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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.

Not Found

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

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

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

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

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

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

Plain Water-based Lubricant

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

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

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

Ask a specific question about this device

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): 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.

Ask a specific question about this device

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

Sutil Rich Personal Lubricant is a non-sterile, water-based personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. Its formulation consists of purified water, propanediol, hyaluronic acid, gluconolactone, sodium benzoate, Nelumbo Nucifera Root Water, Horny Goat (Epimedium Sagittatum) Herb, Siberian Ginseng (Eleuthero) Std. Extract, Jujube (Zizyphus Jujuba) Fruit Powder Extract. The device is provided in tube containers composed of low-density polyethylene (LDPE) with flip-top caps made of high-density polyethylene (HDPE). The packaging configurations range from 0.34 FL OZ (10 mL) to 8 FL OZ (240 mL), depending on the device. The personal lubricant is non-sterile and intended for over-the-counter (OTC) use.

This document is a 510(k) clearance letter for a personal lubricant, not a medical device involving AI or complex clinical studies for diagnosis or treatment. Therefore, many of the typical acceptance criteria and study designs you've asked about (e.g., MRMC studies, expert ground truth establishment for AI, effect size of human readers with AI assistance) are not applicable to this product.

The acceptance criteria here concern physical, chemical, and biological properties of the lubricant, as well as its compatibility with condoms, to ensure it is safe and performs as intended.

Here's an analysis based on the provided text for the Sutil Rich Personal Lubricant:

Device Name: Sutil Rich Personal Lubricant
Device Type: Personal Lubricant (OTC)
Regulatory Class: II
Product Code: NUC (lubricant, personal)

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (e.g., number of batches, number of units) used for each specific test (e.g., pH, viscosity, microbiological assays, biocompatibility, or condom compatibility). It states "samples" were used for shelf-life testing and that "the subject devices" were evaluated for condom compatibility.

• Sample Size: Not explicitly quantified for each test. General reference to "samples" or "the subject devices".
• Data Provenance: The document does not specify the country of origin of the data. The studies performed are laboratory-based and simulated use (e.g., shelf-life, condom compatibility, biocompatibility). These are prospective tests performed on the manufactured product to demonstrate its properties. There is no indication of retrospective data analsysis.

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

• This device clearance is for a personal lubricant, not an AI-powered diagnostic device.
• Ground Truth Establishment: The "ground truth" for the performance of this device is established through standardized laboratory test methods (e.g., USP, ASTM, ISO standards) and adherence to predefined specifications. These methods are analytical and rely on measurements and observations, not on expert consensus or interpretation in the way one would for medical image analysis.
• Experts: The tests are conducted by trained technicians or scientists in specialized laboratories (e.g., chemistry, microbiology, toxicology labs). The document does not specify the number or qualifications of individuals who performed or interpreted these specific lab tests, but it's implied they adhere to the requirements of good laboratory practice (GLP) and the specific test methodologies.

4. Adjudication Method for the Test Set

• Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies where human interpretation of data is subjective (e.g., reading medical images).
• For this device, the "adjudication" is inherent in the objective, quantitative nature of the tests. Results are compared directly against the pre-defined numerical or descriptive specifications. Any deviation would lead to a failure to meet the acceptance criteria, not a need for adjudication.

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

• No, an MRMC study was NOT done. MRMC studies are designed to compare the diagnostic performance of human readers, often with and without AI assistance, on a set of cases. This is not relevant to a personal lubricant.

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

• This question is applicable to AI algorithms.
• No, a standalone algorithm performance study was NOT done because this is not an AI/software device. The performance of the lubricant is intrinsic to its formulation and physical/chemical properties, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this product is based on defined scientific standards and objective measurements from various laboratory tests (chemical analysis, physical properties testing, microbiological analysis, biocompatibility testing, condom compatibility testing).
• It is not based on expert consensus, pathology, or outcomes data in a clinical sense. For example, the "ground truth" for pH is a specific range measured by a pH meter against a standard, not a subjective interpretation.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" as this is not a machine learning or AI device. The product formulation is developed through research and development, and then tested against established industry standards.

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

• This question is not applicable. As there is no training set (being a non-AI product), there is no ground truth for a training set to be established.

