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Interections of 2-in-1 Massage Crème™ is a personal lubricant, to enhance the ease and comfort of intimate sexual activity and supplement the body's in ural. lubrication. This product is compatible with latex condoms.

This device is developed for non-therapeutic body massage and personal lubricant compatible with latex condom that imparts a warming sensation upon the skin.

The provided document is a 510(k) premarket notification for a medical device: K-Y® Brand IntrigueTM 2-in-1 Massage CrèmeTM. This is a personal lubricant, and the submission primarily focuses on demonstrating its substantial equivalence to a predicate device, K-Y® Brand Touch MassageTM 2-in-1 Warming® body massage + Personal lubricant.

The information provided does not describe a study involving an AI or algorithm-driven device. Instead, it outlines the regulatory submission for a physical personal lubricant. Therefore, I cannot provide details on acceptance criteria and a study that proves an AI device meets these criteria based on the input text.

However, I can extract information related to the performance data presented for this physical device, which addresses some aspects of your request, even though it's not for an AI.

Here's the relevant information based on the provided text, structured to align with your request where applicable, but noting its non-relevance for AI:

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

Since this is not an AI device, there are no specific quantitative acceptance criteria like sensitivity, specificity, or AUC that would typically be reported for an AI. Instead, the "acceptance criteria" are implied by the safety and performance standards for personal lubricants, particularly condom compatibility and lubricity.

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

The document mentions "laboratory testing, pre-clinical evaluations and testing, and human use data." However, it does not provide specific sample sizes for these tests. The provenance (e.g., country of origin, retrospective/prospective) is also not detailed in the provided text.

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 to this type of device submission. Ground truth, in the context of AI, usually refers to labeled data for diagnostic purposes. For a personal lubricant, "ground truth" would be established through physical and chemical testing, and human sensory evaluation, not through expert consensus in the diagnostic sense. The document does not specify the number or qualifications of individuals conducting "pre-clinical evaluation" or participating in "human use data collection."

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

Not applicable, as this is not a diagnostic AI device requiring adjudication of 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

Not applicable. This is not an AI device, and no MRMC study involving human readers and AI assistance was conducted.

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

Not applicable. This is not an algorithm.

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

For this device, the "ground truth" for its performance characteristics would be based on:

• Laboratory test results: For condom compatibility and lubricity (e.g., measuring force, friction, integrity).
• Pre-clinical evaluation and testing: Likely involving various biological and chemical assays to assess safety.
• Human use data: Direct experience and feedback from individuals using the product to confirm safety and performance (e.g., absence of irritation, desired lubricity).

8. The sample size for the training set

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

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

Not applicable. There is no training set for an AI algorithm here.

In summary, the provided document is a regulatory submission for a physical medical device (personal lubricant) and does not concern an AI or algorithm-driven device. Therefore, most of the questions regarding AI-specific criteria are not applicable. The information describes standard laboratory, pre-clinical, and human use testing to demonstrate the safety and performance of a physical product.

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K-Y® Brand YOURS+MINE™ is intended as a personal lubricant for penile and vaginal application compatible with latex condom.

The devices are personal lubricants compatible with latex condom.

The provided text describes a 510(k) premarket notification for a personal lubricant, K-Y® Brand YOURS+MINE™. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as would be expected for a typical AI/ML medical device.

Based on the provided information, here's a breakdown of the requested elements:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly uses the "substantial equivalence" framework, meaning the device's performance should be comparable to a legally marketed predicate device. The acceptance criteria are therefore tied to demonstrating this equivalence through various tests.

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

The document mentions "laboratory testing, pre-clinical evaluations and testing, and human use," but does not specify the sample sizes for these tests.
The data provenance is also not specified, such as country of origin or whether it was retrospective or prospective. It infers prospective testing for "pre-clinical evaluations and testing, and human use."

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

This information is not provided in the document. For a personal lubricant, "ground truth" would generally refer to established scientific standards for chemical and physical properties, and safety evaluations. The document does not detail who performed these evaluations or their qualifications beyond stating it was "laboratory testing" and "pre-clinical evaluations."

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of personal lubricant testing, formal adjudication methods (like 2+1 reader consensus) are typically not applicable. The evaluations likely relied on established laboratory protocols and safety assessment methodologies.

