(112 days)
Biomerix ASSURE™ is intended for repair and/or reinforcement of soft tissues where weakness exists in plastic and reconstructive surgery. The resorbable protective film minimizes tissue attachment to the device.
Biomerix ASSURE is a sterile, composite mesh comprised of three layers: 1) a thin sheet of the Biomerix Biomaterial™, 2) a layer of knitted polypropylene monofilament fibers and 3) a resorbable lactide-caprolactone film.
The resorbable film separates the permanent mesh from underlying tissues and organ surfaces, and it is designed to minimize the risk of tissue attachment to the device during the wound healing period.
ASSURE is provided sterile for single use and is available as individually packaged thin sheets in various shapes and sizes.
The medical device in question is the Biomerix ASSURE™ Polymeric Surgical Mesh. The provided text describes the 510(k) summary for this device, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study.
Here's an analysis of the provided information concerning acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific quantitative acceptance criteria (e.g., minimum tensile strength, specific rates of tissue attachment) are not explicitly stated in a numerical or categorical format with corresponding reported device performance values. Instead, the performance data section generally mentions:
Table: Performance Data Summary
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material properties suitable for intended use | "Material testing was performed to demonstrate that the material properties are suitable for the intended use." |
| Device meets performance specifications | "Bench testing was performed to demonstrate that the devices as manufactured meet the performance specifications. Test results demonstrate that the device meets the specifications and is acceptable for clinical use." |
| Biocompatibility in accordance with ISO 10993-1 | "Biocompatibility testing in accordance to ISO 10993-1 recommended standards was conducted, and results demonstrated that the device is biocompatible according to these standards." |
| Minimization of tissue attachment to the device | "Animal testing demonstrates that the Biomerix ASSURE performs equivalently to a predicate device in terms of minimization of tissue attachment to the device..." |
| Histological response | "...and histological response." |
| Equivalent performance to predicate device | "Animal testing demonstrates that the Biomerix ASSURE performs equivalently to a predicate device..." |
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: Not specified for any of the tests (material, bench, biocompatibility, or animal).
- Data Provenance: Not specified for any of the tests. The text does not indicate country of origin or whether the data was retrospective or prospective.
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)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified. This typically applies to clinical studies involving human interpretation or assessment, which is not described here.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a surgical mesh, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no mention of human reader improvement with or without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The device is a physical surgical mesh, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For material and bench testing, the ground truth would be the defined engineering specifications and regulatory standards (e.g., tensile strength, pore size, integrity).
- For biocompatibility testing, the ground truth is defined by the ISO 10993-1 standards and the biological responses observed in the tests.
- For animal testing, the "ground truth" for equivalence regarding tissue attachment and histological response would be the direct observation and histological examination of the tissue in the animal models, compared against the predicate device's known performance in similar animal models or historical data. This usually involves microscopic analysis by veterinary pathologists.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of medical device.
Study Proving Acceptance Criteria:
The studies mentioned that "prove" the device meets the implied acceptance criteria are:
- Material testing: Demonstrated suitable material properties.
- Bench testing: Demonstrated the device meets performance specifications as manufactured.
- Biocompatibility testing: Conducted according to ISO 10993-1, demonstrating biocompatibility.
- Animal testing: Demonstrated equivalent performance to a predicate device in terms of minimizing tissue attachment and histological response.
The provided text clearly states, for each of these tests, that the results demonstrated the device met the specifications or was equivalent to the predicate, leading to the conclusion of substantial equivalence for 510(k) clearance. However, the specific, quantitative criteria and the detailed methodology of these studies are not elaborated in this summary.
§ 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.