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510(k) Data Aggregation
(29 days)
SurgiMend PRS Meshed, Revize-X
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.
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Burst Strength | Not explicitly stated (implied "acceptable") | "All test results were acceptable." |
| Suture Pull-Out | Not explicitly stated (implied "acceptable") | "All test results were acceptable." |
| Conformability | Not explicitly stated (implied "acceptable") | "All test results were acceptable." |
| Differential Scanning Calorimetry (DSC) | Not explicitly stated (implied "acceptable") | "All test results were acceptable." |
| Bioreactivity (Animal Model) | Bioreactivity score of "Non-irritant" | Both meshed (test) and solid (control) configurations exhibited a bioreactivity score of "Non-irritant" in a modified ISO 10993-6 scoring system. No significant differences between predicate and modified device. |
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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