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JO for Him H2O Gel Original 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 for Him H2O Gel Original Personal Lubricant is a clear/water white, 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 and supplement the body's natural lubrication. This product is sold as an over-the-counter (OTC) product in 4 oz. and 8 oz. sizes provided in matte black, polyethylene (PE) tubes. These tubes are capped with silver, glossy, polypropylene (PP) flip tops. The individual tubes are hermetically sealed during the production process. This device is composed of Water (Aqua), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glycerin, Methylparaben, Propylparaben, Hydroxyethylcellulose and Sodium Hydroxide.

The provided document is a 510(k) summary for a personal lubricant, not a medical imaging device or AI algorithm. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance is not present in this document.

The document describes the device specifications for the JO for Him H2O Gel Original Personal Lubricant and the performance testing conducted to demonstrate its safety and effectiveness relative to a predicate device.

Here's an analysis of the available information, structured as closely as possible to your request, but acknowledging the information gaps:

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)

This information is not provided in the document. The studies referenced are standard laboratory tests (e.g., biocompatibility testing according to ISO standards, shelf-life testing, condom compatibility testing according to ASTM standards). These typically involve a defined number of samples or animals for each test component as specified by the standards, but the exact sample sizes are not detailed in this summary. The data provenance is internal testing performed by or for United Consortium.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this type of device and study. The "ground truth" for the performance criteria listed (pH, viscosity, microbial counts, etc.) is established by standard laboratory methods and validated instrumentation, not by human expert consensus or interpretation as would be the case for medical imaging algorithms.

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

This is not applicable to this type of device. Adjudication methods are typically used in clinical studies or expert review processes for diagnostic devices to resolve discrepancies in interpretation. The tests described are objective laboratory 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

This is not applicable to this device. An MRMC study is relevant for diagnostic imaging devices used by human readers with AI assistance. This document describes a personal lubricant.

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

This is not applicable to this device. This would apply to an AI algorithm, not a physical product like a personal lubricant.

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

The "ground truth" for the device specifications (e.g., pH, viscosity, sterility, ingredient presence) is established through standardized analytical chemistry and microbiology laboratory tests (e.g., USP and ASTM methods) and biological evaluations (e.g., ISO 10993 series). For biocompatibility, the ground truth is the biological response observed in the specified animal models or in vitro assays. For shelf-life, the ground truth is the maintenance of specifications over time. For condom compatibility, it is the performance against the ASTM standard.

8. The sample size for the training set

This is not applicable to this device. A "training set" refers to data used to train a machine learning algorithm. This document describes a physical product and its testing.

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

This is not applicable to this device, as there is no training set mentioned or implied.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The device's performance was proven through a series of laboratory and biological tests conducted in accordance with recognized international and national standards:

• Biocompatibility Studies: Performed according to the 2016 FDA guidance document on ISO 10993-1 and specific parts of ISO 10993 (Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), Vaginal Irritation (ISO 10993-10:2010), Penile Irritation (ISO 10993-10:2010), and Acute Systemic Toxicity (ISO 10993-11:2006)). These studies demonstrated that the lubricant is "only slightly cytotoxic, non-irritating, non-sensitizing and non-systemically toxic," meeting the safety requirements.
• Shelf-Life Study: A real-time aging study was conducted for 3 years. All device specifications listed in Table 1 (Appearance, Color, Odor, Viscosity, pH, Specific Gravity, Osmolality, Antimicrobial effectiveness, Microbial counts, and absence of specific pathogens) were tested at 0, 1, 2, and 3 years. The device "met the device specifications at all time points," thus proving its 3-year shelf-life.
• Condom Compatibility Testing: Evaluated in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." The results indicated compatibility with natural rubber latex and polyisoprene condoms, and incompatibility with polyurethane condoms.
• Physical, Chemical, and Microbiological Testing: The device specifications listed in Table 1 (e.g., Viscosity per USP , pH per USP , Specific Gravity per USP , Osmolality per USP , Antimicrobial effectiveness per USP , Microbiological counts per USP and , and presence of pathogens per USP ) were evaluated to ensure the product met defined quality and safety standards. While specific numerical results are not provided for each, the summary implies successful compliance with these specifications.

These studies collectively support the conclusion that the JO for Him H2O Gel Original Personal Lubricant is "as safe and effective as the predicate device and supports a determination of substantial equivalence."

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Bucked Stride Silicone Lubricant is a silicone-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 Thin Silicone Lubricant is a silicone-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.

JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant is a silicone-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.

Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant and JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant are clear, thin, liquid 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.

The Bucked Stride Silicone Lubricant product is to be 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 clear polyethylene terephthalate (PET) cylinder bottles are capped with matte black pumps covered with a metallic coated polypropylene (PP) overcap and shrink wrapped to ensure product integrity.

#LubeLife Thin Silicone Lubricant is to be sold as an over-the-counter (OTC) product in 8 fl. oz./240 mL size bottles. This product is provided in clear, polyethylene terephthalate (PET) cylinder bottles and capped with natural disc tops. The individual bottles are hermetically sealed during the production process.

JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant is to be 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 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 and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

The provided text is a 510(k) Summary for personal lubricants and does not contain information about a medical device that utilizes artificial intelligence or requires extensive clinical studies with human readers or image interpretation. Therefore, a direct answer to the prompt's request for acceptance criteria and studies proving the device meets them, especially those pertaining to AI model performance (like MRMC studies, ground truth establishment for training/test sets, expert adjudication, etc.), cannot be extracted from this document.

The document focuses on the physical and chemical properties, biocompatibility, shelf-life, and condom compatibility of the personal lubricants. The "acceptance criteria" discussed are essentially the device specifications and the results of non-clinical performance testing.

However, I can provide the available information in a structured way that addresses the spirit of the request as much as possible, mapping the given content to the closest relevant sections of your prompt.

Acceptance Criteria and Study for Personal Lubricants (K190858)

1. Table of Acceptance Criteria and the Reported Device Performance:

The device's performance is demonstrated through non-clinical testing against established specifications.

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

• Sample Size: Not explicitly stated as a number of distinct "samples" in microbiological or physical testing terms, but testing was performed on "various packaging types" and "largest volumes associated with each packaging type" for shelf-life, considered "worst case." Biocompatibility tests would involve animal models or cell cultures, but specific numbers are not provided.
• Data Provenance: The studies were non-clinical performance testing (laboratory-based). The country of origin for the data is not specified, but the submission is to the U.S. FDA. The studies are by nature prospective as they are designed to test the product's compliance with specifications.

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

• This is not applicable as the device is a personal lubricant, not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" here is the adherence to physicochemical and biological specifications, determined by standard laboratory methods and validated against USP and ISO standards.

4. Adjudication Method for the Test Set:

• Not applicable. Performance is assessed against predetermined quantitative and qualitative specifications using laboratory measurements.

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 AI-powered diagnostic devices where AI assists human readers (e.g., radiologists) in interpreting medical images. The device in this submission is a personal lubricant.

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

• No, this concept is not applicable. The device is a physical product, not an algorithm. Its "standalone performance" refers to its intrinsic properties and safety/effectiveness without human applied intervention beyond its intended use.

7. The Type of Ground Truth Used:

• For this device, the "ground truth" is based on:
  • Validated laboratory methods and specifications: Adherence to physical properties (viscosity, specific gravity, appearance, color, odor).
  • Industry and regulatory standards: Compliance with USP (, , , ) for antimicrobial effectiveness and microbial counts.
  • International standards (ISO 10993-series) and FDA guidance: For biocompatibility testing (cytotoxicity, sensitization, irritation, acute systemic toxicity).
  • ASTM standards (ASTM D7661-10): For condom compatibility.

8. The Sample Size for the Training Set:

• Not applicable. This device is a manufactured product, not an AI model that undergoes "training."

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

• Not applicable. As the "training set" concept does not apply to this product, neither does the establishment of its ground truth.

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JO Premium Jelly Original 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, polyurethane and polyisoprene condoms.

JO Premium Jelly Original Personal Lubricant is a clear/water white, viscous gel-type personal lubricant that is compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This provided in clear, polyethylene (PE) tubes. These 4 oz. size tubes are capped with silver, glossy, polypropylene (PP) flip tops. The individual tubes are hermetically sealed during the production process.

This document describes a 510(k) submission for a personal lubricant and focuses on demonstrating its substantial equivalence to a predicate device. Therefore, it does not involve AI or machine learning, which are typically associated with complex acceptance criteria and studies like MRMC.

Based on the provided document, here's a breakdown of the acceptance criteria and the studies performed, tailored to a medical device rather than an AI product:

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

The acceptance criteria are primarily based on comparisons to the predicate device and established international standards for medical device safety and performance.

2. Sample sized 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 exact sample sizes for each test in terms of individual units of the lubricant. Instead, it refers to general testing procedures. For biological tests (biocompatibility), typically a minimum number of test units and control units are used as per the specific ISO standards. For chemical/physical property tests, sample sizes are usually defined by the ASTM or USP methods.

