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Wet Flavored Personal Lubricants 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 product is compatible with natural rubber latex and polyisoprene condoms. The product is not compatible with polyurethane condoms.

The Wet Flavored Personal Lubricants are clear, non-sterile, over-the-counter personal lubricants, formulated to be clear, particle-free, and colorless to slight yellow. The device is designed to supplement the body's own natural lubrication fluids during intimate sexual activity. The product is compatible with natural rubber latex and polyisoprene condoms. The product is not compatible with polyurethane condoms. The device formula is neither a contraceptive nor a spermicide.

The provided document describes the FDA's 510(k) clearance for "Wet Flavored Personal Lubricants," establishing its substantial equivalence to a predicate device. The document does not contain details about a study that adheres to the format of acceptance criteria, test set, ground truth, and human reader performance typically associated with AI/ML diagnostic tools. Instead, it presents performance data for the lubricant itself, focusing on biocompatibility, shelf-life, and condom compatibility.

Here's an analysis based on the information provided, reinterpreting the "acceptance criteria" and "study" to fit the context of this device's clearance:

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

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

The document does not specify a "sample size" in the context of a test set for an AI/ML device, nor does it provide data provenance in terms of country of origin or retrospective/prospective nature. Instead, the "test set" would be the samples of the lubricant itself that were subjected to various physical, chemical, and biological tests. The specific quantities of lubricant used for each test are not detailed in this summary.

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 clearance. "Ground truth" for a personal lubricant is established through objective laboratory testing against recognized standards (e.g., USP monographs, ASTM standards, ISO standards for biocompatibility), not by expert consensus in the way a diagnostic AI/ML algorithm's performance is often evaluated. The experts involved would be laboratory technicians and scientists performing the tests, but their number and specific qualifications are not detailed here.

4. Adjudication method for the test set

Not applicable. This concept is typically relevant for subjective assessments in AI/ML performance evaluation where a consensus among human experts is needed. For the lubricant, the results are objective measurements or categorical determinations (e.g., "absent," "meets criteria").

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

Not applicable. This is not an AI/ML device. There are no human readers or AI assistance involved in evaluating the lubricant's performance in this context.

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

Not applicable, as this is not an AI/ML algorithm. The performance evaluation is inherently "standalone" in the sense that the device's properties are measured directly without human interpretation influencing the measurement outcome (though humans operate the testing equipment).

7. The type of ground truth used

The ground truth for this device is based on:

• Objective laboratory measurements and chemical/physical properties: For appearance, color, odor, viscosity, specific gravity, pH, and osmolality.
• Established microbiological standards: USP , , , for antimicrobial effectiveness and microbial counts/absence of pathogens.
• International biological evaluation standards: ISO 10993 series for biocompatibility.
• ASTM standards: For condom compatibility (ASTM D7661-18, ASTM D3492-16).

These standards and measurements define the "ground truth" for whether the product meets its specifications and safety requirements.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no concept of 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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Wet Essential95 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. This product is not compatible with polyurethane condoms.

The Wet Essential95 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. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists primarily of 95% aloe barbadensis leaf juice. Wet Essential95 Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in 4 oz and 6 oz HDPE bottles.

The provided document is a 510(k) summary for a medical device (Wet Essential95 Personal Lubricant). It does not describe an AI/ML-driven device or study. Therefore, most of the requested information regarding acceptance criteria for an AI model, data sets, expert involvement, and statistical studies like MRMC, is not applicable to this document.

However, I can extract information related to the device's performance testing and criteria for its intended use as a personal lubricant.

Here's the information that can be extracted or derived from the document:

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

The document provides specifications that essentially serve as acceptance criteria for the physical and chemical properties of the lubricant, as well as biological and compatibility performance.

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

• Sample Size: The document does not specify exact sample sizes for each test conducted. It states that "testing was conducted" and "results from accelerated testing demonstrated," implying that sufficient samples were used to meet the requirements of the listed standards (e.g., ISO 10993-11, ISO 10993-5, ISO 10993-10, ASTM D7661-10(R) 2017, USP , , , , , ). These standards typically have their own minimum sample size requirements for valid results.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the testing was conducted in accordance with international standards (ISO, ASTM, USP) and FDA guidance, suggesting a robust and controlled testing environment. The data would be considered prospective, as it was generated specifically for this premarket notification.

