Search Results

JO Coconut Hybrid Cooling Personal Lubricant is a 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.

JO Coconut Hybrid Cooling Personal Lubricant is a clear, viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication.

JO Coconut Hybrid Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in a 1 fl. oz./ 30 mL and 4 fl. oz./ 120 mL bottle. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz/ 30 mL size bottle is capped with natural disc tops. The 4 fl. oz/ 120 mL is capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

This device is composed of Water (Aqua), Propylene Glycol, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Flavor (Aroma), Phenoxyethanol, Polyacrylate 13, Cellulose Gum, Raphanus Sativus (Radish) Seed Extract, Polyisobutene, Polysorbate 20, Butyrospermum Parkii (Shea) Butter Extract, Ethyl Menthane Carboxamide, Methyl Diisopropyl Propionamide, Beeswax Glyceryl Stearate, Menthyl Lactate, PEG-100 Stearate, Stearamidopropyl Dimethylamine Lactate, PEG45M, Caprylyl Glycol, Phenethyl Alcohol, Ethylhexylglycerin and Polyquaternium-67.

This document is a 510(k) Premarket Notification from the FDA, and it describes the JO Coconut Hybrid Cooling Personal Lubricant. It does not contain information about an AI/ML medical device. Therefore, I cannot provide the requested information regarding acceptance criteria, study details, and ground truth for an AI/ML device, as those details are not present in the provided text.

The document instead focuses on demonstrating the substantial equivalence of a personal lubricant to a legally marketed predicate device, based on:

• Device Specifications: Physical, chemical, and microbiological properties of the lubricant.
• Biocompatibility Testing: To ensure it's safe for human use (non-cytotoxic, non-irritating, non-sensitizing, not acutely systemically toxic).
• Shelf-Life Testing: To confirm the device maintains its specifications over a 3-year period.
• Condom Compatibility Testing: To determine which types of condoms it can be safely used with.

The provided text describes a traditional medical device (a personal lubricant) and its testing for safety and effectiveness, not an AI/ML device.

Ask a specific question about this device

JO Coconut Hybrid Warming Personal Lubricant is a 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.

JO Coconut Hybrid Warming Personal Lubricant is a clear, viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication.

JO Coconut Hybrid Warming Personal Lubricant is sold as an over-the-counter (OTC) product in a 1 fl. oz./ 30 mL and 4 fl. oz./ 120 mL size. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz/ 30 mL size bottle is capped with natural disc tops. The 4 fl. oz/ 120 mL is capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

This device is composed of Water (Aqua), Propylene Glycol, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Flavor (Aroma), Phenoxyethanol, Polyacrylate 13, Cellulose Gum, Raphanus Sativus (Radish) Seed Extract, Niacin, Polyisobutene, Polysorbate 20, Dipropylene Glycol, Vanillyl Butyl Ether,PEG-45M, Butyrospermum Parkii (Shea) Butter Extract, Ethyl Menthane Carboxamide, Methyl Diisopropyl Propionamide, Polysorbate 80, Caprylyl Glycol, Phenethyl Alcohol, Ethylhexylglycerin, Beeswax, Glyceryl Stearate, Hydroxypropylcellulose, Menthyl Lactate, PEG-100 Stearate, Stearamidopropyl Dimethylamine Lactate, Polyquaternium-67.

The provided text is a 510(k) summary for a personal lubricant (JO Coconut Hybrid Warming Personal Lubricant). It details the device's characteristics, comparison to a predicate device, and non-clinical performance data (biocompatibility, shelf-life, and condom compatibility).

However, the text does not contain any information about an AI/ML-based medical device study. It does not mention:

• Acceptance criteria for an AI/ML model
• Sample sizes for test or training sets for AI/ML
• Provenance of data for AI/ML
• Number or qualifications of experts for AI/ML ground truth
• Adjudication methods for AI/ML ground truth
• Multi-reader multi-case (MRMC) studies
• Standalone algorithm performance
• Type of ground truth used for AI/ML (e.g., pathology, outcomes)
• How ground truth for training data was established for an AI/ML model

Therefore, I cannot fulfill your request for the tables and study details related to an AI/ML device's acceptance criteria and proven performance based on the input text. The information provided is for a traditional, non-AI medical device (a lubricant).

Ask a specific question about this device

JO Water Based Anal Thick Lubricant is a 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.