The data provenance is from non-clinical performance testing, meaning these were laboratory studies rather than studies on human subjects. The country of origin of the data is not explicitly stated, but the testing was conducted in accordance with international standards (ISO) and U.S. Pharmacopeia (USP) guidelines, implying recognized laboratory practices. These would inherently be prospective studies relative to the testing itself (i.e., new tests performed on the device).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This concept of "experts" and "ground truth" to establish a test set is not directly applicable to this type of medical device submission. The "ground truth" here is defined by:

• Established scientific and industry standards (e.g., USP , USP , USP , USP , ASTM D7661-10, ISO 10993 series).
• The specifications of the predicate device.

The "experts" involved would be qualified laboratory technicians and scientists performing the tests and interpreting results against these objective criteria, rather than clinical experts providing subjective assessments.

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

Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where subjective assessments (e.g., image interpretation by radiologists) require a consensus mechanism. This is not applicable here as the performance evaluation relies on objective, quantifiable laboratory tests against established standards. Therefore, the adjudication method is none in this context.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specific to diagnostic aids, particularly those involving human interpretation of data (e.g., medical imaging) and often used to assess the effectiveness of AI assistance. This device is a personal lubricant, and its evaluation does not involve human readers or AI assistance.

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

A standalone (algorithm-only) performance study was not applicable or performed, as the device is not an algorithm or AI product.

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

The "ground truth" for this device's evaluation is primarily established by:

• International Standards and Pharmacopeia Methods: E.g., ISO 10993 for biocompatibility, USP methods for microbiological analysis, and ASTM D7661-10 for condom compatibility. These standards define the acceptable performance parameters.
• Predicate Device Specifications: The composition and performance characteristics of the legally marketed predicate device (Astroglide Diamond Silicone Gel Personal Lubricant, K163395) serve as a benchmark for substantial equivalence.

8. The sample size for the training set

The concept of a "training set" is relevant for machine learning and AI algorithms. Since this device is a physical product (personal lubricant) and not an AI system, there was no training set used.

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

As there was no training set, this question is not applicable.

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JO Actively Trying Personal Lubricant 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 can be used by couples trying to conceive. This product is compatible with natural rubber latex, polyurethane and polyisoprene condoms.

JO Actively Trying Personal Lubricant is a clear, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. This device is a non-sterile personal lubricant for penile and/or vaginal application, 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 sperm, oocytes and embryos and can be used by couples trying to conceive. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles are capped with silver disc top caps. The individual bottles are hermetically sealed during the production process. This device is composed of Water (Aqua), Propylene Glycol, Hydroxyethylcellose, Fructose, Arabinogalactan, Sodium Phosphate, Salt, Potassium Phosphate, Methylparaben.

Here's a breakdown of the acceptance criteria and study information for the JO Actively Trying Personal Lubricant, based on the provided FDA 510(k) summary:

This device is a personal lubricant, and the studies performed are primarily non-clinical laboratory tests to demonstrate its safety, effectiveness, and compatibility for its intended use, rather than clinical studies in humans. Therefore, many of the typical categories for AI/medical device clinical studies (like sample size for test sets, expert ground truth, adjudication methods, MRMC studies) are not applicable here.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable in the context of a typical AI/ML clinical test set. The studies performed are non-clinical laboratory tests on the product itself.
• For tests like HSSA, LAL, antimicrobial, and pathogen tests, the "sample size" would refer to the number of lubricant product samples tested, biological reagents used, or microbial cultures, which are not specified in this summary. The data provenance is from laboratory tests conducted presumably by or for the manufacturer.

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

• Not applicable. This summary does not describe a study involving human experts establishing ground truth for a test set in the way it would for an AI diagnostic device. The "ground truth" for the lubricant's properties (e.g., pH, viscosity, sperm survival, microbial counts) is established by adherence to recognized laboratory standards and methods.

4. Adjudication method for the test set

• Not applicable. No adjudication method is described as this is not a study requiring human interpretation or consensus.

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 a physical product (personal lubricant), not an AI-based diagnostic or assistive device that would involve human readers or cases.

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

• Not applicable. This is a physical product, not an algorithm.