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

This concept is not applicable to this type of device and testing. Ground truth in this context refers to the defined specifications and performance standards established by recognized testing methods (e.g., USP monographs, ISO standards, ASTM standards). The "experts" would be the scientists and technicians performing the lab tests according to these established protocols, and their qualifications would be adherence to Good Laboratory Practices (GLP) and expertise in the specific analytical or biological testing methods. No human interpretation of images or clinical data for "ground truth" establishment in the AI/ML sense is mentioned or relevant here.

4. Adjudication method for the test set:

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are common in clinical studies where human readers interpret data, and discrepancies need to be resolved. This document reports on laboratory and bench testing against defined physical, chemical, and biological specifications, which do not involve such 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 device is a personal lubricant, not an AI-assisted diagnostic or therapeutic tool. No MRMC study was conducted or relevant.

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

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used:

The "ground truth" for this device's performance validation is the adherence to established physical, chemical, and biological standards and specifications. For instance:

• USP (United States Pharmacopeia) Monographs: for pH, viscosity, osmolality, microbial counts, and antimicrobial effectiveness.
• ISO (International Organization for Standardization) Standards: for biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity).
• ASTM (American Society for Testing and Materials) Standards: for condom compatibility.
• Developer-defined specifications: for appearance, color, odor, specific gravity, which are then verified through standard analytical methods.

8. The sample size for the training set:

Not applicable. This is a physical product, not an AI/ML model that requires a training set. The "formulation" or "design" process leads to the product, which is then validated. There isn't a "training set" in the computational sense.

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

Not applicable. See point 8.

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The Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) 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.

The Wet Water Based Personal Lubricant is a non-sterile, water and silicone blend personal lubricant that provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms, and is not compatible with polyurethane condoms. The Wet Water Based Personal Lubricant is provided in 3 oz.high density polyethylene terephthalate bottle is fitted with dispensing bottle cap with a disc-top. Wet Water Based Personal Lubricant is a personal lubricant for over-the-counter (OTC) use.

The provided text describes the acceptance criteria and performance of the "Wet® Water Based Personal Lubricant" device, including its compatibility with condoms and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated for each specific test. The document mentions "results of testing" and "results of accelerated and real-time aging studies" without providing specific numbers of samples tested.
• Data Provenance: The data is generated from performance testing conducted by the manufacturer, Trigg Laboratories, Inc., as part of their 510(k) submission to the FDA. The provenance of external data used for comparison (e.g., predicate device data) is not detailed beyond referencing the predicate K number. The studies appear to be prospective for the subject device.

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

This information is not provided in the document. The tests performed are laboratory-based and generally do not involve human "experts" establishing a ground truth in the way a clinical study would. The acceptance criteria are based on established scientific and regulatory standards (e.g., USP, ISO, ASTM).

4. Adjudication method for the test set:

This information is not applicable as the tests are for physical, chemical, and microbiological properties, as well as biocompatibility, which are objectively measured against predefined standards rather than adjudicated by experts.

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. The device is a personal lubricant, not an AI-powered diagnostic or imaging device, and therefore does not involve human readers or AI assistance in its use or evaluation.

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

This is not applicable. The device is a physical product (lubricant), not an algorithm or software.

7. The type of ground truth used:

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

• Pre-defined chemical and physical specifications: For properties like appearance, color, odor, viscosity, specific gravity, pH, and osmolality.
• Established microbiological standards: USP , , , and for antimicrobial effectiveness and microbial counts.
• International Biocompatibility Standards: ISO 10993-1, 10993-5, 10993-10, 10993-11.
• Condom Compatibility Standards: ASTM D7661-10.
• Accelerated and Real-time Aging Studies: To determine shelf-life.

