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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.

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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.

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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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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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Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) is a personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

The Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) is a hydrous, clear water-based personal lubricant with aloe and vitamin E that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. It is a clear, colorless viscous gel. The lubricant formula is thickened using sodium hyaluronate and hydroxyethylcellulose. It contains a pH buffer system to maintain a slightly acidic pH of 5.9 to 6.9, and is preserved using Symocide pH (Phenoxyethanol, Hydroxyacetophenone, Caprylyl Glycol, and Water).

The Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) may be packaged in two (2) types of polyethylene terephthalate (PET) bottles. One bottle (PET), 5.5 fl. oz. with a screw on, flip-top polypropylene (PP) closure. An induction seal will be placed over the bottle. The second bottle (PET), 4.5 fl. oz., will be the same bottle material with a pump in the bottle. The pump and nozzle will be made of the same material as the flip-top cap (PP). The pump bottle will have a shrink band over the pump.

This document, K180764, is a 510(k) Premarket Notification for a personal lubricant, Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant). It is not a medical imaging AI device, and therefore does not contain information related to AI model training, testing, or human reader studies.

The acceptance criteria and performance data provided in this document pertain to the physical, chemical, and biological properties of the personal lubricant, and its compatibility with condoms, as well as its shelf life.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI device meets those criteria, as this document is for a non-AI medical device.

However, I can extract the acceptance criteria and performance data relevant to this specific device (personal lubricant) as presented in the document.

Acceptance Criteria and Reported Device Performance (for Trojan™ Azul Personal Lubricant):

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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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Gun Oil silicone lubricant is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyurethane condoms. This product is not compatible with polyisoprene or natural rubber latex condoms.

Pink silicone lubricant for women is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyurethane condoms. This product is not compatible with polyisoprene or natural rubber latex condoms.

Gun Oil H20 water-based is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyisoprene condoms. This product is not compatible with polyurethane or natural rubber latex condoms.

Pink Water water-based lubricant for women is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyisoprene condoms. This product is not compatible with polyurethane or natural rubber latex condoms.

Not Found

I am unable to answer this question. The provided document is a letter from the FDA regarding a 510(k) premarket notification for personal lubricants (condoms). It does not contain any information about acceptance criteria, device performance, a study, or any of the other specific details requested in the prompt, such as sample sizes, expert qualifications, or ground truth methods. Therefore, I cannot extract the requested information from this document.

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Intended for use where monitoring airway pressure is desired by providing a visual indication of airway pressure and may be used on all patient populations in the hospital, post-hospital and home care environments
Intended for use where monitoring airway pressure is desired. This device provides a visual indication of airway pressure and may be used on all patient populations in the hospital, pre-hospital, post-hospital and home care environments.

Single patient use mechanical pressure manometer indicator compresses a spring to a position where the force exerted by the gas equals the force exerted by the compressed spring combinations and graduated marking on individual housings allow the device to be offered in 0 - 60 cm H2O and 0 - 15 cm H2O pressure ranges.

The A Plus Medical VentiPlus™ Disposable Pressure Manometer is compared against an electronic pressure measurement device to assess its accuracy.

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 the exact sample size for the test set (number of devices tested or readings taken).

Data provenance: The testing appears to be in-house bench testing conducted by A Plus Medical. No information is provided regarding the country of origin of the data or if it was retrospective or prospective.

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

Not applicable. The ground truth was established using an "electronic pressure measurement device," which is a piece of equipment, not human experts.

4. Adjudication method for the test set

Not applicable. The ground truth was established by an electronic device, not human experts, so no adjudication method was required.

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, an MRMC comparative effectiveness study was not done. This device is a mechanical pressure manometer, not an AI-assisted diagnostic tool.

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

Yes, a standalone performance test was done. The device's accuracy was tested against an electronic pressure measurement device without direct human interaction being part of the measurement process itself beyond initiating and observing the test.

7. The type of ground truth used

The ground truth used was measurements from an "electronic pressure measurement device."

8. The sample size for the training set

Not applicable. This is a mechanical device, not a machine learning algorithm, therefore, there is no training set.

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

Not applicable. As stated above, there is no training set for this type of device.

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The Extreme H2O® 54% (hioxifilcon D) soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 10.00 Diopters.

Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

Extreme H2O® 54% (hioxifilcon D) soft contact lenses are hemispherical shells and are available as spherical (G54 13.6 and G54 14.2) or toric (G54 Toric) lens designs. The Extreme H2O® 54% (hioxifilcon D) soft contact lens is fabricated from hioxifilcon D, which is a non-ionic, copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 46% hioxifilcon D and 54% water by weight when immersed in normal saline solution buffered with either sodium bicarbonate or sodium borate. The lens is available with a blue visibility handling tint. phthalocyanato (2) - (copper).

