(272 days)
Kerecis Silicone is indicated for the management of wounds including:
- Partial and full-thickness wounds
- Pressure ulcers
- Venous ulcers
- Chronic vascular ulcers
- Diabetic ulcers
- Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears)
- Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence)
- Draining Wounds
The subject device is a bilayer of processed resorbable acellular fish dermal matrix adhered to a thin, transparent, porous, soft silicone layer.
The subject device is obtained from fish skin via standardized controlled GMP manufacturing process. The fish dermal matrix layer is approximately 1 mm in thickness and is porous.
The silicone layer is a transparent polyurethane film single-coated with soft, medical grade silicone that is attached to the scaly side of the fish dermal matrix. The silicone layer is porous, soft and conformable to the wound surface.
The subject device is supplied as a sterile intact sheet offered in two configurations: a) with the silicone layer extending beyond the borders of the fish dermal matrix and b) the silicone layer having the same dimension as the fish dermal matrix with no silicone layer extending beyond the fish dermal matrix.
The silicone acts as: protection for the fish dermal matrix layer, as additional wound coverage, and in configuration (a), as an adhesive contact layer to the skin surrounding the wound.
The silicone layer can be peeled off as the fish dermal matrix is resorbed.
The device is intended for single use only.
The provided document is a 510(k) summary for a medical device (Kerecis Silicone) and does not describe a study involving an AI/Machine Learning device or a human-in-the-loop study.
This document describes a medical device, Kerecis Silicone, which is a bilayer wound dressing. The substantial equivalence determination is based on the technological characteristics and performance testing of the device itself (biocompatibility, physical properties, etc.), not on the performance of a software algorithm or AI.
Therefore, most of the requested information regarding AI/ML acceptance criteria, ground truth establishment, sample sizes for AI training/testing, expert adjudication, or MRMC studies for AI assistance is not applicable to this document.
However, I can extract the relevant information regarding the device's acceptance criteria (in terms of performance testing) and the study proving it meets these criteria based on the provided text.
Device: Kerecis Silicone (a bilayer wound dressing)
Regulatory Status: 510(k) clearance (K213231)
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this medical device are based on demonstrating biocompatibility and physical/chemical characteristics that are comparable to or safe for its intended use, typically by meeting the requirements of established ISO and ASTM standards. The reported device performance is indicated by a "Pass" for each test.
| Test | Standard / Method | Acceptance Criteria (Implied: Meeting Standard Requirements) | Reported Device Performance |
|---|---|---|---|
| Cytotoxicity | ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity | Non-cytotoxic | Pass |
| Sensitization | ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization | Non-sensitizing | Pass |
| Intracutaneous Irritation | ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization | Non-irritating | Pass |
| Acute Systemic Toxicity | ISO 10993-11:2017, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity | Non-systemically toxic | Pass |
| Material Mediated Pyrogenicity | ISO 10993-11:2017, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity | Non-pyrogenic | Pass |
| Subacute Systemic Toxicity and Implantation Effects | ISO 10993-6, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation and ISO 10993-11:2017, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity | Acceptable local and systemic effects | Pass |
| Endotoxin Validation and Analysis | ANSI/AAMI ST72 Bacterial Endotoxins - Test Methods, Routine Monitoring, And Alternatives To Batch Testing | Acceptable endotoxin levels | Pass |
| Hydration | N/A (Internal method implied) | Adequate hydration properties (implied) | Pass |
| Shelf Life and Stability | N/A (Internal method implied) | Stable for 36 months | Pass |
| Tensile strength | ASTM D638-14 Tensile Properties of Plastics | Adequate tensile strength (implied) | Pass |
| Implantation (for fish dermal matrix alone) | ISO 10993-6, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation | Acceptable local effects post-implantation | Pass |
| Genotoxicity (for fish dermal matrix alone) | ISO 10993-3, Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | Non-genotoxic | Pass |
| Genotoxicity – Chromosomal Aberration (for fish dermal matrix alone) | ISO 10993-3, Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | No chromosomal aberrations | Pass |
| Subchronic Toxicity (for fish dermal matrix alone) | ISO 10993-11:2017, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity | Non-systemically toxic (subchronic) | Pass |
| Cellular Ingrowth (for fish dermal matrix alone) | N/A (Internal method implied) | Evidence of cellular ingrowth (implied) | Pass |
| Cell Remains and Collagen Structure (for fish dermal matrix alone) | N/A (Internal method implied) | Intact collagen structure, minimal cell remains (implied) | Pass |
| Hemostatic Properties (for fish dermal matrix alone) | N/A (Internal method implied) | Acceptable hemostatic properties (implied) | Pass |
| Resorption in Sprague-Dawley Rats (for fish dermal matrix alone) | N/A (Internal method implied) | Acceptable resorption profile (implied) | Pass |
| Collagen Induced Arthritis Mouse Modal (for fish dermal matrix alone) | N/A (Internal method implied) | No adverse inflammatory response in model (implied) | Pass |
Study Proving Device Meets Acceptance Criteria
The study proving the device meets the acceptance criteria is detailed under "7. PERFORMANCE TESTING" in the 510(k) summary. These are pre-clinical (biocompatibility, physical, and chemical) tests.
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Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes for each specific biological or physical test. These tests generally use a small number of samples (e.g., typically n=3 or n=5 for physical tests, or a defined number of animals for in-vivo biocompatibility tests) as per the specific ISO/ASTM standards referenced.
- The data provenance is not specified in terms of country of origin, but it is implied to be from laboratory testing supporting the device's manufacturing and regulatory submission. The tests are retrospective to the submission date.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as this document does not describe a study involving image interpretation by experts or a clinical diagnostic AI. The "ground truth" here is established by validated laboratory testing methods governed by the cited ISO/ASTM standards, and the results are interpreted by qualified laboratory personnel.
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Adjudication method for the test set:
- Not applicable. There is no "adjudication" in the sense of expert consensus for laboratory tests. The results are typically quantitative or qualitative (e.g., cytotoxic/non-cytotoxic) based on direct measurement and predefined criteria within the respective standards.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This is not an AI/ML diagnostic device, so an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not a software algorithm.
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The type of ground truth used:
- The ground truth for this device's performance is established through adherence to recognized international standards (ISO, ASTM, ANSI/AAMI) for biological safety and physical properties. This involves direct laboratory measurements and observations under controlled conditions to determine if the device elicits specific biological responses or possesses particular physical characteristics as defined by these standards.
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The sample size for the training set:
- Not applicable. This concept applies to machine learning models, not to the pre-clinical performance testing of a physical medical device. The "training" for such a device involves product development and manufacturing process controls, not data-driven algorithm training.
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How the ground truth for the training set was established:
- Not applicable. As above, this pertains to AI/ML context.
N/A