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

No, an MRMC comparative effectiveness study was not conducted as this device is a personal lubricant, not an AI/ML diagnostic tool that would involve human readers interpreting cases.

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

Not applicable. This device is a personal lubricant, not an algorithm or AI/ML product. Therefore, standalone performance of an algorithm is not relevant.

7. The Type of Ground Truth Used:

The ground truth for this device appears to be based on:

• Established scientific and engineering principles for condom compatibility (e.g., integrity, burst pressure).
• Biophysical measurements for lubricity.
• Safety assessments based on pre-clinical evaluations (e.g., toxicology, irritation studies) and human use data (e.g., adverse event reporting, user acceptability).
• Comparison to a legally marketed predicate device and its established performance and safety profiles.

8. The Sample Size for the Training Set:

Not applicable. This device is a personal lubricant and does not involve AI/ML that requires a training set. The term "training set" is not relevant to this submission.

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

Not applicable for the same reasons as above.

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K-Y® Brand Intrigue™ Intense Warming Sensation is intended as a personal lubricant for penile and vaginal application compatible with latex condom.

This device is a personal lubricant compatible with latex condom.

The provided document is a 510(k) Summary for a medical device called "K-Y® Brand Intrigue™ Intense Warming Sensation," which is a personal lubricant. It does not include information about a study involving an AI/algorithmic device with acceptance criteria, ground truth, or expert review in the manner typically described for such technologies.

The performance data mentioned in the document relates to laboratory testing, pre-clinical evaluations, and human use to demonstrate equivalence to a predicate device. This is a very different type of evaluation than what is requested in the prompt for an AI-powered device.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence of a personal lubricant to a legally marketed predicate device based on its physical and performance characteristics, and its safety for human use and compatibility with latex condoms. It does not involve AI or algorithms that would require the specified acceptance criteria and ground truth methodologies.

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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.

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K-Y® Brand SENSUAL MIST™ is intended as a personal lubricant (for penile and vaginal application) compatible with latex condom.

This device is a condom compatible personal lubricant that has been specifically developed to be delivered via a non-aerosol spray pump.

The provided text describes a 510(k) Special Device Modification for the K-Y® Brand SENSUAL MIST™ Personal Lubricant. The filing emphasizes the device's substantial equivalence to predicate devices, particularly K-Y® Brand Liquid. However, the document does not contain explicit acceptance criteria or a study designed to prove the device meets specific performance criteria in the way one might expect for a new, high-risk medical device.

Instead, the submission focuses on demonstrating substantial equivalence to an existing, legally marketed predicate device (K-Y® Brand Liquid). This means the primary "acceptance criterion" is that the modified device performs equivalently to the predicate and is safe and effective for its intended use.

Here's an analysis of the provided information, framed to answer your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit quantitative "acceptance criteria" and their corresponding device performance values are not detailed in the provided text (like sensitivity, specificity, accuracy, etc.), I will extrapolate the information based on the nature of a 510(k) substantial equivalence submission for a personal lubricant.

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

• Sample Size: Not explicitly stated in terms of a specific number of instances. The document mentions "leading commercial brands of latex condoms" for compatibility testing, but not the number of condoms tested. For the "human RIPT," it doesn't specify the number of human participants.
• Data Provenance: The studies mentioned ("laboratory testing," "pre-clinical evaluations," and "human RIPT") appear to be prospective studies conducted specifically for this device modification. The country of origin of the data is not specified, but given the submitter's location (Skillman, NJ, USA) and the FDA submission, it's presumed to be conducted or overseen within the US or to standards acceptable for US regulatory submission.

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

• This information is not provided in the document. The studies described are more focused on direct physical/chemical properties (condom compatibility, lubricity, particle size) and biological responses (RIPT) rather than expert-based "ground truth" establishment for diagnosis or interpretation.

4. Adjudication Method for the Test Set

• This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and their disagreements need to be resolved to establish a ground truth. The studies for this lubricant are laboratory and pre-clinical in nature.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or is not described. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiology AI). The K-Y® Brand SENSUAL MIST™ is a personal lubricant, and its evaluation does not involve human readers interpreting "cases."

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Applicable in a different context: While not an "algorithm" in the AI sense, the performance data presented (condom compatibility, lubricity, particle size analysis, RIPT) can be considered "standalone" performance evaluations of the device itself, without human intervention in its efficacy assessment in the way a human-in-the-loop study would assess an AI. The device's properties were tested objectively.