7. The type of ground truth used

• The "ground truth" for this product is based on objective measurements, quantitative laboratory assays, and adherence to established industry and regulatory standards as defined by:
  • Device specifications (e.g., pH, viscosity, osmolality).
  • Standardized microbiological tests (e.g., USP , , , ).
  • Biocompatibility standards (e.g., ISO 10993 series).
  • Specific performance assays (Human Sperm Survival Assay, Limulus Amebocyte Lysate Gel-Clot Method, Lubricant Barrier Assay, Condom Compatibility per ASTM D7661-10).

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

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

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JO H2O Jelly Original 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 H2O Jelly Original Personal Lubricant is a clear/water white, viscous gel-type personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. This product is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is provided in clear, polyethylene (PE) tubes. These 4 oz. size tubes are capped with silver, glossy, polypropylene (PP) flip tops. The individual tubes are hermetically sealed during the production process.

This document is a 510(k) premarket notification for a personal lubricant (JO H2O Jelly Original Personal Lubricant), and as such, it does not contain the kind of detailed study information (like a multi-reader multi-case study, ground truth establishment for a large training set, or specific acceptance criteria for an AI algorithm's performance on a test set) that would be present for an AI/ML medical device.

The "acceptance criteria" discussed in this document refer to the physical and chemical specifications of the lubricant itself, as well as its biocompatibility and condom compatibility, and microbiological quality, not the performance of an AI model. Therefore, I cannot extract the information required by your prompt, such as:

• A table of acceptance criteria and the reported device performance for an AI algorithm.
• Sample size used for the test set and data provenance for AI evaluation.
• Number of experts used to establish ground truth and their qualifications for AI evaluation.
• Adjudication method for AI evaluation.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• If a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI evaluation.
• The sample size for the training set for an AI algorithm.
• How the ground truth for the training set was established for an AI algorithm.

Instead, the document details the following regarding the lubricant itself:

1. A table of device specifications (acceptance criteria for the product) and the measured or tested performance:

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

• This document does not describe the kind of "test set" or "data provenance" that would apply to an AI/ML device. The testing described is laboratory-based performance testing of the physical product. No geographic data provenance is mentioned. The studies (biocompatibility, shelf-life, condom compatibility) are prospective tests performed on the manufactured product.

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 to this type of device submission. Ground truth is established by standard laboratory testing methods (e.g., USP , ASTM D7661-10) rather than expert consensus on medical images or diagnoses.

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

• Not applicable to this type of device submission.

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 a physical lubricant, not an AI-based diagnostic or assistive device.

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

• Not applicable; this is a physical lubricant, not an AI algorithm.

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

• The "ground truth" for this product is based on established laboratory standards and test methods for material properties, sterility, biocompatibility, and compatibility with other medical devices (condoms). Examples include:
  • USP for antimicrobial effectiveness
  • USP and for microbial counts
  • USP for pathogen presence
  • ISO 10993 series for biocompatibility (e.g., Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity)
  • ASTM D7661-10 for condom compatibility

8. The sample size for the training set

• Not applicable; this is a physical lubricant, not an AI algorithm.

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

• Not applicable; this is a physical lubricant, not an AI algorithm.

In summary, the provided document describes the safety and effectiveness testing of a personal lubricant, focusing on its physical properties, biocompatibility, and compatibility with condoms, rather than the performance of an AI/ML medical device.

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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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JO Naturalove Personal Lubricant and JO Naturalove Strawberry Fields Flavored Personal Lubricant 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, polyurethane and polyisoprene condoms.

JO Naturalove Personal Lubricant and JO Naturalove Strawberry Fields Flavored Personal Lubricant are clear, viscous, amber colored, gel type personal lubricants that are compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. These devices are non-sterile personal lubricants for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Both versions of the subject device have the same formulation, with the exception of the addition of a fragrance to the JO Naturalove Strawberry Fields Flavored Personal Lubricant. These devices are provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural disc top dispenser caps. The 2 oz., 4 oz. and 8 oz. size bottles are capped with silver top dispenser caps. The individual bottles are hermetically sealed during the production process. These products are also available in 0.1 oz and 0.3 oz polyester-faced laminated pouches.

The provided text describes a 510(k) premarket notification for a medical device, specifically a personal lubricant, and does not contain information about an AI/ML device or its associated studies. Therefore, I cannot provide an answer that includes acceptance criteria for an AI/ML device, sample sizes for test sets, expert qualifications, MRMC studies, or standalone algorithm performance.

The document focuses on demonstrating the substantial equivalence of the "JO Naturalove Personal Lubricant and JO Naturalove Strawberry Fields Flavored Personal Lubricant" to a predicate device (JO Gelato Flavored Personal Lubricants) based on physicochemical properties, biocompatibility, shelf-life, and condom compatibility.

