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Vielle™ personal lubricant is intended for personal lubrication, lubrication of a body orifice to facilitate use of diagnostic or therapeutic, to enhance condom use and for vaginal use.

Vielle™ is a clear, water-soluble, silicone based gel. No fragrances or petroleum-based chemicals are used in the formulation.

The provided text describes the 510(k) summary for a personal lubricant, Vielle™ Lubricant, and focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria in a typical AI/software medical device context.

Therefore, many of the requested sections regarding AI/software studies (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) are not applicable to this type of device submission.

However, I can extract the relevant information regarding the device's characteristics and the non-clinical testing performed to establish its substantial equivalence.

Here's the breakdown of what is available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "acceptance criteria" are implied by the characteristics of the predicate devices and the non-clinical tests performed to demonstrate similar safety and effectiveness. There are no explicit numerical acceptance criteria for a lubricant's performance, but rather characteristics and test results showing its safety and compatibility.

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

• Sample Size: Not specified for any of the non-clinical tests (e.g., how many condoms were tested for compatibility, or how many tests for biocompatibility).
• Data Provenance: Not explicitly stated, but the submission is from the UK (CST Medical Ltd, Antrobus House, Petersfield, Hants, GU31 4AD UK). The non-clinical testing was likely conducted in accordance with relevant standards.

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

• Not Applicable. This is a physical device (lubricant) and not an AI/software device that requires expert ground truth for interpretation or classification. The "ground truth" for its properties would be established via standard laboratory testing and compliance with relevant ASTM, ISO, or other recognized standards.

4. Adjudication Method for the Test Set

• Not Applicable. As above, this is for physical device testing, not for expert consensus or image interpretation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No. This type of study is specifically for evaluating the effectiveness of a diagnostic or interpretive AI/software system with human readers. It is not relevant for a personal lubricant.

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

• Not Applicable. This is for AI/software algorithms.

7. The Type of Ground Truth Used

• The "ground truth" for the device's properties (e.g., water-soluble, latex compatible, biocompatible) would have been established through laboratory testing according to recognized industry standards (e.g., ISO, ASTM for condom compatibility and biocompatibility) for physical and chemical properties.

8. The Sample Size for the Training Set

• Not Applicable. This refers to AI/machine learning models, which are not involved in this device submission.

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

• Not Applicable. As above.

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