(255 days)
PELNAC® Meshed Bilayer Wound Matrix is indicated for the management of wounds including:
- · partial and full-thickness wounds,
- · pressure ulcers,
- · venous ulcers,
- · diabetic ulcers,
- · chronic vascular ulcers,
- · surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence),
- · trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears), and
- · draining wounds.
The device may be used in conjunction with negative pressure wound therapy. The device is intended for one-time use.
PELNAC® Meshed Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine derived sponge layer and a silicone film layer. Slits are added to the silicone and collagen layers to aid in the drainage of exudate. When applied to full-thickness skin defects, PELNAC® provides a scaffold for cellular invasion and capillary growth. The device is offered in sheet form of various sizes and is provided terminally sterilized by ethylene oxide, is for single patient use, and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling.
The provided document is a 510(k) Premarket Notification for the PELNAC® Meshed Bilayer Wound Matrix. It demonstrates substantial equivalence to a predicate device, INTEGRA™ Meshed Bilayer Wound Matrix (K081635), and a reference device, PELNAC™ Bilayer Wound Matrix (K191992).
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a "table of acceptance criteria" with "reported device performance" in the format typically seen with quantitative thresholds for diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, it relies on comparative testing to the predicate device and established standards for safety and performance for medical devices.
The acceptance criteria are implicitly met by demonstrating conformance to recognized standards and by showing similar performance characteristics to the predicate and reference devices in non-clinical tests.
However, based on the Non-Clinical Performance Data section, we can infer the following performance characteristics and the fact that they were met:
| Acceptance Criteria (Inferred from testing performed) | Reported Device Performance (Implied "Conforms" or "Met" based on submission for clearance) |
|---|---|
| Animal Tissue Sourcing (FDA Guidance 2019) | Conforms to FDA guidance |
| Viral Inactivation (FDA Guidance 1998) | Conforms to FDA guidance; new viral inactivation studies performed |
| Biocompatibility (ISO 10993-1, FDA Guidance) | Conforms to ISO 10993-1 and FDA guidance (including Implantation, Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Material Mediated Pyrogenicity, Chemical Characterization, Toxicological Risk Assessment) |
| Sterilization (ISO 11135, SAL 10-6) | Conforms to ISO 11135 and achieves SAL 10-6 |
| Packaging (ISO 11607-1, ASTM F1886) | Conforms to ISO 11607-1 and ASTM F1886 |
| Shelf Life (USP Bacterial Endotoxin Test) | 36 months; Conforms to USP |
| Performance Testing: Pore Size | Conforms to product specification |
| Performance Testing: Degree of Cross-Linking | Conforms to product specification |
| Performance Testing: Water Vapor Transmission | Conforms to product specification |
| Performance Testing: Drapeability | Conforms to product specification |
| Performance Testing: Heavy Metal Content | Conforms to product specification |
| Performance Testing: Suture Retention | Conforms to product specification |
| Performance Testing: Tensile Strength | Conforms to product specification |
| NPWT Compatibility (Pressure Stability) | Demonstrated for use with InfoV.A.C. NPWT Therapy System |
| NPWT Compatibility (Fluid Removal) | Demonstrated for use with InfoV.A.C. NPWT Therapy System |
| NPWT Compatibility (Long-Termance) | Demonstrated for use with InfoV.A.C. NPWT Therapy System |
| NPWT Compatibility (Alarm Function) | Demonstrated for use with InfoV.A.C. NPWT Therapy System |
| Risk Analysis (ISO 14971) | Conforms to ISO 14971 |
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 primarily discusses non-clinical performance testing. For these tests, specific sample sizes are not explicitly stated. For example, how many samples of the device were tested for "tensile strength" or "pore size" is not provided. The data provenance is also not specified in terms of country of origin or whether it's retrospective or prospective for these non-clinical tests. However, the tests are laboratory-based, performed according to recognized standards (e.g., ISO, ASTM, USP, FDA guidance).
The document states: "Except for new viral inactivation studies performed on the subject device, all other animal tissue testing was leveraged from the reference device (K191992)." and "All biocompatibility testing of the subject device was leveraged from the reference device (K191992)." and "All sterilization, packaging and shelf life testing of the subject device was leveraged from the reference device (K191992)." This implies that many of the non-clinical tests were not repeated for the subject device but relied on data from the previously cleared reference device.
For the NPWT compatibility testing, it mentions "Side-by-side testing was conducted between the subject device in conjunction with NPWT, the predicate device in conjunction with NPWT, and NPWT without a wound matrix group." This implies a comparative test setup, but the number of test units or replicates used in this "simulated wound model" is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The reported studies are non-clinical performance tests evaluating physical, chemical, and biological properties, as well as compatibility with another medical device (NPWT). These types of studies do not typically involve human expert adjudication to establish ground truth in the way clinical studies for diagnostic devices do. Conformance to specifications and standards is assessed by laboratory testing and technical evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is non-clinical performance and safety testing, there is no "adjudication" of results in the context of clinical expert agreement for a ground truth. Test results are compared against defined specifications and regulatory standards.
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. The device is a "wound matrix," not an AI-powered diagnostic tool, and the studies described are non-clinical. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or software requiring standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance tests, the "ground truth" is defined by:
- Established industry standards (e.g., ISO 10993-1 for biocompatibility, ISO 11135 for sterilization, ASTM F1886 for packaging integrity).
- FDA guidance documents (e.g., regarding animal derived materials, viral safety).
- Product specifications for features like pore size, cross-linking, tensile strength, etc.
- Performance metrics of predicate/reference devices for comparative testing, particularly for NPWT compatibility.
There is no clinical "ground truth" derived from patient outcomes, pathology, or expert consensus required for this type of 510(k) submission focused on non-clinical substantial equivalence.
8. The sample size for the training set
Not applicable. This is a medical device for wound management, not a machine learning model. Therefore, there is no "training set" in the context of artificial intelligence/machine learning.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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