(22 days)
Local management of skin wounds, including pressure ulcers, Stage I-IV, stasis ulcers, first and second degree burns.
The MPM Hydrogel Dressing is a clear, viscous, non-sterile, hydrogel intended for use in the local management of skin wounds. The product is supplied in 4 oz. tubes, 8 oz. spray bottles, and 0.5 oz. and 1.02. syringes and meets USP requirements for Antimicrobial Preservative Effectiveness.
This document is a 510(k) summary for a medical device (MPM Hydrogel Dressing) and details the "Substantial Equivalence" to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically expected for an AI/CADe device. The provided text focuses on demonstrating that the new device is as safe and effective as existing, legally marketed devices, primarily through comparison of composition and biocompatibility testing, rather than performance metrics against specific acceptance criteria.
Therefore, many of the requested fields cannot be populated from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-cytotoxic | Non-cytotoxic |
Explanation: The primary "acceptance criterion" mentioned is non-cytotoxicity. The study performed confirms this.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified. The "test" here refers to a cytotoxicity test of the device material itself, not a clinical study on patients.
- Data provenance: Not specified, but likely laboratory-based (in vitro) testing.
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)
Not applicable. This was a laboratory test (cytotoxicity), not an expert-driven ground truth assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was a laboratory test.
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 is not an AI/CADe device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/CADe device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the cytotoxicity test would be the established scientific method for determining cell toxicity.
8. The sample size for the training set
Not applicable. This device does not use a "training set."
9. How the ground truth for the training set was established
Not applicable. This device does not use a "training set."
In summary: The provided text describes a 510(k) submission for a hydrogel wound dressing, focusing on its substantial equivalence to predicate devices based on composition and a single biocompatibility test (cytotoxicity). It does not involve AI, image analysis, or clinical performance studies with human readers, and therefore, most of your requested information elements are not relevant to this type of device and submission.
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