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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.

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Sensual Massage/Ultra Pure 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.

Sensual Massage/Ultra Pure is a non-sterile, silicone-based personal lubricant comprised on dimethoconol, dimethicone, and cyclopentasiloxane. This over-thecounter product is formulated to be clear, non-greasy, and odorless. The Sensual Massage/Ultra Pure lubricant is neither a contraceptive nor a spermicide.

This document is a 510(k) premarket notification for a personal lubricant, not an AI/ML medical device. Therefore, the information requested about acceptance criteria, study details, and ground truth establishment for AI/ML performance evaluation is not applicable to this document.

The document discusses the following:

• Device Name: Sensual Massage/Ultra Pure (a personal lubricant)
• Regulatory Class: Class II
• Predicate Device: SILICONE Personal Lubricant (K191654)
• Indications for Use: Moisturize and lubricate for comfortable intimate sexual activity, supplement natural lubrication, and compatibility with natural rubber latex and polyisoprene condoms (not polyurethane).
• Performance Data: Biocompatibility testing (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity), shelf-life testing, and condom compatibility testing.

The "acceptance criteria" in this context refer to the chemical and physical specifications of the lubricant and its biological and material compatibility, not performance metrics of an AI algorithm.

Therefore, I cannot provide the requested information regarding AI/ML device performance, sample sizes for AI/ML test/training sets, expert adjudication, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to AI/ML, as this is not an AI/ML device submission.

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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.

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Durex Play™ Soft & Sensual™ is a personal lubricant, for vaginal or penile 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 only.

Durex Play Soft & Sensual Lubricant is a clear, colorless, unperfumed vaginal lubricant with a pH similar to the normal pH range of the vagina.

This document describes a 510(k) premarket notification for a personal lubricant, not a medical device that requires clinical performance studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies in the way requested.

The submission for Durex Play Soft & Sensual Lubricant (K071626) primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, not on proving clinical effectiveness through detailed performance metrics against pre-defined acceptance criteria.

Therefore, the information requested in your prompt (e.g., acceptance criteria table, sample sizes for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) is not applicable or not provided in this type of regulatory submission for this product.

Here's why and what information is relevant from the document:

Key Takeaways from the Document:

• Device Type: Personal lubricant, classified as a Class II medical device (Regulation Number: 21 CFR §884.5300, Product Code: NUC).
• Regulatory Pathway: 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device.
• Predicate Devices: Durex Play™ personal lubricant (K032124), Durex Play™ Assorted Temptations lubricants (K060098), Durex Play™ Warmer lubricant (K042563), KY liquid (K955648), and Lifestyles (K033076).
• Basis for Substantial Equivalence: The document states the proposed and predicate devices are: "non-sterile, water-soluble, chemically preserved, multi-dose lubricants, and compatible with natural rubber latex condoms." The intended use and labeling are also considered substantially equivalent.
• "Acceptance Criteria" in a 510(k) Context: For this type of device and regulatory pathway, the "acceptance criteria" isn't a specific set of clinical performance metrics, but rather the demonstration that the new device is as safe and effective as a legally marketed predicate device. This is often achieved through comparison of technical characteristics, intended use, and performance data if relevant (e.g., biocompatibility testing, lubricant compatibility with condoms), rather than complex clinical outcomes studies.

Regarding your specific questions:

1. Table of acceptance criteria and reported device performance: Not applicable. There are no clinical performance metrics or acceptance criteria presented in this type of 510(k) submission for a personal lubricant. The "performance" is demonstrated by its similarity to already approved lubricants.
2. Sample sizes used for the test set and data provenance: Not applicable for clinical performance. Any testing (e.g., for biocompatibility or condom compatibility) would have its own sample size, but that is not detailed here in the context of human clinical data for establishing performance.
3. Number of experts used to establish ground truth and qualifications: Not applicable. This type of submission does not involve expert review for clinical ground truth.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This is not a diagnostic device where human readers are interpreting results.
6. Standalone performance (algorithm only without human-in-the loop performance): Not applicable, as this is not an algorithm-driven device.
7. Type of ground truth used: Not applicable. For material performance (e.g., condom compatibility), the "ground truth" would be established by standardized laboratory testing methods, not clinical outcomes.
8. Sample size for the training set: Not applicable. This is not an AI/ML-driven device requiring training data.
9. How the ground truth for the training set was established: Not applicable.

