Search Results

K-Y® Brand Touch Massage® 2-in-1 Tingling™ is intended as a body massage + personal IN-1 - Drain For penile and vaginal application compatible with latex condom.

This device is a body massage + personal lubricant compatible with latex condom that has been specifically developed produce a tingling sensation and a minty scent.

The provided text is a 510(k) Summary of Safety and Effectiveness for a personal lubricant and body massage product. It does not describe an AI medical device or a study involving acceptance criteria and device performance in the way a typical AI medical device submission would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through laboratory testing and pre-clinical evaluations.

Therefore, many of the requested categories (such as sample size for test/training set, number of experts, adjudication method, MRMC study, standalone performance, and ground truth type) are not applicable to this particular submission.

Here's a breakdown of the relevant information from the provided text according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test set sample size: Not explicitly stated as a single "test set" in the context of an AI device. The submission mentions "laboratory testing, pre-clinical evaluations and testing, human RIPT and use test." Specific sample sizes for each of these tests are not provided.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Not applicable as this is not an AI device relying on expert-defined ground truth for image interpretation or diagnosis. The "ground truth" here is based on chemical and physical properties testing, and human safety testing.

4. Adjudication method for the test set:

• Not applicable.

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, as this is not an AI medical device.

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

• Not applicable, as this is not an AI medical device.

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

• The "ground truth" or basis for claims in this submission is derived from:
  • Laboratory testing: For properties like condom compatibility and lubricity.
  • Pre-clinical evaluations: For ingredient safety.
  • Human Repeat Insult Patch Test (RIPT): For skin sensitization.
  • Use test: Implied for overall performance and user experience, but details are not provided.

8. The sample size for the training set:

• Not applicable, as this is not an AI medical device.

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

• Not applicable, as this is not an AI medical device.

Summary of the Study (as described for this device):

The study to "prove the device meets acceptance criteria" involved a series of laboratory tests, pre-clinical evaluations, and human safety tests.

• Laboratory Testing: Demonstrated compatibility with leading commercial latex condoms and confirmed lubricity comparable to the predicate device.
• Pre-clinical Evaluations: Assessed the safety of the ingredients, noting they are "generally recognized as safe (GRAS)" and that prototype testing confirmed overall safety for use in personal lubricant products.
• Human RIPT (Repeat Insult Patch Test): Concluded that the device is non-sensitizing.
• Use Test: Mentioned generally as contributing to the equivalency demonstration.

The overall conclusion was that these tests collectively demonstrate the proposed device is substantially equivalent to the predicate device (K-Y® Brand ULTRA GEL™) in terms of technology, intended use, safety, and suitability characteristics.

Ask a specific question about this device