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Water-based lubricant is intended for penile, vaginal and/or anal application to moisturize and lubricant, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubricant. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

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The provided FDA 510(k) clearance letter for the "Water-based Lubricant" device (K250142) does not contain the detailed information requested regarding acceptance criteria and the study that proves the device meets those criteria.

This document is a clearance letter, which confirms that the FDA has reviewed the submission and found the device substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and provides contact information but does not typically include the technical details of performance studies.

Therefore, I cannot extract the following information from the provided text:

1. Table of acceptance criteria and the reported device performance: This information is not present in the clearance letter.
2. Sample size used for the test set and the data provenance: This information is not present in the clearance letter.
3. Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present in the clearance letter.
4. Adjudication method for the test set: This information is not present in the clearance letter.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done and any effect size: This information is not present in the clearance letter.
6. If a standalone (algorithm only) performance was done: This information is not present in the clearance letter.
7. The type of ground truth used: This information is not present in the clearance letter.
8. The sample size for the training set: This information is not present in the clearance letter.
9. How the ground truth for the training set was established: This information is not present in the clearance letter.

The clearance letter focuses on the regulatory determination of substantial equivalence, the device's classification, and general regulatory requirements, rather than the specifics of the performance testing. To obtain the requested information, one would need to refer to the actual 510(k) submission document filed by Global Protection Corp. for the Water-based Lubricant.

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Plain water-based lubricant is a water-based lubricant intended for penile, vaginal and/or anal application to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Plain Water-based Lubricant

I'm sorry, I cannot fulfill this request. The provided document is an FDA 510(k) clearance letter for a "Plain Water-based Lubricant." This document is a regulatory communication from the FDA to the manufacturer, indicating that the device has been cleared for marketing.

It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or clinical study methodologies (such as MRMC studies or standalone performance). The letter focuses on regulatory compliance and substantial equivalence to a predicate device, not on detailed performance study results.

Therefore, I cannot extract the requested information about device performance and study details from the provided text.

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Play and Joy Water-Based Lubricant is a water-based personal lubricant, for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

Play and Joy Water-Based Lubricant is a non-sterile, clear, semi-viscous water-based personal lubricant that provides lubrication during intimate sexual activity. The subject device is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. Its formulation consists of water, xantham gum, glycerine, Chondrus crispus extract, sodium hyaluronate, saccharide isomerate, hydroxyethylcellulose, citric acid, sodium citrate, lactic acid, 1,2-pentanediol, phenoxyethanol, iodopropynyl butylcarbamate, hydroxyacetophenone, gluconolactone, and sodium benzoate. Play and Joy Water-Based Lubricant is for over-the-counter use and is provided in volumes of 50 mL and 100 mL in polyethylene tubes closed with polypropylene caps.

The provided document is a 510(k) Summary for a medical device called "Play and Joy Water-Based Lubricant." It is a submission to the FDA demonstrating substantial equivalence to a predicate device.

This document does not contain the type of acceptance criteria and study information (such as AI performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods) typically found for AI/ML-driven medical devices.

The product described is a personal lubricant, and the performance testing focuses on its physical characteristics, biocompatibility, and condom compatibility, not on an AI algorithm's diagnostic performance. Therefore, I cannot extract the information requested in your prompt regarding AI device acceptance criteria and study data from this document.

However, I can provide the acceptance criteria and performance data for the mechanical/physical performance of the lubricant as reported in the document:

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

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The Bloomi Smooth Water Based Personal Lubricant is a water-based personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.

This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

The Bloomi Smooth Water Based Personal Lubricant is a non-sterile, water-based personal lubricant that is intended for penile and vaginal application to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Its formulation consists of Water, Hydroxyethylcellulose, Microcare SB (water, sodium benzoate, potassium sorbate), Activsoft S (Cyamopsis Tetragonoloba (Guar) Gum), Citric Acid, Sodium Hyaluronate, Organic Sunflower Extract, Organic Green Tea Extract (Organic Camellia Sinensis Leaf (Green Tea) Extract).

The Bloomi Smooth Water Based Personal Lubricant is packaged in a MDPE (medium density polyethylene) 3 oz tube, packaged in an outer box for OTC use.

