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Astroglide® Diamond Silicone Gel Personal Lubricant 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, polyurethane, and polyisoprene condoms.

Astroglide® Diamond Silicone Gel Personal Lubricant is non-sterile, clear, odorless, and silicone-based lubricant. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

This product primary packaging is a white LDPE 3 ounce tube with a screw on polypropylene flip-top cap. The tube and cap constitute the device final packaging.

The provided text is a 510(k) Summary for a medical device (Astroglide® Diamond Silicone Gel Personal Lubricant), seeking to demonstrate substantial equivalence to a predicate device. It primarily focuses on the device's physical properties, biocompatibility, and compatibility with condoms.

This document does not contain information about an AI/Algorithm-based medical device, a multi-reader multi-case (MRMC) study, or any details related to establishing ground truth for a training or test set using experts, as would be expected for an AI/ML device.

Therefore, I cannot extract the information required to answer your questions about acceptance criteria, study details, sample sizes, expert involvement, or adjudication methods for an AI/ML device. The document describes a traditional medical device's non-clinical performance testing.

The information I can provide based on the document is:

• Device Performance Reported: The document describes the performance of the personal lubricant in relation to its physical specifications and safety testing.

  • Color: Colorless
  • Clarity: Clear
  • Odor: Odorless
  • Absence of particulate matter: Absent
  • Viscosity: 12,000-22,000 cP
  • Total yeast/mold count: <10 cfu/mL
  • Total aerobic microbial count: <100 cfu/mL
  • Pathogens (Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans): Absent
  • Biocompatibility: Non-cytotoxic, non-sensitizing, non-irritating (vaginal), non-systematically toxic.
  • Condom Compatibility: Compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
  • Shelf life: 2 years (based on 8 months accelerated aging).

• Nature of Study: Non-clinical performance testing (biocompatibility, condom compatibility, shelf-life verification) for a personal lubricant seeking 510(k) clearance based on substantial equivalence.

To answer your specific questions, I would need a different type of document, specifically one detailing the validation of an AI/ML medical device.

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Astroglide® TTC 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. Astroglide TTC is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. Astroglide® TTC is compatible with natural rubber latex, polyisoprene and polyurethane condoms.

Astroglide® TTC Fertility Friendly Personal Lubricant is a non-sterile, clear, and water-based personal lubricant for penile and/or vaginal application. Astroglide® TTC has a pH and osmolarity that is compatible with sperm survival and migration. The device is packaged in pre-filled tube applicators which may be used for single use intra-vaginal application or applied directly to penis or vagina. Astroglide® TTC is formulated using water, propylene glycol, hydroxyethylcellulose, fructose, methylparaben, sodium phosphate, potassium phosphate, propyl paraben, galactose, and sodium hydroxide. This device is batch lot tested for appearance, color, viscosity, pH, microbial count, osmolality, endotoxin, mouse embryo assay and human sperm survival assay.

The provided text discusses the premarket notification for Astroglide TTC Fertility Friendly Personal Lubricant, detailing its characteristics and comparison to a predicate device. It includes a summary of performance data to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the studies mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for the test sets (e.g., number of mouse embryos, human sperm samples, or animals for biocompatibility). The studies performed are laboratory-based and animal studies (New Zealand White Rabbits for irritation, Guinea Pig for sensitization, mice for embryo assay). The data provenance is not explicitly stated as "country of origin" but implies controlled laboratory settings, which are typically retrospective in terms of analyzing the results from a pre-defined experiment.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of medical image analysis or diagnostic studies. The ground truth for these types of in vitro and in vivo studies is established by the experimental protocols themselves, with results interpreted against scientific and regulatory standards (e.g., ISO standards for biocompatibility).

4. Adjudication Method for the Test Set

Not applicable. The studies described are laboratory, animal, and in vitro tests, not clinical trials requiring adjudication of observer interpretations.

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 medical device (personal lubricant) and the studies do not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study and effect size in human reader improvement are not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is not an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth used in these studies is primarily:

• Experimental Results against predefined thresholds/standards: For pH, osmolarity, endotoxin, MEA, HSSA, and condom compatibility, the "ground truth" is whether the measured values or observed outcomes meet the established scientific and regulatory criteria (e.g., >80% expanded blastocysts, ≥80% sperm survival).
• Biocompatibility Standards: For cytotoxicity, sensitization, irritation, and systemic toxicity, the ground truth is whether the device passes the requirements of specific ISO 10993 standards.
• Functional Assays: For sperm function (penetration, motility, DNA integrity) and IVF, the ground truth is the scientific demonstration that the device does not impede or harm these biological processes.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this type of device.

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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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Astroglide® Natural 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 ONLY compatible with natural rubber latex and polyisoprene condoms.

Astroglide Natural personal lubricant is non-sterile, clear and water based. Astroglide® Natural is a proprietary blend consisting mainly of water soluble ingredients similar to other lubricants currently on the market. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. This product primary packaging is a clear PET bottle with a screw on flip top cap comprised of polypropylene. Each bottle is packaged into a cardboard carton, which constitutes the device outer packaging.

The provided document is a 510(k) Summary for a medical device (personal lubricant) and does not contain information about the acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML-enabled medical device.

The document describes the "Astroglide Natural" personal lubricant and its substantial equivalence to a predicate device, "Glycerin and Paraben Free Astroglide." It outlines:

• Indications for Use: Moisturize and lubricate to enhance intimate sexual activity and compatible with natural rubber latex and polyisoprene condoms.
• Technological Characteristics: Comparison of ingredients, storage, pH, osmolarity, viscosity, and condom compatibility between the proposed device and the predicate.
• Biocompatibility Testing: Results of cytotoxicity, guinea pig maximization, vaginal irritation, penile irritation, and systemic toxicity tests.
• Specifications: Lot release specifications for quality control (color, clarity, odor, pH, viscosity, microbial counts).
• Shelf Life: 3 years based on real-time and accelerated aging studies.
• Condom Compatibility Testing: Tested with ASTM D7661-10, showing compatibility with latex and polyisoprene, but not polyurethane.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML-enabled medical device, as this document is for a personal lubricant and does not involve AI or ML.

