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Vashe® Wound Cleanser is intended for cleansing, irrigating, moistening, and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, postsurgical wounds, first and second degree burns, abrasions and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.

The subject device is a wound cleansing and disinfecting solution that is intended for cleansing, irrigating, debriding and disinfecting dermal wounds in addition to moistening and lubricating absorbent wound dressings. The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. Vashe is offered in various volumes.

The provided text is a 510(k) Summary for the Vashe™ Wound Cleanser and an FDA clearance letter for a later submission (K092232) for Vashe® Wound Cleanser. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and supporting data for a new device's performance.

Therefore, many of the requested sections about acceptance criteria, detailed study design, ground truth, and sample sizes for testing and training sets cannot be extracted from this document in the typical sense applied to a performance study for, for example, an AI medical device.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Performance for wound cleansers is typically demonstrated through biocompatibility, chemical and physical properties, and a comparison of intended use to similar predicate devices. The document does not specify quantitative "acceptance criteria" in the format one might expect for a performance study (e.g., specific sensitivity/specificity thresholds). Instead, "performance" is implicitly demonstrated through substantial equivalence to existing, legally marketed devices.

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

The provided text does not describe a "test set" in the context of an algorithm or performance study involving specific data samples (e.g., patient images or cases). The "pre-clinical testing" for biocompatibility would have involved a sample size of test subjects (e.g., animals or in vitro cultures), but this specific information is not provided.

• Sample Size for Test Set: Not specified in the provided text for a "test set" for performance evaluation. The "pre-clinical testing" likely involved a sample size for biocompatibility testing, but details are not given.
• Data Provenance: Not applicable in the context of a "test set" for algorithm performance. The pre-clinical testing would have been conducted in a laboratory setting.

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

This information is not applicable/not provided. The device is a wound cleanser, not an AI diagnostic device that requires expert-established ground truth on a test set of medical cases. Biocompatibility testing is typically assessed by laboratory experts following standardized protocols, not by medical experts establishing "ground truth" on patient data.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. There is no "test set" or diagnostic assessment that would require an adjudication method.

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

This information is not applicable. The device is a wound cleanser, not an AI system. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

This information is not applicable. The device is a wound cleanser, not an algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically used for AI medical devices (e.g., pathology, outcomes data) is not directly applicable here. For a wound cleanser, the "ground truth" for demonstrating safety and effectiveness relies on:

• Biocompatibility testing standards: Meeting established standards for non-toxicity, non-irritation, etc.
• Chemical and physical properties: Verifying the composition and stability of the solution.
• Clinical experience with predicate devices: Relying on the known safety and effectiveness of similar products already on the market.

8. The Sample Size for the Training Set

This information is not applicable. The device is a wound cleanser, not an AI system that requires a training set.

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

This information is not applicable. The device is a wound cleanser, not an AI system that requires a training set with established ground truth.

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