Here is an analysis of the available information, structured to address parts of your request where applicable, but noting the absence of AI/ML-specific details:

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

The document provides a "Device Specifications" table, which functions as the acceptance criteria for the physical and chemical properties and microbial counts of the lubricant. The reported performance refers to the device meeting these specifications.

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 (e.g., number of batches, units tested) for the performance tests (e.g., viscosity, pH, microbial counts, biocompatibility, shelf-life, condom compatibility). The data provenance (country of origin, retrospective/prospective) is also not mentioned, as these are typically internal laboratory tests conducted by the manufacturer or contracted labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable to this type of device submission. Ground truth, in the context of an AI/ML device, refers to expertly verified labels or diagnoses. For a personal lubricant, "ground truth" is established by laboratory measurements against defined chemical, physical, and biological standards. There are no "experts" in the sense of clinicians interpreting outputs for ground truth establishment.

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

Not applicable. This device does not involve human interpretation or adjudication of results in the way an AI/ML diagnostic device would.

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 device and therefore no MRMC study was conducted.

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

Not applicable. This is not an AI/ML device.

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

For the physical and chemical properties, the "ground truth" is derived from established laboratory measurement techniques (e.g., pH meters for pH, viscometers for viscosity, osmometers for osmolality) compared against predetermined standard specifications. For microbial testing, it's based on standard microbiological culture methods. For biocompatibility, it's based on the results of specific in-vitro and in-vivo tests according to ISO 10993 standards. For condom compatibility, it's based on the standard ASTM D7661-10 test method.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in that context.

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

Not applicable. As there is no AI/ML training set, the concept of establishing ground truth for it does not apply.

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JO Classic Hybrid 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 Classic Hybrid Personal Lubricant is an off-white, semi-viscous, translucent gel type personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. This product is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural polypropylene disc top dispenser caps. The 2 oz., 4 oz. and 8 oz. size bottles are capped with silver polypropylene disc top dispenser caps. The individual bottles are hermetically sealed during the production process. This product is also available in polyester-faced laminated pouches.

This document describes the premarket notification (510(k)) for the JO Classic Hybrid Personal Lubricant. Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

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

The document does not explicitly state a "test set" in the context of a typical AI/software study. This is a medical device (personal lubricant), and the performance is evaluated through material properties and biocompatibility testing.

• For Shelf-Life and Device Specifications: The "test set" would be samples of the lubricant tested at different time points (0, 1, 2, and 3 years). The specific number of samples tested at each time point is not provided. The data provenance is internal testing performed by the manufacturer (United Consortium).
• For Biocompatibility: The "test set" involves biological models (in vitro and in vivo studies). The specific sample sizes for each biocompatibility test (e.g., number of cells in cytotoxicity, number of animals in sensitization/irritation/toxicity studies) are not provided in this summary. The data provenance is from studies conforming to ISO 10993 standards.
• For Condom Compatibility: The "test set" would be lubricant samples tested with natural rubber latex, polyisoprene, and polyurethane condoms. The specific number of samples / tests is not provided. The data provenance is from studies conforming to ASTM D7661-10.

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 this type of medical device submission. "Ground truth" in this context is established by standardized material testing and biocompatibility protocols, not expert consensus on interpretations. Laboratories performing these tests would have qualified personnel, but they are not "experts establishing ground truth" in the same way radiologists might for an imaging AI.

4. Adjudication method for the test set

Not applicable as it's not an expert-based subjective assessment. The results are from objective laboratory tests.

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 a personal lubricant, not an AI-powered diagnostic or assistive device requiring human interpretation.

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

Not applicable. This is a physical, chemical, and biological performance evaluation of a personal lubricant, not an algorithm.

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

The "ground truth" for this device is based on:

• Standardized Material/Chemical Specifications: Adherence to defined physical and chemical properties (e.g., pH range, viscosity range, osmolality range, microbial limits).
• International Standards: Compliance with recognized international standards for biocompatibility (ISO 10993 series) and condom compatibility (ASTM D7661-10). These standards define the test methods and acceptance criteria.
• Defined Acceptance Criteria: The device must meet the predefined specifications for each tested property.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of software development.

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

Not applicable.

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Coconut Infused Hybrid 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.

Coconut Infused Hybrid Personal Lubricant is a translucent cream, white to off-white in color, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. This device is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural disc top dispenser caps and the 4 oz. size bottles are capped with silver disc top dispenser caps. The individual bottles are hermetically sealed during the production process. This product is also available in polyester-faced laminated pouches.

