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Astroglide Warming 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Astroglide Warming is non-sterile, clear and water based personal lubricant. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms only. It is not compatible with polyurethane condoms. The device is composed of water, glycerin, propylene glycol, polyquaternium-7 and citric acid.

The provided document describes the K221036 submission for Astroglide Warming, a personal lubricant. It does not describe a study involving an AI/ML device and human readers. Therefore, I cannot fulfill all aspects of your request as it pertains to AI/ML device performance, ground truth, expert opinions, or MRMC studies.

However, I can extract the acceptance criteria and the summary of non-clinical performance testing for the Astroglide Warming device itself.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes non-clinical performance testing for a personal lubricant, not an AI/ML device. Therefore, the concept of "test set" in the context of AI/ML is not applicable here. The testing involved samples of the product itself.

• Biocompatibility testing: Not specified number of samples, but refers to ISO and ASTM standards.
• Shelf Life Accelerated Aging Study: Not specified number of samples. The study duration was 3 months at 40°C.
• Condom Compatibility: Not specified number of samples, but refers to ASTM D7661-18.
• Data provenance: Not explicitly stated, but assumed to be from internal lab testing conducted by or for BioFilm, Inc. It is retrospective in the sense that the tests were completed before submission.

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

Not applicable. This is a physical product, not an AI/ML device requiring expert ground truth for image or data interpretation.

4. Adjudication method for the test set:

Not applicable. This is a physical product, not an AI/ML device requiring adjudication for ambiguous cases.

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 physical product, not an AI/ML device.

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

Not applicable. This is a physical product, not an AI/ML algorithm. The "standalone" performance here refers to the device's inherent physical and chemical properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this product is based on established industry standards and validated test methods as defined by organizations like ISO, ASTM, and USP. For example:

• Physical and Chemical Properties: The specifications (e.g., viscosity, pH, osmolality, color, odor, clarity, absence of particulate matter) are based on direct measurements against defined ranges.
• Microbial Limits: Determined by specific USP <61> and <62> methods.
• Antimicrobial Effectiveness: Determined by USP <51> methods.
• Biocompatibility: Determined by ISO 10993-5, ISO 10993-11, and ASTM D6355 standards.
• Condom Compatibility: Determined by ASTM D7661-18.

8. The sample size for the training set:

Not applicable. This is a physical product, not an AI/ML 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

Astroglide Ultra Gentle Gel 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Astroglide Ultra Gentle Gel is a non-sterile, clear, odorless, and water based personal lubricant. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. The device is composed of water, propylene glycol, hydroxyethylcellulose, polyquaternium 7, potassium sorbate, sodium benzoate and citric acid. The product primary packaging is a white LDPE 3-ounce tube with a screw on cap. The tube and cap constitute the device final packaging.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes for each test in the "Summary of Non-Clinical Performance Testing" section. For the Shelf Life study, it mentions an "accelerated aging study, conducted for 8 months at 40°C," but doesn't detail the number of samples or batches tested. The provenance of the data is internal to BioFilm, Inc., as these are non-clinical performance tests conducted for device clearance. There is no information regarding country of origin or whether it's retrospective or prospective beyond the description of the tests themselves.

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

This information is not applicable to this type of device and study. The testing described (biocompatibility, shelf life, condom compatibility) are laboratory-based, objective performance tests conducted against established international or national standards (e.g., ISO, ASTM, USP). Ground truth is established by the test method's specified criteria, not by expert consensus in the way a clinical diagnostic device would require.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the tests are objective laboratory performance tests, not subjective interpretations requiring adjudication among experts.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI-driven diagnostic or screening devices involving human interpretation, not for a personal lubricant.

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

This is not applicable. The device is a personal lubricant, not an AI algorithm. The performance tests are directly on the physical product.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the acceptance criteria for most of the parameters (Color, Clarity, Odor, Absence of particulate matter, Viscosity, pH, Osmolality, Microbial Limits, Antimicrobial effectiveness) is based on pre-defined quantifiable specifications and standard laboratory test methods (USP <61>, USP <62>, USP <51>).

For Biocompatibility, the ground truth is established by the pass/fail criteria defined in international standards like ISO 10993-1, ISO 10993-5, ISO 10993-11, and ASTM D6355.

For Condom Compatibility, the ground truth is established by the pass/fail criteria defined in ASTM D7661-18.

For Shelf Life, the ground truth is that the device must continue to meet all the physical, chemical, and microbiological specifications after accelerated aging, following ASTM F1980-16.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML algorithm. There is no "training set" for a physical personal lubricant.

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

This is not applicable as there is no training set for this device.