7. Type of Ground Truth Used

• The "ground truth" in this context is established through a combination of:
  • Laboratory measurements: For condom compatibility, lubricity (presumably measured by standardized methods), and particle size analysis.
  • Pre-clinical evaluations: For ingredient safety.
  • Human RIPT (Repeat Insult Patch Test): For skin sensitization, where the "ground truth" is the observed biological reaction (or lack thereof) in human participants.
  • Regulatory standards/guidelines: Underlying the expectation for GRAS ingredients and the design of the RIPT.

8. Sample Size for the Training Set

• Not applicable/not provided. The concept of a "training set" is relevant for machine learning algorithms. This submission is for a physical medical device (personal lubricant), not an AI/ML algorithm.

9. How Ground Truth for the Training Set Was Established

• Not applicable/not provided. As there is no training set for an AI/ML model, the establishment of ground truth for such a set is not relevant to this submission.

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K-Y® Brand WARMING UltraGEL is intended as personal lubricant to be used with or without a condom.

The lubricous nature of this product helps to supplement the body's own natural lubricating fluids, thereby relieving friction to help enhance the ease and comfort of intimate sexual activity. This lubricant may be safely applied to vaginal, anal or penile tissues for purpose of lubrication, and moisturization and is compatible with latex condoms. K-Y® Brand WARMING UltraGEL has the additional benefit of imparting a warming sensation when applied to the genital area.

Personal Lubricant For vaginal/penile and condom application during sexual intimacy

K-Y® Brand WARMING UltraGEL is a non-sterile, clear, non-staining, non-greasy, water soluble gel for use as a personal lubricant. This product imparts a gentle warming sensation when applied to the genitalia. This product was designed to meet a customer need for an intimate lubricant that does not feel cold when applied. K-Y® Brand Warming UltraGEL can reduce friction during sexual intercourse thereby enhancing sexual intimacy. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards as defined by ASTM D 3492. K-Y® Brand WARMING UltraGel is not a contraceptive nor spermicide.

This document describes the 510(k) clearance for K-Y® Brand WARMING UltraGEL Personal Lubricant, focusing on demonstrating its substantial equivalence to the predicate device, K-Y® Brand Warming LIQUID Personal Lubricant. Since this is a personal lubricant, the "device performance" in the context of this submission refers to its safety and effectiveness in providing lubrication and a warming sensation, especially its compatibility with condoms.

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Biocompatibility Testing: Not specified, but conducted by an "outside laboratory." Usually involves in-vitro and in-vivo animal models per ISO 10993, but specific numbers are not provided for the test set.
• Human Repeated Insult Patch Test: Not specified.
• Consumer Perception Study: Not specified for the number of subjects, only percentages reported.
• In-Home Consumer Use Study: 245 reported responses. Data provenance is implied to be from the US, as the study was conducted under FDA regulations (21CFR Part 812 for Investigational Device Exemption and 21CFR Parts 50 and 56). This was a prospective study.

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

• Biocompatibility Testing: Conducted by an "outside laboratory in compliance with Good Laboratory Practices (GLPs)." No specific number or qualifications of experts are provided in the summary.
• Human Repeated Insult Patch Test: Not specified. Conducted by an "outside laboratory."
• Consumer Perception Study: The "ground truth" here is the subjects' subjective experience and self-reported perceptions of warmth. No external experts defining ground truth.
• In-Home Consumer Use Study:
  • Tolerability/Irritation: "Consented female subjects received gynecological examinations at baseline and following the last coital episode." This implies gynecologists were the experts establishing the ground truth for physical irritation. The number of gynecologists is not specified, nor are their specific qualifications (e.g., years of experience), but it is generally assumed that certified medical professionals perform such examinations.
  • Warming Sensation/Enhanced Intimacy: The "ground truth" is the subjects' subjective self-reported experiences and perceptions. No external experts defining ground truth.

4. Adjudication Method for the Test Set

• Biocompatibility Testing: No information on adjudication method. Results were likely evaluated against ISO 10993 and G95-1 criteria.
• Human Repeated Insult Patch Test: No information on adjudication method. Clinical assessment by trained personnel would be standard.
• Consumer Perception Study: No adjudication as it relies on subjective self-reporting.
• In-Home Consumer Use Study:
  • Tolerability/Irritation (Gynecological Exam): Not explicitly stated, but typically a single gynecologist would perform the examinations for consistency. If multiple gynecologists were involved, a consensus or independent review process might be employed, but it is not detailed.
  • Warming Sensation/Enhanced Intimacy: No adjudication as it relies on subjective self-reporting.

