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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.

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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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.

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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The device is intended 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, leg ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, abrasions and minor irritations of the skin.

NeutroPhase is a wound cleansing solution for irrigating and cleansing of dermal wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of foreign objects such as dirt and debris. The device is offered in various bottle sizes.

The provided text describes a 510(k) summary for the NeutroPhase Wound Cleanser, a medical device. However, this document does not contain information about acceptance criteria, specific device performance metrics in a study, sample sizes for test/training sets, or details about ground truth establishment or expert involvement.

The document primarily focuses on establishing substantial equivalence to a predicate device (NeutroPhase K071056). It states that the "Modified NeutroPhase" represents a "minor change" to the predicate specification and that "The NeutroPhase verification testing under the company's Design Control Process has confirmed the device's conformance with specifications." However, it does not elaborate on what those specifications or acceptance criteria are, nor does it provide any quantitative performance data from such testing.

Therefore, I cannot fulfill your request for the specific types of information you've asked for. The text explicitly states:

• "The specifications do not include any significant differences from those of the predicate." This implies that the performance expectations are the same as the predicate, but it doesn't state what those are.
• "The NeutroPhase verification testing under the company's Design Control Process has confirmed the device's conformance with specifications." This confirms testing was done internally as per design controls, but the results and methodologies are not detailed in this public summary.

In summary, based only on the provided text, the requested information cannot be extracted. The document is a regulatory submission for substantial equivalence based on minor modification, not a detailed performance study report.

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The device is intended for moistening absorbent wound dressings and irrigating and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. It is also intended for moistening, debriding and irrigating acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, leg ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, abrasions and minor irritations of the skin.

NeutroPhase™ is a wound cleansing solution for irrigating and cleansing of dermal wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of foreign objects such as dirt and debris.

The provided text is for a 510(k) premarket notification for a medical device called NeutroPhase™ Wound Cleanser. This type of submission focuses on establishing substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria as typically seen for AI/ML-driven devices.

Therefore, many of the requested data points (such as acceptance criteria tables, sample sizes for test/training sets, expert consensus, MRMC studies, standalone performance, etc.) are not applicable or not provided within this document. The device in question is a wound cleansing solution, not an AI-powered diagnostic or predictive tool.

Here's a breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

• Not Applicable / Not Provided: The document states, "The NeutroPhase™ verification testing has confirmed the device's conformance with specifications. The functional specifications do not include any significant differences from those of the predicates." However, it does not specify what those "specifications" or "acceptance criteria" were, nor does it provide a table with quantitative performance metrics against such criteria. The focus is on substantial equivalence to existing devices rather than meeting new, pre-defined quantitative performance targets.

2. Sample Size Used for the Test Set and Data Provenance

• Not Applicable / Not Provided: This device is a wound cleanser, not a data-driven diagnostic tool. Therefore, there is no "test set" in the context of AI/ML performance evaluation. The "verification testing" mentioned would likely refer to chemical, physical, and sterility testing of the solution, not performance on a dataset of patient samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable / Not Provided: See point 2.

4. Adjudication Method for the Test Set

• Not Applicable / Not Provided: See point 2.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not Applicable / Not Provided: The device is a wound cleanser, not an AI tool designed to assist human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable / Not Provided: The device is a wound cleanser, not an algorithm.

7. The Type of Ground Truth Used

• Not Applicable / Not Provided: There is no "ground truth" in the context of AI model training or evaluation for this type of device. The "verification testing" likely relies on established laboratory methodologies for product quality and safety.

8. The Sample Size for the Training Set

• Not Applicable / Not Provided: This device is a wound cleanser, not an AI model.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable / Not Provided: See point 8.

Summary of the Study (Based on Provided Text):

The "study" described in the document is a 510(k) premarket notification to establish substantial equivalence of the NeutroPhase™ Wound Cleanser to two predicate devices: Dermacyn Wound Care (K060113) and Dermacyn Wound Irrigation (K042729).

• Objective: To demonstrate that NeutroPhase™ is as safe and effective as the predicate devices.
• Methodology: The submission highlights that the "intended use and technological specifications" of NeutroPhase™ are "substantially equivalent" to those of the predicate devices. It states that "NeutroPhase™ verification testing has confirmed the device's conformance with specifications." This implies internal testing was conducted, but the details of this testing (specific parameters, methods, and results) are not elaborated in the provided summary.
• Conclusion: The FDA reviewed the submission and determined that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market. The basis for this determination is the shared intended use and lack of significant differences in functional specifications from the predicates.

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