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

Chiavaye Personal Moisturizer is a clear to slightly yellow and odorless oil-based personal lubricant that is not compatible with condoms made of natural rubber latex, polyisoprene, or polyurethane. This device is a non-sterile personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.

This device is sold as an over-the-counter (OTC) product in 30 mL and 100 mL sizes provided in black 'MIRON' glass, with a Polypropylene (PP) protective cap. The pump cap is made of Polypropylene (actuator), Nitrile (seal), and Polyethylene (tube).

The device is composed of Almond Oil, Coconut Oil, Grape Seed Oil, Sunflower Oil, Evening Primrose Oil, and Vitamin E.

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

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Ceryne Intimate Care is a silicone-based personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product is compatible with natural rubber latex, and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Ceryne Intimate Care is a non-sterile, silicone-based personal lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Its formulation consists of Dimethicone, Dimethiconol Silicone blend, 2-Octyldodecanol, Cholestrol, Span 60, Stearic Acid, Tocopheryl Acetate, Arlacel 165, Cetyl Stearyl Alcohol, Sodium Benzoate, Glycogen, L-Lactic Acid and Water. This device compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.

The lubricant is packaged in 15g and 30g tubes.

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The Lifestyles® HydraFeel Natural Rubber Latex Condom is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STIs).

The LifeStyles® HydraFeel Natural Rubber Latex Condom is a single use condom made of natural rubber latex, featuring a straight-shaft, smooth-walled membrane that closely fits the penis. It acts as an barrier to prevent the transmission of sperm, bodily fluids, or STIs into the reproductive tract. The condom is coated with an aqueous lubricant and includes an integral bead at the open end for retention and a reservoir tip at the closed end to contain semen. The LifeStyles® HydraFeel Natural Rubber Latex Condom has a nominal length of 180 mm, width of 52 mm, and thickness of 0.045 mm. Each condom is packaged individually in laminate foils that are secondarily packaged in cardboard shelf boxes.

The device conforms with all sections of consensus standards ISO 4074:2015, Natural rubber latex male condoms – Requirements and test methods, and ASTM D3492-16, Standard Specification for Rubber Contraceptives (Male Condoms).

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

Water-soluble Personal Lubricant is a non-sterile, water-based personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Its formulation consists of pure water, glycerin, hydroxyethyl cellulose, potassium sorbate, sodium benzoate, sodium lactate, flavors, ethylenediaminetetraacetic acid, etc. The subject device includes four different flavors of water-soluble personal lubricants: Vitamin E flavor, Caramel flavor, Peach flavor, and Strawberry flavor. This device is not compatible with natural rubber latex, polyisoprene and polyurethane condoms.

The lubricant is packaged in PE bottles of 100gm.

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

Plain Water-based Lubricant

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

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

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

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

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

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

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

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

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

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The Natural rubber latex male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Natural rubber latex male condom

This document is a 510(k) clearance letter from the FDA for a Natural rubber latex male condom. It is not a document about an AI/ML medical device and therefore does not contain any information about acceptance criteria, study data, ground truth, or expert review related to AI/ML performance.

The provided text only addresses the regulatory clearance for a physical medical device (condom) based on substantial equivalence to a predicate device. It details the product name, regulation number, regulatory class, and indications for use. It also outlines general regulatory requirements such as quality system regulations, UDI, and adverse event reporting.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth for an AI/ML device, as this information is not present in the provided document.

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

LubriZenzs is a non-sterile, water-based, over-the-counter personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. Its formulation consists of water, propanediol, cellulose gum, algin, 1,2-hexanediol, sodium hyaluronate, lactic acid, gluconolactone, Tremella fuciformis (mushroom) extract, caprylhydroxamic acid, sodium benzoate, calcium gluconate, sodium hydroxide, xylitylglucoside, anhydroxylitol, glycogen, xylitol, and glucose.

The Lubricant comes in a 100 mL white polypropylene plastic airless pump bottle, with a clear overcap. The lubricant has a shelf-life of 2 years.

Specifications:

• Appearance: Clear, flowable
• Color: Colorless
• Odor: Odorless
• pH: 4.5-5.0
• Viscosity: 10,000 – 25,000 cps
• Osmolality: 135 - 380 mOsm/kg (1:10 dilution)
• Total Microbial Count (TAMC): < 100 cfu/g
• Fungal/Yeast/Mold Limits (TYMC): < 10 cfu/g
• Absence of Pathogenic Organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella, Escherichia coli, Candida albicans): Absent
• Antimicrobial Effectiveness: Meets USP <51> criteria for category 2. Bacteria: No less than 2.0 log reduction from initial count at 14 days, and no increase from the 14-day count at 28 days. Yeast and Molds: No increase from the initial calculated count at 14 days and 28 days.

The FDA 510(k) clearance letter for LubriZenzs (K242712) pertains to a personal lubricant, not an AI-powered medical device. Therefore, the information requested in points 2, 3, 4, 5, 6, 7, 8, and 9 (related to AI study design, experts, ground truth, and training sets) is not applicable to this submission.