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. The device is a personal lubricant, not an imaging or diagnostic AI system. Therefore, an MRMC comparative effectiveness study involving human "readers" (e.g., radiologists) with or without AI assistance was not performed and is irrelevant to this submission.

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

• This is not applicable. As mentioned above, the device is a personal lubricant, not an algorithm or AI system. Its performance is directly tied to human interaction and perception, and there is no "standalone" algorithmic performance to evaluate.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Biocompatibility: Scientific standards (ISO 10993, G95-1) and laboratory test results.
• Human Contact Sensitization: Clinical observation and assessment by medical professionals (implied).
• Warming Sensation/Enhanced Intimacy: Subjective self-reported perceptions and experiences of male and female subjects.
• Tolerability/Irritation: Objective clinical assessment by gynecologists (mottled irregular erythema observation) and subjective self-reported experiences.

8. The Sample Size for the Training Set

• Not applicable / No specific training set mentioned. For a personal lubricant, there is typically no "training set" in the sense of machine learning. The studies described are validation studies to demonstrate safety and effectiveness for substantial equivalence. The product formulation itself resulted from R&D, not an algorithm trained on a dataset.

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

• Not applicable. As there is no "training set" for an AI or algorithmic device, the concept of establishing ground truth for it does not apply here. The product's development would have involved formulation chemists and product developers, guided by established chemical and physiological principles, and consumer research to meet desired characteristics.

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For vaginal/penile and condom application during sexual intimacy

Description of Delly is a non-sterile, clear, non-staining, non-greasy, water soluble ielly for use as a personal lubricant. This product imparts a gentle warming sensation when Jen' for use as a personal nas designed to meet a customer need for a lubricant that does not feel cold when applied. K-Y® Brand Warming Jelly reduce can reduce friction that does not feel cold which upplives and intimacy. It is compatible with latex during sexual mercounse theres your Compatibility Testing conducted according the condonis as defined by ASTM D 3492. K-Y® Brand WARMING Jelly is not a contraceptive nor spermicide.

The provided text describes the 510(k) summary for the K-Y® Brand WARMING Jelly Personal Lubricant. It outlines preclinical and clinical testing to demonstrate safety and substantial equivalence to a predicate device. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" with numerical thresholds for each test. Instead, it describes the tests and then reports the positive (or negative, where appropriate) outcomes as evidence of safety and performance. I've inferred the acceptance criteria based on the reported results.

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

• Human Repeated Insult Patch Test: The sample size is not explicitly stated, but the test compared the product to the currently marketed K-Y® Brand Warming LIQUID.
• Consumer Perception Study (Warming): The total number of participants is not explicitly stated. It mentions "75.50% of the participants felt the product warmed well."
• In Home Consumer Use Study:
  • Female subjects: Consented female subjects received speculum examinations at baseline and following the last coital episode. The exact number of subjects is not explicitly stated but is implied to be at least 245 based on the reported responses.
  • Reported Responses: 245 reported responses for various criteria.
  • Data Provenance: The studies are described as "Human Clinical Testing" and "Preclinical Testing of Formulation," implying prospective human studies conducted by an "outside laboratory." The country of origin is not explicitly stated, but the submission is to the FDA in the US.

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

• In Home Consumer Use Study (Gynecological Examinations): The study involved "gynecological examinations at baseline and following the last coital episode." It then states, "It was concluded that the product did not cause irritation as determined by final gynecological examination." This implies a medical professional (likely a gynecologist) performed these examinations. The number of such experts and their specific qualifications (e.g., years of experience) are not specified in this document.
• Other studies (Human Repeated Insult Patch Test, Biocompatibility): The "ground truth" here would be laboratory analysis and expert interpretation of those results. The number and qualifications of experts involved in these analyses are not specified.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for any of its human studies. The results appear to be reported based on the observations and findings of the individuals conducting the tests and assessments. For the In Home Consumer Use Study, the "conclusion" about irritation was "determined by final gynecological examination," suggesting a single expert's assessment or the consensus of a study team.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or interpretative tasks where multiple human readers assess cases with and without AI assistance. The K-Y® Brand Warming Jelly is a personal lubricant, and the studies focused on safety, biocompatibility, and consumer perception, not diagnostic effectiveness.

