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The intended use of this device is as a personal lubricant compatible with latex condom.
K-Y® Brand Warming Liquid is intended as a personal lubricant compatible with latex condom.

Device Description

This device is a condom compatible personal lubricant that has been specifically developed to produce a warming sensation when in contact with moist skin and mucosal membrane.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria:

Device: K-Y® Brand Warming Liquid (Personal Lubricant)

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria / Performance Claim	Reported Device Performance
Condom compatibility	"The proposed device is compatible with the leading commercial brands of latex condoms."
Lubricity	"Lubricity of the proposed device is comparable to the lubricity of predicate device."
Safety (Ingredients)	"The ingredients used in the formulation... are generally recognized as safe (GRAS) and the pre-clinical evaluation... has determined that they are safe for use in personal lubricant products."
Warming claim	"The consumer use test has shown that the product meets its warming claim."
Non-sensitizing	"The human RIPT shows that the proposed device is non-sensitizing."
Overall substantial equivalence	"The proposed device is substantially equivalent to the currently marketed products in technology, intended use, safety, and suitability characteristics."

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

The document does not explicitly state the sample sizes for the "test set" in terms of specific numbers of condoms, consumers for the use test, or participants for the RIPT.

Condom Compatibility: Tested with "leading commercial brands of latex condoms." (No specific number mentioned). Data provenance is from "laboratory testing."
Lubricity: Compared to the "predicate device." Data provenance is from "laboratory testing."
Warming Claim: Assessed via a "consumer use test." Data provenance is from human participants. No country of origin is specified, nor whether it was retrospective or prospective, but "consumer use test" typically implies prospective.
Non-sensitizing: Assessed via "human RIPT" (Repeat Insult Patch Test). Data provenance is from human participants. No country of origin is specified, nor whether it was retrospective or prospective, but an RIPT is a prospective clinical study.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of medical device evaluation (e.g., radiologists interpreting images). The evaluations are based on:

Laboratory testing for physical properties (condom compatibility, lubricity).
Pre-clinical evaluations for ingredient safety.
Consumer self-reporting for the warming claim (implied from "consumer use test").
Medical/Toxicological experts for interpreting RIPT results (implied by "human RIPT shows that the proposed device is non-sensitizing," but no specific number or qualifications are provided).

4. Adjudication Method for the Test Set:

No specific adjudication method (like 2+1 or 3+1) is described for any of the tests. The results seem to be direct outcomes of laboratory measurements, pre-clinical assessments, and consumer feedback/RIPT results.

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 typically associated with diagnostic imaging devices where multiple human readers evaluate cases with and without AI assistance to measure improvement in diagnostic performance. The K-Y® Brand Warming Liquid is a personal lubricant, not a diagnostic device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is not an algorithm or AI-driven system. The "performance data" refers to the physical and biological characteristics of the lubricant itself.

7. The Type of Ground Truth Used:

The "ground truth" for this device's evaluation is based on a combination of:

Objective Laboratory Data: For condom compatibility and lubricity.
Pre-clinical Safety Data: For ingredient safety.
Subjective Human Perception/Response: For the warming claim (consumer use test) and non-sensitization (RIPT, which has objective endpoints but measures a biological response in humans).
Comparison to Predicate Device: Many of the claims are based on "comparable" or "equivalent" performance to legally marketed predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve a "training set" in the context of an AI/ML algorithm. The product formulation and testing are based on traditional chemical and biological safety/efficacy assessments.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for an algorithm.

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K Number

K021492

Device Name

K-Y BRAND WARMING LIQUID PERSONAL LUBRICANT

Manufacturer

PERSONAL PRODUCTS CO., DIV. OF MCNEIL PPC, INC.

Date Cleared

2002-08-07

(90 days)

Product Code

NUC

Regulation Number

884.5300

Type

Traditional

Panel

Obstetrics/Gynecology

Reference & Predicate Devices

K024039

Intended Use

Patient lubricants are devices intended to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. When used as an accessory to a medical device such as a condom, they are considered Class II Medical Devices.

K-Y® Brand WARMING LIQUID is principally intended as personal lubricant to supplement the body's own natural lubricating fluids, to moisturize, relieve friction and to enhance the ease and comfort of intimate sexual activity. This lubricant may be safely applied to vaginal, anal or penile tissue for purpose of lubrication, and moisturization. It is also compatible with latex condoms.
Personal Lubricant (compatible with latex condoms)

Device Description

K-Y® Brand WARMING LIQUID is a non-sterile clear non-staining, 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. K-Y® Brand WARMING LIQUID is not a contraceptive or spermicide. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards defined by ASTM D 3492.

