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Over-the-Counter Use: For moistening absorbent wound dreaning minor cuts, minor burns, superficial abrasions, and minor irritations of the skin. Prescription Use: For moistening absorbent wound dressing and for moistening, debriding, and cleaning acute and chronic dernal lesions, such as Stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second-degree burns, cuts, abrasions, and minor skin irritations and for device irrigation.

The subject device Sterile Water USP, and Sterile 0.9% Normal Saline USP is a colorless, transparent solution with no preservatives or antimicrobial agents added. It is used only for external irrigation, and not for injection purposes and it is a single use device. The subject device is packaged in clear, polypropylene (PP) bottles capped with PP Screw cap and filled with a sterile, preservative-free, clear, colorless aqueous solution and sealed with a PP/PET aluminum induction seal. The aqueous solution composition is either sterile 0.9% normal saline, both which meet their respective USP monograph criteria and contain no additives. The container and closure system for the 250mL, and 1000mL sizes include PP bottles with a PP screw cap with a PP/PET aluminum induction seal and a tamper evident plastic shrink wrap. The container and closure system for the 100mL size includes a PP bottle with a PP screw cap and a PP/PET aluminum induction seal. These single-use devices are labeled for device irrigation and wound debridement and are not intended for injection. The subject device will function by the mechanical action associated with applying and moving an aqueous solution across a wound or device surface, which facilitates the moisturizing, debridement and irrigation of these surfaces.

The provided text is a 510(k) summary for a medical device clearance, specifically for "Sterile Water USP and Sterile 0.9% Normal Saline USP" for use as sterile irrigation solutions. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for an AI/software device.

Therefore, the information required to answer your prompt, which is tailored for an AI/software medical device's performance evaluation (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details), is not present in the provided document.

The document discusses performance testing, but these are primarily bench tests, biocompatibility tests, and packaging tests for the physical product (sterile water/saline solution and its container), not performance metrics for an AI/software algorithm.

Here's a breakdown of why each point in your prompt cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: The document does not define "acceptance criteria" in the context of an AI/software's performance (e.g., accuracy, sensitivity, specificity). It lists various tests (biocompatibility, packaging, non-clinical bench tests for chemical properties and sterility) and reports that the device "complies with the criteria" or "successfully withstood" them. These are not performance metrics for a diagnostic or AI device.

2. Sample sized used for the test set and the data provenance: Not applicable. There is no AI/software test set. The tests mentioned are for physical product characteristics (e.g., "no bottles exhibited leakage," "containers remained undamaged").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth established by experts for an AI/software test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no test set in the context of AI/software performance.

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 device is sterile water/saline, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in the AI/software sense is not relevant here. The "truth" for this product is its chemical composition, sterility, and physical integrity, which are verified through standard laboratory tests.

8. The sample size for the training set: Not applicable. There is no training set for an AI/software.

9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA 510(k) summary pertains to a physical medical device (sterile water/saline solution) and its substantial equivalence to a predicate device. It does not contain information about the development, validation, or performance of an AI/software medical device, which would typically involve the type of acceptance criteria and study details you have requested.

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