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

Joylux Intimacy Gel is a non-sterile, water-based, clear gel personal lubricant. It contains Water, Hydroxyethylcellulose, Polyquaterium-5, Propylene Glycol, PEG-45, Aloe Vera 200x Powder, Sodium Hyaluronate, Geogard Ultra (gluconolactone & sodium benzoate). The lubricant is compatible with natural rubber latex and polyisoprene condoms. The lubricant is not compatible with polyurethane condoms.

The lubricant is packaged in a 4oz / 120mL flip-top 5-layer polyethylene tube made up of 70% LDPE and 30% HDPE.

The provided document is a 510(k) summary for the Joylux Intimacy Gel (PG3100), a water-based personal lubricant. It describes the device, its intended use, comparison to a predicate device, and the non-clinical performance testing conducted to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided:

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 typical "test set" sample sizes in the way one might for an AI/ML device. Instead, the testing described is analytical and performance testing for a personal lubricant.

• Biocompatibility: The sample size for animals or cell cultures used in these tests (Cytotoxicity, Guinea Pig Maximization, Vaginal Irritation, Acute Systemic Toxicity) is not explicitly stated.
• Shelf Life: Not specified, but standard aging study protocols typically involve multiple units tested at various time points.
• Condom Compatibility: The specific number of condoms or lubricant samples tested is not provided, but it would adhere to the ASTM D7661-18 standard method.

The data provenance is from non-clinical performance testing conducted on the Joylux Intimacy Gel device itself, likely performed in laboratories according to recognized international standards (ISO, USP, ASTM). It is prospective in the sense that the testing was conducted specifically for this submission. The country of origin of the data is not specified but is implicitly from testing labs adhering to these international standards.

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

This question is not applicable in the context of this device. The ground truth for the performance of a personal lubricant is established through objective laboratory testing against defined physical, chemical, and biological specifications, not through expert consensus on interpretation of data like in medical imaging.

4. Adjudication method for the test set

Not applicable. As described above, the determination of meeting specifications is based on objective laboratory measurements and adherence to test standards, not on subjective expert interpretation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/Machine Learning device or an imaging device requiring human readers or AI assistance.

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

Not applicable. This is not an AI/Machine Learning device. The performance testing is for the physical and chemical properties of the lubricant itself.

7. The type of ground truth used

The ground truth for this device is based on:

• Established industry standards and methods: USP (United States Pharmacopeia) for pH, viscosity, osmolality, and microbial limits; ISO 10993 series for biocompatibility; ASTM D7661-18 for condom compatibility, and ASTM F1980-21 for accelerated aging.
• Pre-defined specifications: The specific quantitative and qualitative acceptance criteria listed in Table 1 for parameters like pH, viscosity, microbial counts, appearance, and odor.

8. The sample size for the training set

Not applicable. This is not an AI/Machine Learning device, so there is no "training set."

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

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

Ask a specific question about this device

Sutil Luxe Personal Lubricant, Sutil Luxe Vanilla Personal Lubricant, Sutil Luxe Coconut Personal Lubricant, and Sutil Luxe Mint Personal Lubricant are personal lubricants for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The products are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.

Sutil Luxe Personal Lubricant, Sutil Luxe Vanilla Personal Lubricant, Sutil Luxe Coconut Personal Lubricant, and Sutil Luxe Mint Personal Lubricant are non-sterile, water-based personal lubricants that are compatible with natural rubber latex and polyisoprene condoms. They are not compatible with polyurethane condoms.

Sutil Luxe Personal Lubricant, Sutil Luxe Vanilla Personal Lubricant, Sutil Luxe Coconut Personal Lubricant, and Sutil Luxe Mint Personal Lubricant are sold as over-the-counter (OTC) products in tube packaging made of low-density polythethylene (outer layer), ethylene vinyl alcohol copolymer (middle layer) and low-density polyethylene (inner layer), ranging from 0.34 fl oz to 8 fl oz, depending on formulation.

These products are composed of purified water, propanediol, oat beta glucan, hyaluronic acid, gluconolactone, sodium benzoate, steviol glycosides, and Nelumbo Nucifera (Lotus) Root water. Depending on the formulation, the flavored formulations contain natural vanilla 1.5X flavor extract, organic coconut flavor concentrate, or organic mint flavor concentrate.

