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Durex Embrace Pleasure Gels, which includes the Warming Sensation Gel and Tingling Experience Gel, are intended 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 lubricants are compatible with natural rubber latex, synthetic polyisoprene and polyurethane condoms.

Durex Embrace Pleasure Gels are clear odorless slightly viscous liquids that are packaged together and consist of two different formulation is water-based with multisensate (Tingling Experience Gel) and the female formulation (Warming Sensation Gel) is Vanillyl Butyl Ether in Glycerine base. The female lubricant (Pink Bottle) offers a warming experience, and one for the male partner (Purple bottle) offers a tingling experience. Devices are supplied in 60 ml PETG pump bottles. Both lubricant bottles are covered with a shrink sleeve including graphics that also provides tamper evident protection. Bottles are then placed in clear trays, which are then shrink-wrapped and placed in printed cartons.

The provided text describes the submission for a 510(k) premarket notification for Durex Embrace Pleasure Gels, seeking substantial equivalence to a predicate device (KY Yours + Mine). It outlines performance testing, but it is not a study that proves the device meets specific acceptance criteria in the context of an AI/ML device.

The document is for a personal lubricant, not an AI/ML device, and therefore does not have acceptance criteria or studies related to AI/ML performance metrics (like sensitivity, specificity, F1-score, AUC, etc.).

However, I can extract the relevant information regarding the device's acceptance criteria and the studies performed to demonstrate its safety and performance based on the provided document.

Here's an interpretation of the request in the context of this non-AI medical device submission:

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

The document lists "Specifications" for which "acceptance specifications" have been developed, but it does not explicitly state the numerical acceptance criteria or the specific reported device performance values for each specification. It only states that "testing on samples collected up to 12 months of aging... showed that devices met their acceptance criteria" and that test results "demonstrated device materials to be biocompatible" and "non-irritating" or "did not elicit sensitization reactions."

Regarding AI/ML specific information, this document does not contain any of the following because it is not an AI/ML device:

• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• Multi reader multi case (MRMC) comparative effectiveness study
• Standalone (i.e. algorithm only without human-in-the-loop performance) study
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for test set
• Sample size for the training set
• How the ground truth for the training set was established

Detailed information from the document (non-AI related):

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

• Acute Systemic Toxicity: "test group animals" (number not specified). Data provenance: Not specified, but likely conducted in a laboratory setting as per GLP requirements.
• Vaginal Irritation Testing: Not specified, but involved "rabbits" and assessed the Warming Sensation Gel.
• Penile Irritation Study: Not specified, but involved "rabbits" and assessed the Tingling Experience Gel.
• Cytotoxicity: Not specified, but tested using "tissue culture agar diffusion test."
• Sensitization: "study animals" (number not specified). Involved "Guinea Pig Maximization test."
• Condom Compatibility: Not specified for number of condoms or samples. Testing was "conducted in accordance with ASTM D7661-10."
• Stability: "samples collected up to 12 months of aging (real-time and accelerated at 40 C-75%RH)" (number of samples not specified).
• Data Provenance: Not explicitly stated, but all studies were conducted in accordance with GLP requirements and applicable ISO 10993 standards or ASTM D7661-10, implying controlled laboratory conditions.

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

• Not applicable as this is a physical/chemical/biological performance study, not an AI/ML ground truth establishment. The "ground truth" is determined by standardized test methods and observations/measurements.

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

• Not applicable for this type of performance study. Results are based on direct observation, measurement, or established biological outcomes according to standard protocols.

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 as 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 as this is not an AI/ML device. The performance tests are for the product itself (lubricant).

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

• The "ground truth" for these studies is based on observable biological reactions (e.g., irritation, sensitization, systemic toxicity), physical/chemical properties (e.g., pH, viscosity), and mechanical integrity (condom compatibility), as defined by established international standards (ISO 10993, ASTM D7661).

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

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