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Personal Warming Gel is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms

Personal Warming Gel is a non-sterile, clear, non-staining, nongreasy, 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.

The provided text describes a 510(k) premarket notification for a medical device called "Personal Warming Gel." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific performance acceptance criteria through the kind of study described in the prompt. Therefore, much of the requested information is not applicable or cannot be extracted from the provided document.

Here's a breakdown of what can be derived and what cannot:

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

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

• Not applicable/Not provided. This document describes non-clinical studies (stability, preservative effectiveness, comparison to predicate). These studies do not typically involve a "test set" in the context of human subject testing for diagnostic or therapeutic efficacy.

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)

• Not applicable/Not provided. No "ground truth" establishment by experts is described, as this is a non-clinical evaluation comparing a new device to a predicate based on physical and chemical properties, stability, and preservative effectiveness.

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

• Not applicable/None. Adjudication methods are typically for clinical trials or expert review panels for ground truth determination, which are not part of this 510(k) summary for a personal lubricant.

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/Not done. This type of study is for diagnostic devices, particularly those involving image interpretation by human readers (e.g., radiologists, pathologists) with or without AI assistance. The Personal Warming Gel is a personal lubricant, not a diagnostic device.

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

• Not applicable/Not done. Standalone algorithm performance refers to AI/software performance without human intervention. This device is a physical product (personal lubricant), not an algorithm or AI.

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

• Not applicable. The "ground truth" for the non-clinical studies in this 510(k) submission would be based on established laboratory testing methods and industry standards for stability, preservative effectiveness, and chemical composition analysis, rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning device. The studies described are non-clinical evaluations of material properties and performance.

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

• Not applicable. As there is no training set, there is no ground truth establishment for one.

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Personal Warming Jelly is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms.

Personal Warming Jelly is a non-sterile, clear, non-staining, I ersonal walling Jelly used as a personal lubricant. This non groups, inquily lubricous and may be used with or without a latex condom during intimate sexual activity.

The provided text describes a 510(k) premarket notification for "Personal Warming Jelly," a personal lubricant. The submission focuses on demonstrating substantial equivalence to a predicate device, K-Y Brand Warming Jelly Personal Lubricant, rather than establishing de novo performance criteria against a disease or condition. Therefore, many of the typical elements of acceptance criteria and study design for medical devices that involve clinical performance or diagnostic accuracy are not applicable here.

This submission is for a Class II medical device (Condom, Product Code: 85 NUC), which aligns with the general controls and special controls applied to such devices. The performance data presented is primarily non-clinical, focusing on stability and preservative effectiveness, as well as a direct comparison to the predicate device’s physical and chemical properties and warming loss.

Here's a breakdown based on the provided text, indicating where information is not applicable for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. For non-clinical studies (stability, preservative challenge), the "sample size" would refer to the number of batches or units tested, which is not specified in this summary. For the comparative analysis, this was a review of characteristics rather than a test on a specific patient population.
• Data Provenance: Not applicable in the context of clinical data (e.g., country of origin, retrospective/prospective). The studies are non-clinical (laboratory-based).

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

• Not applicable. This submission does not involve diagnostic accuracy or interpretation of medical images/data by experts. Ground truth, in this context, refers to objective laboratory measurements and comparisons.

4. Adjudication Method for the Test Set

• Not applicable. There is no expert adjudication process for this type of non-clinical product comparison.

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

• No. An MRMC study is relevant for diagnostic devices interpreting medical images or data. This is a personal lubricant.

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

• No. This is not an AI-powered algorithm or diagnostic device.

7. The Type of Ground Truth Used

• For Stability: Laboratory measurements of physical, chemical, and functional properties over time.
• For Preservative Effectiveness: Laboratory challenge tests using specified microorganisms and methods.
• For Comparison with Predicate Device: Direct comparison of product specifications, physical and chemical properties, ingredients lists, label claims, and packaging characteristics against the established predicate device's information.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. (See #8)

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (which are fundamentally criteria for demonstrating substantial equivalence to a legally marketed predicate device) consists of:

1. Non-Clinical Stability Study: "Personal Warming Jelly has successfully passed 90 day accelerated stability." This demonstrates the product maintains its properties and safety over a simulated shelf life.
2. Preservative Effectiveness Study: An "anti-microbial preservative challenge has been completed on Qualis Personal Warming Jelly." This study, detailed in Attachment E (not provided in the excerpt), ascertains the product's ability to resist microbial contamination during storage and use.
3. Comparison Report (Shuster comparison Report in Attachment B): This report outlines a direct comparison of Personal Warming Jelly to the predicate device (K-Y Brand Warming Jelly Personal Lubricant). The comparison was based on:
   • Warming loss characteristics.
   • Physical and chemical properties.
   • Ingredients list review.
   • Label claims.
   • Packaging.