Ask a specific question about this device

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 <61>, USP <62>) 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

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 <791>)	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 <912>)	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 <785>)	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 <51>)	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 <61> & USP <62>)	< 10 cfu/mL	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 aerobic microbial count (per USP <61> & USP <62>)	< 100 cfu/mL	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.)
   Absence of pathogenic organisms (Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans - per USP <61> & USP <62>)	Absent	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.)
   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® X Silicone 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 and polyurethane condoms.

Astroglide® X Silicone Personal Lubricant is non-sterile, clear, odorless, and siliconebased lubricant. This product is not a spermicide or contraceptive. Astroglide® X Silicone Personal Lubricant is compatible with natural rubber latex condoms. Astroglide® X Silicone Personal Lubricant is not compatible with polyurethane, or polyisoprene condoms. This product's primary packaging is a PETE clear bottle with a screw on polypropylene flip-top cap. The bottle is packaged in a cardboard carton which constitutes the final packaging.

The provided text describes the acceptance criteria and a study for the Astroglide® X Silicone Personal Lubricant.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "Reported Device Performance" column reflects that the device met the stated specifications/criteria, as confirmed by the "Summary of Non-Clinical Performance Testing" section.

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

The document does not specify a distinct "test set" in the context of a clinical trial or a specific number of samples for each non-clinical test. The testing described is non-clinical performance testing.

• Sample Size: Not explicitly stated for each test. The document refers to "the subject lubricant" being tested.
• Data Provenance: Not explicitly stated. The tests are non-clinical (laboratory-based) and conducted according to international standards (ISO, ASTM, USP). There's no mention of country of origin for data or if it's retrospective/prospective in a clinical sense.

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

This section is not applicable. The evaluations are based on internationally recognized laboratory test methods (ISO, ASTM, USP), not expert consensus on individual cases or ground truth derived from clinical experts.

4. Adjudication method for the test set

This section is not applicable. The evaluations are based on objective laboratory test results against defined specifications, not on human interpretation requiring adjudication.

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

This section is not applicable. This document pertains to the regulatory submission of a personal lubricant, not an AI-powered diagnostic device, so an MRMC comparative effectiveness study is irrelevant.

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

This section is not applicable. This document pertains to the regulatory submission of a personal lubricant, not an AI-powered algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is established by objective measurements against predetermined specifications and international standards. This includes:

• Physical property measurements (viscosity, appearance, odor, water activity).
• Microbiological testing (total yeast/mold count, aerobic microbial count, absence of specific pathogens).
• Biocompatibility testing results (cytotoxicity, irritation, sensitization, systemic toxicity) as per ISO 10993.
• Condom compatibility testing results as per ASTM D7661-10.
• Shelf-life testing results as per ASTM F1980-16.

8. The sample size for the training set

This section is not applicable. There is no "training set" as this is a physical medical device (personal lubricant) undergoing non-clinical performance testing, not a machine learning model.

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

This section is not applicable, as there is no training set for this type of device.

Ask a specific question about this device

Astroglide® Organix® Gel 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. The product is not compatible with polyurethane condoms.

Astroglide® Organix ® Gel is non-sterile, translucent, colorless to slight yellow, water-based personal lubricant intended for penile and vaginal application 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 and is not compatible with polyurethane condoms. This product is for over-the-counter (OTC) use. Astroglide® Organix ® Gel's formulation consists of water, glycerine, xanthan gum, gellan gum, aloe barbabensis powder, chamomilla recutita (matricaria) flower extract, calendula officinalis flower extract, vaccinium macrocarpon (cranberry) fruit extract, passiflora incarnata flower extract, sodium benzoate, potassium sorbate, and citric acid. It is packaged in white LDPE tube with a screw on flip top cap comprised of polypropylene. This product is also provided in 2.5 ml foil packs.

This document is a 510(k) Premarket Notification from the FDA regarding a personal lubricant, Astroglide® Organix® Gel. It is a not a study of an AI/ML medical device. Therefore, I cannot extract the information required using the provided text.

The request asks for specific details related to the validation of an AI/ML medical device, such as acceptance criteria based on AI performance metrics (e.g., sensitivity, specificity), details about test sets (sample size, provenance, ground truth establishment, expert qualifications, adjudication methods), information on multi-reader multi-case (MRMC) studies, and details about training sets. These concepts are entirely absent from the provided document, which focuses on the chemical, physical, and biocompatibility testing of a personal lubricant to demonstrate its substantial equivalence to a predicate device.

Ask a specific question about this device

Astroglide® Organix® Liquid 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.

