(107 days)
Astroglide Ultra Gentle Gel 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 Ultra Gentle Gel is a non-sterile, clear, odorless, and water based personal lubricant. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. The device is composed of water, propylene glycol, hydroxyethylcellulose, polyquaternium 7, potassium sorbate, sodium benzoate and citric acid. The product primary packaging is a white LDPE 3-ounce tube with a screw on cap. The tube and cap constitute the device final packaging.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Specification) | Reported Device Performance (Met/Not Met/Not Applicable) |
|---|---|---|
| Color | Clear to golden | Met (Implied, as testing "met specifications") |
| Clarity | Clear | Met (Implied, as testing "met specifications") |
| Odor | Odorless | Met (Implied, as testing "met specifications") |
| Absence of particulate matter | No particles | Met (Implied, as testing "met specifications") |
| Viscosity | 10,000-25,000 cP | Met (Implied, as testing "met specifications") |
| pH | 3.5-5.5 | Met (Implied, as testing "met specifications") |
| Osmolality | 200-300 mOsm/kg, 1:5 dilution factor | Met (Implied, as testing "met specifications") |
| Total yeast/mold count (TYMC) | ) | Met (Implied, as testing "met specifications") |
| Total aerobic microbial count (TAMC) | ) | Met (Implied, as testing "met specifications") |
| Presence of Pathogenic Organisms (Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans) | Absent (USP ) | Met (Implied, as testing "met specifications") |
| Antimicrobial effectiveness | Meets USP acceptance criteria for Category 2 products | Met (Implied, as testing "met specifications") |
| Cytotoxicity | Non-cytotoxic (per ISO 10993-5:2009/(R)2014) | Met |
| Sensitization/Irritation | Non-sensitizing, Non-irritating (per ASTM D6355) | Met |
| Systemic Toxicity | Not systemically toxic (per ISO 10993-11:2017) | Met |
| Shelf Life (24 months) | Maintain all specifications listed in Table 1 | Met (Confirmed by accelerated aging study) |
| Compatibility with Natural Rubber Latex Condoms | Compatible (per ASTM D7661-18) | Compatible |
| Compatibility with Polyisoprene Condoms | Compatible (per ASTM D7661-18) | Compatible |
| Compatibility with Polyurethane Condoms | Not Compatible (per ASTM D7661-18) | Not Compatible (This is a reported finding, not a failure of a positive criterion) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each test in the "Summary of Non-Clinical Performance Testing" section. For the Shelf Life study, it mentions an "accelerated aging study, conducted for 8 months at 40°C," but doesn't detail the number of samples or batches tested. The provenance of the data is internal to BioFilm, Inc., as these are non-clinical performance tests conducted for device clearance. There is no information regarding country of origin or whether it's retrospective or prospective beyond the description of the tests themselves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. The testing described (biocompatibility, shelf life, condom compatibility) are laboratory-based, objective performance tests conducted against established international or national standards (e.g., ISO, ASTM, USP). Ground truth is established by the test method's specified criteria, not by expert consensus in the way a clinical diagnostic device would require.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the tests are objective laboratory performance tests, not subjective interpretations requiring adjudication among experts.
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 typically performed for AI-driven diagnostic or screening devices involving human interpretation, not for a personal lubricant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a personal lubricant, not an AI algorithm. The performance tests are directly on the physical product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the acceptance criteria for most of the parameters (Color, Clarity, Odor, Absence of particulate matter, Viscosity, pH, Osmolality, Microbial Limits, Antimicrobial effectiveness) is based on pre-defined quantifiable specifications and standard laboratory test methods (USP , USP , USP ).
For Biocompatibility, the ground truth is established by the pass/fail criteria defined in international standards like ISO 10993-1, ISO 10993-5, ISO 10993-11, and ASTM D6355.
For Condom Compatibility, the ground truth is established by the pass/fail criteria defined in ASTM D7661-18.
For Shelf Life, the ground truth is that the device must continue to meet all the physical, chemical, and microbiological specifications after accelerated aging, following ASTM F1980-16.
8. The sample size for the training set
This is not applicable as the device is not an AI/ML algorithm. There is no "training set" for a physical personal lubricant.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this device.
§ 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.