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Glycerin and Paraben Free Astroglide® is a personal lubricant, for penile, anal, 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 latex condoms.

Glycerin & Paraben Free Astroglide® is a non-sterile, clear, non-greasy, high viscosity liquid used as a personal lubricant. Glycerin & Paraben Free Astroglide® is not a contraceptive or spermicide. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards defined by ASTM D 3492.

This document is a 510(k) summary for a personal lubricant, Glycerin & Paraben Free Astroglide®. It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices and its safety. Since this is a submission for a personal lubricant and not an AI/ML powered medical device, the questions regarding AI/ML device performance metrics (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable in this context.

Here's an analysis of the provided text in relation to the acceptance criteria and study information, with an emphasis that many of the requested AI-specific points are not relevant for this type of device:

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

For a personal lubricant, acceptance criteria typically involve biocompatibility, compatibility with condoms, and performance related to its intended use (lubrication, moisturizing). The studies performed address these aspects.

Regarding AI-specific questions (2-9):

The device in question, Glycerin & Paraben Free Astroglide®, is a personal lubricant, which is a physical product and not an AI/ML powered medical device. Therefore, the following points are not applicable (N/A) to this 510(k) submission.

2. Sample size used for the test set and the data provenance: N/A (not an AI/ML device)
* For biocompatibility: Guinea pigs, rabbits, mice were used for animal studies. 50 human subjects were used for the Repeat Insult Patch Test. Data provenance is implied by the testing being conducted by "outside laboratories, in compliance with Good Laboratory Practices (GLP's)".

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (not an AI/ML device)
* For the non-AI tests, "ground truth" is established by laboratory measurements and observations in controlled animal and human studies, interpreted by qualified laboratory personnel and clinicians.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (not an AI/ML device)

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: N/A (not an AI/ML device)

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (not an AI/ML device)

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (not an AI/ML device)
* The "ground truth" for this product is derived from direct biological response in controlled experiments (e.g., irritation, sensitization, toxicity, condom compatibility).

8. The sample size for the training set: N/A (not an AI/ML device)

9. How the ground truth for the training set was established: N/A (not an AI/ML device)

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Astroglide® Brand WARMING LIQUID is recommended as a personal lubricant to enhance intimate activities. It is designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse. Astroglide® Brand WARMING LIQUID may be used with condoms.

Astroglide® Brand WARMING LIQUID is a non-sterile clear non-greasy, high viscosity liquid used as a personal lubricant. The product is highly lubricous and may be used with or without a condom during sexual activity. Astroglide® Brand WARMING LIQUID is not a contraceptive or spermicide. It is compatible with latex condoms as demonstrated in condom compatibility testing conducted according to standards defined by ASTM D 3492.

This document describes the 510(k) premarket notification for the Astroglide® Brand WARMING LIQUID personal lubricant. It does NOT contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/medical device. Instead, it describes biocompatibility testing results for a personal lubricant.

Therefore, I cannot provide the requested information from the given input.

The input document outlines:

• Device Description and Intended Use: Astroglide® Brand WARMING LIQUID is a non-sterile, clear, non-greasy, high viscosity liquid personal lubricant. It is intended to enhance intimate activities by providing supplemental vaginal lubrication and can be used with or without condoms.
• Technological Characteristics: The formula is proprietary, mainly water-soluble ingredients, and produces a slight warming sensation. It is noted to be slightly more lubricious than its predicate due to an additional ingredient.
• Substantial Equivalence: It is deemed substantially equivalent to the K-Y Brand WARMING LIQUID personal lubricant (K021492) based on similar intended use and formulas.
• Product Testing (Biocompatibility): This section details various biocompatibility studies performed on the product. These are not "acceptance criteria" in the sense of performance metrics for an AI model, but rather safety and tolerability assessments for a topically applied medical device.

Biocompatibility Testing Results (Not Acceptance Criteria in the AI context):

The document does NOT contain any information relevant to the following requested items because it is not about an AI/medical device:

• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone (algorithm only) performance
• Type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

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Good Lubrications patient lubricant is a medical device intended for medical purposes to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.

Good Lubrications is recommended as a personal lubricant to enhance intimate activities. It is designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse.

Good lubrications may be used with condoms.

Good Lubrications Personal Lubricant

The provided text is a 510(k) Premarket Notification from the FDA for a device named "Good Lubrications." This document does not describe acceptance criteria, device performance, or a study proving that the device meets acceptance criteria.

Instead, it is a letter from the FDA to BioFilm, Inc. stating that their device has been found substantially equivalent to legally marketed predicate devices. This means the device can be marketed in the US.

Therefore, I cannot extract the requested information concerning acceptance criteria, study details, sample sizes, expert qualifications, ground truth, or MRMC studies from this document. The document is an administrative approval of a medical device based on substantial equivalence, not a medical device performance study report.

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A lubricant for non-sterile gynecological and hospital procedures. Not harmful to rubber appliances or medical instruments.

Recommended for personal lubrication when vaginal dryness causes discomfort. Lubrication for insertion of rectal thermometers, enemas, douches, and similar types of nozzles.

Not Found

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to BioFilm, Inc. regarding their Exam Room Astroglide and Target Lubricating Jelly devices.

This document is a regulatory approval letter and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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