JO Water Based Anal Thick Lubricant is a clear, semi-viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication.

JO Water Based Anal Thick Lubricant is sold as an over-the-counter (OTC) product in 2 fl. oz./ 60 mL, 4 fl. oz./120 mL and 8 fl. oz./ 240 mL bottles. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle and capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

This device is composed of Water (Aqua), Glycerin, Polysorbate 20, Propylene Glycol, Hydroxyethyl cellulose, Chlorphenesin, Vitamin E Acetate and Sodium Hydroxide.

The provided text describes the acceptance criteria and study for a medical device called "JO Water Based Anal Thick Lubricant." However, it is a 510(k) submission, which is for demonstrating substantial equivalence to a predicate device, not for a comparative effectiveness study with or without AI assistance, or for a standalone AI algorithm performance study.

Therefore, many of the requested categories in your prompt (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, ground truth type and training set information) are not applicable to this type of regulatory submission and information is not present in the provided document. This document focuses on the physical, chemical, and biological properties of the lubricant and its compatibility with condoms, as well as its shelf-life.

Here's the information that can be extracted from the provided text, primarily focusing on the device's specifications and performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The device specifications in Table 1 serve as the acceptance criteria for the JO Water Based Anal Thick Lubricant.

Performance Study Details:

• Biocompatibility Studies:

  • Tests Conducted: Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), Vaginal Irritation (ISO 10993-10:2010), Acute Systemic Toxicity (ISO 10993-11:2017).
  • Results: The lubricant was demonstrated to be non-cytotoxic, non-irritating, non-sensitizing, and not acutely systemically toxic.

• Shelf-Life Study:

  • Methodology: Real-time and accelerated aging study.
  • Results: Demonstrated the device maintains its specifications (from Table 1) for an 18-month shelf-life.

• Condom Compatibility Study:

  • Methodology: Evaluated in accordance with ASTM D7661-18 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms.
  • Results: Compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane condoms.

Regarding the requested information that is not applicable or not present:

2. Sample size used for the test set and the data provenance: Not applicable. This is not a study involving human or image data for AI evaluation. The "test set" here refers to samples of the product for laboratory testing. The document does not specify the number of product samples used for each test (e.g., how many bottles were tested for viscosity). Data provenance is also not relevant in the context of these device characteristic tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/diagnostic studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for these tests would be the chemical and physical properties measured by standard laboratory methods.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable. This is not a diagnostic device or an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable.
7. The type of ground truth used: For the physical/chemical tests, the ground truth is established by validated laboratory measurement methods and standard testing protocols (e.g., USP and ASTM standards). For biocompatibility, it's based on animal testing results and established biological endpoints (e.g., non-cytotoxic).
8. The sample size for the training set: Not applicable. This involves product testing, not AI model training.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

JO CUMPLAY Personal Lubricant is a 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.

JO CUMPLAY Personal Lubricant is a non-sterile, 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 device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms.

Its formulation consists of Water (Aqua), Propylene Glycol, Dimethicone, Dimethiconol, Lauryl Glucoside, Aloe Barbadensis Leaf Powder, Vitamin E Acetate, Hydroxyethylcellulose, PEG-90M, Hydrogenated Polydecene, Acrylic Copolymer, Sodium Acrylates/Beheneth-25 Metharylate Crosspolymer, and Chlorphenesin.

JO CUMPLAY Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in a 4 fl. Oz./120 mL polyethylene terephthalate bottle and capped with matte black Polypropylene (PP) pump closure.

The provided document is a 510(k) Summary for a personal lubricant, not a study involving AI or human readers for comparative effectiveness. Therefore, many of the requested categories related to AI performance, expert ground truth, and MRMC studies are not applicable to this document.

However, I can extract the acceptance criteria and the results of the studies conducted for the device.

Here's the information based on the provided text:

Device: JO CUMPLAY Personal Lubricant

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 for specific tests (e.g., how many units were tested for viscosity, pH, etc.). However, for condom compatibility, the test method is ASTM D7661-10(R) 2017, which would define the sample size.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be non-clinical performance testing conducted by the manufacturer or a contracted lab. The studies are prospective in the sense that they were conducted specifically for this device submission to demonstrate its performance.

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. This is a physical and chemical product, not an AI or diagnostic device that requires expert-established ground truth. The "ground truth" for these tests comes from established international standards (e.g., USP, ISO, ASTM) and analytical methods.

