(87 days)
JO Premium Jelly Original 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 product is compatible with natural rubber latex, polyurethane and polyisoprene condoms.
JO Premium Jelly Original Personal Lubricant is a clear/water white, viscous gel-type personal lubricant that is compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This provided in clear, polyethylene (PE) tubes. These 4 oz. size tubes are capped with silver, glossy, polypropylene (PP) flip tops. The individual tubes are hermetically sealed during the production process.
This document describes a 510(k) submission for a personal lubricant and focuses on demonstrating its substantial equivalence to a predicate device. Therefore, it does not involve AI or machine learning, which are typically associated with complex acceptance criteria and studies like MRMC.
Based on the provided document, here's a breakdown of the acceptance criteria and the studies performed, tailored to a medical device rather than an AI product:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are primarily based on comparisons to the predicate device and established international standards for medical device safety and performance.
| Property | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Appearance | Viscous gel | Viscous gel |
| Color | Clear, water white | Clear, water white |
| Odor | Odorless | Odorless |
| Viscosity (cps) | 1375 cps to 1700 cps | Meets specification (implied by "device met the device specifications at all time points") |
| Specific Gravity | 0.870 to 1.025 | Meets specification (implied by "device met the device specifications at all time points") |
| 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 | Absent (for Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella/Shigella, Escherichia coli, Candida albicans) | Absent (for Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella/Shigella, Escherichia coli, Candida albicans) |
| Biocompatibility | Biocompatible according to ISO 10993 series | Demonstrated to be biocompatible |
| Shelf-Life | 2 years, maintaining all device specifications | 2 years, maintaining all device specifications at 0, 1, and 2 years |
| Condom Compatibility | Compatible with natural rubber latex, polyurethane, and polyisoprene condoms per ASTM D7661-10 | Compatible with natural rubber latex, polyurethane, and polyisoprene condoms |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify exact sample sizes for each test in terms of individual units of the lubricant. Instead, it refers to general testing procedures. For biological tests (biocompatibility), typically a minimum number of test units and control units are used as per the specific ISO standards. For chemical/physical property tests, sample sizes are usually defined by the ASTM or USP methods.
The data provenance is from non-clinical performance testing, meaning these were laboratory studies rather than studies on human subjects. The country of origin of the data is not explicitly stated, but the testing was conducted in accordance with international standards (ISO) and U.S. Pharmacopeia (USP) guidelines, implying recognized laboratory practices. These would inherently be prospective studies relative to the testing itself (i.e., new tests performed on the device).
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 concept of "experts" and "ground truth" to establish a test set is not directly applicable to this type of medical device submission. The "ground truth" here is defined by:
- Established scientific and industry standards (e.g., USP , USP , USP , USP , ASTM D7661-10, ISO 10993 series).
- The specifications of the predicate device.
The "experts" involved would be qualified laboratory technicians and scientists performing the tests and interpreting results against these objective criteria, rather than clinical experts providing subjective assessments.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where subjective assessments (e.g., image interpretation by radiologists) require a consensus mechanism. This is not applicable here as the performance evaluation relies on objective, quantifiable laboratory tests against established standards. Therefore, the adjudication method is none in this context.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specific to diagnostic aids, particularly those involving human interpretation of data (e.g., medical imaging) and often used to assess the effectiveness of AI assistance. This device is a personal lubricant, and its evaluation does not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone (algorithm-only) performance study was not applicable or performed, as the device is not an algorithm or AI product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's evaluation is primarily established by:
- International Standards and Pharmacopeia Methods: E.g., ISO 10993 for biocompatibility, USP methods for microbiological analysis, and ASTM D7661-10 for condom compatibility. These standards define the acceptable performance parameters.
- Predicate Device Specifications: The composition and performance characteristics of the legally marketed predicate device (Astroglide Diamond Silicone Gel Personal Lubricant, K163395) serve as a benchmark for substantial equivalence.
8. The sample size for the training set
The concept of a "training set" is relevant for machine learning and AI algorithms. Since this device is a physical product (personal lubricant) and not an AI system, there was no training set used.
9. How the ground truth for the training set was established
As there was no training set, this question is not applicable.
§ 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.