AI/ML Overview

The provided document describes the safety and performance testing of K-Y® Brand WARMING LIQUID™ Personal Lubricant, not an AI device. As such, many of the requested categories related to AI device evaluation (e.g., sample size for the test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable.

However, I can extract the acceptance criteria and reported device performance from the provided text, focusing on the aspects that were evaluated.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Type
Dermal Sensitization	Not to be a contact sensitizing agent.	The product was considered not to be a contact sensitizing agent.	Dermal Sensitization Study (in albino guinea pigs)
Penile Irritation	Not to cause any significant adverse effects or significant irritation.	The product did not cause any significant adverse effects and did not produce any significant irritation.	Rabbit Penile Irritation Study
Vaginal Irritation (Chronic)	Not to cause any pharmacotoxic effects; acceptable for use in humans.	The product did not cause any pharmacotoxic effects and was minimally irritating to the rabbit vaginal epithelium but considered acceptable for use in humans.	10-Day Rabbit Vaginal Irritation Study
Systemic Toxicity	Not to cause mortality and not to be associated with systemic toxicity.	The product did not cause mortality and was not associated with systemic toxicity.	Mouse Systemic Injection Study (25% w/v at 50mg/kg i.p.)
Human Cumulative Irritation	To be mildly irritating and elicit no evidence of sensitization.	The product was considered to be only mildly irritating and elicited no evidence of sensitization on the skin of healthy humans.	Human 21-Day Cumulative Irritation Assay (occluded conditions)
Human Contact Sensitization	To be essentially non-irritating and not elicit evidence of sensitization.	The product was considered essentially non-irritating and did not elicit evidence of sensitization on healthy human skin.	Human Repeat Insult Patch Test (Modified Draize Procedure), compared to K-Y® Liquid
Consumer Perception of Warmth	Desired warming sensation perceived by consumers.	Greater than 85% of the participants perceived a warming sensation while using the product.	Two-Phase Consumer Use Study
Human Irritation (Post-Use)	No observed irritation upon gynecological examination after use.	After one week of home use, there was no observed irritation upon gynecological examination.	Two-Phase Consumer Use Study
Condom Compatibility	Compatible with latex condoms.	Compatible with latex condoms as demonstrated.	Condom Compatibility Testing (according to ASTM D 3492)
Lubricity	Comparable to predicate device (K-Y® Brand LIQUID Personal Lubricant).	Comparable lubricity was demonstrated.	Laboratory coefficient of friction testing

Study Details (Non-AI Specific)

Sample size used for the test set and the data provenance:
- Dermal Sensitization Study: Albino guinea pigs (specific number not provided).
- Rabbit Penile Irritation Study: Rabbits (specific number not provided).
- 10-Day Rabbit Vaginal Irritation Study: Rabbits (specific number not provided).
- Mouse Systemic Injection Study: Mice (specific number not provided).
- Human 21-Day Cumulative Irritation Assay: Healthy humans (specific number not provided).
- Human Repeat Insult Patch Test: Healthy human skin (specific number not provided).
- Two-Phase Consumer Use Study: Males and Females (initial perception and home use). Number of participants not explicitly stated, but implies a cohort.
- Data Provenance: Studies conducted by "outside laboratories" (preclinical) and within the US (implied by FDA submission context and "healthy humans" / "consumers" for clinical tests). These are prospective studies designed to evaluate the product.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for these types of preclinical and clinical safety/performance studies. Ground truth is established by direct observation, laboratory measurements, and clinical assessments (e.g., macroscopic and microscopic findings for irritation, gynecological examinations).
Adjudication method for the test set: Not applicable for these types of studies. Results are based on direct measurements and observations, not a consensus among reviewers of a complex output.
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 device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
The type of ground truth used:
- Preclinical: Histopathological examination (macroscopic and microscopic findings), physiological responses (mortality), and direct observation of skin reactions.
- Clinical: Direct observation of skin reactions, gynecological examinations, and subject self-reporting (perception of warmth).
- Compatability/Lubricity: ASTM standard testing and laboratory coefficient of friction measurements.
The sample size for the training set: Not applicable. This is not an AI device.
How the ground truth for the training set was established: Not applicable. This is not an AI device.

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