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

• Not applicable. This is not a study requiring human adjudication of results. The tests are based on objective chemical and physical measurements.

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 device is a personal lubricant, not an AI system.

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 AI algorithm.

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

• For the physical, chemical, and microbiological properties, the "ground truth" is defined by the established specifications and validated test methods from recognized standards (e.g., USP, ISO, ASTM).
• For biocompatibility, the ground truth is determined by the results of standardized biological tests that evaluate the material's interaction with biological systems according to ISO 10993 series.
• For condom compatibility, the ground truth is determined by the results of the specific ASTM standard test method.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI model requiring a training set.

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

• Not applicable.

Ask a specific question about this device

Actively Trying Personal Lubricant Rose Scented is a personal lubricant for penile, and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive.This product is compatible with natural rubber latex and polvisoprene condoms. This product is not compatible with polyurethane condoms.

Actively Trying Personal Lubricant Rose Scented is a clear, semi-viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. This product is compatible with sperm, oocytes and can be used by couples trying to conceive. Actively Trying Personal Lubricant Rose Scented is sold as an over-the-counter (OTC) product in 4 fl. oz./120 mL size. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The individual bottles are hermetically sealed during the production process. This device is composed of Water (Aqua), Hydroxyethylcellulose, Sodium Chloride, Sodium Phosphate, Potassium Phosphate, Propylene Glycol, Chlorphenisen, Fructose, Arabinogalactan, and Rose water (Damascena).

This document describes the acceptance criteria and the study results for the "Actively Trying Personal Lubricant Rose Scented" to demonstrate its substantial equivalence to a predicate device.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of clinical trials with human subjects. The testing described is primarily non-clinical, involving laboratory assays and material compatibility tests. Therefore, typical "sample size" for a clinical test set and "data provenance" (country of origin, retrospective/prospective) are not applicable in the way they would be for a diagnostic device or a drug.

For the biocompatibility studies and non-clinical performance testing (Human Sperm Survival Assay, Endotoxin Testing, Lubricant Barrier Assay), these are laboratory-based tests conducted under specific standards (e.g., ISO 10993, USP, ASTM D7661-10). The sample size would refer to the number of lubricant batches or test replicates used in each assay, which is not detailed in the document beyond stating that the tests were performed.

For shelf-life, tests were conducted at 0, 1, and 2 years. This is a prospective aging study performed on the device product itself.

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

This information is not applicable to the non-clinical performance and biocompatibility testing described. These studies rely on standardized laboratory protocols and measurement techniques rather than expert consensus on a "ground truth" derived from human data. The "ground truth" for these tests comes from the established scientific and regulatory standards themselves (e.g., ISO, USP, ASTM).

4. Adjudication method for the test set

Not applicable, as the tests are objective laboratory measurements against defined acceptance criteria, not subjective interpretations requiring adjudication.

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-powered diagnostic device, but a personal lubricant undergoing non-clinical performance testing for substantial equivalence to a predicate device.

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

Not applicable, as this is not an algorithm or AI-based device.

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

The "ground truth" for the performance and safety of this device is established by adherence to internationally recognized standards and pharmacopoeial methods. These include:

• ISO 10993 series: for biocompatibility (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity).
• USP (United States Pharmacopeia) methods: for physical/chemical properties (Viscosity , pH , Specific Gravity , Osmolality ), endotoxin , antimicrobial effectiveness , and microbial counts , , .
• ASTM D7661-10 Standard Test Method: for condom compatibility (Lubricant Barrier Assay).
• Human Sperm Survival Assay: an established method for evaluating sperm compatibility.

Meeting the predefined specifications and passing these standardized tests constitutes the "ground truth" for demonstrating the device's acceptable performance and safety.

8. The sample size for the training set

Not applicable, as this device does not involve machine learning or AI algorithms requiring a training set.

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

Actively Trying Personal Lubricant Unfragranced is a personal lubricant for penile, and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive. This product is compatible with natural rubber latex and polvisoprene condoms. This product is not compatible with polyurethane condoms.

Actively Trying Personal Lubricant Unfragranced is a clear, semi-viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. This product is compatible with sperm, oocytes and can be used by couples trying to conceive. Actively Trying Personal Lubricant Unfragranced is sold as an over-the-counter (OTC) product in 4 fl. oz./120 mL size. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The individual bottles are hermetically sealed during the production process. This device is composed of Water (Aqua), Hydroxyethylcellulose, Sodium Chloride, Sodium Phosphate, Potassium Phosphate, Propylene Glycol, Chlorphenisen, Fructose and Arabinogalactan.