However, I can extract the acceptance criteria and the summary of performance testing for the LubriZenzs device as described in the provided text.

Acceptance Criteria and Device Performance for LubriZenzs

1. Table of Acceptance Criteria and Reported Device Performance

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

• Biocompatibility: The document does not specify the exact sample sizes for each biological test (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity). The provenance of the data (e.g., country of origin, retrospective/prospective) is not mentioned.
• Condom Compatibility: The document does not specify the sample size of condoms or lubricant used for testing. The provenance of the data is not mentioned.
• Shelf-Life Testing: The document does not specify the number of samples or batches tested for real-time stability. The provenance of the data is not mentioned.
• Other Device Specifications (Appearance, Color, Odor, pH, Viscosity, Osmolality, Microbial Counts): The document does not specify sample sizes for these tests or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a lubricant, and its performance is assessed via standardized chemical, physical, and biological tests, not expert interpretation of diagnostic images or clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Performance is based on objective measurements against predefined specifications using established test methods.

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-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is 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 compliance with predefined physical, chemical, and biological specifications established by relevant industry standards (e.g., USP, ASTM, ISO) and regulatory guidance. For example:

• Chemical/Physical properties (pH, viscosity, osmolality): Measured against numerical ranges.
• Microbiological purity: Measured against limits for colony-forming units and absence of specific pathogens.
• Biocompatibility: Assessed through in-vitro and in-vivo tests designed to detect cytotoxic, sensitizing, irritating, or toxic effects.
• Condom compatibility: Tested according to a specific ASTM standard (ASTM D7661-18) which defines compatibility criteria.

8. The sample size for the training set:
Not applicable. This is a physical product (lubricant), not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established:
Not applicable. As above, no training set is involved.

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

Water Solubility Human Body Lubricant is a clear, colorless, odorless and semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene, and is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal, and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is sold as an over-the-counter (OTC) product in 120 mL size provided in clear polyethylene terephthalate (PET) bottle. The bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process. The device is composed of Hyaluronic acid, Lubrajel CG, Lubrajel oil, Panthenol, Trimethyl glycine, Pentanediol, Hydroxyacetophenone, Ethylene glycol, Glycerol, Purified water.

This FDA clearance letter is for a Water Solubility Human Body Lubricant, which is regulated as a condom accessory (personal lubricant). The information provided is standard for a 510(k) submission for such a device and focuses on biocompatibility, shelf-life, and condom compatibility.

Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-based medical device (like those requiring MRMC studies, ground truth establishment by experts, training/test sets) does not apply to this product.

The document discusses performance testing, but these tests are for physical, chemical, and biological properties of the lubricant itself, not for an AI algorithm's diagnostic or assistive performance.

Here's why the AI-related questions cannot be answered based on the provided text:

• No AI/Algorithm: The device is a "Water Solubility Human Body Lubricant," a physical product, not an AI software or algorithm.
• No Diagnostic/Clinical Performance: The device's function is lubrication, not diagnosis, image analysis, or any task typically performed by an AI in healthcare.
• No Human Readers/Experts for AI Ground Truth: Since there's no AI, there's no need for human readers to establish ground truth or conduct MRMC studies.

Instead, I can summarize the performance criteria and the studies conducted for this specific medical device (the lubricant):

Device Category: Personal Lubricant (regulated under Condom, Product Code NUC)

The acceptance criteria and studies for the Water Solubility Human Body Lubricant are focused on its physical, chemical, microbiological properties, biocompatibility, shelf-life, and compatibility with condoms, as is standard for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes used for each physical, chemical, or microbiological test (e.g., how many units were tested for viscosity or pH, or how many animals for biocompatibility). These are typically standard laboratory sample sizes for quality control and testing.
• Data Provenance: The tests were conducted according to recognized international and US standards (USP, ISO, ASTM). The manufacturer is "Dongguan Yanxuan Biotechnology Co., Ltd." in China, and the studies were performed as part of their 510(k) submission to the US FDA. The studies are prospective tests performed on the manufactured product to demonstrate compliance.

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

N/A - This device is a physical product (lubricant), not an AI/algorithmic device that requires expert-established ground truth for performance evaluation. The "ground truth" here is the result of the standardized laboratory tests meeting predefined physical, chemical, and biological specifications.

4. Adjudication Method for the Test Set

N/A - Not applicable for this type of product testing. Results are quantitative measurements or qualitative observations based on direct testing according to established standards.

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

N/A - MRMC studies are for evaluating the performance of diagnostic devices, especially those involving human interpretation (e.g., radiologists reading images) sometimes with AI assistance. This device is a lubricant.

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

N/A - There is no algorithm for this device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective laboratory measurements and tests against pre-defined specifications from recognized standards (e.g., USP monographs, ISO biocompatibility standards, ASTM condom compatibility standards).

8. The Sample Size for the Training Set

N/A - Not applicable. There is no AI model to train.

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

N/A - Not applicable. There is no AI model to train.

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