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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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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.

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