This document describes the regulatory submission for the Actively Trying Personal Lubricant Unfragranced (K212705). The information provided focuses on the device's characteristics and the non-clinical performance testing conducted to demonstrate its safety and effectiveness.

Here’s a breakdown as requested:

1. 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)

The document does not specify the exact sample sizes for each non-clinical test (e.g., number of animals for toxicity, number of sperm samples for HSSA). The data provenance is not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective, but they are described as "non-clinical performance testing" and "real time aging study", implying prospective testing for the shelf life.

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

Not applicable. This is a non-clinical device that does not involve human readers or interpretation of medical images. Ground truth is established through laboratory test results against predefined scientific and regulatory standards (e.g., USP, ISO, ASTM).

4. Adjudication method for the test set

Not applicable. As noted above, this device does not involve expert adjudication for ground truth.

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 document is for a personal lubricant, not an AI-powered diagnostic or interpretive device.

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

Not applicable. This is not an algorithm or AI device.

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

The ground truth for the performance criteria is established by:

• Physical and Chemical Property Standards: USP (United States Pharmacopeia) standards for viscosity, pH, specific gravity, osmolality.
• Biological Standards: ISO (International Organization for Standardization) standards for biocompatibility (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity), USP standards for LAL (endotoxin) and antimicrobial effectiveness, and HSSA guidelines.
• Microbiological Standards: USP standards for total aerobic microbial count, total yeast and mold count, and presence of specific pathogens.
• Material Compatibility Standards: ASTM (American Society for Testing and Materials) standards for condom compatibility.
• Real-time aging study: to determine shelf life.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Ask a specific question about this device

H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming and #LubeLife Sensations Pleasure Kit for Two are 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. These products are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.

H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming and #LubeLife Sensations Pleasure Kit for Two are clear, semi-viscous personal lubricants that are compatible with natural rubber latex and polyisoprene condoms. 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 supplement the body's natural lubrication. These devices are composed of water (aqua), Glycerin, Propylene Glycol, Hydroxyethylcellulose, Chlorphenesin, Capsicum Frutescens Fruit Extract and PEG-60 Hydrogenated Castor Oil.

This document describes the validation of several personal lubricants for over-the-counter use. The products are H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, and #LubeLife Sensations Pleasure Kit for Two.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of a dataset for an AI/algorithm study. The performance data is derived from various laboratory tests and a real-time aging study of the physical lubricant products themselves. Therefore, information on sample size and data provenance in terms of country of origin or retrospective/prospective for a test set is not applicable here.

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

This information is not applicable as there is no mention of a test set requiring expert ground truth in the context of an AI/algorithm study. The "ground truth" for the device specifications and biocompatibility is established through adherence to recognized scientific standards (USP, ISO, ASTM) and laboratory testing by presumably qualified personnel in those fields.

4. Adjudication Method for the Test Set

This information is not applicable as there is no test set requiring adjudication in the context of an AI/algorithm study.

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

An MRMC comparative effectiveness study was not done. This document concerns the performance of personal lubricants, not an AI or imaging device that would involve human readers.

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

A standalone performance study for an algorithm was not done. This document is about physical personal lubricant products.

7. The type of ground truth used

The ground truth for the device's performance is based on:

• Established scientific standards and pharmacopeial monographs: USP (United States Pharmacopeia) for viscosity, pH, specific gravity, osmolality, antimicrobial effectiveness, and microbial counts.
• International standards: ISO 10993 for biocompatibility (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity), and ASTM D7661-10 for condom compatibility.
• Laboratory test results: Derived from direct measurements and analyses of the lubricant's physical and chemical properties, as well as its interaction with biological systems (biocompatibility) and condoms.
• Real-time aging study: For shelf-life determination.

8. The Sample Size for the Training Set

This information is not applicable as there is no mention of a "training set" in the context of an AI/algorithm study for these personal lubricants. The product formulation development and testing would constitute the "development" phase, but it's not described as a training set for an AI.

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

This information is not applicable as there is no "training set" in the context of an AI/algorithm study. The composition and characteristics of the lubricants were developed and confirmed through standard chemical formulation, analytical testing, and quality control processes.

