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Aqua Lube® Natural 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.

Aqua Lube® Natural Personal Lubricant is a non-sterile, water-based, personal lubricant designed to supplement the body's own natural lubrication fluids. Aqua Lube® Natural Personal Lubricant consists of two models: "Regular" and "Warming." This product is a clear, non-greasy, high-viscosity, liquid. This product is composed primarily of organic aloe, hydroxyethycellulose, sorbitol, and tocopherols (vitamin E). The Warming model contains the same ingredients as the Regular model plus the additional ingredient organic peppermint oil. Aqua Lube® Natural Personal Lubricant causes a warming response. This product may be used with or without a condom during intimate sexual activity. This product is packaged in a tube made of low density polyethylene with a polypropylene cap. Tube sizes included 1 oz., 2.5 oz, and 4.0 oz. Each tube is packaged in a paperboard carton, which constitutes the device's individual carton.

Here's a breakdown of the acceptance criteria and study information for the Aqua Lube® Natural Personal Lubricant, based on the provided text:

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 for the individual tests (Cytotoxicity, Irritation, Toxicity, Sensitization). However, it does state that "Biocompatibility testing was conducted on Aqua Lube® Natural Personal Lubricant per ISO 10993 series," which implies standard biological testing methods for medical devices.

• Provenance: The data provenance (country of origin, retrospective/prospective) is not explicitly stated. The studies were conducted in compliance with Good Laboratory Practices (GLPs), which are a set of principles for conducting non-clinical laboratory studies.

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

This information is not provided in the document. The studies listed (e.g., cytotoxicity, irritation, sensitization) are laboratory tests with objective endpoints, rather than subjective evaluations that typically require human expert consensus for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The tests described are primarily objective laboratory assessments, not requiring an adjudication method like those used for interpreting ambiguous results in image-based diagnostics.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for AI-powered diagnostic tools to assess the impact of AI assistance on human reader performance. The Aqua Lube device is a personal lubricant, not a diagnostic tool.

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

No, a standalone algorithm performance study was not done. This concept is relevant for AI algorithms, which are not applicable to a personal lubricant.

7. The Type of Ground Truth Used

The ground truth for the device's performance relies on objective laboratory measurements and standardized testing protocols:

• Biocompatibility: Results were based on measurable biological responses (e.g., cell viability for cytotoxicity, observable tissue reactions for irritation, systemic effects for toxicity, immune responses for sensitization) defined by the ISO 10993 series.
• Condom Compatibility: Results were based on mechanical and physical integrity testing of condoms as defined by ASTM D7661-10.
• Shelf Life: Results were based on real-time stability data, indicating the maintenance of product characteristics over time.

8. The Sample Size for the Training Set

This information is not applicable. The Aqua Lube device is a physical product, not an AI model requiring a "training set."

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

This information is not applicable. As stated above, this is not an AI model.

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Kimono MicroThin with Aqua Lube / Reality Ultra Lubricated condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is lubricated by a water based lubricant system. Typical (Average) Product Characteristics are as follows: • Straight walled, reservoir end • Nominal length (mm): 190mm+/-10mm • Nominal width (mm): 52 mm +/- 2mm • Nominal thickness (mm) .04 -0.01 Kimono MicroThin with Aqua Lube: .049mm +/- 0.01 Reality Ultra Lubricated: .065mm +/- 0.01mm

The provided text describes a 510(k) submission for new latex condoms and the FDA's clearance of the device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone study with detailed performance metrics and ground truth establishment, as would be typical for a novel AI/medical imaging device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not applicable or cannot be extracted from this document because the device is a physical product (condom) and not a diagnostic AI system.

Here's the information that can be extracted or deduced from the provided text:

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

2. Sample sized used for the test set and the data provenance
Not explicitly stated for the testing confirming conformance to standards. The document outlines a 510(k) submission for substantial equivalence based on adherence to standards, not a specific clinical trial with a defined test set sample size for a diagnostic AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically understood for AI/diagnostic devices (e.g., expert consensus on medical images) is not relevant for the physical testing of condoms against established standards.

4. Adjudication method for the test set
Not applicable.

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 product, 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 physical product.

7. The type of ground truth used
The "ground truth" in this context is adherence to established national and international standards (ASTM D3492 and ISO 4074) and the manufacturer's own specifications for physical properties and performance (e.g., air inflation). This does not involve expert consensus on clinical cases or pathology as would be used for diagnostic devices.

8. The sample size for the training set
Not applicable. This is a physical product, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established
Not applicable.

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Aqua Lube 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, polyisoprene, and polyurethane condoms.

Aqua Lube® is a non-sterile, water-based, personal lubricant designed to supplement the body's own natural lubrication fluids. This product is a clear, non-greasy, high-viscosity, liquid. This product may be used with or without a condom during intimate sexual activity.

This document describes the safety testing and substantial equivalence of the Aqua Lube® Personal Lubricant (K110325) to predicate devices. It is not a study proving the device meets specific performance criteria in a clinical setting as would typically be described for a diagnostic or AI-based device. Instead, it focuses on laboratory tests to demonstrate safety and compatibility.

Therefore, many of the requested elements for a study on "acceptance criteria" and "device performance" in the context of an AI or diagnostic device are not applicable to this 510(k) submission for a personal lubricant.

However, I can extract the relevant information regarding the acceptance criteria and how the device proved to meet them in the context of the provided document.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for individual tests. The document broadly states "laboratory studies" and "studies on latex condom compatibility." For biocompatibility and toxicity studies, it refers to "the proposed devices" (plural, likely implying multiple samples of Aqua Lube were tested).
• Data Provenance: The studies were conducted by "outside laboratories." The country of origin is not specified, but the submission is to the U.S. FDA. The studies are by nature prospective, as they were conducted specifically for the purpose of demonstrating safety and equivalence for this submission.

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

Not applicable. This is a laboratory-based safety and compatibility assessment, not a clinical study involving expert interpretation of diagnostic output or ground truth establishment based on human review. The "ground truth" or "reference standard" for these tests would be the established scientific methods and pass/fail criteria for biocompatibility and condom compatibility.

4. Adjudication Method for the Test Set

Not applicable. This is not a study where human adjudication of results would be relevant. The outcome of the laboratory tests (e.g., cytotoxicity assay results, physical property measurements of condoms) are objectively measured.

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

Not applicable. This type of study is used for diagnostic or AI-assisted interpretation, where human readers evaluate cases with and without AI assistance. This document describes laboratory safety and compatibility testing for a personal lubricant.

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

Not applicable. This is a physical product (personal lubricant), not an algorithm or AI. The tests performed are inherent to the product itself.

7. The Type of Ground Truth Used

The "ground truth" or reference standard for these tests are the established scientific and regulatory methods for evaluating:

• Biocompatibility: Standardized assays (e.g., ISO standards for cytotoxicity, irritation, sensitization, systemic toxicity) with predefined pass/fail criteria.
• Condom Compatibility: Standardized methods to assess the mechanical and physical integrity of condoms after exposure to the lubricant (e.g., burst pressure, tensile strength tests) with established acceptance limits for material degradation.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an artificial intelligence or machine learning device.

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

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

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