(104 days)
JO Agapé Personal Lubricant is a 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 product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
The JO Agapé Personal Lubricant is a clear, colorless, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. It is not compatible with polyurethane condoms. The device is a non-sterile lubricant for penile and/or vaginal application, to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is provided in Polyethylene Terephthalate (PET) bottles fitted with Polypropylene caps. The individual bottles are sealed using an induction seal constructed of aluminized mylar.
The provided document pertains to the 510(k) premarket notification for the JO Agapé Personal Lubricant. This is a Class II medical device (a personal lubricant) and the information presented primarily focuses on its physical and biological properties, as well as its compatibility with condoms, to establish substantial equivalence with a predicate device.
The questions regarding acceptance criteria and study design, training and test sets, expert involvement, and reader studies are typically applicable to AI/ML-driven diagnostic or medical imaging devices. This document describes a personal lubricant, which does not involve such AI components or diagnostic performance metrics. Therefore, many of the requested details are not applicable to this type of device.
However, I can extract the acceptance criteria and the information about the studies conducted to meet them as they relate to the properties of the lubricant.
1. A table of acceptance criteria and the reported device performance
| Property | Acceptance Criteria (Specification) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Device Specifications (Table 1) | ||
| Appearance | Clear, semi-viscous liquid | Met specification (implied, as the document states "The subject device met the device specifications at all time points" for shelf-life testing). |
| Color | Clear, colorless | Met specification (implied). |
| Odor | Odorless | Met specification (implied). |
| Viscosity (cps) | 2400 cps to 3100 cps | Met specification (implied). |
| Specific Gravity | 1.020 to 1.026 | Met specification (implied). |
| pH | 3.60 to 4.30 | Met specification (implied). |
| Osmolality | 250 to 350 mOsm/kg | Met specification (implied). |
| Antimicrobial effectiveness per USP | Meets USP acceptance criteria for Category 2 products | "Meets USP acceptance criteria for Category 2 products." |
| Total aerobic microbial count (TAMC) per USP and | Less than 10 cfu/g | "Less than 10 cfu/g." |
| Total yeast and mold count (TYMC) per USP and | Less than 10 cfu/g | "Less than 10 cfu/g." |
| Presence of Pathogens per USP : | ||
| - Pseudomonas aeruginosa | Absent | "Absent." |
| - Staphylococcus aureus | Absent | "Absent." |
| - Salmonella | Absent | "Absent." |
| - Candida albicans | Absent | "Absent." |
| Biocompatibility | Demonstrates biocompatibility per ISO 10993 standards | "The results of this testing demonstrated that the subject lubricant is biocompatible." (Studies included Cytotoxicity, Sensitization, Vaginal Irritation, Penile Irritation, Acute Systemic Toxicity). |
| Shelf-Life | Maintain all device specifications for 36 months | "The subject device met the device specifications at all time points" for a 36-month shelf-life, evaluated at 0, 1, 2, and 3 years in real-time and accelerated aging studies. |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms per ASTM D7661-10 | "The results of this test indicate that the JO Agapé Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms." (Evaluated against ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify exact sample sizes for each test (e.g., number of lubricant units tested for viscosity, pH, etc., or number of condoms tested). It refers to the tests performed according to specific standards (e.g., USP, ISO, ASTM), which would implicitly define typical sample sizes for those methodologies.
- Data Provenance: The studies were conducted by "independent third-party laboratories." The country of origin is not specified, but the use of international standards (ISO, USP, ASTM) suggests widely accepted scientific practices. The studies appear to be prospective in nature, as they involve testing the device against predefined specifications and standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable. The device is a personal lubricant, not an AI/ML diagnostic. The "ground truth" for this device is defined by meeting physical, chemical, biological, and compatibility specifications outlined in recognized standards (e.g., USP, ISO, ASTM) and internal product specifications. There is no mention of human experts establishing ground truth in the context of diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations in diagnostic studies, typically when establishing a ground truth for AI models. This type of device does not involve such expert adjudications. The results are based on objective laboratory measurements and standardized biological/chemical tests.
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 question is not applicable. MRMC studies are relevant for evaluating the performance of diagnostic imaging systems and AI-assisted interpretation, often involving multiple human readers. This device is a personal lubricant and does not involve human readers interpreting cases or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a personal lubricant, which is a physical product, not an algorithm. Therefore, there is no "standalone" algorithm performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on:
- Predetermined Specifications: Numerical ranges or qualitative descriptions for physical/chemical properties (viscosity, pH, osmolality, color, odor, appearance, specific gravity).
- Regulatory Standards: Compliance with pharmacopeial standards for microbial limits and effectiveness (USP , , , ).
- International Standards: Biocompatibility according to ISO 10993 standards and condom compatibility according to ASTM D7661-10.
- Stability over Time: Maintaining the above specifications over a set shelf-life period.
These are established through objective laboratory testing, not human diagnostic interpretation.
8. The sample size for the training set
This question is not applicable. This device is not an AI/ML model and therefore does not have a "training set" in the context of machine learning. The "training" for the product development would involve chemical formulation and process optimization, but not AI model training with data sets.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated above.
§ 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.