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Personal Warming Lubricant is a non-sterile, clear, nonstaining, non-greasy, high viscosity liquid gel used as a personal lubricant. This product is highly lubricous and may be used with or without a latex condom during intimate sexual activity.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a Personal Warming Lubricant. The information primarily focuses on establishing substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study proving performance against those criteria in the way a medical diagnostic or AI device submission might.

Based on the provided text, here's a breakdown of the requested information, adapted to the nature of this submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (personal lubricant), the "acceptance criteria" are primarily related to safety, physical/chemical properties, and performance relative to the predicate device, rather than diagnostic accuracy metrics.

Acceptance Criteria Category	Specific Criteria (Implicit or Explicit in Document)	Reported Device Performance
Stability	Successful completion of accelerated stability testing.	"Personal Warming Lubricant has successfully passed 90 day accelerated stability."
Preservative Effectiveness	Meeting requirements of Qualis, Inc. anti-microbial preservative challenge.	"Personal Warming Lubricant successfully passed the requirements of the Qualis, Inc., anti-microbial preservative challenge." (Reference to "Attachment D for the Preservative Effectiveness Study Report")
Comparison to Predicate Device	Perceptual qualities, physical and chemical properties, ingredients list, label claims, and packaging are acceptably comparable to the predicate device (K-Y Brand Warming Liquid Personal Lubricant).	"Personal Warming Lubricant was compared to K-Y Brand Warming Liquid Personal Lubricant on the basis of perceptual qualities, physical and chemical properties, ingredients list review, label claims, and packaging. The result of this review was an acceptable comparison." (Reference to "Attachment B for the ACTS comparison Report.")
Intended Use Compatibility	Designed to enhance ease and comfort of intimate activity and compatible with latex condoms.	Stated in "Indications For Use" section: "Personal Warming Lubricant is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms." Compatibility with latex condoms is a key aspect, implying some form of testing or ingredient analysis to confirm non-degradation of latex.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify a numerical "sample size" for a traditional test set in the context of device performance testing for diagnostic accuracy. The studies mentioned (Stability, Preservative Effectiveness, Comparison to Predicate Device) would have involved samples of the product itself rather than human subjects or data sets in the way an AI/diagnostic device would. For the "Comparison with Predicate Device," the "test set" would implicitly be the new device and the predicate device being compared.
Data Provenance: Not applicable in the traditional sense. The studies were non-clinical, involving the product itself.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. For non-clinical product testing like stability or preservative effectiveness, "experts" might be laboratory technicians or chemists, but their number and specific qualifications are not detailed here. For the "perceptual qualities" comparison, it's possible human evaluators were used, but no details are given.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable for this type of non-clinical product submission. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical image or data interpretation studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of cases, often with and without AI assistance, to measure changes in human reader performance. This personal lubricant submission does not involve such a scenario.

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

No, a standalone study was not done. This concept is specific to AI algorithms. This submission is for a physical product, not an algorithm.

7. The Type of Ground Truth Used

For Stability: The "ground truth" is adherence to predefined physical/chemical specifications over time.
For Preservative Effectiveness: The "ground truth" is successful inhibition of microbial growth according to established challenge test criteria.
For Comparison to Predicate Device: The "ground truth" for "acceptable comparison" would be a qualitative and quantitative assessment of physical, chemical, and perceptual attributes aligning closely with the predicate device, as determined by laboratory analysis and potentially human sensory evaluation according to an internal protocol.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" for this type of product submission, as it does not involve machine learning or AI algorithms. Product development might involve various formulation iterations and testing, but these are not considered "training sets" in the AI context.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no training set mentioned or implied in the context of an AI/ML device.

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