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

N/A (Not Applicable). This device is a personal lubricant, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not relevant to this product. The testing performed evaluates the product's direct interaction with the human body and user perception.

7. The Type of Ground Truth Used

• Biocompatibility: Laboratory test results (e.g., contact sensitization, systemic toxicity measurements) interpreted against established scientific standards (ISO 10993 and G93-1).
• Human Repeated Insult Patch Test: Clinical observation by trained professionals for skin reactions, comparing the test product to a predicate.
• Consumer Perception Studies: Self-reported subjective experience of participants (e.g., rating warming, feedback on intimacy enhancement, discomfort).
• In Home Consumer Use Study (Irritation): Objective medical assessment via "gynecological examinations" by a qualified professional.
• Condom Compatibility: Laboratory testing results based on ASTM D 3492.

8. The Sample Size for the Training Set

N/A (Not Applicable). This device is a personal lubricant, not an AI or machine learning model. Therefore, there is no "training set" in the context of data science. The "formulation" of the product is proprietary and developed through chemical and material science processes, not through a data-driven training set.

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

N/A (Not Applicable). As explained above, there is no "training set" for this product. The ground truth for its development and testing is established through standard preclinical and clinical methodologies for medical devices, focusing on safety, biocompatibility, and intended use performance.

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o.b.® Tampons are to be inserted into the vagina in order to absorb menstrual fluid.

The device is a cotton/rayon pledget with a removal string. It is available in various absorbencies.

Acceptance Criteria and Study for o.b.® Tampons:

1. Table of Acceptance Criteria and Reported Device Performance

Study Information:

The provided document describes a modification to the o.b.® Tampons and aims to establish substantial equivalence to legally marketed o.b.® tampons. The study supporting this claim of substantial equivalence is outlined in the "Performance data" and "Clinical Equivalency" sections.

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

• Sample Size for Test Set: The document states "healthy females" for the clinical equivalency study. However, the specific number of subjects in this study is not provided.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study. It does not explicitly state retrospective or prospective, but the description of a "randomized, double-blind, two-way crossover study" implies a prospective clinical trial.

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

• Number of Experts: This information is not provided in the document.
• Qualifications of Experts: This information is not provided in the document. The assessments mentioned (vaginal culture, speculum examinations, colposcopy) would typically be performed by medical professionals (e.g., gynecologists or trained clinicians), but their specific qualifications, number, or role in establishing ground truth (other than performing examinations) are not detailed.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method for the test set. It mentions assessments were performed, but not how disagreements or interpretations between multiple assessors (if any) were resolved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance?

• Not Applicable. This document describes the safety and effectiveness of a menstrual tampon, not an AI-assisted diagnostic or imaging device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study regarding AI assistance is not relevant or mentioned.

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

• Not Applicable. This document describes the safety and effectiveness of a menstrual tampon, not an algorithm or AI device.

7. The Type of Ground Truth Used

• The ground truth for the clinical equivalency study appears to be established through a combination of:
  • Clinical Assessments: Vaginal culture, speculum examinations, vaginal and cervical colposcopy performed by healthcare professionals.
  • Subjective Reporting: Subject diaries detailing tampon use.
  • Lab Tests: The "Performance Data" section also details various in-vitro and animal toxicology studies (e.g., cytotoxicity, irritation tests, TSST-1).

8. The Sample Size for the Training Set

• Not Applicable. As this is not an AI/ML device, there is no "training set." The studies described are for direct evaluation of the medical device itself.

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

• Not Applicable. See response to #8.

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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)

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.

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

Study Details (Non-AI Specific)

1. 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.

2. 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).

3. 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.

4. 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.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.

6. 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.

7. The sample size for the training set: Not applicable. This is not an AI device.

8. How the ground truth for the training set was established: Not applicable. This is not an AI device.

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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 condom, patient lubricants are deemed Class II Medical Devices.

K-Y® Brand Ultra Gel™ 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 lubrication, and moisturization purposes. It is also compatible with latex condoms.

Personal Lubricant compatible with latex condoms, helps enhance intimacy.

