(115 days)
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:
| Acceptance Criteria (Demonstrated Equivalence to Predicate) | Reported Device Performance (SurgiMend MP) |
|---|---|
| Design: Same as predicate. | Same design as predicate, with an additional "perforated configuration" (holes 2-3 mm diameter in a staggered array) allowing for better fluid flow. The core design (acellular bovine dermis) remains unchanged. |
| Material: Same as predicate. | Same materials (acellular dermal tissue derived from bovine dermis) as predicate. |
| Manufacturing Process: Same as predicate. | Same manufacturing process as predicate. |
| Packaging & Sterilization: Same as predicate. | Same packaging and sterilization parameters as predicate. |
| Biocompatibility: Safe for use. | Biocompatibility testing conducted on the predicate device (K083898) confirms the biological safety of SurgiMend MP. (Implies SurgiMend MP is expected to have the same biocompatibility profile due to identical materials and processing). |
| Mechanical Properties: Equivalent to predicate; compliant with FDA Guidance for Surgical Mesh. | Mechanical testing (tensile strength, suture pull-out, tear resistance, and ball burst) were conducted. All test results were acceptable and complied with FDA Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh, March 2, 1999. (Implies performance similar to or within acceptable ranges of the predicate). |
| In Vivo Performance (Reinforcement, Revascularization, Tissue Integration): Basic properties unchanged from predicate after implantation. | Implantation studies were conducted in three different animal models (12-week rat hernia repair, 4-week rat intra-abdominal, 2-week rat intra-muscle implant). |
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.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.