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Relimesh prostheses are intended for use in the reconstruction of soft tissue deficiencies, such as but not limited to the repair of hernias and chest wall defects

Relimesh prostheses are dual component meshes made of non-absorbable monofilament polypropylene mesh on one side and a layer of ePTFE on the other side.
Relimesh is warp knitted in such a way that the mesh may be cut into preshaped designs without unraveling and will maintain excellent isotropic properties because of its knitted construction. The ePTFE layer is heat sealed to the polypropylene layer
These meshes have the necessary strength, flexibility, and durability for the various stresses which may be encountered in the body.
The devices are supplied as sterile, single-use surgical meshes.

This document describes the premarket notification (510(k)) for the Herniamesh Relimesh, a surgical mesh intended for the reconstruction of soft tissue deficiencies. The device's acceptance criteria and the study proving it meets these criteria are established through a comparison to legally marketed predicate devices, Composite Mesh (C.R. Bard Inc.) and Hermesh 7 (Herniamesh Srl).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Relimesh device are based on demonstrating substantial equivalence to predicate devices through functional and material characteristic comparisons. The specific acceptance criteria are that the Relimesh device's performance characteristics (suture retention, burst strength, tensile strength) are comparable to or better than the predicate devices, and that its material properties and intended use are similar. The reported device performance is shown in the table below:

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PROCEED Mesh may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

PROCEED* Surgical Mesh is a sterile mesh designed for the repair of hernias and other fascial deficiencies. The mesh product has separate layers comprising of PROLENE* Soft Mesh, a nonabsorbable polypropylene mesh, a fabric of oxidized regenerated cellulose (ORC) and a polydioxanone polymer film.

Acceptance Criteria and Device Performance Study for PROCEED* Trilaminate Surgical Mesh

The provided document describes the predicate equivalence of the PROCEED* Trilaminate Surgical Mesh. The nature of this submission (a 510(k) for a medical device) means that the "acceptance criteria" are primarily related to demonstrating substantial equivalence to a legally marketed predicate device rather than meeting specific performance metrics with predefined thresholds like a diagnostic AI model.

The study presented focuses entirely on non-clinical laboratory and in-vivo animal testing to demonstrate comparability and intended performance. It does not involve human readers, AI algorithms, or clinical trials with human subjects.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document specifies non-clinical laboratory testing and in-vivo testing.

• Sample size for test set: Not explicitly stated. The nature of the non-clinical lab and in-vivo testing (which implies animal studies in this context) would typically involve specific numbers of samples or animals, but these are not provided in this summary.
• Data provenance: Not explicitly stated, but based on the context of a 510(k) submission, this data would primarily be generated by the manufacturer (Ethicon, Inc.) through their own testing facilities or contracted labs. The "in-vivo testing" suggests animal studies were conducted. It is retrospective in the sense that the testing was completed before the submission.

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

This question is not applicable. The study does not involve expert readers establishing ground truth for image interpretation or similar diagnostic tasks. The "ground truth" for a surgical mesh device would be derived from physical property measurements and biological responses in animal models, not expert interpretations of data.

4. Adjudication method for the test set

This question is not applicable. There is no adjudication method described as the study does not involve human interpretation or consensus for a test set.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is for a surgical mesh and does not involve AI assistance, human readers, or diagnostic performance evaluation.

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

No, a standalone (algorithm only) performance study was not done. This study is for a surgical mesh and does not involve any algorithms or AI.

7. The type of ground truth used

The ground truth used for this type of device would be:

• Benchtop Data: Physical and mechanical properties of the mesh (e.g., tensile strength, pore size, burst strength, pliability) compared to predicate devices and engineering specifications.
• In-vivo (Animal) Data: Biological response and performance in animal models (e.g., tissue integration, adhesion formation, inflammatory response, degradation profile, functional outcome related to hernia repair).

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of this 510(k) submission for a non-AI surgical device. All testing described falls under verification and validation activities.

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

This question is not applicable, as there is no training set mentioned or implied by the type of device and study.

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Sepramesh™ Biosurgical Composite is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

Sepramesh™ Biosurgical Composite (Sepramesh™) is a dual-component (absorbable and non-absorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. Sepramesh™ is constructed of a polypropylene mesh that is coated on one side with a bioresorbable coating composed of sodium hyaluronate (HA) and carboxymethylcellulose (CMC).

The uncoated side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, encouraging tissue ingrowth similar to polypropylene mesh alone and providing support for soft tissue repair. The HA/CMC side of the mesh provides a hydrophilic bioresorbable coating separating the mesh from underlying tissue and organ surfaces during the critical wound-healing period to minimize tissue attachment to the mesh. Shortly after placement, the HA/CMC coating becomes a hydrated gel that is slowly resorbed from the site of placement within 5-7 days and excreted from the body within 30 days.

This 510(k) summary describes a medical device called Sepramesh™ Biosurgical Composite and compares it to legally marketed predicate devices to establish substantial equivalence.

Here's an analysis of the provided information, framed by your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating "substantially equivalent" performance to predicate devices across key characteristics. The performance results are reported as meeting or exceeding these criteria for most aspects.

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

• Test Set Sample Size: The document mentions "in vivo in a rabbit hernia repair model" for effectiveness testing and comparisons. However, the specific number of rabbits or individual test samples used in this study is not provided.
• Data Provenance: The in vivo study used a "rabbit hernia repair model." The country of origin for the data is not specified, but the submission is to the US FDA. The study is described as an in vivo comparison, suggesting it was prospective for the purpose of this submission, although the precise nature of the study (e.g., dedicated study for this submission vs. previously conducted data) is not detailed.

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

This type of information is not applicable or not provided in this 510(k) summary. The "ground truth" for material performance and biological response (like adhesion and tissue ingrowth) in in vivo studies is typically established through direct observation, histology, and quantitative measurements by scientific and medical professionals involved in the study. There's no mention of a panel of experts formally adjudicating the in vivo results in the way it might occur for, e.g., diagnostic imaging.

4. Adjudication Method for the Test Set

Not explicitly described. For in vivo studies, data is typically collected, analyzed, and interpreted by researchers and veterinarians. While there are typically standardized protocols and objective measurements, a formal "adjudication method" involving multiple reviewers (like 2+1 or 3+1) for the in vivo results as is common in clinical imaging trials is not mentioned.

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

No MRMC comparative effectiveness study was done, and AI assistance is not relevant to this device. This device is a surgical mesh, a physical implant, not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. As stated above, this is a physical surgical mesh, not an algorithm.

7. The Type of Ground Truth Used

For the in vivo studies, the ground truth was based on:

• Direct observation and measurement of biological responses:
  • Adhesion formation (qualitative and quantitative assessment of extent and tenacity).
  • Tissue ingrowth (histological assessment of cellular response and incorporation into the mesh interstices).
  • Biocompatibility assays (e.g., toxicity, mutagenicity, sensitization studies).
• Mechanical testing results: Burst strength, suture retention.

These are established through recognized scientific and histological methods for material science and in vivo testing in animal models.

8. The Sample Size for the Training Set

Not applicable. This summary describes a physical medical device (surgical mesh), not a machine learning model, so there is no "training set."

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

Not applicable. See point 8.

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