This FDA 510(k) summary provides information for a personal lubricant and as such, it does not involve an AI/ML device. Therefore, many of the requested sections regarding AI/ML device evaluation criteria, such as "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "Multi reader multi case (MRMC) comparative effectiveness study," "Standalone (i.e. algorithm only without human-in-the loop performance)," "Type of ground truth," "Sample size for the training set," and "How the ground truth for the training set was established," are not applicable to this document.

However, I can provide the acceptance criteria and the study that proves the device meets those criteria, based on the provided text.

Acceptance Criteria and Device Performance for Sutil Luxe Personal Lubricants

The Sutil Luxe Personal Lubricant devices (Sutil Luxe Personal Lubricant, Sutil Luxe Vanilla Personal Lubricant, Sutil Luxe Coconut Personal Lubricant, and Sutil Luxe Mint Personal Lubricant) were evaluated against several performance parameters to demonstrate their safety and effectiveness.

1. Table of Acceptance Criteria and the Reported Device Performance

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

The document does not explicitly state the sample sizes used for each specific test (e.g., how many units were tested for viscosity, pH, etc.). However, it refers to "testing on samples" for shelf-life, and general "testing" for other parameters. The data provenance (country of origin, retrospective/prospective) is not specified, but the testing would have been conducted as part of a prospective evaluation for regulatory submission.

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

Not applicable. This is a physical/chemical product, not an AI/ML device requiring expert ground truth for image or data interpretation. Performance is measured using standardized laboratory test methods.

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

Not applicable. This is a physical/chemical product, and performance is determined by meeting objective industrial/pharmacopoeial standards, not by human adjudication of interpretations.

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/chemical product, not an AI/ML device.

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

Not applicable. This is a physical/chemical product, not an AI/ML device.

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

The "ground truth" for this device is established by meeting predefined, objective specifications and standards set by pharmacopoeias (USP) and international standards organizations (ISO, ASTM). These are laboratory-derived measurements and tests, not human-interpreted ground truth.

8. The sample size for the training set

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

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

Not applicable. This is a physical/chemical product, not an AI/ML device.

Ask a specific question about this device

INA Moisturizing Intimate Water-Based Personal lubricant, for penile and or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant is a non-sterile, water-based, personal lubricant that is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. The device is for penile 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. INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant is sold as an over-the-counter (OTC) product in a 3 fl. oz./ 90 mL Polyethylene vinyl alcohol bottle with Polypropylene flip cap. The Tube will be packaged in an outer box. This product is composed of Deionized Water, Organic Certified Aloe Vera Gel, Madecassoside, Asiaticoside, Centella Asiatica Leaf Extract, Propanediol, Sclerotium Gum, Sodium Hyaluronate, Tremella Fuciformis Sporocarp Extract, Xanthan Gum, Lactic Acid, Red Alga Gel EC, Sodium Benzoate, Potassium Sorbate, Moringa Oleifera Seed Oil, Cariborg Sea Buckthorn Oil Refined.

The provided text is a 510(k) summary for the medical device "INA Moisturizing Intimate Water-Based Personal Lubricant". It details the device's characteristics and its comparison to a predicate device, as well as the performance data used to establish its safety and effectiveness.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes for each individual test (e.g., number of lubricant batches for viscosity, number of animals for biocompatibility tests, number of condoms for compatibility).

Regarding data provenance, the testing was performed in accordance with international standards, such as ISO and ASTM, and USP pharmacopeia, indicating a standardized and controlled environment for generating technical data. The tests were conducted on the "subject lubricant" (INA Moisturizing Intimate Water-Based Personal Lubricant) and are thus prospective data from laboratory testing specifically for this device. The country of origin of the data is not explicitly stated, but adherence to international standards implies global applicability.

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 device and testing. The "ground truth" for the performance specifications of a personal lubricant is established by international standards (e.g., ISO, ASTM, USP) and scientific methodologies, not by expert consensus on clinical cases. The interpretation of these test results would be performed by qualified laboratory personnel following the specified test methods.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic evaluations where human readers provide interpretations that need to be resolved. For laboratory-based performance testing of a lubricant, results are objectively measured against predefined specifications.

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. An MRMC comparative effectiveness study is relevant for AI-powered diagnostic devices or systems where human readers interpret medical images or data. The device in question is a personal lubricant, not a diagnostic or AI-driven system.