These are objective standards and laboratory test results, not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set:

This is not applicable. As a physical product, there is no "training set" in the context of machine learning or AI models. The device formulation and manufacturing process would be developed and refined through R&D, but this is not analogous to a training set for an algorithm.

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

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

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The Trigg Laboratories Wet Platinum Premium 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, polyisoprene, and polyurethane condoms.

The Wet Platinum Premium Lubricant® is a non-sterile, silicone based personal lubricant, an over-the-counter personal lubricant, formulated to be clear, non-irritating, non-greasy natural and odorless. It is a Silicone soluble, gel-like liquid for use as a personal lubricant. The Wet Platinum Premium Lubricant® contains a blend of silicone fluid ingredients similar to ingredients found in the predicate device.

The specifications for Wet Platinum include appearance, odor, viscosity, specific gravity, total aerobic microbial count, total yeast and mold count, absence of pathogenic organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Escherichia coli, Salmonella, and Clostrida), and antimicrobial effectiveness. Osmolality and pH are not applicable specifications because the subject lubricant is anhydrous.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Wet Platinum Premium Lubricant®, however, it's crucial to note that this 510(k) summary is for a personal lubricant, not a medical device involving AI or complex performance metrics typically found in device studies. Therefore, many of the requested points related to AI, medical imaging, human experts, and specific statistical analyses (like MRMC) are not applicable to this document.

I will fill in the relevant information and explicitly state when a requested point is not applicable or cannot be determined from the provided text.

Acceptance Criteria and Device Performance

Study Details

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

   • Biocompatibility Tests: The document does not specify the exact sample sizes (number of lubricant samples or animals used) for the cytotoxicity, sensitization, and vaginal irritation tests. The provenance is implied to be laboratory testing conducted to ISO 10993-1 and other standards. It is a prospective laboratory study.
   • Condom Compatibility Tests: The tests were performed on "three marketed brands of Natural Rubber Latex condoms, two brands of Polyisoprene condoms, and one brand of Polyurethane condoms." The specific number of condoms tested per brand is not provided. The provenance is laboratory testing in accordance with ASTM Condom D7661-10. This is a prospective laboratory study.
   • Shelf Life Testing: The sample size for the accelerated aging study is not specified. This is a prospective laboratory study.

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

   • Not Applicable. This device is a personal lubricant, not an diagnostic or imaging device requiring expert interpretation for "ground truth." The "ground truth" for this product is established through standardized laboratory testing protocols (e.g., ISO, ASTM standards) and direct measurement of physical and biological properties.

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

   • Not Applicable. As per the previous point, there are no human interpretations or judgments in the "test set" that would require adjudication in the way medical imaging or AI performance studies do. The results are objective measurements from laboratory tests.

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

   • Not Applicable. This is not an AI-assisted device. No MRMC study was conducted.

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

   • Not Applicable. This is not an algorithm or AI device.

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

   • The "ground truth" for the performance of this personal lubricant is established through objective measurements and observations from standardized laboratory tests (e.g., cytotoxicity assays, sensitization responses in animal models, visual and microscopic examination for irritation, mechanical properties of condoms after lubricant exposure, and stability readings from aging studies). It's essentially the direct experimental outcome based on established scientific protocols.

7. The sample size for the training set:

   • Not Applicable. This is not a machine learning or AI device that requires a "training set."

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

   • Not Applicable. No training set was used.

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WET® Light Personal Moisturizer is intended for which Bight refections. It is used to supplement over the counter abouther aginal area to enhance personal morscure in the vaguer used for lubricating sexual preasure. There easy insertion of rectal thermometers, tampons, douche and enema nozzles.

Not Found

The provided text primarily consists of a 510(k) clearance letter from the FDA for the "WET® Light Personal Moisturizer" and "WET® Flavored Personal Moistures (5 Flavors)". This document focuses on the regulatory approval process and does not contain information about acceptance criteria or a study proving that the device meets those criteria.

Therefore, I cannot provide the requested information as the input document does not contain details about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
6. Standalone device performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document is a regulatory approval letter based on "substantial equivalence" to legally marketed predicate devices, not a scientific study report demonstrating performance against specific acceptance criteria.

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