The outcome of these studies, particularly the comparison report, led to the conclusion that "The result of this review was an acceptable comparison," which substantiated the claim of equivalence. The FDA, in its decision letter, concurred with this assessment, stating they "determined the device is substantially equivalent... for the indications for use stated above."

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Personal Lubricating Gel is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms.

Personal Lubricating Gel is a non-sterile, clear, non-staining, non-greasy, 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.

The provided document is a 510(k) Premarket Notification for a Personal Lubricating Gel. It details the device's substantial equivalence to a predicate device, its intended use, and non-clinical performance data. However, the document does NOT contain information about specific acceptance criteria related to a study that proves the device meets those criteria, nor does it describe a study involving a "device" in the context of an AI/ML algorithm or diagnostic tool.

The document focuses on:

• Substantial Equivalence: Comparing the new lubricating gel to an existing, legally marketed predicate device (K-Y Ultra Gel Personal Lubricant) based on features, chemical properties, ingredients, and perceptual qualities.
• Non-Clinical Studies: Stability and preservative effectiveness of the new lubricating gel.
• Intended Use: "designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms."

Therefore, I cannot provide the requested table and information as it pertains to AI/ML or diagnostic device studies. The document describes a medical device (personal lubricant) and its regulatory submission, which does not typically involve the types of acceptance criteria, test sets, ground truth establishment, or multi-reader studies you've asked about for AI/ML performance.

Specifically, the information requested below is not present in the provided text:

1. A table of acceptance criteria and the reported device performance.
2. Sample sized used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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Personal Warming Lubricant is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms

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.

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.

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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Personal Lubricating Liquid is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms.

Lubricating Liquid is a water-based, nonsticky. Personal nonstaining personal lubricant that is compatible with condoms and diagrams.

The provided 510(k) summary for K973780, "Personal Lubricating Liquid," describes a comparison study against a predicate device, KY Liquid (K790087). However, it does not provide acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy), nor does it detail a study that would typically be associated with such criteria for a diagnostic or AI device.

This submission is for a medical device that is a personal lubricant, not an AI or diagnostic device. Therefore, the questions related to clinical performance, ground truth, experts, and AI-specific metrics are not applicable to the information provided.

Based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. The study involved a comparison of properties and qualities, not a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth was established through laboratory testing and comparative analysis of product attributes.

4. Adjudication method for the test set: Not applicable. No test set requiring adjudication was described.

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-assisted device.

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: For stability and preservative effectiveness, the ground truth was based on established laboratory protocols and industry standards for product quality and safety. For the comparison with the predicate device, it was based on an assessment of perceptual qualities, physical and chemical properties, ingredient list review, label claims, and packaging of both products.

8. The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of device submission.

9. How the ground truth for the training set was established: Not applicable.

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Lubriglide is a non-sterile personal lubricant for over-the-counter use. Its primary use is to apply the product to the genital area to reduce the discomfort associated with sexual activity. Lubriglide can also be used to lubricate rectal thermometers, tampons, douches, and enemas.

Lubriglide is a water-based, water-soluble personal lubricant designed to imitate the body's own lubricating fluids. It is nonirritating, non-staining, and won't dry out or leave behind any solid residues. Lubriglide is non-toxic and is easily removed with water.

This document is a 510(k) summary for Lubriglide, a personal lubricant, and does not describe a study involving device performance metrics like sensitivity, specificity, or AUC, nor does it involve a ground truth established by experts or a training set for an AI/algorithm. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Astroglide) based on non-clinical studies and comparisons of characteristics.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document as it pertains to medical device performance studies, typically for diagnostic or therapeutic devices, rather than a personal lubricant.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable. This document describes non-clinical studies (stability, preservative effectiveness, and comparative analysis with a predicate device), not a clinical trial or performance study with a test set of human data.

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

• Not applicable. There is no ground truth established by experts for a test set in this document.

4. Adjudication method for the test set:

• Not applicable. No test set or expert adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. An MRMC study was not done.

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 system.

7. The type of ground truth used:

• Not applicable. The concept of "ground truth" as typically used in medical device performance studies (e.g., pathology, clinical outcomes) is not relevant to the non-clinical tests performed for this lubricant. The "ground truth" for the non-clinical tests would be the established protocol specifications for stability and preservative effectiveness and the characteristics of the predicate device for comparison.

8. The sample size for the training set:

• Not applicable. This document does not describe the development or testing of an AI/algorithm, so there is no training set.

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

• Not applicable. There is no training set mentioned.

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