(225 days)
NeutroPhase Skin and Wound Cleanser is intended for use under the supervision of healthcare professionals for cleansing and removal of foreign material including microorganisms and debris from wounds and for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. It is also intended for moistening and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites.
NeutroPhase Skin and Wound Cleanser is a clear, liquid solution cleanser and wound dressing that helps maintain a moist wound environment by removing dirt, debris and foreign material by the action of the skin and wound cleanser moving across the wound bed. The product is composed of HOCl 0.01% in saline. The antimicrobial agent inhibits the growth of microorganisms in solution.
The provided text describes modifications to an existing device, NeutroPhase Skin and Wound Cleanser, and outlines the performance data submitted for its 510(k) clearance. However, it does not contain information typically found in a study demonstrating how a device meets acceptance criteria, especially for AI/ML devices. The device described is a medical cleanser, not an AI-powered diagnostic or therapeutic tool.
Therefore, many of the requested categories in your prompt are not applicable to the provided document. I will describe what is present and explicitly state what information is missing based on the context of the device.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the device (a wound cleanser) and the information provided, the "acceptance criteria" appear to be related to its antimicrobial activity and material compatibility, rather than a diagnostic performance metric.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Antimicrobial activity in solution (criteria specified in USP ). | "Antimicrobial activity in solution is documented by extensive testing performed by NovaBay together with additional testing by a certified test laboratory to criteria specified in USP ." |
| Materials compatibility of the spray attachment. | "The provision of a spray attachment to the bottle has been tested for verification of materials compatibility." |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified in terms of number of samples/tests, but it mentions "extensive testing" and "additional testing by a certified test laboratory."
- Data provenance: Not explicitly stated (e.g., country of origin). The testing was conducted by NovaBay and a "certified test laboratory," implying internal and external validation.
- Retrospective or Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a cleanser, not a diagnostic tool requiring expert interpretation or ground truth establishment in the traditional sense of medical imaging or clinical decision support. The testing involves chemical and microbiological standards (USP ) and material science.
4. Adjudication method for the test set
Not applicable. There is no mention of human adjudication for the performance tests, as these appear to be laboratory-based chemical and microbiological evaluations and material compatibility 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 is not an AI device, and no MRMC study was conducted or is relevant for this product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
The "ground truth" for the performance claims appears to be:
- USP criteria: Standardized microbiological tests for antimicrobial effectiveness.
- Material Science Standards: Implicitly, for the compatibility of the spray attachment.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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