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K-Y® Brand SENSUAL MIST™ is intended as a personal lubricant (for penile and vaginal application) compatible with latex condom.

This device is a condom compatible personal lubricant that has been specifically developed to be delivered via a non-aerosol spray pump.

The provided text describes a 510(k) Special Device Modification for the K-Y® Brand SENSUAL MIST™ Personal Lubricant. The filing emphasizes the device's substantial equivalence to predicate devices, particularly K-Y® Brand Liquid. However, the document does not contain explicit acceptance criteria or a study designed to prove the device meets specific performance criteria in the way one might expect for a new, high-risk medical device.

Instead, the submission focuses on demonstrating substantial equivalence to an existing, legally marketed predicate device (K-Y® Brand Liquid). This means the primary "acceptance criterion" is that the modified device performs equivalently to the predicate and is safe and effective for its intended use.

Here's an analysis of the provided information, framed to answer your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit quantitative "acceptance criteria" and their corresponding device performance values are not detailed in the provided text (like sensitivity, specificity, accuracy, etc.), I will extrapolate the information based on the nature of a 510(k) substantial equivalence submission for a personal lubricant.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated in terms of a specific number of instances. The document mentions "leading commercial brands of latex condoms" for compatibility testing, but not the number of condoms tested. For the "human RIPT," it doesn't specify the number of human participants.
• Data Provenance: The studies mentioned ("laboratory testing," "pre-clinical evaluations," and "human RIPT") appear to be prospective studies conducted specifically for this device modification. The country of origin of the data is not specified, but given the submitter's location (Skillman, NJ, USA) and the FDA submission, it's presumed to be conducted or overseen within the US or to standards acceptable for US regulatory submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• This information is not provided in the document. The studies described are more focused on direct physical/chemical properties (condom compatibility, lubricity, particle size) and biological responses (RIPT) rather than expert-based "ground truth" establishment for diagnosis or interpretation.

4. Adjudication Method for the Test Set

• This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and their disagreements need to be resolved to establish a ground truth. The studies for this lubricant are laboratory and pre-clinical in nature.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or is not described. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiology AI). The K-Y® Brand SENSUAL MIST™ is a personal lubricant, and its evaluation does not involve human readers interpreting "cases."

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Applicable in a different context: While not an "algorithm" in the AI sense, the performance data presented (condom compatibility, lubricity, particle size analysis, RIPT) can be considered "standalone" performance evaluations of the device itself, without human intervention in its efficacy assessment in the way a human-in-the-loop study would assess an AI. The device's properties were tested objectively.

7. Type of Ground Truth Used

• The "ground truth" in this context is established through a combination of:
  • Laboratory measurements: For condom compatibility, lubricity (presumably measured by standardized methods), and particle size analysis.
  • Pre-clinical evaluations: For ingredient safety.
  • Human RIPT (Repeat Insult Patch Test): For skin sensitization, where the "ground truth" is the observed biological reaction (or lack thereof) in human participants.
  • Regulatory standards/guidelines: Underlying the expectation for GRAS ingredients and the design of the RIPT.

8. Sample Size for the Training Set

• Not applicable/not provided. The concept of a "training set" is relevant for machine learning algorithms. This submission is for a physical medical device (personal lubricant), not an AI/ML algorithm.

9. How Ground Truth for the Training Set Was Established

• Not applicable/not provided. As there is no training set for an AI/ML model, the establishment of ground truth for such a set is not relevant to this submission.

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Intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and the responsiveness (ease and comfort) during intimate sexual activity.

SENSUA! is a clear, colorless personal lubricant composed of: purified water. Propylene glycol, L-arginine, Hydroxyethyl cellulose, Methylparaben and other ingredients.

This document is a 510(k) summary for a personal lubricant called "SENSUA! Personal Lubricant". It is not a study about a medical device that utilizes an algorithm or AI. Therefore, it does not contain the information required to answer the questions about acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance.

The document discusses the device's general information, predicate devices, description, and intended use as a moisturizer for vaginal dryness and personal lubrication. It also confirms that the device has been tested for condom compatibility and preservative effectiveness to demonstrate substantial equivalence to predicate devices. However, no specific performance metrics or studies are detailed in relation to these tests.

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