(224 days)
Aloe Glide Lubricant 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.
Aloe Glide Lubricant is a personal lubricant that is non-sterile, waterbased, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms, and is not compatible with polyurethane condoms. Its formulation consists of water, xanthan gum, licorice and marshmallow extract, aloe barbadensis leaf extract, potassium sorbate, citric acid, and natapres. Aloe Glide is packaged in 2, 4, and 8 fl. oz bottles composed of polyethylene terephthalate (PET). Aloe Glide lubricant is a personal lubricant for over-the-counter (OTC) use.
This looks like a 510(k) summary for a medical device called "Aloe Glide Lubricant." The document states that the device 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. It is compatible with natural rubber latex and polyisoprene condoms but not with polyurethane condoms.
The document is a US FDA 510(k) clearance letter, which means the device has been found to be substantially equivalent to a legally marketed predicate device. This is primarily a regulatory submission for market clearance, not typically a clinical study demonstrating performance against specific clinical efficacy or diagnostic accuracy acceptance criteria in the same way an AI/ML device would.
Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies, does not apply to this type of device and submission. The "study" here refers to the performance testing to demonstrate substantial equivalence, focusing on safety and technical characteristics rather than clinical performance or diagnostic accuracy.
Here's a breakdown of the provided information, framed as closely as possible to your request, but highlighting where your specific questions are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for a personal lubricant, in the context of a 510(k) submission, are primarily defined by the specifications to demonstrate safety and functional equivalency to a predicate device. These are detailed in Table 1 (Device Specifications) and through performance testing results.
| Property | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Appearance | Clear and transparent | Demonstrated to meet this specification. |
| Odor | Characteristic | Demonstrated to meet this specification. |
| Viscosity | 10,000 - 15,000 cps | Demonstrated to meet this specification. |
| Osmolality | 300 – 400 mOsm/kg | Demonstrated to meet this specification. |
| pH at 25 °C | 4.5 – 5.8 | Demonstrated to meet this specification. |
| Total Aerobic Microbial Count (USP ) | ) | ) |
| Antimicrobial Effectiveness (USP ) | E. coli, P. aeruginosa, S. aureus: NLT 2.0 log reduction from initial count at 14 days and no increase from 14-day count at 28 days. | Demonstrated to meet these specifications. |
| C. albicans, A. niger: No increase from initial calculated count at 14 and 28 days. | Demonstrated to meet these specifications. | |
| Biocompatibility | Non-cytotoxic, non-sensitizing, non-irritating, non-systemically toxic | Reported: Non-cytotoxic (based on alternate testing comparable to ISO 10993-5:2009), non-sensitizing (human repeat insult patch testing), non-irritating (human repeat insult patch testing), and non-systemically toxic (acute systemic toxicity testing per ISO 10993-11:2017). |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms; Not compatible with polyurethane condoms | Reported: Compatible with natural rubber latex and polyisoprene condoms; Not compatible with polyurethane condoms (evaluated per ASTM D7661-10). |
| Shelf Life (1-year accelerated aging study) | Maintain specifications (Table 1) over duration of shelf life | Reported: Device can maintain its specifications over the duration of its shelf life. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The "tests" here refer to chemical, physical, and biological performance evaluations of the lubricant itself, or compatibility tests with condoms. These are not clinical studies with patient test sets in the typical sense of diagnostic performance.
- Data Provenance: Not applicable for a clinical test set. The data originates from laboratory performance testing performed by the manufacturer or contracted labs.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. Ground truth as typically defined in diagnostic studies (e.g., expert consensus on medical images) is not relevant for lubricant safety and performance testing.
- Qualifications of Experts: Not applicable. The "ground truth" for the performance tests relies on established scientific methods and criteria for chemical, microbiological, and biocompatibility assessments, not clinical interpretation by expert readers.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no "test set" requiring adjudication in the context of clinical or diagnostic performance. The results of the laboratory tests are factual measurements and observations against predefined specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks involving interpretation of complex data (e.g., medical images). It is not applicable to a personal lubricant's safety and performance evaluation.
- Effect Size: Not applicable as no MRMC study was performed.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study: No, a standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not done. This concept is relevant for AI/ML diagnostic tools. For this device, the "performance" is inherent in the product's physical and biological properties.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" is established by standardized laboratory test methods and scientific principles for assessing material properties, microbiological purity, biocompatibility, and condom compatibility. This is based on industry standards (e.g., USP, ISO 10993, ASTM D7661-10) rather than expert consensus on medical conditions, pathology, or clinical outcomes data.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set. The formulation and manufacturing processes are developed through traditional pharmaceutical/cosmetic science and engineering, not machine learning.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable. As there is no AI/ML algorithm or training set, this question is not relevant.
§ 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.