This document describes the acceptance criteria and the studies performed to demonstrate that the Bloomi Smooth Water Based Personal Lubricant meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not explicitly state the sample sizes used for each specific test within the non-clinical performance evaluations (Biocompatibility, Shelf Life, Condom Compatibility). The data provenance is derived from these non-clinical performance studies conducted on the device itself. The studies appear to be prospective, as they were carried out to demonstrate the device's characteristics for regulatory submission. There is no indication of country of origin of the data beyond the standards used (ISO, USP, ASTM).

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable. The device is a personal lubricant, and the evaluations performed are non-clinical (laboratory and in-vitro testing). Therefore, there is no "ground truth" established by human experts in the context of clinical interpretation, like radiologists or pathologists. The ground truth for these tests is based on established scientific and regulatory standards (e.g., ISO, USP, ASTM methods) and objective measurements.

4. Adjudication Method for Test Set

This information is not applicable. As explained above, the tests are non-clinical, objective measurements based on established protocols, not subjective human interpretations requiring adjudication.

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

No MRMC comparative effectiveness study was done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or other data, and the AI's assistance is evaluated. This is not relevant for a personal lubricant.

6. Standalone Performance (Algorithm Only)

This information is not applicable. The device is a physical product (personal lubricant), not an algorithm or AI system. Therefore, the concept of "standalone performance" without human-in-the-loop is not relevant.

7. Type of Ground Truth Used

The ground truth for the non-clinical performance testing (biocompatibility, shelf life, condom compatibility) is based on:

• Established scientific and regulatory standards: ISO 10993 series for biocompatibility, USP , , for microbial limits and antimicrobial effectiveness, and ASTM D7661-18 for condom compatibility.
• Objective laboratory measurements: Viscosity, Osmolality, pH, microbial counts, etc.
• Defined acceptance criteria: These criteria are based on scientific understanding and regulatory expectations for the safety and performance of personal lubricants.

8. Sample Size for the Training Set

This information is not applicable. As the device is a personal lubricant and not an AI/ML algorithm, there is no "training set." The product's formulation and manufacturing processes are developed and refined based on general scientific principles and quality control measures, not machine learning training.

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

This information is not applicable, as there is no training set for this type of device.

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Passion Natural Water Based Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with polyisoprene condoms. This product is not compatible with natural rubber latex and polyurethane condoms.

The Passion Natural Water Based Lubricant is a non-sterile, water-based personal lubricant that is intended for penile and vaginal application to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with polyisoprene condoms, and is not compatible with natural rubber latex and polyurethane condoms. Its formulation consists of purified water, propanediol, xanthan gum, methocel, sodium benzoate, potassium sorbate, citric acid, and hydroxyethylcellulose. Passion Natural Water Based Lubricant is packaged in 4 oz polyethylene terephthalate bottles with a cap. Passion Natural Water Based Lubricant is a personal lubricant for over-the-counter (OTC) use.

Here's a breakdown of the acceptance criteria and the study information for the "Passion Natural Water Based Lubricant" based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not explicitly state a separate "test set" sample size in the context of an algorithm or AI model evaluation. The non-clinical performance testing described seems to refer to standard product testing rather than algorithm validation.

• Sample Size: Not specified for individual tests beyond general descriptions (e.g., "results showed that Passion Natural Water Based Lubricant...").
• Data Provenance: Not specified. It's implied to be internal testing conducted by or for the manufacturer (XR, LLC). The document does not indicate country of origin for the data or if it's retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable. The product is a personal lubricant, and the "ground truth" for its performance is established through laboratory and in-vivo (animal) biocompatibility testing, chemical/physical specification testing, and condom compatibility testing against established ASTM and USP standards, not through expert human review of data like in an imaging AI study.

4. Adjudication Method for Test Set

This information is not applicable for this type of device. The evaluation relies on standardized tests with objective pass/fail criteria, not on human adjudication of subjective interpretations.

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

No MRMC study was done. This type of study is relevant for AI systems that assist human readers in tasks like medical image interpretation. This device is a physical product, not an AI system.

6. Standalone Performance Study (Algorithm Only)

No standalone algorithm performance study was done. This document pertains to a physical medical device (personal lubricant), not an AI algorithm.

