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SurgiMend® Meshed is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend® Meshed is specifically indicated for plastic and reconstructive surgery.

SurgiMend Meshed is a meshed acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in various sizes and designed to expand at a 2:1 ratio when hydrated with 0.9% saline.

The provided text describes a 510(k) premarket notification for a medical device called SurgiMend® Meshed Collagen Matrix for Soft Tissue Reconstruction. It is a submission for a modified device, not an AI/ML powered device. Therefore, the information required to answer the prompt for acceptance criteria and study proving device meets acceptance criteria, in the context specified (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size, etc.), is not present in the document.

The document discusses substantial equivalence to a predicate device and includes information about performance testing, but not in the format or with the details requested for AI/ML device evaluation.

However, I can extract the available information related to the device's performance and testing:

Device Name: SurgiMend® Meshed Collagen Matrix for Soft Tissue Reconstruction

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

The document mentions that "All test results were acceptable," but does not explicitly list the acceptance criteria or specific numerical performance metrics for each test. It only states the types of tests performed.

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

The document mentions a "pre-clinical, acute/subacute animal model" but does not specify the sample size (number of animals or implants) used for this study. The provenance (country of origin or retrospective/prospective) is not specified.

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 information is not applicable and not provided since the study is a pre-clinical animal model evaluation of a surgical mesh, not an AI/ML device relying on expert-annotated ground truth.

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

Not applicable/provided for this type of device and study.

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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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

For the animal study: "Gross, sub-gross and histological evaluation of explanted materials and surrounding tissues" were used to assess the biological response, revascularization, and resorption/remodeling. This is akin to pathological evaluation.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes.

SurgiMend is specifically indicated for:

• · Plastic and reconstructive surgery
• · Muscle flap reinforcement
• · Hernia repair including abdominal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias.

SurgiMend is an acellular dermal tissue derived from bovine dermis. The device is available in solid, fenestrated, and perforated configurations. The device is supplied sterile in a variety of sizes, shapes, and thicknesses.

The provided text is a 510(k) Premarket Notification for a medical device (SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction), seeking substantial equivalence to a predicate device. It is a regulatory document and does not describe a study involving an AI/Machine Learning device or a diagnostic product that would require acceptance criteria in the sense of performance metrics (like sensitivity, specificity, accuracy) typically associated with AI models or diagnostic tests.

Instead, the "acceptance criteria" and "study" described in this document relate to the physicochemical, mechanical, and biological properties of the medical mesh device itself, and the "study" is a comparison to a predicate device to demonstrate substantial equivalence for regulatory approval.

Therefore, many of the requested items in the prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable (N/A) to this type of device and regulatory submission.

However, I can extract and present the information that is relevant to the document provided, reinterpreting "acceptance criteria" and "study" within the context of a medical device 510(k) submission for a surgical mesh.

Device: SurgiMend® MP Collagen Matrix for Soft Tissue Reconstruction

Type of Device: Surgical Mesh (Class II)

Purpose of Submission (510(k)): To demonstrate substantial equivalence to a legally marketed predicate device (SurgiMend® Collagen Matrix for Soft Tissue Reconstruction, K083898).

Here's an interpretation of the requested information based on the provided document:

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

Primary Endpoint: Mechanical strength to support soft tissue reinforcement.
Secondary Endpoints: Revascularization and tissue integration of perforated test and non-perforated control configurations.

Result: Studies demonstrated "the basic properties of the subject device after implantation remain unchanged from the predicate." |
| Indended Use: Equivalent to predicate. | Same Indications for Use as the predicate: implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes, specifically for plastic and reconstructive surgery, muscle flap reinforcement, and hernia repair (abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias). The minor modification (perforations) does not change intended use. |
| Safety & Effectiveness: No new issues raised. | The modifications do not change the intended use, nor alter the fundamental scientific technology of the device, and do not raise any new issues of safety and effectiveness. |

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

• Test Set Sample Size: No specific numerical sample size for "test sets" in the context of an AI model is provided. This document refers to pre-clinical studies (animal models) and mechanical testing of the device itself.
  • Mechanical Testing: Not specified, but implied to be sufficient for compliance with FDA guidance.
  • Animal Implantation Studies: "three different animal models" were used (rat hernia repair, rat intra-abdominal, rat intra-muscle implant). The number of animals per model is not specified.
• Data Provenance: Not specified, but implied to be from studies conducted by or for TEI Biosciences Inc. (now Integra LifeSciences Corporation), located in the USA. These are pre-clinical (animal) studies, not human retrospective/prospective data.

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

• N/A. This is not an AI/diagnostic device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for this device's performance relates to its physical, mechanical, and biological properties as measured in laboratory and animal studies, not human expert consensus on images.

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

• N/A. Not applicable to this type of device testing.

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:

• N/A. This is a surgical mesh, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

• N/A. This is a physical medical device, not an algorithm.

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

• For mechanical performance: The "ground truth" is established by direct physical measurements according to specified ASTM/ISO standards and compliance with FDA guidance for surgical mesh, likely verified by internal quality control.
• For biocompatibility: The "ground truth" is established by standard biocompatibility testing protocols, referencing the predicate device's confirmed biological safety.
• For in vivo performance: The "ground truth" is established through direct observation and measurement in animal models (e.g., assessing mechanical strength of repair, revascularization, tissue integration post-implantation). This would involve histological analysis and biomechanical testing of harvested tissues.

8. The sample size for the training set:

• N/A. This is not an AI/ML device, so there is no training set in that context. The "training" in this context would be the predicate device's historical performance data.

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

• N/A. As above, no training set for an AI model. The "ground truth" for the predicate device's established safety and effectiveness would have been based on its own prior regulatory approvals, mechanical testing, biocompatibility studies, and potentially human clinical experience that led to its initial market clearance.

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SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: Plastic and reconstructive surgery Muscle flap reinforcement Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias

SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.

This document is a 510(k) Premarket Notification for a medical device called SurgiMend Collagen Matrix for Soft Tissue Reconstruction. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided text.

The document primarily states:

• Device Description: SurgiMend is an acellular dermal tissue matrix derived from bovine dermis for soft tissue reinforcement and repair.
• Intended Use: Plastic and reconstructive surgery, muscle flap reinforcement, and hernia repair.
• Predicate Devices: SurgiMend (K071807) and TissueMend (K020488) from TEI Biosciences.
• Technological Characteristics: Substantially equivalent to other surgical meshes.
• Biocompatibility: A rigorous assessment by an independent laboratory demonstrated biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, intramuscular implantation, hemolysis, and pyrogenicity). Viral inactivation methods were also tested.

Essentially, this submission asserts that the new SurgiMend device is safe and effective because it is fundamentally the same as devices already on the market, which presumably had their safety and effectiveness established through other means (e.g., prior clinical data for older predicate devices, or through general knowledge of the safety of collagen matrix materials). There is no "study that proves the device meets the acceptance criteria" in the format of specific performance metrics against pre-defined thresholds.

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