(91 days)
ally® Warming Liquid is a personal lubricant, for penile 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.
The device is non-sterile, clear, non-staining, non-greasy, high viscosity liquid gel used as a personal lubricant. This product is highly lubricous and may be used with or without a natural rubber latex or polyisoprene condom during intimate sexual activity. This product is not a contraceptive or spermicide. The product is packaged in 2 to 8 ounce plastic bottles with tamperproof seals.
This document is a 510(k) premarket notification for a personal lubricant, not a device that uses artificial intelligence or requires complex algorithms for analysis. Therefore, most of the requested information regarding acceptance criteria, study methodologies for AI/ML devices, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable.
However, I can extract the relevant information regarding the performance testing conducted to demonstrate substantial equivalence for this specific medical device.
Key Information from the Document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical targets for each test, as might be seen for an AI/ML device. Instead, it lists the standards against which testing was performed and states that the device was found to be in compliance. The "reported device performance" is implicitly that the device met the requirements of these standards.
| Test Category | Relevant Standard / Criteria | Reported Performance (Implied) |
|---|---|---|
| Biocompatibility | ISO 10993-5 (Cytotoxicity) | Compliant (Implied by "were conducted on the device ... in compliance") |
| ISO 10993-10 (Irritation & Sensitization) | Compliant | |
| ISO 10993-11 (Systemic Toxicity) | Compliant | |
| USP (Biological Reactivity, In Vivo) | Compliant | |
| Microbiology | USP (Antimicrobial Effectiveness) | Compliant |
| USP (Microbial Enumeration) | Compliant | |
| USP (Specified Microorganisms) | Compliant | |
| Condom Compatibility | ASTM D7661-10 (Natural Rubber Latex & Polyisoprene Condoms) | Compliant |
| Shelf Life | ICH Q1A(R2) Guidelines | 10-month shelf life initially, with intent to extend to 2-3 years after real-time testing. |
| Shipping Testing | ISTA 3A | Compliant |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in terms of number of units tested for each standard. The document only mentions "testing were conducted on the device." For a physical product, this typically refers to a statistically significant number of units or batches tested per standard.
- Data Provenance: The document states that testing was "conducted on the device by outside laboratories." The country of origin of the data is not specified, but the applicant (Guy & O'Neill, Inc.) is located in Fredonia, WI, USA. The studies are prospective in the sense that they were performed specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This concept is not applicable here. Ground truth, in the context of an AI/ML device, refers to expert-validated diagnoses or labels. For a personal lubricant, the "ground truth" is determined by established scientific and regulatory standards (e.g., ISO, USP, ASTM) and the results of laboratory tests run against those standards. The expertise lies in the accredited laboratories and their personnel performing the tests according to the standards, rather than a panel of clinical experts establishing diagnostic "ground truth."
4. Adjudication Method for the Test Set
Not applicable. There is no subjective interpretation or diagnostic labeling requiring adjudication. The outcome of the tests (e.g., cytotoxicity, microbial count, condom integrity) is objectively measured against the specified standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a study design used to evaluate the impact of an AI algorithm on human reader performance for diagnostic tasks.
6. Standalone Performance (i.e., algorithm only without human-in-the-loop performance)
Not applicable. This device does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is the successful fulfillment of the criteria outlined in the referenced consensus standards (ASTM, ISO, USP, ISTA, ICH). These standards provide objective, measurable parameters for safety (biocompatibility, microbiology) and compatibility (condom compatibility, shelf-life, shipping integrity).
8. The Sample Size for the Training Set
Not applicable. There is no training set as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set and thus no ground truth to establish for it.
§ 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.