7. Type of Ground Truth Used

The ground truth for the device's performance was established through:

• Laboratory measurements and assays: For properties like appearance, color, odor, viscosity, specific gravity, pH, osmolality, and microbial counts.
• In-vivo (animal) testing: For biocompatibility (sensitization, vaginal irritation, acute systemic toxicity).
• Established
  standard test methods: Such as ASTM D7661-10 for condom compatibility, USP , , , for microbial limits and effectiveness, and ISO 10993 series for biocompatibility.
• Accelerated aging studies (ASTM F1980-16): For shelf-life determination.

8. Sample Size for Training Set

This information is not applicable. There is no AI model or algorithm being developed or "trained" for this device.

9. How Ground Truth for Training Set Was Established

This information is not applicable as there is no training set for an AI model.

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JO Agapé Original Personal Lubricant is a water-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

MUSE Essence Water-Based Lubricant is a water-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber lates and polyisoprene condoms. This product is not compatible with polyurethane condoms.

#LubeLife Water-Based Lubricant is a water-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

#LubeLife Water-Based Anal Lubricant is a water-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber lates and polyisoprene condoms. This product is not compatible with polyurethane condoms.

JO Agapé Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant and #LubeLife Water-Based Anal Lubricant are clear/water white, viscous personal lubricants that are compatible with condoms made of natural rubber latex and polyisoprene. These products are not compatible with polyurethane condoms. These devices are non-sterile personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. All of these devices contain the same formulation.

The provided document is a 510(k) premarket notification for personal lubricants. It focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and study data for a novel device or AI/ML-driven medical device. Therefore, much of the requested information (like AI assistance effect size, expert qualifications, sample size for training sets, etc.) is not applicable or available in this context.

However, I can extract information related to the device specifications and the performance studies conducted to show that the device meets certain standards.

Here's the available information relevant to acceptance criteria and performance, as best as can be inferred from the document:

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

The document provides "Device Specifications" which act as acceptance criteria for the physical and chemical properties, and microbial limits of the lubricants. It also states the results of performance tests.

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

The document does not specify the exact sample sizes for each test conducted (e.g., number of lubricant samples for chemical/microbial tests, number of animals for biocompatibility, or number of condoms for compatibility).

• Provenance: The tests were performed in accordance with recognized standards (USP, ISO, ASTM). The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective, but given they are performance tests for regulatory submission, they would generally be prospective studies conducted in a controlled laboratory environment.

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

This is not applicable as the device is a personal lubricant, not an interpretive medical device like an AI/ML diagnostic. The "ground truth" here refers to objective physical, chemical, and biological properties measured via standardized lab tests, not expert consensus on interpretations.

4. Adjudication method for the test set

Not applicable for this type of device and testing. Test results are typically objective measurements against a defined specification.

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/ML-driven device or an interpretive device requiring human readers.

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

Not applicable. This is a physical product (lubricant), not an algorithm.

7. The type of ground truth used

The "ground truth" for the acceptance criteria and performance evaluations are based on:

• Standardized Test Methods: USP (United States Pharmacopeia), ISO (International Organization for Standardization), ASTM (American Society for Testing and Materials) standards for chemical composition, physical properties, microbiological contamination, biocompatibility, and condom compatibility.
• Objective Measurements: Laboratory measurements against predefined numerical or qualitative specifications.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of medical device as it is not an AI/ML system.

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

Not applicable.

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The Swiss Navy Premium Lubricants are personal lubricants for penile and / or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.

Swiss Navy® Premium Silicone Lubricant is a non-sterile, silicone-based personal lubricant for use with or without a condom. It is specifically formulated to be a clear, non-irritating, non-greasy and odorless liquid. This device is not a contraceptive, not does it contain any spermicidal components. Swiss Navy Premium Silicone Lubricant comes packaged in the following configurations: 20 ml square PET mini bottle with an aluminized Mylar seal, 2ounce, 4-ounce, 16-ounce, and 32-ounce PET bottles with a pump. All have the cap or pump shrink-wrapped. The 32-ounce PET size contains a travel cap with an aluminized Mylar induction seal. A pump is included with this size. This product also is packaged in 5-ml foil sachets.

The specifications for this device include color, odor, viscosity, water activity level, total aerobic microbial count, total yeast and mold count, absence of pathogenic organisms, and specific gravity.

