(56 days)
NeutroPhase® Skin and Wound Cleanser OTC is intended for the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.
NeutroPhase® Skin and Wound Cleanser OTC is a clear, liquid solution cleanser and wound dressing that was previously cleared by FDA for Rx Use only. The device for OTC use is exactly the same as the Rx product. It is composed of hypochlorous acid (HOCI) 0.01% in saline. As a known antimicrobial, it inhibits growth of microorganisms in solution. The cleanser is provided in a glass bottle; a pump attachment for use in spraying the cleanser on wounds is also provided.
Here's an analysis of the provided text regarding the acceptance criteria and study for NeutroPhase® Skin and Wound Cleanser OTC:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes performance testing related to antimicrobial activity and biocompatibility, but does not explicitly state numerical acceptance criteria in a structured manner. Instead, it states that the product is "documented by extensive testing" and that "results establishing the NeutroPhase® product is safe, biocompatible and non-toxic for the use intended."
However, based on the information provided, we can infer some "acceptance criteria" through the testing performed.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Antimicrobial Effectiveness: | |
| Meet criteria specified in USP Antimicrobial Effectiveness Test against: | Documented effectiveness against: |
| - Pseudomonas aeruginosa | - Pseudomonas aeruginosa |
| - Escherichia coli | - Escherichia coli |
| - Staphylococcus aureus | - Staphylococcus aureus |
| - Candida albicans (fungi) | - Candida albicans |
| - Aspergillus niger (fungi) | - Aspergillus niger |
| Stability: | |
| Support a specified shelf life | Shelf life of 24 months supported |
| Biocompatibility: | |
| Meet requirements of ISO 10993 for body contact device (safe, biocompatible, non-toxic for intended use) | Results establish product is safe, biocompatible, and non-toxic for the use intended. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the antimicrobial effectiveness, stability, or biocompatibility testing.
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data provided. It mentions "testing performed both by NovaBay and certified test laboratories," suggesting a combination of internal and external testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable in the context of this device. The testing described (antimicrobial, stability, biocompatibility) are laboratory-based tests with objective endpoints, not human interpretation requiring expert adjudication for ground truth.
4. Adjudication Method for the Test Set
This is not applicable for the type of laboratory testing described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this is not an imaging or diagnostic device that relies on human interpretation.
6. Standalone Performance Study
The described testing (antimicrobial activity, stability, biocompatibility) can be considered standalone (algorithm only without human-in-the-loop performance) in the sense that the device's inherent properties are being tested directly in a laboratory setting, independent of human interaction beyond the conduct of the test.
7. Type of Ground Truth Used
The "ground truth" for the tests described is based on:
- Antimicrobial Effectiveness: Adherence to the criteria specified in USP Antimicrobial Effectiveness Test. This is a recognized standard method to determine the efficacy of antimicrobial preservatives in pharmaceutical products. The presence or absence of growth of specific microorganisms after exposure to the product serves as the ground truth.
- Stability: Laboratory measurements over time to confirm the product maintains its specified characteristics (e.g., concentration of active ingredients, physical properties) for the claimed shelf life.
- Biocompatibility: Results from ISO 10993 standard tests, which evaluate the biological response of medical devices to contact with the body. These tests have defined endpoints and criteria for safety, biocompatibility, and non-toxicity.
8. Sample Size for the Training Set
This information is not applicable. The NeutroPhase® Skin and Wound Cleanser OTC is a chemical formulation, not an algorithm or AI model that requires a "training set." The testing described verifies the product's inherent properties.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this type of device.
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