(265 days)
For debridement and the removal of foreign material and debris from exudating and/or dirty wounds, abrasions and minor irritations, cuts, exit sites, and intact skin.
ExSept WC is a clear to slight yellow, slight chlorine odor, solution which is intended for the mechanical cleansing of debris and foreign material from exudating/dirty epidermal and dermal wounds. It is supplied in a 200 ml pump-spray and a 100 ml, 250 ml, and 500 ml pour white, opaque, bottles. ExSept WC has a shelf-life of 30 months.
The provided 510(k) summary is for a wound cleanser (ExSept WC), which is a medical device. Medical devices, especially wound cleansers, typically do not undergo the same type of performance studies (e.g., studies using AI, human readers, or image analysis) as diagnostic or imaging devices. The document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical in-vitro testing for biocompatibility and shelf-life, rather than clinical performance metrics in the way a diagnostic AI would.
Therefore, the requested information (acceptance criteria and study details for device performance like those used in AI/diagnostic studies) is not present in the provided text. The device approval is based on substantial equivalence to existing predicate devices (Allclenz Wound Cleaner, CarraKlenz Wound Cleanser, Dermacyn Wound Cleanser) in terms of its "cleansing functions and intended uses."
Here's a breakdown of what can be extracted or inferred based on the document, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Based on the document, the acceptance criteria are not explicitly stated in terms of performance metrics like sensitivity, specificity, accuracy, or effect size. Instead, the primary acceptance criterion appears to be demonstrating substantial equivalence to predicate devices. This equivalence is based on the device having the same intended use and similar technological characteristics (a flushing action to remove foreign material and debris from wounds).
- Reported Device Performance: The document states: "Non-clinical in-vitro testing was performed to demonstrate the biocompatibility of ExSept WC for it's intended purpose and to support the 30 month shelf-life for the product." And the conclusion is: "Based upon the information in the 510(k) submission, ExSept WC will perform as intended as a wound cleanser, and is substantially equivalent in its actions and functions as the marketed devices Allclenz, CarraKlenz, and Dermacyn."
- Biocompatibility: The device passed biocompatibility testing. No specific metrics are given.
- Shelf-life: The device met the criteria for a 30-month shelf-life. No specific metrics are given.
- Cleansing Function: The device is considered substantially equivalent in its cleansing function to predicate devices. No specific quantitative performance metrics for cleansing are provided.
Therefore, a table cannot be constructed with quantitative performance metrics for "device performance" in the way one would for an AI or diagnostic device.
2. Sample size used for the test set and the data provenance:
- Not applicable/Not provided. The testing mentioned is "non-clinical in-vitro testing" for biocompatibility and shelf-life, not clinical performance testing with a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. Ground truth establishment for a diagnostic test set is not relevant for a wound cleanser's substantial equivalence determination.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. Adjudication methods are relevant for expert review of diagnostic cases, which is not part of this submission.
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/Not done. This device is a wound cleanser, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not done. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For in-vitro biocompatibility and shelf-life testing, "ground truth" would refer to established laboratory standards and methods rather than clinical outcome data or expert consensus on patient cases.
8. The sample size for the training set:
- Not applicable. There is no AI algorithm being trained for this device.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI algorithm being trained for this device.
In summary, the 510(k) summary for ExSept WC wound cleanser confirms its substantial equivalence based on non-clinical in-vitro testing for biocompatibility and shelf-life, and its similarity in function and intended use to existing predicate devices. It does not involve performance studies typically associated with AI or diagnostic imaging devices.
N/A