The provided text is a 510(k) summary for a medical device (Coconut Infused Hybrid Personal Lubricant). It describes the device, its indications for use, comparison to a predicate device, and a summary of performance data.

However, the questions you've asked are typically related to the performance evaluation of a diagnostic or AI-powered medical device, which would involve metrics like accuracy, sensitivity, specificity, and studies with human readers or standalone algorithm performance.

The provided document describes a personal lubricant, which is a Class II medical device, and the "performance data" presented focuses on biocompatibility, shelf-life, and condom compatibility. These are very different types of evaluations than what your questions imply.

Therefore, I cannot extract the information you've requested regarding acceptance criteria and study details as they pertain to diagnostic performance, MRMC studies, or ground truth establishment in the context of an AI/diagnostic device.

Here's why I cannot answer your questions with the provided text:

• No Diagnostic Acceptance Criteria: The document does not define acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it focuses on physical and chemical specifications, biocompatibility, and compatibility with other products (condoms).
• No Device Performance Metrics: There are no reported device performance metrics like sensitivity, specificity, or accuracy that would be relevant to diagnosing a condition or aiding in image interpretation.
• No Test Set/Ground Truth: The concept of a "test set" with "ground truth" established by experts is not applicable to a personal lubricant. The "ground truth" here is determined by chemical and biological testing results against established standards.
• No Experts/Adjudication Method: The studies described (biocompatibility, shelf-life, condom compatibility) do not involve human experts establishing ground truth or adjudication methods.
• No MRMC or Standalone Studies: These types of studies are for evaluating diagnostic accuracy or reader improvement with AI assistance, which is irrelevant for a personal lubricant.
• No Training Set: The processes involved in developing a personal lubricant do not include "training sets" in the machine learning sense.

Instead, the document details the following performance and acceptance criteria relevant to a personal lubricant:

1. Table of Acceptance Criteria and Reported Device Performance (as per the document):

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 in the diagnostic sense. The "test sets" here refer to samples of the lubricant product used in laboratory testing for physical properties, microbiological counts, biocompatibility (animal or in-vitro models), and condom compatibility.
• Provenance: Not specified in terms of country of origin. The studies are performed "in accordance with" international and FDA guidance documents (e.g., ISO, USP, ASTM).
• Nature: These are likely prospective laboratory tests performed on samples of the manufactured device.

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. The ground truth for this device is established by standardized laboratory tests and their results, not expert consensus in a clinical diagnostic sense. The expertise lies in the laboratory technicians and scientists performing and interpreting these standardized tests.

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

• Not applicable. Adjudication methods are used to reconcile disagreements among human readers/experts, which is not part of this type of device testing.

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, this is a personal lubricant, not an AI-powered diagnostic device. MRMC studies are not relevant.

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

• No, 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 this device is based on standardized laboratory test results and adherence to established international and national standards (e.g., ISO 10993 for biocompatibility, USP , , , for microbiological quality, ASTM D7661-10 for condom compatibility).

8. The sample size for the training set

• Not applicable. There is no training set in the context of machine learning for this device.

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

• Not applicable, as there is no training set.

Ask a specific question about this device

JO H2O Flavored Personal Lubricants are water-based 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.

JO H2O Flavored Personal Lubricants are clear, semi-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, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.

These products are provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural disc top dispenser caps and the 4 oz. size bottles are capped with silver disc top dispenser caps. The individual bottles are hermetically sealed during the production process. These products are also available in polyester-faced laminated pouches.

The provided text is a 510(k) Premarket Notification from the FDA regarding "JO H2O Flavored Personal Lubricants." This document describes the device, its intended use, comparison to a predicate device, and performance data from various tests. However, it does not pertain to an AI/ML-enabled medical device or a study involving human readers and AI assistance. Therefore, I am unable to extract the specific information requested in the prompt regarding acceptance criteria and studies proving the device meets those criteria for an AI/ML context.

The document discusses acceptance criteria and studies for a personal lubricant, focusing on:

• Biocompatibility: Acute Systemic Toxicity, Vaginal Irritation, Penile Irritation, Cytotoxicity, and Sensitization.
• Shelf-Life: Real-time aging study testing device specifications at 0, 1, 2, and 3 years.
• Condom Compatibility: Evaluation with different condom materials (natural rubber latex, polyisoprene, polyurethane) in accordance with ASTM D7661-10.

Without information specific to an AI/ML medical device, I cannot fulfill the request as formatted.

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