(237 days)
Astroglide Sensual Strawberry 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, polyisoprene, and polyurethane condoms.
Astroglide Sensual Strawberry personal lubricant is non-sterile, clear. colorless, and water based. It has a subtle flavor and fragrance of strawberry. Astroglide Sensual Strawberry is a proprietary blend consisting mainly of water soluble ingredients similar to the predicate device and other personal lubricant devices currently on the market. This product is not a spermicide or contraceptive. The product is provided in a clear bottle or a tube with flip top cap and it is compatible with natural rubber latex, polyisoprene and polyurethane condoms.
The provided text is a 510(k) Summary for the medical device "Astroglide Sensual Strawberry." This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission does not typically involve the rigorous clinical studies or complex AI performance metrics that your request implies.
Therefore, many of the requested categories (e.g., sample size for test and training sets, number of experts for ground truth, adjudication method, MRMC studies, standalone algorithm performance) are not applicable to this type of device and submission.
However, I can extract information related to the acceptance criteria and the studies performed to demonstrate equivalence and safety.
Here's a summary based on the provided text, focusing on the relevant criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Specification | Reported Device Performance | Study / Test Method |
|---|---|---|
| Biocompatibility: | ||
| Non-cytotoxic | Results show the product is non-cytotoxic. | ISO 10993-5 (Cytotoxicity) |
| No irritation or sensitization | The product did not elicit any irritation or sensitization reactions. | ISO 10993-10 (Guinea Pig Maximization) |
| Non-irritating to vaginal mucosa | The product was considered non-irritating to the vaginal mucosa in New Zealand White Rabbits. | ISO 10993-10 (Vaginal Irritation) |
| Meets ISO 10993-11 requirements, no biological reactivity | The product met the requirements of ISO 10993-11. No test animals exhibited any biological reactivity. | ISO 10993-11 (Acute Systemic Toxicity) |
| Lot Release Specifications: | (Maintained throughout shelf-life) | |
| Color | Specifications maintained | In-house specifications |
| Clarity | Specifications maintained | In-house specifications |
| Odor | Specifications maintained | In-house specifications |
| Absence of particulate matter | Specifications maintained | In-house specifications |
| pH | Specifications maintained | In-house specifications |
| Viscosity | Specifications maintained | In-house specifications |
| Total yeast/mold count | Specifications maintained | In-house specifications |
| Total aerobic microbial count | Specifications maintained | In-house specifications |
| Absence of pathogens (Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans) | Specifications maintained | In-house specifications |
| Shelf Life: | ||
| 2-year shelf-life | Demonstrated a shelf-life of 2 years. | 8-month accelerated stability study and ongoing real-time stability study with preservative effectiveness testing. |
| Condom Compatibility: | ||
| Compatible with natural rubber latex, polyisoprene, and polyurethane condoms | Results show Astroglide Sensual Strawberry is compatible with latex, polyisoprene, and polyurethane condoms. | ASTM D7661-10 (Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms) |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility Studies (ISO 10993 series): Numbers of animals used for these tests are generally small, as per standard test protocols (e.g., typically 3 animals for acute systemic toxicity, 5 for guinea pig maximization, a specified number for vaginal irritation). The document does not specify the exact number of animals for each test but indicates the tests were performed "in accordance with ISO 10993." These are controlled laboratory experiments, not field data.
- Stability Studies: The stability studies involved product samples tested at various time points across an 8-month accelerated study and an ongoing real-time study. The exact number of samples tested at each time point is not specified.
- Condom Compatibility Study (ASTM D7661-10): This standard typically requires testing a specific number of condom samples (e.g., 30 condoms per lubricant-condom combination for certain tensile property tests). The document does not specify the exact number of condoms tested.
- Data Provenance: Laboratory studies conducted according to international standards (ISO, ASTM). The location of the testing labs or the specific country of origin for the data is not mentioned, but it's typically performed by certified contract research organizations. These are prospective experimental studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. This device is a personal lubricant, and its efficacy and safety are assessed through physicochemical properties, biocompatibility, and material compatibility tests, not through expert-reviewed "ground truth" labels in a clinical diagnostic context. The "ground truth" for these tests is defined by the standardized methodologies themselves (e.g., non-cytotoxic if cell viability is >70% compared to control).
4. Adjudication Method for the Test Set
- Not Applicable. As above, this type of product assessment does not involve human adjudication in the traditional sense. Test results are interpreted against predefined passing criteria in the respective ISO and ASTM standards.
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 not an AI-powered diagnostic device, and therefore no MRMC study or AI-related comparative effectiveness was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI algorithm. Its performance is intrinsic to the product's chemical and physical characteristics.
7. The Type of Ground Truth Used
- The "ground truth" for this device's evaluation is based on:
- Standardized Test Results: Adherence to defined endpoints (e.g., cell viability, irritation scores, tensile strength of condoms) established by recognized international standards (ISO, ASTM).
- Physicochemical Measurements: Direct measurement of properties like pH, viscosity, and microbial counts against internal specifications.
- Stability Performance: Evaluation of product characteristics over time under controlled conditions to ensure specifications are maintained.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of this device. The development of the formulation and manufacturing processes is an iterative design process, but it doesn't involve a dataset in the way an AI model is trained.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set for an AI model, this question is not relevant. The "ground truth" for product development is established through formulation science, quality control, and adherence to relevant regulatory and safety standards.
§ 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.