(85 days)
Astroglide Warming is a personal lubricant for penile, vaginal, and/or anal 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.
Astroglide Warming is non-sterile, clear and water based personal lubricant. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms only. It is not compatible with polyurethane condoms. The device is composed of water, glycerin, propylene glycol, polyquaternium-7 and citric acid.
The provided document describes the K221036 submission for Astroglide Warming, a personal lubricant. It does not describe a study involving an AI/ML device and human readers. Therefore, I cannot fulfill all aspects of your request as it pertains to AI/ML device performance, ground truth, expert opinions, or MRMC studies.
However, I can extract the acceptance criteria and the summary of non-clinical performance testing for the Astroglide Warming device itself.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Test Method) | Reported Device Performance |
|---|---|---|
| Absence of particulate matter | No particles | Met specification (implied by "met the specifications at all time points") |
| Color | Colorless | Met specification (implied by "met the specifications at all time points") |
| Clarity | Clear | Met specification (implied by "met the specifications at all time points") |
| Odor | Odorless | Met specification (implied by "met the specifications at all time points") |
| Viscosity | 175 - 330 cP | Met specification (implied by "met the specifications at all time points") |
| Osmolality | 2600 – 2800 mOsm/kg, dilution factor of 5 | Met specification (implied by "met the specifications at all time points") |
| pH | 3.5-5.5 | Met specification (implied by "met the specifications at all time points") |
| Total yeast/mold count (TYMC) | ) | Met specification (implied by "met the specifications at all time points") |
| Total aerobic microbial count (TAMC) | ) | Met specification (implied by "met the specifications at all time points") |
| Presence of pathogenic organisms (Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans) | Absent (USP) | Met specification (implied by "met the specifications at all time points") |
| Antimicrobial effectiveness | Meets USP acceptance criteria for Category 2 products. | Met specification (implied by "met the specifications at all time points") |
| Biocompatibility: Cytotoxicity | Non-cytotoxic (per ISO 10993-5:2009/(R)2014) | Non-cytotoxic |
| Biocompatibility: Sensitization and Irritation | Non-sensitizing, non-irritating (per ASTM D6355) | Non-sensitizing, non-irritating |
| Biocompatibility: Systemic Toxicity | Not systemically toxic (per ISO 10993-11:2017) | Not systemically toxic |
| Shelf Life (8.5 months) | Met all specifications in Table 1 | Met the specifications at all time points during accelerated aging study. |
| Condom Compatibility: Natural Rubber Latex Condoms | Compatible (per ASTM D7661-18) | Compatible with natural rubber latex condoms. |
| Condom Compatibility: Polyisoprene Condoms | Compatible (per ASTM D7661-18) | Compatible with polyisoprene condoms. |
| Condom Compatibility: Polyurethane Condoms | Not compatible (per ASTM D7661-18) | Not compatible with polyurethane condoms. |
2. Sample size used for the test set and the data provenance:
The document describes non-clinical performance testing for a personal lubricant, not an AI/ML device. Therefore, the concept of "test set" in the context of AI/ML is not applicable here. The testing involved samples of the product itself.
- Biocompatibility testing: Not specified number of samples, but refers to ISO and ASTM standards.
- Shelf Life Accelerated Aging Study: Not specified number of samples. The study duration was 3 months at 40°C.
- Condom Compatibility: Not specified number of samples, but refers to ASTM D7661-18.
- Data provenance: Not explicitly stated, but assumed to be from internal lab testing conducted by or for BioFilm, Inc. It is retrospective in the sense that the tests were completed before submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a physical product, not an AI/ML device requiring expert ground truth for image or data interpretation.
4. Adjudication method for the test set:
Not applicable. This is a physical product, not an AI/ML device requiring adjudication for ambiguous cases.
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:
Not applicable. This is a physical product, not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical product, not an AI/ML algorithm. The "standalone" performance here refers to the device's inherent physical and chemical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this product is based on established industry standards and validated test methods as defined by organizations like ISO, ASTM, and USP. For example:
- Physical and Chemical Properties: The specifications (e.g., viscosity, pH, osmolality, color, odor, clarity, absence of particulate matter) are based on direct measurements against defined ranges.
- Microbial Limits: Determined by specific USP and methods.
- Antimicrobial Effectiveness: Determined by USP methods.
- Biocompatibility: Determined by ISO 10993-5, ISO 10993-11, and ASTM D6355 standards.
- Condom Compatibility: Determined by ASTM D7661-18.
8. The sample size for the training set:
Not applicable. This is a physical product, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
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.