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Sensuva Premium Silicone Personal Lubricant is a silicone-based personal lubricant for penile, anal 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.

Sensuva Premium Silicone Personal Lubricant is a non-sterile, clear, colorless, thin liquid, silicone-based personal lubricant. This device is for penile, anal, 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. It is compatible with natural rubber latex, polyisoprene and polyurethane condoms. Its formulation consists of dimethicone, dimethiconol, and cyclopentasiloxane. Sensuva Premium Silicone Personal Lubricant is sold as an over-the-counter (OTC) device and is provided in polyethylene terephthalate bottles. The 1.93 fl. oz./57 mL bottles are fitted with 20/410 smooth black pump sprayers and clear polypropylene caps. The 4.23 fl. oz./125 mL and 8.12 fl. oz./240 mL bottles are capped with 24/410 smooth black lotion pumps.

This document is a 510(k) Premarket Notification for a personal lubricant, not an AI/ML medical device. Therefore, the requested information regarding AI/ML device performance, training data, ground truth establishment, and expert involvement is not applicable.

However, I can extract the acceptance criteria and the studies performed for the Sensuva Premium Silicone Personal Lubricant as described in the document.

Acceptance Criteria and Device Performance for Sensuva Premium Silicone Personal Lubricant

The device is a non-sterile, clear, colorless, thin liquid, silicone-based personal lubricant.

1. Table of acceptance criteria and the reported device performance:

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

   • The document does not explicitly state the sample sizes for the individual non-clinical tests (biocompatibility, shelf-life, condom compatibility).
   • The data provenance is from non-clinical performance data (laboratory testing) as described. The country of origin of the data is not specified. All studies appear to be prospective in nature (i.e., tests were conducted on the device to assess its performance against defined criteria).

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):

   • This question is not applicable as this is not an AI/ML device or a diagnostic device requiring expert interpretation for ground truth. The acceptance criteria for the physical, chemical, and biological properties are established by recognized standards (e.g., USP, ISO, ASTM).

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

   • Not applicable as this is not an AI/ML device or a diagnostic device requiring expert adjudication. The results of the non-clinical tests are objectively measured against defined specifications in established standards.

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/ML device.

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

   • Not applicable. This is not an AI/ML device.

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 standard specifications and methodologies for physical, chemical, and biological properties relevant to personal lubricants as per recognized guidelines (e.g., USP , , , ISO 10993 series, ASTM D7661-18). For biocompatibility, the truth is whether the device elicits a toxic or sensitizing response according to the ISO standards. For condom compatibility, it's whether the lubricant degrades the condom material beyond an acceptable threshold per ASTM. For shelf-life, it's whether the product meets its specifications over time under accelerated aging conditions.

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device.

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

   • Not applicable. This is not an AI/ML device.

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The Sensuva Personal Lubricants are personal lubricants, for penile, anal 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. These products are compatible with natural latex, polyisoprene, and polyurethane condoms.

The Sensuva Personal Lubricants are water-based, non-sterile personal lubricants for over-the-counter use, formulated to be slightly cloudy and odorless. The device is designed to supplement the body's own natural lubrication and is compatible for use with natural rubber latex, polyurethane, and polyisoprene condoms during intimate sexual activity. Sensuva Personal Lubricants are neither a contraceptive nor a spermicide.

The provided document is a 510(k) summary for a medical device (Sensuva Personal Lubricants). It outlines the device's characteristics and compares it to a predicate device to demonstrate substantial equivalence, rather than detailing an AI/ML device study.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies related to an AI/ML device cannot be extracted from this document, as it does not pertain to such a device.

However, I can extract the acceptance criteria and performance related to the physical and chemical properties of the Sensuva Personal Lubricants, as described in the "Summary of Non-Clinical Performance Testing" section, and how they meet established standards.

Acceptance Criteria for Sensuva Personal Lubricants (Non-AI/ML Device):

Study Information (Non-AI/ML Device):

1. Sample size used for the test set and the data provenance: Not explicitly detailed for each test beyond "the Sensuva Personal Lubricants." The data provenance is internal testing performed for FDA 510(k) submission.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for these physical and chemical tests is established by adherence to recognized international and U.S. standards (e.g., ISO, USP, ASTM) and observed laboratory results, not expert consensus in the human interpretation sense.
3. Adjudication method for the test set: Not applicable. Results are based on direct measurement and observation against established scientific and regulatory standards.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an AI/ML device that requires human-reader interaction studies.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is not an AI/ML device.
6. The type of ground truth used:
   • Biocompatibility: Established by adherence to ISO 10993 standards (10993-5:2009, 10993-10:2010, 10993-11:2006).
   • Shelf-Life: Established by accelerated aging studies per ASTM F1980-16.
   • Condom Compatibility: Established by ASTM D7661-10.
   • Physical/Chemical Properties & Microbial Counts: Established by USP standards (, , , ) and internal specifications.
7. The sample size for the training set: Not applicable, as this is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

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