Ask a specific question about this device

H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling and #LubeLife Sensations Pleasure Kit for Two are 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. These products are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.

H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling and #LubeLife Sensations Pleasure Kit for Two are clear, semi-viscous personal lubricants that are compatible with natural rubber latex and polyisoprene condoms. 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 supplement the body's natural lubrication.

H2O Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL, 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

H2O Anal Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in 2 fl. oz/60 mL and 4 fl. oz./120 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

JO 2 To Tango for Me is sold as an over the counter (OTC) product in 2 fl. oz/60 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

JO 2 To Tango Couples Pleasure Kit is sold as an over the counter (OTC) product in 2 fl. oz/60 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

#LubeLife Sensations Cooling is sold as an over the counter (OTC) product in 4 fl. oz./120 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 4 fl. oz./120 mL size bottles are capped with natural disc tops. The individual bottles are hermetically sealed during the production process.

#LubeLife Sensations Pleasure Kit for Two is sold as an over the counter (OTC) product in 4 fl. oz./120 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 4 fl. oz./120 mL size bottles are capped with natural disc tops. The individual bottles are hermetically sealed during the production process.

These devices are composed of Water (Aqua), Glycerin, Polysorbate 20, Propylene Glycol, Hydroxyethylcellulose, Chlorphenesin, Mentha Piperita (Peppermint) Leaf Extract and Sodium Hydroxide.

The document describes the acceptance criteria and supporting studies for several H2O and JO brand cooling personal lubricants.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Biocompatibility: The document states that "Biocompatibility studies... were performed," implying specific samples were used for testing. However, the exact sample sizes (e.g., number of animals or in-vitro replicates) are not specified. The provenance is not explicitly stated beyond being performed "in accordance with the 2020 FDA Guidance document Use of International Standard ISO 10993-1" and "ISO 10993-1:2019." These are international standards. The study is prospective in nature as it involves testing the device.
• Shelf-Life: The document states "All the devices specifications listed in Table 1 were tested at 0, 1, 2 and 3 years." This indicates longitudinal testing of samples over time. The sample size at each time point is not specified. Data provenance is not detailed, but it's a real-time aging study, implying internal testing by the manufacturer. This is a prospective study.
• Condom Compatibility: The document states "The compatibility... was evaluated in accordance with ASTM D7661-10 (Reapproved 2017)." The number of lubricant and condom samples tested is not specified. This is a prospective study following an ASTM standard.

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

This information is not applicable as the device is a personal lubricant, and the testing involves laboratory and in-vivo biocompatibility, shelf-life, and material compatibility tests, not clinical performance requiring expert interpretation of diagnostic images or patient data. The criteria are based on established scientific standards and physical properties.

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

This information is not applicable for the type of testing performed (laboratory and material compatibility). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for resolving discrepancies in expert interpretations (e.g., radiology reads).

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 information is not applicable. The device is a personal lubricant, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance comparisons are not relevant.

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

This information is not applicable. The device is a personal lubricant, not an algorithm or AI system.

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

The "ground truth" for the performance criteria is established by:

• Established physical and chemical specifications: For properties like appearance, color, odor, viscosity, pH, specific gravity, and osmolality.
• Microbiological standards: For antimicrobial effectiveness (USP ) and microbial counts/absence of pathogens (USP , , ).
• International and national testing standards: Specifically ISO 10993 for biocompatibility and ASTM D7661-10 for condom compatibility. These standards define the methodologies and corresponding acceptance criteria.
• Real-time aging study: For shelf-life, the ground truth is the documented stability of the product properties over the specified time period.

8. The sample size for the training set:

This information is not applicable. As a physical product, there is no "training set" in the context of machine learning or AI development.

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

This information is not applicable. There is no training set for this type of device.

Ask a specific question about this device

Agape Cooling Personal Lubricant is a 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.

Agape Cooling Personal Lubricant is a clear, semi-viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication.

The device is provided in 1 fl. oz./30 mL and 2 fl. oz./60 mL sizes provided in clear polyethylene terephthalate (PET) cylinder bottles. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

This device is composed of Water, Propanediol, Gluconolactone, Hydroxyethylcellulose, Sodium Benzoate, Polysorbate 20, Citric Acid and Mentha Piperita (Peppermint) Leaf Extract.

