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510(k) Data Aggregation
(313 days)
Playboy Premium Silicone Lubricant is indicated for penile, vaginal and/or anal 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.
Playboy Premium Silicone Lubricant is a non-sterile, silicone-based personal lubricant for penile, anal, and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of dimethicone. Playboy Premium Silicone Lubricant is sold as an over-the-counter (OTC) product and is provided in 88.7 mL LDPE bottles.
The provided text describes a 510(k) submission for the "Playboy Premium Silicone Lubricant." This is a medical device approval document, not a study evaluating an AI/ML powered device. As such, the specific information requested in the prompt (acceptance criteria and a study proving an AI device meets them, including sample sizes, ground truth, expert opinions, MRMC studies, etc.) is not present in the given text.
The document focuses on demonstrating substantial equivalence to a predicate device (K-Y Silicone K173504) for a personal lubricant. It does this by comparing indications for use, technological characteristics, and non-clinical performance testing.
Here's how the available information relates to the prompt, with the understanding that it's for a traditional medical device, not an AI one:
1. A table of acceptance criteria and the reported device performance
The document provides "Device Specifications" which can be considered acceptance criteria for the physical and biological properties of the lubricant. It also implicitly reports the device performance by stating that it meets these specifications and compares them to the predicate device.
| Property | Acceptance Criteria (Specification) | Reported Device Performance (Implicitly met as per submission) |
|---|---|---|
| Appearance | Clear, free from suspended matter and sediment | Clear, free from suspended matter and sediment |
| Color | Clear | Clear |
| Odor | Odorless | Odorless |
| Viscosity | 315 – 385 cps | 315 – 385 cps |
| Total Aerobic Microbial Count (TAMC) | <100 cfu/g | <100 cfu/g |
| Total Yeast and Mold Count (TYMC) | <10 cfu/g | <10 cfu/g |
| Presence of Pathogens (Pseudomonas aeruginosa) | Absent | Absent |
| Presence of Pathogens (Staphylococcus aureus) | Absent | Absent |
| Presence of Pathogens (Candida albicans) | Absent | Absent |
| Presence of Pathogens (Escherichia coli) | Absent | Absent |
| Presence of Pathogens (Salmonella) | Absent | Absent |
| Biocompatibility | Met ISO 10993 standards | Met ISO 10993 standards (Tested and results support) |
| Shelf-Life | 36 months, maintaining specifications | 36 months (Real-time testing demonstrated maintenance) |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms | Compatible with natural rubber latex and polyisoprene condoms; Not compatible with polyurethane condoms |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for the non-clinical performance tests (biocompatibility, shelf-life, condom compatibility). It only states that these tests were performed according to relevant standards (e.g., ISO 10993, ASTM D7661-10(R) 2017). The data provenance is implied to be from internal testing conducted by or for Thai Nippon Rubber Industry Public Company Limited. It's a prospective evaluation for the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable to this type of device and submission. "Ground truth" established by experts is relevant to diagnostic or interpretative AI systems, which this lubricant is not. The evaluation here relies on standardized laboratory testing protocols, not expert interpretation of results.
4. Adjudication method
This is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving human readers/interpreters to reconcile differing opinions, which is not relevant here.
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
This is not applicable as the device is a personal lubricant, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a personal lubricant, not an AI algorithm.
7. The type of ground truth used
For the physical and biological properties, the "ground truth" is based on objective measurements and laboratory test results against predefined specifications from recognized standards (e.g., USP <61>, USP <62>, ISO 10993, ASTM D7661-10(R) 2017). For example, a viscosity reading of 350 cps is a measured truth, not an expert's opinion.
8. The sample size for the training set
This is not applicable. The concept of a "training set" refers to data used to train an AI model. This document describes a traditional medical device, not an AI system.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
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