Search Results

JoyDrops® Natural Personal Lubricant Gel is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

JoyDrops® Natural Personal Lubricant Gel is a water-based personal lubricant gel that is contained in a 3.38 fluid ounces (100 mL) polymer container with a pump dispenser.

The provided document is a 510(k) premarket notification for a medical device: Joy Drops™ Natural Personal Lubricant Gel. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets acceptance criteria through clinical studies involving human readers or AI.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a diagnostic device utilizing AI is not applicable to this document.

The document primarily focuses on:

• Biocompatibility testing: To ensure the product is safe for contact with human tissue.
• Condom compatibility testing: To ensure it doesn't degrade various types of condoms.
• Comparison to a predicate device: To demonstrate substantial equivalence based on intended use, technological characteristics, and safety/performance data.

Here's an attempt to answer the questions based only on the information available for this specific product, acknowledging that many questions are not directly relevant to a lubricant's 510(k) submission:

1. 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)

The document does not explicitly state the sample sizes for the condom compatibility or biocompatibility tests (e.g., number of condoms tested, number of animals, or human subjects for patch tests). It refers to "standard practices" and ISO methodologies.

• Data Provenance: The document does not specify the country of origin of the data for the tests. It refers to "an independent laboratory" for stability testing. The submitter is from Turkey (Turkuaz Sağlik Hizmetleri Medikal Temizlik Kimyasal Urünler San. ve Tic. LTD ŞTI). The studies appear to be prospective, laboratory-based tests.

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 question is not applicable. The device is a personal lubricant, not a diagnostic device requiring expert interpretation of results to establish ground truth for a test set. The tests performed (biocompatibility, condom compatibility) are objective laboratory measurements, not subjective expert evaluations.

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

This question is not applicable. Adjudication methods like 2+1 are used for diagnostic interpretations by experts, which is not relevant for this product's testing. Laboratory tests have defined protocols and result interpretations.

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 question is not applicable, as the device is a personal lubricant and does not involve AI, human readers, or diagnostic interpretation.

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

This question is not applicable, as the device is a personal lubricant and does not involve an algorithm or AI.

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

This question is not applicable in the context of diagnostic "ground truth." The "ground truth" for this product's performance refers to the objective results of standardized laboratory tests for:

• Condom integrity: Measured by established ASTM and ARDL methods.
• Biocompatibility: Measured by ISO 10993 standards for cytotoxicity, irritation, sensitization, and systemic toxicity.
• Shelf-life: Measured by stability studies under controlled temperature conditions.

8. The sample size for the training set

This question is not applicable, as the device does not employ machine learning or AI, and therefore does not have a "training set."

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

This question is not applicable, as the device does not employ machine learning or AI, and therefore does not have a "training set" or "ground truth for a training set."

Ask a specific question about this device