Search Results

Astroglide® Glycerin & Paraben Free is a personal lubricant for penile, 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® Glycerin & Paraben Free is a non-sterile, water-based liquid personal lubricant for penile, anal, and/or vaginal application. 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. The subject device is sold as an overthe-counter (OTC) product in a 2.5 oz. clear PETE bottle with a screw on polypropylene flip-top cap. The bottle is labeled front and back and then packaged in a cardboard carton which constitutes the final packaging. This device is composed of water, butylene glycol, propylene glycol, xylitol, methyl gluceth-20, polyquarternium-7, hydroxyethyl cellulose, potassium sorbate, sodium benzoate, citric acid.

The provided document is a 510(k) Premarket Notification from the FDA for a personal lubricant called Astroglide® Glycerin & Paraben Free. It primarily focuses on demonstrating substantial equivalence to a previously marketed predicate device, rather than providing details on a study of a device's performance against specific clinical acceptance criteria for diagnostic or AI-driven devices.

Therefore, much of the requested information (sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone AI performance, training set details) is not applicable to this type of regulatory submission for a personal lubricant.

However, I can extract information related to the acceptance criteria for the product's physical and chemical properties, as well as its biocompatibility and condom compatibility.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• For physical/chemical specifications: The document refers to standard test methods (e.g., USP , USP ) but does not specify the sample size for these tests. The data provenance is implied to be from BioFilm, Inc.'s internal testing, likely from the U.S.
• For biocompatibility: No specific sample sizes for human subjects or animal models are provided for the HRIPT or systemic toxicity tests. For cytotoxicity, it's generally in vitro testing. Data provenance is implied to be from BioFilm, Inc.'s testing.
• For condom compatibility: No specific sample size (i.e., number of condoms tested) is explicitly mentioned, but the testing was conducted according to ASTM D7661-18. Data provenance is implied to be from BioFilm, Inc.'s testing.
• For shelf life: The study was an accelerated aging study conducted for 8 months at 40°C, per ASTM F1980-16. No sample sizes (number of devices) are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study requiring expert clinical review or ground truth establishment for diagnostic accuracy. The ground truth for the physical/chemical properties, biocompatibility, and condom compatibility are defined by the standardized test methods themselves.

4. Adjudication method for the test set

Not applicable. There is no subjective assessment requiring adjudication in this type of testing.

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 personal lubricant device, not an AI-driven diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a personal lubricant device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the various acceptance criteria were established by:

• Standardized laboratory methods/specifications: For color, clarity, odor, particulate matter, viscosity, pH, osmolality, microbial counts (TYMC, TAMC, pathogens), and antimicrobial effectiveness, the ground truth is defined by specified ranges, limits, or absence/presence criteria according to recognized pharmacopeial (USP) or internal standards.
• International Standards (ISO) and ASTM Standards:
  • Biocompatibility: ISO 10993-5 (cytotoxicity), ASTM D6355 (sensitization/irritation), ISO 10993-11 (systemic toxicity).
  • Shelf Life: ASTM F1980-16 (accelerated aging for medical devices).
  • Condom Compatibility: ASTM D7661-18.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-driven device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Ask a specific question about this device

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)

Ask a specific question about this device

This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Nitrile Examination Gloves, Coated With Cucumber With Glycerine, Blue Color

This is an FDA 510(k) clearance letter for Powder Free Nitrile Examination Gloves. The information provided in the letter and the associated "Indication for Use" statement does not contain the details required to answer the prompt.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, number of experts for ground truth, or adjudication methods in a study.
• Information about multi-reader, multi-case comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used, training set sample size, or how ground truth for the training set was established.

This document is a regulatory approval based on "substantial equivalence" to a predicate device, not a detailed technical report of a device performance study with specific acceptance criteria and study results. Therefore, I cannot provide the requested information from the given text.

Ask a specific question about this device

These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These latex gloves contain 50 micrograms or less of water extractable protein per gram.

Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove With Hydrasoft Coating (containing Glycerine) And Protein Labeling Claim (50 micrograms or less) are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination. These latex gloves contain 50 micrograms or less of water extractable protein per gram.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove With Hydrasoft Coating (containing Glycerine) And Protein Labeling Claim (50 micrograms or less)

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided text does not explicitly state the sample size used for the non-clinical tests. It refers to these as "performance test data of the non-clinical tests."

The data provenance is not specified (e.g., country of origin). Since it refers to widely used ASTM and ISO standards, it's likely that the tests were conducted in a laboratory setting adhering to these international standards. The study appears to be retrospective in the sense that the data being presented are from tests already performed to demonstrate compliance with existing standards.

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

The document does not mention the use of experts in the context of establishing ground truth for the device's performance against the listed standards. The acceptance criteria are based on established industry standards (ASTM, ISO), which inherently represent a consensus of expert knowledge in glove manufacturing and medical device safety. The "ground truth" for these tests is the quantitative measurement or qualitative observation against the predefined parameters of these standards.

4. Adjudication Method for the Test Set:

There is no explicit adjudication method described. Compliance with the standards would typically involve laboratory analysis and direct measurement against the specified thresholds. Discrepancies, if any, would be resolved by re-testing or investigation, but no formal expert adjudication process (like 2+1, 3+1) is mentioned or typically required for this type of product testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No. The device is a sterile latex surgical glove. MRMC studies are typically used for diagnostic or screening devices that involve human interpretation of images or other data. This product does not involve such a human-in-the-loop diagnostic process.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

Yes, in essence. The performance tests described (Dimensions, Physical Properties, Freedom from Holes, Powder-Free, Biocompatibility components, Protein Label Claim) are all standalone performance evaluations of the glove itself. These tests are conducted without any human-in-the-loop assistance in decision-making related to the device's function as a diagnostic or analytical tool. The human element would be in conducting the tests and recording results, but not in interpreting the "output" of the device for a medical diagnosis.

7. The Type of Ground Truth Used:

The ground truth used is primarily established industry standards and regulatory requirements. This includes:

• ASTM (American Society for Testing and Materials) standards: D 3577 (Dimensions, Physical Properties, Freedom from Holes), D 5151 (Freedom from Holes), D 6124 (Powder-Free), D 5712-99 (Protein Analysis).
• ISO (International Organization for Standardization) standards: for Biocompatibility (Maximization Sensitization Study).
• FHSA (Federal Hazardous Substances Act) standards: for Biocompatibility (Skin Irritation Study).
• FDA hole requirements: mentioned as a general compliance point.

8. The Sample Size for the Training Set:

This question is not applicable to this type of device. The device is a physical medical product (surgical glove), not an AI/ML algorithm or a device that requires a "training set" in the context of machine learning. The term "training set" is relevant for AI models, not for characterizing a physical product like a glove.

9. How the Ground Truth for the Training Set was Established:

This question is not applicable for the same reason as point 8.

Ask a specific question about this device

Ask a specific question about this device