(135 days)
Water-soluble Personal Lubricant is a 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Water-soluble Personal Lubricant is a non-sterile, water-based personal lubricant for penile, 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 water, propylene glycol, hydroxyethyl cellulose, sodium hyaluronate, potassium sorbate, citric acid, EDTA-2Na, and sodium polyacrylate. Water-soluble Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in 250 mL polyethylene terephthalate bottles.
This document is a 510(k) premarket notification for a medical device (Water-soluble Personal Lubricant). It focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets acceptance criteria through a traditional study with a test set, ground truth experts, and statistical evaluation as you would typically find for, say, an AI-powered diagnostic device.
Therefore, the requested information regarding acceptance criteria and a study proving device performance (especially for AI/ML aspects like accuracy, sensitivity, specificity, MRMC studies, etc.) is largely not applicable to this type of regulatory submission for a personal lubricant.
However, I can extract and present the performance specifications and the tests conducted to show that the device meets its own internal specifications and relevant industry standards, which serve a similar purpose to "acceptance criteria" in this context.
Here's how the provided information maps to your request, with an emphasis on what is and is not present:
Context: This document is a 510(k) submission for a Class II medical device: a Water-soluble Personal Lubricant. The primary goal is to demonstrate "substantial equivalence" to a predicate device, not necessarily to prove clinical efficacy through comparative effectiveness studies on human subjects or complex AI algorithm performance.
1. A table of acceptance criteria and the reported device performance
For a personal lubricant, the "acceptance criteria" are primarily its physical, chemical, and microbiological specifications, along with compatibility and biocompatibility standards. The document presents these in Table 1, and the "reported device performance" implies that the device met these specifications.
| Property | Acceptance Criteria (Specification) | Reported Device Performance (Implied) |
|---|---|---|
| Appearance | Semi-Viscous liquid | Met |
| Color | Clear | Met |
| Odor | Odorless | Met |
| Viscosity | 3,000 - 5,000 mPa.s | Met |
| pH | 5.0 - 6.0 | Met |
| Osmolality | 700 - 850 mOsm/kg | Met |
| Total Aerobic Microbial Count (TAMC, per USP ) | ) | )** |
| Pseudomonas aeruginosa | Absent | Met (Absent) |
| Staphylococcus aureus | Absent | Met (Absent) |
| Candida albicans | Absent | Met (Absent) |
| Escherichia coli | Absent | Met (Absent) |
| Clostridia | Absent | Met (Absent) |
| Salmonella | Absent | Met (Absent) |
| Bile tolerant Gram-negative bacteria | Absent | Met (Absent) |
| Antimicrobial Effectiveness Testing (per USP ) | ||
| Bacteria | Meets USP criteria for category 2. No less than 2.0 log reduction from initial count at 14 days and no increase from the 14-day count at 28 days | Met |
| Yeast and Molds | No increase from the initial calculated count at 14 and 28 days | Met |
| Biocompatibility | Met ISO 10993-1, -5, -10, -11 | Met |
| Shelf-Life | 3 years (maintains specifications) | Met |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms; Not compatible with polyurethane condoms | Met |
2. Sample sizes used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of a "test set" for an algorithmic performance study. The tests performed are laboratory-based, chemical, physical, and microbiological analyses (e.g., measuring pH, viscosity, microbial counts) on samples of the product. The specific number of distinct product batches or individual units tested for each specification is not detailed in this summary.
- Data Provenance: The manufacturing entity is Foshan PingChuang Medical Technology Co., Ltd. in Foshan City, Guangdong, China. The testing would have been conducted by the manufacturer or a contracted lab. The document does not specify if the testing was prospective (e.g., part of a clinical trial) or retrospective (analysis of existing data), but for device specifications, it's typically part of the manufacturing quality control and development process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth, in the sense of expert consensus on interpretations (e.g., radiology images), is not relevant for this device. The "ground truth" for chemical and physical properties is defined by established laboratory standards and test methods (e.g., USP , USP , USP , ISO 10993, ASTM D7661-10(R) 2017).
- Qualifications of Experts: Not applicable. The testing is performed by laboratory technicians following validated protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This concept is typically used in clinical studies where multiple human readers interpret data, and discrepancies need resolution. For laboratory testing of product specifications, results are definitive measurements against pre-defined criteria.
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
- MRMC Study: No. This is not an AI-powered device, nor is it a diagnostic device where comparative effectiveness with human readers would be relevant.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The ground truth for this device's performance is established by objective, standardized laboratory test methods and predefined physical, chemical, and microbiological specifications (e.g., pH meter readings, viscosity measurements, plate counts for microbiology, results from validated biocompatibility assays). There is no "expert consensus" or "pathology" involved in determining if the lubricant's pH is within specification.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As there is no training set for an algorithm, this question is not relevant.
In summary, this regulatory submission demonstrates the device's adherence to established safety and performance standards relevant to its classification as a personal lubricant, not the performance of an AI model or a complex diagnostic. The "acceptance criteria" are the physical, chemical, and biological specifications, and the "study" involves laboratory testing to confirm these specifications are met, along with biocompatibility and condom compatibility assessments.
§ 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.