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Astroglide® Sensual Strawberry Personal Lubricant 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 condoms. This product is not compatible with polyisoprene or polyurethane condoms.

Astroglide® Sensual Strawberry Personal Lubricant is a non-sterile, clear, strawberry-scented and flavored, water-based personal lubricant intended for penile, anal, or vaginal application. This product is not a spermicide or contraceptive. Astroglide® Sensual Strawberry Personal Lubricant is compatible with natural rubber latex condoms. It is not compatible with polyisoprene and polyurethane condoms. This product's primary packaging is a PETE clear bottle with a screw on polypropylene flip-top cap. The bottle is then packaged in a cardboard carton which constitutes the final packaging.

This document is a 510(k) Premarket Notification from BioFilm, Inc. to the FDA for their product, Astroglide® Sensual Strawberry Personal Lubricant. It aims to demonstrate substantial equivalence to a legally marketed predicate device (Glycerin & Paraben Free Astroglide, K072647).

Therefore, this document does not describe:

• Acceptance criteria and device performance for an AI/ML medical device.
• A study proving the performance of an AI/ML medical device.
• Data provenance, sample sizes for test/training sets, expert qualifications, or adjudication methods related to AI/ML model development or validation.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone AI performance.
• Details about ground truth establishment for AI/ML models.

Instead, the document focuses on:

• Device Description: A water-based personal lubricant, its physical characteristics, and specifications.
• Predicate Device Comparison: Highlighting similarities (indications for use, over-the-counter status, base type, pH) and differences (ingredients, osmolality, viscosity, packaging, shelf-life). The document asserts that these differences do not raise new questions of safety and effectiveness.
• Non-Clinical Performance Testing: This is the equivalent of "proof" in this context, demonstrating the device's safety and effectiveness through:
  • Biocompatibility Testing: Cytotoxicity, sensitization, irritation, and acute systemic toxicity.
  • Condom Compatibility Testing: Specifically with natural rubber latex condoms using ASTM D7661-10.
  • Shelf-Life Testing: Using accelerated aging (ASTM F1980-16) to determine an 8.5-month shelf-life.

To answer your specific questions based on the provided document, which is NOT about an AI/ML device:

1. A table of acceptance criteria and the reported device performance:

   Physical Specification Tests	Acceptance Criteria / Ranges/Specifications	Reported Device Performance (from text, implicitly met for approval)
   Particulate matter	No particles	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study.")
   Color	Clear to slight golden	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study.")
   Clarity	Clear	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study.")
   Odor	Strawberry scent	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study.")
   pH (per USP )	3.5-5.5	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study." Also stated in comparison table as "Same" to predicate.)
   Viscosity (per USP )	200 - 450 cps	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study." The value 200-450 cps is the reported device performance for this specific product, which is different from the predicate, but deemed acceptable by the FDA.)
   Osmolality (per USP )	200 - 450 mOsm/kg, dilution factor of 5	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study." The value 200-450 mOsm/kg is the reported device performance for this specific product, which is different from the predicate, but deemed acceptable by the FDA.)
   Antimicrobial effectiveness (per USP )	Category 2: bacteria show ≥2.0 log reduction at 14 days, no increase from 14-day count at 28-day count; yeast/molds show no increase from initial calculated count at 14 and 28 days.	Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study." Also stated in comparison table as "Same" to predicate.)
   Total yeast/mold count (per USP & USP )	& USP )	& USP )
   Biocompatibility	Non-cytotoxic, non-sensitizing, non-irritating, not systemically toxic	Demonstrated to be non-cytotoxic, non-sensitizing, non-irritating, and not systemically toxic.
   Condom Compatibility (Natural Rubber Latex) (per ASTM D7661-10)	Compatible	Results show that Astroglide® Sensual Strawberry Personal Lubricant is compatible with natural rubber latex condoms.
   Shelf-Life (per ASTM F1980-16)	All specifications from Section IV met throughout the study.	8.5 months shelf-life achieved; all specifications in Section IV were met throughout the shelf-life study.

2. Sample size used for the test set and the data provenance: This document describes non-clinical performance testing for a personal lubricant, not an AI/ML device using a "test set" in the machine learning sense. The tests are laboratory-based.

   • Sample Size: Not explicitly stated for each test (e.g., number of lubricant samples tested for pH, viscosity, microbial counts). For biocompatibility, it's not specified how many samples/subjects were used for the in-vitro and in-vivo tests. For condom compatibility, ASTM D7661-10 would specify the number of condoms and lubricant samples, but this detail is not provided in the summary. For shelf-life, a sufficient number of product units would have been put on accelerated aging.
   • Data Provenance: Not applicable in the geopolitical sense. The data comes from the results of laboratory testing conducted for the purpose of this 510(k) submission. These are not "retrospective or prospective" patient data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a lubricant is established by laboratory measurements (e.g., pH meter for pH, viscometer for viscosity, microbial culture for counts, established protocols for biocompatibility and condom compatibility). There are no human "experts" establishing a "ground truth" for classification or detection tasks as would be the case for an AI/ML device.

4. Adjudication method: Not applicable. This is not a human-reader study where adjudication is needed.

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 document is not about an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an AI/ML device.

7. The type of ground truth used:

   • Physical Specifications: Instrumental measurements (pH meters, viscometers, osmolality readers) and laboratory assays (microbial cultures, particulate inspection).
   • Biocompatibility: In-vitro (cytotoxicity) and in-vivo (sensitization, irritation, acute systemic toxicity) testing according to ISO standards.
   • Condom Compatibility: Standardized mechanical and material property testing (ASTM D7661-10).
   • Shelf-Life: Stability testing over time under accelerated conditions according to ASTM F1980-16, measuring the physical specifications listed in the table.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Ask a specific question about this device

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

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.

Ask a specific question about this device