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The intended use of the BAND-AID® brand solvent based Liquid bandage is for providing a covering over minor cuts and scrapes that are clean and dry.

Solvent based liquid bandages are single- use liquid bandages that have three components: polymer solution, a foam applicator and aluminum foil pouch. Inside pouch, the swab is vertically situated with foam head down and saturated by the polymer solution. The pouch is sealed prior to use. The pouch will be open by tearing the notch. Upon application, the solvents will quickly evaporate and the polymer will form a clear and flexible film to cover skin /wound. The pouches will be sterilized either in bulk or in retail carton.

The provided text describes a 510(k) summary for the Johnson & Johnson Liquid Bandage, which is a Class I medical device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics through standalone studies with acceptance criteria as one might expect for a higher-risk device or an AI/ML powered device.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable or explicitly stated in this type of submission.

Here's an analysis based on the provided text:

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

No explicit quantitative acceptance criteria or corresponding reported device performance metrics are provided in this 510(k) summary. The submission focuses on demonstrating substantial equivalence based on material characteristics and intended use.

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

The text mentions a "Scarification study on humans to assess irritation potential." While it states "Both the new and predicate and BAND-AID® Liquid bandage were categorized as being very low for irritation potential," it does not specify the sample size for this study or its provenance. It is a prospective study as it assesses potential for irritation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The "Scarification study" likely involved clinical observation and assessment by medical professionals, but the number or qualifications of 'experts' for establishing ground truth are not mentioned in the context of this type of device.

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

Not applicable. This type of device evaluation does not typically involve adjudication methods for a test set in the way a diagnostic imaging device with expert interpretations would. The irritation study would be based on clinical assessment, likely following a standardized scale.

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 is not an AI-powered device, nor is it a diagnostic device where reader performance is the primary measure.

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

Not applicable. This is not an AI-powered device.

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

For the "Scarification study on humans to assess irritation potential," the ground truth would be based on clinical assessment of irritation potential using a standardized scale. This would be a form of expert assessment of clinical outcomes (irritation levels).

8. The sample size for the training set

Not applicable. This is not an AI-powered device that requires a training set.

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

Not applicable. This is not an AI-powered device.

In summary, the provided 510(k) uses a "substantial equivalence" pathway, meaning the primary "study" is a comparison to legally marketed predicate devices. The study mentioned (Scarification study) is used to support safety claims (biocompatibility, irritation potential) rather than performance against defined acceptance criteria for diagnostic accuracy or similar metrics.

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