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The Reactive Skin Decontamination Lotion is intended to remove or neutralize chemical warfare agents and T-2 toxin from the skin.

The RSDL lotion is pre-impregnated in a 2 x 3.9 x 0.4 inch, or 3.9 x 3.9 x 0.4 inch foam sponge applicator pad. Each applicator pad is packaged as a single unit in a heat-sealed polyethylene-lined aluminum foil pouch. The foil pouch is covered by a kraft paper outer layer to facilitate coloring of the finished package and to make opening the package possible when wearing CW protective clothing.

The provided text describes the Reactive Skin Decontamination Lotion (RSDL) and its premarket notification to the FDA. However, the document does NOT contain the detailed information needed to fill out all requested sections about acceptance criteria, specific study designs, sample sizes, ground truth establishment, or expert qualifications for an AI/device performance study in the way typically found for diagnostic devices.

The RSDL is a decontamination lotion, and the performance criteria and studies for it are related to its efficacy in removing chemical agents and its safety/biocompatibility, rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC which are common for AI-driven devices.

Based on the provided text, here is what can be extracted and inferred:

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

2. Sample size used for the test set and the data provenance:

• Sample size for test set: Not specified in the provided text. The tests conducted were for efficacy, biocompatibility, safety, and compatibility, likely involving chemical agents and potentially biological samples/models, but the exact sample sizes are not given.
• Data provenance: Not explicitly stated. Given the applicant is the "U.S. Department of the Army" and the context of chemical warfare agents, the studies were likely conducted in a controlled laboratory or military testing environment, possibly in the USA. It's not specified if data was retrospective or prospective in detail, but implied as a series of tests for regulatory submission.

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

• This concept of "experts establishing ground truth" for a diagnostic device test set is not directly applicable to the RSDL's reported tests. The "ground truth" for RSDL would likely be objective measurements of chemical agent reduction/neutralization, and observations of biological responses for safety/biocompatibility, rather than expert consensus on interpretive tasks.
• No information on "experts" or their qualifications for establishing ground truth is provided.

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

• This is not applicable to the type of product and studies described. Adjudication methods are typically used in studies where human interpretation of data (e.g., medical images) forms the ground truth or is being evaluated, which is not the case here.

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:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices involving human readers/interpreters, which the RSDL is not.

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

• Yes, performance evaluations of the RSDL were conducted as a standalone product. The "device" (RSDL lotion) itself was tested for its direct chemical and biological effects. There is no "algorithm" or "human-in-the-loop" component for this type of product.

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

• The ground truth for efficacy would be objective chemical and biological measurements of agent neutralization/removal and biological impact. For safety and biocompatibility, it would be direct experimental observations and measurements of biological responses in test models or subjects (e.g., skin irritation tests, toxicity assays).

8. The sample size for the training set:

• This concept is not applicable. The RSDL is a chemical solution device, not an AI model that requires a training set. The "development" would involve chemical formulation and laboratory testing, not machine learning training.

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

• Not applicable, as there is no training set for an AI algorithm.

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