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Onetouch™ Non-paraben Lubricant Gel is a personal lubricant, for penile, vaginal and/or anal application, intended to moisturize and lubricate, 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.

Onetouch™ Non-paraben Lubricant Gel is a non-sterile, water-based, over-the-counter use personal lubricant that is 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. Onetouch™ Nonparaben Lubricant Gel is compatible with natural rubber latex and polyisoprene condoms. The product is not compatible with polyurethane condoms.

Onetouch™ Non-paraben Lubricant Gel has the following eight flavor and color versions:

• 1. Natural Color, No Flavor
• 2. Natural Color, Cucumber Flavor
• 3. Natural Color, Mixfruit Flavor
• Pink Color, Strawberry Flavor 4.
• 5. Natural Color, Strawberry Flavor
• 6. Natural Color, Vanilla Flavor
• 7. Natural Color, Mentha Piperita (Peppermint) Flavor
• Natural Color, Aloe Vera Flavor 8.

The formulations of all versions consist of purified water, hydroxyethyl cellulose, refined glycerin, propane-1,3-diol, sodium benzoate, and PEG-40 hydrogenated castor oil. Specific versions of the device include flavors or a pink colorant, as shown in the list above.

Onetouch™ Non-paraben Lubricant Gel is packaged in 75ml LDPE plastic tubes or 5 ml PE layered aluminum foil sachets. Sachets and tubes are secondarily packaged in cartons.

The provided document describes the acceptance criteria and study for the Onetouch™ Non-paraben Lubricant Gel, which is a personal lubricant. It does not pertain to an AI/ML device. Therefore, many of the requested fields are not applicable.

Here's the information extracted from the document:

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 for the specific tests, nor does it detail the data provenance (country of origin, retrospective/prospective). It refers to standard testing methods (e.g., USP, ISO, ASTM standards) which inherently include sample size considerations, but the exact numbers are not provided in this summary.

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 medical device (personal lubricant) requiring laboratory and biomechanical testing, not an AI/ML device relying on expert interpretation for ground truth.

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

Not applicable. This is a medical device (personal lubricant) requiring laboratory and biomechanical testing, not an AI/ML device involving human reader 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 a medical device (personal lubricant), 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 medical device (personal lubricant), not an AI/ML algorithm.

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

The "ground truth" for this device is established through standardized laboratory testing and accepted industry methods (e.g., USP, ISO, ASTM standards). This includes:

• Chemical and Physical Properties: Direct measurements of appearance, color, odor, viscosity, pH, and osmolality.
• Microbiological Purity: Laboratory culture methods to count microbial load and detect specific pathogens.
• Biocompatibility: In vitro (cytotoxicity) and in vivo (sensitization, irritation, acute systemic toxicity) animal models.
• Shelf-Life: Real-time and accelerated aging studies to observe property changes over time.
• Condom Compatibility: Standardized mechanical testing of condom integrity after exposure to the lubricant.

8. The sample size for the training set

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

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Playboy Premium Silicone Lubricant is indicated for penile, vaginal and/or anal 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.

Playboy Premium Silicone Lubricant is a non-sterile, silicone-based personal lubricant for penile, anal, and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of dimethicone. Playboy Premium Silicone Lubricant is sold as an over-the-counter (OTC) product and is provided in 88.7 mL LDPE bottles.

The provided text describes a 510(k) submission for the "Playboy Premium Silicone Lubricant." This is a medical device approval document, not a study evaluating an AI/ML powered device. As such, the specific information requested in the prompt (acceptance criteria and a study proving an AI device meets them, including sample sizes, ground truth, expert opinions, MRMC studies, etc.) is not present in the given text.

The document focuses on demonstrating substantial equivalence to a predicate device (K-Y Silicone K173504) for a personal lubricant. It does this by comparing indications for use, technological characteristics, and non-clinical performance testing.

Here's how the available information relates to the prompt, with the understanding that it's for a traditional medical device, not an AI one:

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

The document provides "Device Specifications" which can be considered acceptance criteria for the physical and biological properties of the lubricant. It also implicitly reports the device performance by stating that it meets these specifications and compares them to the predicate device.

8. The sample size for the training set

This is not applicable. The concept of a "training set" refers to data used to train an AI model. This document describes a traditional medical device, not an AI system.

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 Playboy 3 Contour Condom is used for contraception and for prophylactic purposes (preventing transmission of sexually transmitted infections).

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I am sorry, but the provided text from the FDA letter about K211450 for the "Playboy 3 Contour Condom" does not contain information about acceptance criteria or a study proving the device meets those criteria, as it relates to device performance metrics typically found in AI/ML medical device submissions.

The document is a 510(k) clearance letter for a condom, outlining its regulatory classification, indications for use, and general controls. It's a standard FDA clearance document that confirms substantial equivalence to a predicate device, rather than a detailed report of performance studies against specific acceptance criteria for an AI/ML device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method.
5. MRMC study information or effect size.
6. Standalone performance.
7. Type of ground truth used.
8. Training set sample size.
9. How ground truth for the training set was established.

This information is typically found in pre-market submissions for AI/ML-powered medical devices, which undergo rigorous validation studies to demonstrate their diagnostic or prognostic capabilities. The provided text concerns a physical barrier contraception device, for which performance is assessed against different types of standards (e.g., burst strength, leakage, etc., though these specific tests are not detailed in this clearance letter).

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The One Touch Spiral Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

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This document is a 510(k) clearance letter for the "One Touch Spiral Condom" and describes its indications for use. It outlines administrative details, regulatory compliance information, and contact details for further inquiries regarding FDA regulations. However, this document does not contain information about the acceptance criteria for a device's performance, nor does it detail any study proving a device meets such criteria.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts or their qualifications for ground truth.
• Adjudication method for the test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results of a standalone (algorithm only) performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

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I am sorry, but the provided text from the FDA letter (K171213) does not contain information about the acceptance criteria or a study that proves the device meets those criteria for the "One Touch Condom with Benzocaine."

The text is a standard FDA 510(k) clearance letter, which states that the device is substantially equivalent to a predicate device and can be marketed. It outlines the regulatory framework, general controls, and other requirements for the manufacturer. It does not include specific performance data, study designs, or acceptance criteria.

Therefore, I cannot provide the requested information based on the input text.

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