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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.

AI/ML Overview

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.

Feature / Acceptance Criteria	Sepramesh™ Biosurgical Composite Performance	Equivalence Claim
Indication	Reconstruction of soft tissue deficiencies, such as for the repair of hernias	Substantially Equivalent to predicate devices (Bard® Mesh, Bard® Composix™ Mesh, Mersilene™ Mesh)
Labeling Claims (Adhesion)	HA/CMC surface minimizes tissue and visceral adhesions to device	Substantially Equivalent (compared to Bard® Composix™ Mesh's ePTFE claim; Bard® Mesh & Mersilene™ had none)
Mesh Design (Knit)	Single bar knit from 6 mil monofilament polypropylene fiber	Substantially Equivalent to Bard® Mesh
Mesh Pore Size	Substantially Equivalent to predicate devices	Substantially Equivalent
Burst Strength	Substantially Equivalent to predicate devices	Substantially Equivalent
Suture Retention	Substantially Equivalent to predicate devices	Substantially Equivalent
Tissue Ingrowth	Complete tissue incorporation of implant	Substantially Equivalent to Bard® Mesh and Bard® Composix™ Mesh
Tissue Attachment (Adhesions) to Mesh	Decreased compared to Bard® Mesh and Composix™	Substantially Equivalent (or better than predicate where applicable)
Sterilization	Gamma	Substantially Equivalent (compared to EtO, Gamma, Steam of predicates)
Sizes	3"x6" to 8"x12"	Substantially Equivalent (compared to ranges of predicates)
Biocompatibility & Safety	Non-toxic, non-mutagenic, non-sensitizing, biocompatible and safe	Meets requirements (based on ISO 10993 and GLP)

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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