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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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LTM-Perforated Surgical Mesh is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and/ or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.

LTM-Perforated Surgical Mesh is intended for single patient one-time use only.

LTM-Perforated Surgical Mesh is a surgical mesh that is derived from porcine dermis and then processed and preserved in a patented phosphate buffered aqueous solution containing matrix stabilizers. The device is designed to perform as a surgical mesh for soft tissue repair. The device consists of a terminally sterilized sheet of processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses. The device is packaged in a double pouch configuration, and is sterilized via electron beam irradiation. The device is considered a single use device which is to be used in a healthcare facility or hospital.

The subject device shares the same underlying scientific design as a porcine derived acellular dermal matrix, and has the same Intended Use, Indications for Use, and principles of operation as the cleared predicate device, LTM-Surgical Mesh (K070560). This 510(k) premarket notification describes a new design feature of the subject device, which introduces a pre-defined pattern of perforations throughout the tissue matrix.

The document is a 510(k) premarket notification for the LTM-Perforated Surgical Mesh. It focuses on demonstrating substantial equivalence to a predicate device, LTM-Surgical Mesh (K070560), rather than providing acceptance criteria and a study proving the device meets those criteria in the traditional sense of a clinical trial for diagnostic AI.

However, based on the provided text, I can extract information related to "acceptance criteria" (in this case, performance specifications for substantial equivalence) and the "study" (bench testing) used to support the claim.

Here's a breakdown of the requested information based on the document:

1. Table of acceptance criteria and the reported device performance

The document doesn't provide specific numerical acceptance criteria or performance values for the LTM-Perforated Surgical Mesh. Instead, it states that the device "maintains similar mechanical properties and meets the established specifications as the predicate device." The "acceptance criteria" are implied by the listed bench tests and the goal to be "substantially equivalent" to the predicate.

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

• Sample Size: The document does not specify the sample size for the bench testing performed. It refers to "relevant elements" of the FDA guidance for test performance.
• Data Provenance: The bench testing was performed on the "subject LTM-Perforated Surgical Mesh device." It implies in-house testing by the manufacturer (LifeCell Corporation). The type of data is physical/mechanical test results.

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

Not applicable. This is a medical device (surgical mesh), not an AI/diagnostic device where expert assessment of "ground truth" (e.g., image interpretation) would be relevant. The "ground truth" for this device's performance is established by objective physical and mechanical tests against defined standards and comparison to a predicate device.

4. Adjudication method for the test set

Not applicable. This is a medical device (surgical mesh), not an AI/diagnostic device requiring expert adjudication.

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 medical device (surgical mesh) and not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device (surgical mesh) and not an AI algorithm.

7. The type of ground truth used

For the bench testing, the "ground truth" is established by:

• Objective physical and mechanical measurements.
• Adherence to recognized industry standards (ASTM D5735-95 for Tear Resistance, ASTM D6797-07 for Burst Strength).
• Comparison to the established performance specifications and characteristics of the legally marketed predicate device (LTM-Surgical Mesh K070560).
• Prior biocompatibility and viral inactivation data from the predicate device, which is deemed applicable due to identical raw materials and manufacturing processes (except for the perforations).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable.

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