Swiss Navy® Premium Water-Based Lubricant is a non-sterile water-based personal lubricant for use with or without a condom. It is clear, non-irritating and non-greasy. It is not a contraceptive, nor does it contain any spermicidal components. Swiss Navy® Premium Water Based into the following configurations: 20 ml square PET mini bottle with ascrew-on cap fitted with an aluminized Mylar seal, 2-ounce, 8-ounce, 16-ounce, and 32-ounce PET bottles with a pump. All have the cap or pump shrink-wrapped. The 32-ounce PET size contains a travel cap with an aluminized Mylar induction seal. A pump is included with this size. This product also is packaged in 5-ml foil sachets.

The specifications for this device include pH, osmolality, color, viscosity, water activity level, total aerobic microbial count, total yeast and mold count, absence of pathogenic organisms, and specific gravity.

The provided document is a 510(k) premarket notification for "Swiss Navy Premium Silicone Lubricant" and "Swiss Navy Premium Water-Based Lubricant." It details the FDA's determination of substantial equivalence to previously marketed predicate devices.

Here's an analysis of the acceptance criteria and supporting studies as presented in this document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabulated format, but rather presents the results of various tests demonstrating the safety and performance of the lubricants. We can infer the acceptance criteria from the reported "Results" for each test.

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

• Biocompatibility: The document refers to ISO standards (10993-5, 10993-10, 10993-11) for testing methods. These standards typically specify sample sizes for in-vitro and animal tests. However, the exact number of samples used in these specific tests (e.g., number of cell cultures, guinea pigs, mice, New Zealand White Rabbits) is not provided in this document.
• Condom Compatibility: The test was performed on "three marketed brands of Natural Rubber Latex Condoms and one brand of Polyisoprene condoms." The specific number of condoms tested per brand or the total sample size is not provided.
• Data Provenance: The document states that biocompatibility testing was performed by "independent third-party laboratories." The country of origin for the data is not explicitly stated. The studies appear to be prospective as they were conducted as part of the device's evaluation for market clearance.

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

For the testing described (biocompatibility and condom compatibility), the "ground truth" is established by the results of the standardized scientific tests themselves (e.g., observing cell viability, animal reactions, or condom integrity post-exposure).

• No explicit mention of "experts" in the context of establishing ground truth for these specific tests as you would for clinical image interpretation. The interpretation of these laboratory and animal test results would be conducted by qualified laboratory personnel following established protocols. Their qualifications are not specified beyond being "independent third-party laboratories."

4. Adjudication Method for the Test Set

This type of information (e.g., 2+1, 3+1) is typically relevant for studies involving subjective interpretation, like image reading by multiple experts. For the objective, standardized tests reported here (biocompatibility, condom compatibility), an adjudication method in this sense is not applicable and therefore not mentioned. The results are quantitative or clearly observable outcomes.

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

• No MRMC study was conducted or mentioned. The device is a personal lubricant, not an AI-powered diagnostic tool. This type of study is entirely irrelevant to the submission for this device.

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

• No standalone algorithm performance study was conducted or mentioned. The device is a personal lubricant, not an algorithm. This question is irrelevant to this device.

7. The Type of Ground Truth Used

• Biocompatibility: The ground truth is based on standardized in-vitro and in-vivo (animal) test results (e.g., cell viability, observed sensitization, systemic toxicity, or irritation in animal models) according to internationally recognized ISO 10993 series standards.
• Condom Compatibility: The ground truth is based on standardized physical integrity testing of condoms (e.g., burst strength, freedom from holes) after exposure to the lubricant, as per ATM D7661-10.
• Shelf Life: The ground truth is based on accelerated aging study results with ongoing real-time aging study for confirmation, implying stability parameters (e.g., viscosity, pH, microbial counts) remain within acceptable limits over time.

8. The Sample Size for the Training Set

• This device is not an AI/ML algorithm that requires a "training set." Therefore, this information is not applicable and not provided.

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

• As there is no training set for this device, this information is not applicable and not provided.

In summary, this 510(k) submission focuses on demonstrating the safety and performance of the lubricants through standardized physical, chemical, and biological (biocompatibility) tests, and not on AI or diagnostic capabilities. Therefore, many of the requested details related to AI evaluation are not found in this document.

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