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped. However, it will return to its proper configuration when completely rehydrated in the proper storage solution.

Here is the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device Name: Extreme H2O® 54% (hioxifilcon D) Soft Contact Lens for Daily Wear

1. Table of Acceptance Criteria and Reported Device Performance

The submission relies on a comparison to a predicate device (59% Extreme H2O® (hioxifilcon A) soft contact lens) and chemical/physical/toxicological testing to establish substantial equivalence. Direct "acceptance criteria" and "reported performance" for specific clinical outcomes are not explicitly stated as they would be for a novel device. Instead, the "acceptance criteria" are implied by demonstrating that the new device's material properties fall within the range of, or are comparable to, already cleared materials and predicate devices.

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

• Test Set Sample Size: Not applicable in the context of a clinical study. The "test set" here refers to the new device (Extreme H2O® 54%), which underwent material characterization and toxicology testing.
• Data Provenance: The toxicology tests were performed on the Extreme H2O® 54% material (hioxifilcon D). The document implies these were standard ISO tests. The country of origin and whether the data was retrospective or prospective is not specified for these specific tests, but they are generally carried out prospectively as part of product development.

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

Not applicable. Ground truth, in the sense of expert consensus on clinical findings, was not established for this submission. The "ground truth" for the material properties and toxicology was based on established scientific and regulatory standards for material characterization and pre-clinical safety testing (e.g., ISO standards for toxicology).

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication in the context of expert consensus or diagnostic accuracy.

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

No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a contact lens, not an AI algorithm. Its performance is inherent to the physical and chemical properties of the lens, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission was based on:

• Material Characterization: Scientific measurements of properties like water content, refractive index, light transmission, specific gravity, and oxygen permeability.
• Toxicology Data: Results from standardized ISO safety tests (Systemic Injection Test, Agar Diffusion Test, Primary Ocular Irritation).
• Substantial Equivalence to Predicate Device: The established safety and effectiveness of the legally marketed predicate device(s) (59% Extreme H2O® (hioxifilcon A) and Benz-G 3X (hioxifilcon B)).

8. The Sample Size for the Training Set

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

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

Not applicable.

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The 59% Extreme H2O (hioxifilcon A) toric soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 10.00 Diopters or less.

Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

59% Extreme H2O (hioxifilcon A) soft contact lenses are hemispherical shells and are available as spherical (G59 S-Thin and G59 S-Xtra) or toric (G59 Toric) lens designs. The 59% Extreme H2O (hioxifilcon A) soft contact lens is fabricated from hioxifilcon A, which is a non-ionic, copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 41% hioxifilcon A and 59% water by weight when immersed in normal saline solution buffered with either sodium bicarbonate or sodium perforate. The lens is available with a blue visibility handling tint, phthalocyanato (2) - (copper).

The provided text is a 510(k) Premarket Notification for a soft contact lens and does not contain information about acceptance criteria, device performance metrics, or a study evaluating such performance.

Instead, it focuses on demonstrating substantial equivalence to a previously cleared device. Therefore, I cannot provide the requested information.

Here's why and what's missing:

• No Acceptance Criteria or Performance Metrics: The document describes the device, its intended use, and argues for its substantial equivalence to another cleared product. It does not list specific performance criteria (e.g., visual acuity targets, comfort scores, lens fit parameters) that the new toric lens must meet, nor does it report data on how the device performed against such criteria.
• No Study Described: There is no mention of a clinical trial or a formal study designed to assess the performance of the 59% Extreme H2O (hioxifilcon A) toric soft contact lens. The clearance is based on its similarity to an existing spherical lens, assuming similar safety and effectiveness.
• No Information on Experts, Sample Sizes, or Ground Truth: Since no performance study is described, there is no information regarding sample sizes for test or training sets, data provenance, the number or qualifications of experts, adjudication methods, or the type of ground truth used.
• No MRMC or Standalone Performance: These terms are relevant to assessing the performance of AI/CAD systems, which is not the subject of this 510(k) submission.

Summary of what can be extracted related to the device:

• Device Name: 59% Extreme H2O (hioxifilcon A) toric soft contact lens
• Intended Use: Correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic, who exhibit astigmatism of 10.00 Diopters or less.
• Predicate Device: 59% Extreme H2O (hioxifilcon A) spherical lens (K992692)
• Basis for Clearance: Substantial Equivalence to the predicate device, differing only in design (toric vs. spherical).

To answer the questions posed, a document detailing a clinical or non-clinical performance study of the 59% Extreme H2O toric soft contact lens would be required.

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