(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) | , USP , 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.
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.