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To cleanse minor wounds and scrapes.

The product is not to be used for body cavities, canals, eyes, or mouth.

Dr. Mehta's Wound Wash Saline SprayTM consists of drug and preservative-free sterile isotonic saline solution that is delivered in atomized spray form by means of activating the actuator. Dr. Mehta's Wound Wash Saline SprayTM distributed as a single can includes 0.9% saline (sodium chloride) solution. The product utilizes bag-on-valve technology (bag in can). The propellant, compressed air, is charged into the container between bag and the can creating a means to dispense the contents of the bag, i.e., sterile isotonic salution. The product consists of specially designed actuator to deliver an effective consistent spray of the solution on the wound area. The filled device is sterilized by gamma radiation utilizing parameters those are validated according to ISO/AAMI 11137 requirements (Sterilization of health care products -Requirements for validation and routine control - Radiation sterilization). The product passes USP Sterility Test. Dr. Mehta's Wound Wash Saline Spray™ is available as an over-thecounter product, and will be labeled with the following indication: "To cleanse minor wounds and scrapes.".

This document describes Dr. Mehta's Wound Wash Saline SprayTM, which is a medical device. The document is primarily a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study of its performance against specific acceptance criteria.

Therefore, the information required to fully answer your request regarding acceptance criteria and a study proving the device meets them is not fully available in the provided text. The document does not describe a performance study as you might expect for a novel or high-risk device. Instead, it relies on demonstrating that the device is substantially equivalent to an existing, legally marketed predicate device.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance:

Since this is a submission for substantial equivalence rather than a de novo or PMA application, explicit "acceptance criteria" are not framed in terms of clinical performance metrics like sensitivity, specificity, or reader improvement. Instead, the "acceptance criteria" are implicit in demonstrating substantial equivalence to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No separate "test set" in the context of clinical performance data (e.g., patient images, clinical cases) is described. The "tests" mentioned are non-clinical bench tests:

• USP Sterility Test
• LAL Test (Bacterial Endotoxins Test)
• MEM Elution Test (Cytotoxicity Test)

The sample sizes for these bench tests are not specified in the document, nor is the country of origin for the data or whether they were retrospective or prospective. It is standard practice that these are prospective tests conducted on manufactured batches of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as there is no human-interpreted "test set" like imaging data requiring expert ground truth establishment. The ground truth for the non-clinical tests (sterility, endotoxins, cytotoxicity) is established by laboratory parameters and standards (e.g., USP criteria, LAL assay thresholds).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This is not applicable for the non-clinical bench tests described.

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:

This is not applicable. The device is a wound wash saline spray, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This is not applicable. The device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for this device's evaluation (for its 510(k) submission) is based on established laboratory standards and regulatory requirements for sterility, biocompatibility, and chemical composition. For instance:

• Sterility: USP criteria.
• Biocompatibility: LAL test and MEM Elution test standards.
• Composition: USP grade specifications for sodium chloride and purified water, and 0.9% isotonic saline concentration.

8. The sample size for the training set:

This is not applicable as the device does not employ an AI algorithm requiring a training set.

9. How the ground truth for the training set was established:

This is not applicable as the device does not employ an AI algorithm requiring a training set.

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