The document describes the regulatory approval for "Agape Cooling Personal Lubricant" and includes details about its acceptance criteria and the studies performed to demonstrate its safety and effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each specific test mentioned (e.g., biocompatibility, condom compatibility, microbiological tests, or shelf-life). The data provenance is not specified in terms of country of origin, but the studies were conducted to comply with US FDA guidance and international ISO standards. All studies appear to be prospective as they are testing the product prior to its market release.

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

The document does not specify the number of experts or their qualifications for establishing ground truth. The acceptance criteria and testing methods refer to internationally recognized standards (e.g., USP, ISO, ASTM), implying that expert consensus is embedded within these standards, but individuals involved in performing or interpreting these tests are not detailed.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method (e.g., 2+1, 3+1). The testing process relies on standardized laboratory methods (USP, ISO, ASTM) and the results are reported as meeting or not meeting these standards.

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 performed. This type of study is typically associated with imaging algorithms or diagnostic devices where human readers interpret cases. The device in question is a personal lubricant, and its performance evaluation does not involve human readers interpreting cases.

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

This question is not applicable. The device is a personal lubricant, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance tests conducted are "standalone" in the sense that they evaluate the lubricant itself against physical, chemical, and biological criteria, without human interaction as part of the primary performance metric.

7. The Type of Ground Truth Used

The ground truth for the performance tests is based on:

• Established industry standards and regulatory guidelines: USP (United States Pharmacopeia), ISO (International Organization for Standardization), and ASTM (American Society for Testing and Materials) standards define the acceptable limits and methodologies for testing.
• Scientific measurement and observation: Laboratory tests measure properties like viscosity, pH, osmolality, microbial counts, and observe biological responses (cytotoxicity, irritation, sensitization).
• Predicate device comparison: The device's safety and effectiveness are also framed in comparison to a legally marketed predicate device (Premium Cooling Personal Lubricant K200602), showing substantial equivalence despite some formulation differences.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical product (personal lubricant), not an AI algorithm that requires a "training set" of data.

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

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

Ask a specific question about this device

Premium Cooling Personal Lubricant is a 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, polyisoprene and polyurethane condoms.

Premium Anal Cooling Lubricant is a 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, polyisoprene and polyurethane condoms.

Premium Cooling Personal Lubricant and Premium Anal Cooling Lubricant are clear, semi-viscous personal lubricants that are compatible with natural rubber latex, polyisoprene and 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 supplement the body's natural lubrication.

Premium Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL and 2 fl. oz./60 mL sizes. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

Premium Anal Cooling Lubricant is sold as an over-the-counter (OTC) product in 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

These devices are composed of Dimethicone, Dimethiconol and Menthol.

The provided FDA 510(k) summary document for "Premium Cooling Personal Lubricant" and "Premium Anal Cooling Lubricant" is for a personal lubricant, not an AI/ML device. Therefore, the questions related to AI/ML device acceptance criteria and studies (such as sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, and ground truth establishment for training) are not applicable to this document.

However, I can extract the acceptance criteria and study information for this non-AI/ML medical device from the document.

Acceptance Criteria and Reported Device Performance

Study Information (for non-AI/ML device):

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

   • Biocompatibility Studies: Not specified in terms of sample size for living organisms. The tests performed are standard in vitro and in vivo toxicology tests (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity). Data provenance is not mentioned.
   • Shelf-Life Study: Samples were tested at 0, 1, 2, and 3 years. The number of individual product units tested at each time point is not specified. Data provenance is not mentioned.
   • Condom Compatibility Study: Evaluated in accordance with ASTM D7661-18. The number of condoms or lubricant samples tested is not specified. Data provenance is not mentioned.

2. 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 as this is not an AI/ML diagnostic device requiring expert interpretation for ground truth. Performance is assessed against scientific/regulatory standards and specifications.

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

   • Not applicable as this is not an AI/ML diagnostic device.

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 as this is not an AI/ML diagnostic device.

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

   • Not applicable as this is not an AI/ML device. The device itself is the "standalone" product being evaluated.

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

   • The "ground truth" here refers to established scientific and regulatory standards/specifications (e.g., USP monographs for viscosity, microbial limits, and antimicrobial effectiveness; ISO standards for biocompatibility; ASTM standards for condom compatibility).

7. The sample size for the training set:

   • Not applicable as this is not an AI/ML device that requires training data.

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

   • Not applicable as this is not an AI/ML device that requires training data.

Ask a specific question about this device