(265 days)
Smile Makers Personal Lubricants are water-based personal lubricants for 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 product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Smile Makers personal lubricants are water-based personal lubricants. There are three formulations, Generous Gel, Stay Silky Serum, and Little Light Liquid, that contain the same ingredients, and only differ in amounts of specific ingredients. Ingredients of the lubricants include the following: water (aqua), glycerin, propylene glycol, methyl propanediol, carbomer, sodium benzoate, sodium hydroxide, and dipotassium glycyprizate. They are compatible with natural rubber latex and polyisoprene condoms, but are not compatible with polyurethane condoms. They are provided non-sterile. The product is packaged in 30 ml transparent plastic bottles made of acrylonitrile styrene and polyethylene terephthalate. The bottle contains a pump dispenser made of polypropylene and the cap is made of an aluminum coated low density polyethylene. It is for over-the-counter use.
This document describes the premarket notification (510(k)) for "Smile Makers Personal Lubricants." Therefore, the information provided focuses on demonstrating substantial equivalence to a predicate device, rather than a study proving the device meets acceptance criteria in the context of an AI-powered medical device study. Concepts like "acceptance criteria," "sample size for test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "ground truth," and "training set" are specific to the development and validation of AI/ML medical devices, which is not what this document addresses.
However, I can extract the closest analogous information from the provided text regarding the device specifications and the studies performed to demonstrate performance and safety in relation to these specifications and the predicate device.
Here's an interpretation based on the provided document, restructured to address your questions where possible, and noting where the information is not applicable to a traditional AI/ML device study:
Device: Smile Makers Personal Lubricants (Smile Makers Little Light Liquid, Smile Makers Stay Silky Serum, and Smile Makers Generous Gel)
Purpose of the Submission: 510(k) Premarket Notification to demonstrate substantial equivalence to a legally marketed predicate device (BioFilm, Inc. - Astroglide Sensual Strawberry, K140590).
1. Table of Acceptance Criteria (Specifications) and Reported Device Performance
The acceptance criteria here refer to the product specifications that the manufacturer sets for the lubricant. The "reported device performance" refers to the results of tests demonstrating compliance with these specifications.
| Parameter | Specification (Test Method) | Reported Device Performance (Implied "Met Specification") |
|---|---|---|
| Appearance & Color | Clear gel, viscous, no visible foreign matter | Implied: Met specification (as concluded to be safe and effective and substantially equivalent). |
| Odor | Characteristic odor | Implied: Met specification. |
| Osmolality (10% (w/w) dilution with water) | 299 – 449 mOsm/kg | Implied: Met specification. |
| pH (at 25 °C) | 4.90 - 5.50 | Implied: Met specification. |
| Viscosity | 56,000 – 84,000 cps (Generous Gel) | |
| 6,200 – 10,000 cps (Stay Silky Serum) | ||
| 3,700 - 5,600 cps (Little Light Liquid) | Implied: Met specification. | |
| Total Aerobic Microbial Count (USP ) | ) | ) - Bacterial (E. coli, P. aeruginosa, S. aureus) |
| Antimicrobial Effectiveness (USP ) - Fungal (C. albicans, A. brasiliensis) | No increase from the initial count at 14 and 28 days | Implied: Met specification. |
| Absence of Pathogenic Organisms (USP ) - S. aureus, P. aeruginosa, C. albicans | Absent | Implied: Met specification. |
| Biocompatibility | Non-cytotoxic, non-sensitizing, non-irritating, and non-systemically toxic (based on ISO 10993-5, 10993-10, 10993-11) | Tested as compliant: "The results demonstrate that the subject lubricants are non-cytotoxic, non-sensitizing, non-irritating, and non-systemically toxic." |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms (based on ASTM D7661-10) | Tested as compliant: "was determined to be compatible with natural rubber latex and polyisoprene condoms. The subject device was determined not to be compatible with polyurethane condoms." (Note: Incompatibility with polyurethane condoms is stated as a difference from the predicate but not raising new safety/effectiveness questions, and is explicitly stated in Indications for Use). |
| Shelf-life | One-year shelf-life (based on real-time aging study, meeting all Table 1 specifications throughout) | Tested as compliant: "The Smile Makers Personal Lubricant has a one-year shelf-life based on the results of a real-time aging study. Testing demonstrated that the device met specifications for parameters shown in Table 1." |
2. Sample Size Used for the Test Set and the Data Provenance
This is not applicable as this is not an AI/ML device study. The "test set" here would refer to the specific samples of lubricant used for the various physical, chemical, and biological tests. The document does not specify the exact batch sizes or numbers of samples tested for each parameter (e.g., how many bottles were tested for viscosity, how many animal subjects for biocompatibility). The studies are conducted by the manufacturer, LFBeauty (Thailand) Limited. The data provenance is from in vitro laboratory tests and in vivo animal tests, performed by or on behalf of the manufacturer, to demonstrate product specifications and safety/performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is not an AI/ML device requiring human expert annotation for ground truth. Technical specifications are verified through standardized laboratory test methods (e.g., USP, ISO, ASTM).
4. Adjudication Method for the Test Set
Not applicable. Ground truth for physical/chemical/biological properties is established by defined test methods, not by human adjudication of opinions.
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-powered medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's characteristics and performance is established through standardized laboratory testing protocols (USP, ISO, ASTM) for chemical, physical, and biological properties, and in vivo animal model biocompatibility studies. For example, pH is measured by a pH meter against calibrated standards, microbial counts are determined by microbiological culture methods, and condom compatibility is assessed by stress-strain tests per ASTM standards.
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.
§ 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.