithm-based diagnostic or assistive system that typically involves expert review of images or data. The evaluation relied on standard physical, chemical, and biological testing, not expert interpretation of results in a clinical context.

4. Adjudication Method

Not applicable for the reasons stated above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The Miromatrix Biological Mesh is a physical implantable device, not an AI or algorithm that assists human readers.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The Miromatrix Biological Mesh is a physical implantable device; it does not involve algorithms or standalone performance in the context of AI.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation was based on:

• Biocompatibility Standards: Established guidelines and methods for assessing the biological response to materials, including specific tests for cytotoxicity, systemic toxicity, sensitization, etc.
• Mechanical Property Standards: Industry-recognized physical tests to measure properties like tensile strength, suture retention, burst force, and tear resistance.
• Histological Evaluation from Animal Studies: Direct observation and analysis of tissue response and incorporation within the rat implantation study.

Essentially, the ground truth was established by recognized scientific and engineering principles and experimental results, rather than clinical outcomes or expert consensus on interpretations.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in the computational sense. The "training" in the context of device development would refer to the iterative design and testing phases, but not a formal training set for an algorithm.

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

Not applicable for the same reasons above.

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