K-Y® Brand Ultra Gel™ is a non-sterile water- based personal lubricant designed to supplement the body's own natural lubrication fluids. This formula is a clear, non-irritating, non-greasy, non-staining, high viscosity liquid gel. This highly lubricous product may be used with or without a latex condom during intimate sexual activity. K-Y® Brand Ultra Gel™ is not a contraceptive or spermicide. It is however, compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards defined by ASTM D 3492.

This K-Y® Brand Ultra Gel™ Personal Lubricant 510(k) summary does not contain the level of detail typically found in a clinical study report for a diagnostic device. It focuses on demonstrating substantial equivalence to a predicate device through pre-clinical and limited clinical testing, rather than establishing specific performance metrics against a defined acceptance criterion with a dedicated study.

However, based on the provided text, I can infer the "acceptance criteria" relate to performance as safe and effective, and "substantially equivalent" to the predicate device. The "study" refers to the body of testing conducted to support this claim.

Here's an attempt to structure the information based on your request, with significant caveats due to the nature of the provided document:

Acceptance Criteria and Device Performance for K-Y® Brand Ultra Gel™ Personal Lubricant

This submission focuses on demonstrating substantial equivalence of K-Y® Brand Ultra Gel™ Personal Lubricant to its predicate device, K-Y® Brand LIQUID Personal Lubricant. The acceptance criteria are implicitly met by demonstrating safety, non-irritation, and comparable performance to the predicate device, particularly in terms of lubricity and consumer satisfaction.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for Test Set and Data Provenance

Due to the nature of this 510(k) summary, specific sample sizes for each test are not explicitly provided.

• Preclinical Biocompatibility Studies: Conducted by outside laboratories. Data provenance not specified (e.g., country of origin). These would typically be prospective animal or in vitro studies.
• Human Irritation Studies: Involved human subjects. Details on number of subjects, country of origin, or retrospective/prospective nature are not provided. These are typically prospective clinical trials.
• Consumer-Use Testing: Involved consumers. Specific sample size, country of origin, or retrospective/prospective nature are not provided. These are typically prospective user studies.
• Condom Compatibility Testing: Conducted according to ASTM D 3492 standards. This is lab-based testing; human subjects are not involved for this specific test.

3. Number of Experts and Qualifications for Ground Truth

Not applicable in the context of this 510(k) summary. "Ground truth" as understood in AI/imaging devices (e.g., expert consensus on medical images) is not relevant here. The "truth" is established by laboratory measurements, biological responses, and consumer feedback against defined criteria.

4. Adjudication Method for the Test Set

Not applicable. The tests described are laboratory analyses (e.g., coefficient of friction, biocompatibility, ASTM standards) and direct human or consumer responses (irritation, consumer preference). There is no "test set" requiring adjudication by multiple experts in the sense of a diagnostic interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study (MRMC) is relevant for diagnostic devices where human readers interpret medical images or data, and its goal is to assess the impact of AI assistance on human performance. K-Y® Brand Ultra Gel™ is a personal lubricant, not a diagnostic device.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

No. This concept applies to AI algorithms. K-Y® Brand Ultra Gel™ is a physical product, not an algorithm. Its performance is evaluated through physical and biological interactions, as well as user experience.

7. Type of Ground Truth Used

The "ground truth" for the various tests can be categorized as follows:

• Preclinical Biocompatibility (Non-irritation, non-sensitizing, no toxicity): Laboratory measurements and biological assays (e.g., cytotoxicity tests, sensitization tests, systemic toxicity tests) following established GLP guidelines.
• Human Irritation Studies: Direct human response/observation by trained medical professionals (e.g., dermatologists or clinical researchers) assessing skin reactions.
• Condom Compatibility: Adherence to the specified ASTM D 3492 standard, which involves physical testing methods to evaluate material integrity and performance.
• Lubricity: Objective laboratory measurement of the coefficient of friction.
• Consumer-Use Testing (Texture/Consistency, Moisturizing Properties): Subjective consumer feedback and preference ratings, likely via questionnaires or surveys, quantified statistically.

8. Sample Size for the Training Set

Not applicable. The concept of a "training set" is relevant for machine learning algorithms. K-Y® Brand Ultra Gel™ is a chemical formulation, not an AI model.

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

Not applicable. There is no training set for this type of product.

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