Astroglide® Organix® Liquid is a non-sterile, colorless to slight yellow, water-based personal lubricant intended for penile and vaginal application 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 and is not compatible with polyurethane condoms. This product is for over-the-counter (OTC) use. Astroglide® Organix® Liquid's formulation consists of water, glycerin, xanthan gum, aloe barbabensis powder, chamomilla recutita (matricaria) flower extract, calendula officinalis flower extract, vaccinium macrocarpon (cranberry) fruit extract, passiflora incarnata flower extract, sodium benzoate, potassium sorbate, and citric acid. It is packaged in 2.5 oz polyethylene terephthalate bottles with a polypropylene flip-top cap. Bottles are secondarily packaged in cardboard cartons. This product is also provided in 2.5 ml foil packs.

The document describes the Astroglide® Organix® Liquid personal lubricant and its substantial equivalence to a predicate device, Astroglide® Natural. The provided text outlines non-clinical performance testing conducted to support its safety and effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a table of device specifications (acceptance criteria) and the reported performance for the Astroglide® Organix® Liquid.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not explicitly state the sample sizes for the individual tests (biocompatibility, condom compatibility, shelf-life, or other device specifications). It also does not specify the country of origin for the data or whether the studies were retrospective or prospective. The testing was conducted in accordance with recognized international standards (ISO, USP, ASTM), which implies a specific methodology, but sample sizes are not reported.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable to this type of device and study. The testing for this personal lubricant involves objective physical, chemical, and biological evaluations according to established standards (e.g., pH, viscosity, microbial counts, biocompatibility assays, condom compatibility tests). Ground truth is established by the results of these standardized tests, not by expert consensus or interpretation of images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable as it pertains to subjective assessments or diagnostic interpretations, which are not relevant for a personal lubricant's performance 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:

This information is not applicable. An MRMC study is relevant for medical imaging or diagnostic AI devices where human readers interpret cases. This document describes the testing of a personal lubricant, not an AI-assisted diagnostic device.

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

This information is not applicable. This refers to AI algorithm performance studies, which are not relevant to this product.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the performance criteria is established by objective measurements and standardized test results as defined by the USP, ISO, and ASTM standards. For example:

• pH: Measured directly against the specified range.
• Microbial counts: Counted according to USP<61> and compared to the acceptable limits.
• Biocompatibility: Determined by the specific outcomes of ISO 10993 tests (e.g., cell viability for cytotoxicity, skin reaction for irritation/sensitization).
• Condom Compatibility: Determined by physical tests on condoms as per ASTM D7661-10.
• Shelf-life: Determined by maintaining all device specifications (as defined in Section IV) over the specified time period under controlled conditions.

8. The sample size for the training set:

This information is not applicable. This document describes the performance testing of a physical product (personal lubricant), not the development or validation of an AI algorithm that would require a training set.

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

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

Ask a specific question about this device

Astroglide® O Oil Personal Lubricant & Massage Oil 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 not compatible with condoms.

Astroglide® O Oil Personal Lubricant & Massage Oil is non-sterile, light yellow, lightly coconut and ylang-ylang scented, and oil-based lubricant. All oils used in the subject formulation are certified organic, and the subject lubricant is a USDA certified organic final product. This product is not a spermicide or contraceptive. It is NOT compatible with natural rubber latex, polyurethane, or polyisoprene condoms.

This product primary packaging is a PETE amber bottle with a screw on polypropylene flip-top cap. The bottle and cap constitute the device are labeled front and back and then packaged in a cardboard carton which constitutes the final packaging.

The provided text is a 510(k) summary for the Astroglide® O Oil Personal Lubricant & Massage Oil. It details the device, its intended use, and its comparison to a predicate device. However, it does not describe a study involving an AI-powered device or software. Therefore, I cannot extract the information requested about acceptance criteria, study details, ground truth, or MRMC studies for an AI device from this document.

The document focuses on non-clinical performance testing for a personal lubricant to demonstrate its safety and effectiveness, which is a different type of evaluation than what would be conducted for an AI/ML medical device.

If the request was intended to ask about the non-clinical performance testing detailed in the document, here is a summary of that information:

1. A table of acceptance criteria and the reported device performance for Astroglide® O Oil Personal Lubricant & Massage Oil (non-AI device):

Regarding the other points (#2-9), this information is not applicable to an AI device and is not contained in the document for this non-AI product.

• Sample size for test set and data provenance: N/A for an AI device. For the lubricant, samples were tested per the specified ASTM and USP methods.
• Number of experts and qualifications: N/A for an AI device. Testing was conducted according to standardized laboratory methods.
• Adjudication method: N/A for an AI device.
• MRMC comparative effectiveness study: N/A as this is not an AI device.
• Standalone performance: N/A as this is not an AI device. Its performance is evaluated through material and biological testing.
• Type of ground truth used: N/A for an AI device. The ground truth for this product is based on established scientific standards and analytical test results for chemical and biological properties.
• Sample size for training set: N/A as this is not an AI device.
• How ground truth for training set was established: N/A as this is not an AI device.

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