(85 days)
The SS Matrix™ is intended for the management of wounds including: partial and fullthickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.
The SS MatrixTM is primarily composed of porcine collagen that is supplied in sheet form in sizes ranging from 2 x 4 cm to 20 x 40 cm.
The provided text describes a 510(k) submission for a medical device called "SS Matrix™ Topical Wound Dressing." This submission is focused on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and reported performance metrics in the way a clinical trial for a novel device would.
Therefore, many of the requested categories in your prompt are not applicable or cannot be extracted from this document, as a substantial equivalence filing does not typically include a detailed performance study with human readers, ground truth establishment, or specific statistical efficacy metrics.
However, I can extract information related to the tests and conclusions provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Passed requirements of all tests | SS Matrix™ passed the requirements of all tests. |
2. Sample size used for the test set and the data provenance
The document states, "The SS Matrix™ was subjected to a panel of tests to assess biocompatibility." It does not specify the sample size for these tests, nor does it provide information on data provenance (country of origin, retrospective/prospective). This is typical for biocompatibility testing, which often involves in-vitro and in-vivo animal studies rather than human clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically understood in AI/imaging studies (e.g., expert consensus on medical images) is not relevant for biocompatibility testing of a wound dressing.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in interpreting data, which is not described for the biocompatibility tests.
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. This device is a topical wound dressing, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted or is relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product, not an algorithm.
7. The type of ground truth used
For biocompatibility testing, the "ground truth" would be established by standardized laboratory assays and histological examinations, adhering to recognized safety standards (e.g., ISO 10993). The document doesn't detail these specifics but implies adherence by stating the device "passed the requirements of all tests."
8. The sample size for the training set
Not applicable. There is no AI component or training set involved for this device.
9. How the ground truth for the training set was established
Not applicable. There is no AI component or training set involved for this device.
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