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

This is not applicable. This question pertains to AI algorithms. The device is a personal lubricant, which does not involve an algorithm.

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

The "ground truth" for this device's performance is based on objective measurements and interpretations of established international standards and laboratory test methodologies. For example:

• Chemical/Physical properties: Measured values (pH, viscosity, osmolality) compared to defined numerical ranges.
• Microbial limits: Laboratory culture results compared to specified CFU/g limits and absence criteria for pathogens.
• Biocompatibility: In vitro and in vivo test results (e.g., cell viability, skin reactions) interpreted against ISO standard criteria.
• Condom compatibility: Physical properties of condoms after exposure to the lubricant, measured and compared to ASTM standard criteria.
• Shelf life: Real-time stability testing to confirm that all specified properties are maintained over the claimed period.

8. The sample size for the training set

This is not applicable. The device is a physical product (lubricant), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The product formulation is developed through research and development, not by training on data.

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

This is not applicable for the same reason as point 8.

Ask a specific question about this device

ID Free® Personal Lubricant is for or 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 polyisoprenecondoms. This product is not compatible with polyurethane condoms.

ID Free® Personal 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. The product is intended for over-the-counter use.

The device is a non-sterile water based personal lubricant with a clear, odorless formulation. The device is packaged in nonsterile 8.5 fl. oz/250 ml plastic/PET bottles with a screw-on cap and flip top closure, or in 0.14 fl. oz/4 ml foil sachets.

The device is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. This product is not a contraceptive and does not contain a spermicide.

The device formulation consists of water, propanediol, hydroxyethyl cellulose, carbomer, PEG-45M, tetrahydroxypropyl ethylenediamine, EDTA, caprylhydroxamic acid, and sucralose.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: ID Free® Personal Lubricant
Regulation Name: Condom (as a personal lubricant, product code NUC)

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test in phrases like "The results of this testing demonstrate..." or "The results of the testing demonstrate that...". It refers to the standards (e.g., USP , USP , USP , ISO 10993 series, ASTM D7661-18) which would define the sample sizes required for each specific test.

• Data Provenance: The studies are non-clinical performance tests conducted for regulatory submission. There is no mention of country of origin for the data or whether it was retrospective or prospective in terms of patient data, as these are in vitro and in vivo animal (for some biocompatibility) tests, not human trials.

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

Not applicable. The ground truth for this medical device (a personal lubricant) is established by adherence to recognized international and national standards and test methods (e.g., ISO, ASTM, USP) for specific physical, chemical, microbiological, and biological properties, rather than expert consensus on a diagnostic outcome. The "experts" would be the scientists and technicians conducting the tests according to the specified methodologies.

4. Adjudication Method for the Test Set

Not applicable for this type of device and testing. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or human-reader performance evaluations, particularly for image-based diagnostics. The performance of this device is determined by quantitative and qualitative measurements against established specifications in laboratory settings.

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

No. An MRMC study is not relevant for this device. It is a type of study used to evaluate diagnostic imaging systems where multiple human readers interpret cases, often with and without AI assistance, to assess the impact of AI on diagnostic performance. This device is a personal lubricant, not a diagnostic tool.

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

Not applicable. This device is a physical product (personal lubricant), not an algorithm or AI system.

7. The Type of Ground Truth Used

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

• Defined Specifications: Physical and chemical properties (color, appearance, odor, viscosity, pH, osmolality) have explicit numerical ranges or descriptions that must be met.
• Standardized Test Methods and Criteria:
  • Microbiological: Adherence to USP (Total microbial counts) and USP (Absence of specified objectionable microorganisms), and USP (Antimicrobial Effectiveness Test) acceptance criteria. These standards define the "ground truth" for microbiological safety.
  • Biocompatibility: Adherence to ISO 10993 series standards outcomes (non-cytotoxic, non-sensitizing, non-irritating, not systemically toxic).
  • Condom Compatibility: Adherence to ASTM D7661-18 for compatibility with specific condom materials.
• Real-time Stability Data: The device maintained its specifications over a 24-month shelf-life at a specified condition (25°C).

8. The Sample Size for the Training Set

Not applicable. This is a physical product, not an AI/ML algorithm that requires a training set.

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

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

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