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SILICONE 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. This product is not compatible with polyurethane condoms.

SILICONE Personal Lubricant is a non-sterile, clear and odorless siliconebased personal lubricant for use during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms. This device is not compatible with polyurethane condoms. Its formulation consists of dimethicone and dimethiconol. The product is packed into a 3.38 oz (100 mL) bottle.

This document describes the non-clinical performance testing for the "SILICONE Personal Lubricant" device (K191654) to demonstrate its substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Microbial Purity and Viscosity: The document does not specify a separate "test set" sample size for these chemical and microbiological tests. These are typically performed on representative batches of the final product. The data provenance is implied to be from the manufacturer's internal testing as part of their quality control and submission process.
• Shelf Life: The sample size for the accelerated aging study is not explicitly stated. The data provenance is from the manufacturer's testing.
• Condom Compatibility: The testing involved "three different brands of natural rubber latex," "one brand of polyisoprene," and "one brand of polyurethane condoms." The specific number of individual condoms tested for each brand is not provided. The data provenance is from testing performed to ASTM D7661-10.
• Biocompatibility: The specific sample sizes (e.g., number of animals for irritation/sensitization, cell cultures for cytotoxicity) are not provided in this summary. The data provenance is from testing performed according to ISO 10993 standards.

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

This document describes non-clinical performance testing for a medical device (personal lubricant) rather than a diagnostic or AI-driven device. Therefore, the concept of "experts" establishing a "ground truth" for a test set in the way it applies to image interpretation or clinical diagnosis is not directly applicable here. The "ground truth" for these tests is based on established scientific methods and standards (USP, ASTM, ISO) and laboratory measurements.

4. Adjudication method for the test set

Not applicable, as this is non-clinical performance testing following standardized protocols, not human-in-the-loop diagnostic assessment.

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-driven or diagnostic device, so MRMC studies are not relevant.

6. 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.

7. The type of ground truth used

The "ground truth" for the various tests is established by:

• Laboratory measurements and analytical chemistry: For properties like viscosity, appearance, color, and odor.
• Microbiological testing standards (USP , USP ): For microbial counts and absence of specific pathogens.
• Accelerated aging protocols: For shelf life, confirming product specifications remain within limits over time.
• ASTM D7661-10 standard: For condom compatibility, which involves physical testing of condom integrity after exposure to the lubricant.
• ISO 10993 series of standards: For biocompatibility, involving in vitro (cytotoxicity) and in vivo (sensitization, irritation, acute systemic toxicity) tests.

8. The sample size for the training set

Not applicable. This document does not describe an AI or machine learning model that requires a training set.

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

Not applicable. There is no training set mentioned in this document.

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Silicone Personal Lubricant is a silicone-based personal lubricant for vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyurethane and polyisoprene condoms.

ALL-IN-ONE is a 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 product is compatible with natural rubber latex, polyurethane and polyisoprene condoms.

Silicone Personal Lubricant and ALL-IN-ONE are clear, semi-viscous personal lubricants that are compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. The devices are non-sterile personal lubricants for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.

These products are provided in Polyethylene Terephthalate (PET) bottles capped with natural polypropylene disc top dispenser caps. The individual bottles are hermetically sealed during the production process. There is also 16 fl. oz./480 mL bottle with a different configuration for the Silicone Personal Lubricant. This consists of a clear Polyethylene Terephthalate (PET) bottle with a polypropylene lotion pump instead of the disc top dispenser used in all other sizes. This bottle is configured with a shrink wrap seal. These products are also available in polyester-faced laminated pouches.

The provided document is a 510(k) premarket notification for a medical device: "Silicone Personal Lubricant, ALL-IN-ONE." This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

The document does not describe an AI/ML-driven medical device, nor does it detail a study involving human readers, ground truth establishment by experts, or MRMC comparative effectiveness. The "acceptance criteria" discussed are for the physical and chemical properties of a personal lubricant, and the "study" involves laboratory testing to confirm these properties and biocompatibility.

Therefore, I cannot extract the information required to answer your questions regarding a device that uses AI/ML, human readers, or expert-established ground truth. The document describes a traditional medical device (a lubricant) and its physical, chemical, and biological testing for substantial equivalence.

Here's an analysis based on the document related to the lubricant's acceptance criteria and performance, as much as possible given the focus of the original request on AI/ML devices:

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

The document describes the device specifications as performance criteria.

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

• Test set sample size: Not explicitly stated in terms of number of units or batches, but testing was performed according to Pharmacopeial standards (USP) and ISO standards. These standards typically specify the number of samples to be tested.
• Data Provenance: Not specified in terms of country of origin. The studies appear to be laboratory-based (e.g., in vitro, animal irritation studies as per ISO 10993). The document states "real time and accelerated aging study" for shelf-life, which implies prospective testing.

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

This is not applicable as the studies are for a physical/chemical product, not an AI/ML device requiring human expert annotation or ground truth based on medical imaging or diagnostic outcomes. Testing was performed according to established international standards (ISO, ASTM, USP).

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

Not applicable. The "tests" are laboratory-based, objective measurements and biological assessments against predefined criteria. There is no human subjective assessment or adjudication process described as would be for an AI/ML system.

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/ML diagnostic tool. No human reader study was conducted.

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

Not applicable. This is not an algorithm. The "standalone performance" refers to the lubricant's intrinsic properties as measured in a lab.

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

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

• Established physical/chemical specifications (e.g., viscosity, specific gravity, appearance, odor).
• Microbiological absence/presence thresholds per USP ,,.
• Biocompatibility criteria defined by ISO 10993 standards (e.g., lack of cytotoxicity, irritation, sensitization).
• Condom compatibility per ASTM D7661-10.

These are objective, quantitative or qualitative laboratory results against predefined standards, not expert consensus on medical images or diagnostic outcomes.

8. The sample size for the training set:

Not applicable. This is not an AI/ML 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 an AI/ML model.

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