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pjur® Backdoor Anal Glide and pjur® Analyse Me! are personal lubricants for penile, vaginal, and/or anal application . intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex, synthetic polyisoprene, and polyurethane condoms.

The pjur® Backdoor Anal Glide or pjur® Analyse Me! device is a non-sterile, silicone-based personal lubricant. This over-the-counter product is formulated to be clear, non-irritating, non-greasy, and odorless. The pjur® Backdoor Anal Glide or pjur® Analyse Me! Device is a silicone based lubricant contains neither a contraceptive nor a spermicide. The product contains Cyclopentasiloxane, Dimethicone, Dimethiconol, and jojoba.

This document is a 510(k) Pre-market Notification for a medical device, specifically personal lubricants. It does not contain information about an AI/ML powered medical device study with acceptance criteria. Instead, it details the substantial equivalence of the "pjur® Backdoor Anal Glide or pjur® Analyse Me!" personal lubricants to a predicate device, "Wet Platinum Premium Lubricant® (K130012)".

The "acceptance criteria" discussed are related to the performance of the lubricant itself and its compatibility with condoms, rather than the performance of an AI algorithm.

Here's a breakdown of the requested information based on the provided document, noting where the information is not applicable to AI/ML studies:

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

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

This information is not applicable as the document describes a 510(k) submission for a personal lubricant, not an AI/ML device study. The "tests" here refer to physical, chemical, and biological compatibility tests of the lubricant. Specific sample sizes for each of these tests are not provided in this summary, nor is the country of origin or retrospective/prospective nature of the test data detailed beyond stating "Biocompatibility testing was performed in accordance with ISO 10993–1".

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)

This is not applicable as there is no "ground truth" in the context of an AI/ML study to be established by experts. The tests performed are laboratory-based and measure physical, chemical, and biological properties.

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

This is not applicable. There is no adjudication method described as it's not an expert-based evaluation.

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. This document does not describe an AI/ML powered medical device, therefore no MRMC study involving human readers and AI assistance was conducted or reported.

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

This is not applicable. This document does not describe an AI/ML algorithm.

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

This is not applicable in the context of an AI/ML study. The "ground truth" for the lubricant's performance is determined by the results of standardized physical, chemical, and biological tests (e.g., cytotoxicity, irritation, viscosity, condom compatibility as per ASTM D7661-10).

8. The sample size for the training set

This is not applicable as there is no AI/ML algorithm and therefore no training set.

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

This is not applicable as there is no AI/ML algorithm and therefore no ground truth for a training set.

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