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Durex Polyisoprene Condom is used for contraception and for prophylactic purposes (to help regnancy and the transmission of sexually transmitted infections, STIs).

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The provided document is an FDA 510(k) clearance letter for the Durex Polyisoprene Condom. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance in a clinical or AI context.

The letter focuses on regulatory approval, including:

• Device Name: Durex Polyisoprene Condom
• Regulation Number: 21 CFR 884.5300 (Condom)
• Regulatory Class: II
• Product Code: MOL
• Indications for Use: Contraception and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections, STIs).
• Type of Use: Over-The-Counter Use

The content discusses regulatory compliance, quality systems, labeling, adverse event reporting, and unique device identification. It does not include information about clinical trials, performance metrics, ground truth establishment, sample sizes for training or testing, or expert reviews as would be relevant for an AI/ML device or a device with specific performance criteria beyond general manufacturing standards.

Therefore, I cannot provide the requested information based on the given text.

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Belle Sensilube is intended for penile, vaginal and/or anal application to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Belle Sensilube is compatible with natural rubber latex and polyisoprene condoms. Belle Sensilube is not compatible with polyurethane condoms.

Belle Sensilube is a water-based personal lubricant for over-the-counter use. The subject device is a non-sterile liquid preparation containing water, propylene qlycol, hyroxyethylcellulose, polyacrylamide anionic, lactic acid and potassium lactate, and benzoic acid. The subject device will be packaged in a 40 mL high-density polyethylene bottle fitted with a polypropylene cap. The lubricant is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.

The provided text describes the submission of a 510(k) premarket notification for a personal lubricant named "Belle Sensilube." This document focuses on demonstrating the substantial equivalence of Belle Sensilube to a legally marketed predicate device (KY Banksy Aloe) rather than outlining a study that proves a device meets specific acceptance criteria for a new medical device.

The information you are requesting, such as ground truth establishment for a test set, sample sizes for training/test sets in the context of an AI/ML-driven device, multireader-multicase studies or the effect size of AI assistance on human readers, and the number of experts for ground truth, is not present in this document. This is because Belle Sensilube is a physical product (personal lubricant), not an AI/ML-driven medical device that would require such studies. The regulatory submission process for this type of device primarily involves demonstrating biocompatibility, shelf-life, and compatibility with other medical devices (like condoms) to establish substantial equivalence to an existing product.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them in the context of an AI/ML device, as the provided document pertains to a personal lubricant.

However, I can extract the "acceptance criteria" (specifications) and performance data for Belle Sensilube as a physical product from the document.

Acceptance Criteria and Reported Device Performance for "Belle Sensilube" (as a physical product):

The table below summarizes the specifications (acceptance criteria) for the Belle Sensilube personal lubricant and the implied performance, as the document states the device met these specifications.

Since the document is for a personal lubricant, the following requested information is not applicable:

• Sample size used for the test set and the data provenance: Not an AI/ML context. Testing for physical properties does not typically involve "test sets" in the same way.
• Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. Ground truth for a lubricant's physical or chemical properties is established by laboratory measurements against defined standards, not by expert consensus readings of data.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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, as this is not an AI-driven device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for a lubricant is based on chemical/physical testing standards (e.g., USP, EP, ASTM standards) and biocompatibility testing.
• The sample size for the training set: Not applicable, as this is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

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Grosz Warming Liquid is intended for penile, vaginal and/or anal 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, polyisoprene and polyurethane condoms.

Grosz Play Tingling is intended for penile, vaginal and/or anal 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. This product is not compatible with polyurethane condoms.

Grosz KY Yours & Mine is intended for penile, vaginal and/or anal application to mosturize 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.

Grosz Warming Liquid is a non-sterile, silicone-based personal lubricant compatible with natural rubber latex, polyisoprene, and polyurethane condoms. Its formulation consists of Dimethicone and Sensate. Grosz Warming Liquid is packaged in a 30 mL high density polyethylene bottle (HDPE) mono layer and topped with a polypropylene cap. The bottle is then packaged in a carton. Grosz Warming Liquid is a personal lubricant for over-the-counter (OTC) use.

Grosz Play Tingling is a non-sterile, water-based personal lubricant compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. Its formulation consists of Water, Propylene Glycol, Carbomer, Xanthan Gum, Sensate, Benzoic Acid, Sodium Saccharin, and Sodium Hydroxide. Grosz Play Tingling is packaged in a 50 mL HDPE bottle and topped with a polypropylene cap. The bottle is then packaged in a carton. Grosz Play Tingling is a personal lubricant for OTC use.

Grosz KY Yours & Mine are two personal lubricants with the same formulations and specifications as Grosz Warming Liquid and Grosz Play Tingling, respectively, packaged together and compatible with natural rubber latex and polyisoprene condoms. Grosz KY Yours & Mine is not compatible with polyurethane condoms when used as intended. Grosz KY Yours and Grosz KY Mine are individual lubricants separately packaged in a 44 mL polyethylene terephthalate bottles and topped with a polypropylene cap and packaged together in a carton. Grosz KY Yours & Mine are for OTC use.

The provided text describes information for a 510(k) submission for personal lubricants (Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine). It details the product specifications, comparison to a predicate device, and performance data to demonstrate substantial equivalence.

Here's the breakdown of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text presents two tables (Table 1 for Grosz Warming Liquid and Grosz KY Yours, Table 2 for Grosz Play Tingling and Grosz KY Mine) listing properties and their corresponding specifications, which serve as acceptance criteria. The performance is reported as meeting these specifications throughout the shelf-life duration.

Table 1: Grosz Warming Liquid and Grosz KY Yours

• Physical/Chemical Properties: Viscosity (per USP ), pH (per USP ), and Osmolality (per USP ) were tested where applicable, with results meeting the specified ranges.

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

The document does not explicitly state the numerical sample size for the test sets in the performance studies (e.g., number of batches, number of samples per test). It mentions that "the results of this testing demonstrated that the subject lubricants are biocompatible" and "all specifications... were met throughout the shelf-life duration," implying that sufficient samples were tested to support these conclusions.

The provenance (country of origin, retrospective/prospective) of the data is not mentioned. These types of studies for personal lubricants are typically laboratory-based tests on manufactured products, rather than clinical studies involving human subjects for the primary performance criteria listed.

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

Not applicable. The "ground truth" for the performance criteria of these personal lubricants is established by adherence to recognized national and international standards and pharmacopeial monographs (e.g., USP, ISO, ASTM, EP). These tests have objective endpoints (e.g., cfu/g, cPs, pH values, log reduction) that do not typically require expert human interpretation in the same way an imaging or diagnostic device might.

4. Adjudication Method for the Test Set

Not applicable, as expert consensus or adjudication is not typically used for these types of objective laboratory performance tests.

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 device is a personal lubricant, not an AI-assisted diagnostic or imaging device for which MRMC studies would be relevant.

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

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

7. The Type of Ground Truth Used

The ground truth for the performance criteria is based on established scientific standards, pharmacopeial monographs, and consensus standards (e.g., USP Viscosity, USP Antimicrobial Effectiveness, ASTM D7661-10 for Condom Compatibility, ISO 10993 for Biocompatibility, EP for Pathogens). These standards define the acceptable ranges or outcomes for each property.

8. The Sample Size for the Training Set

Not applicable. This device is a personal lubricant, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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Durex Patronus CloseFit and Durex Patronus Regular condoms are used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).

Durex Patronus CloseFit and Durex Patronus Regular are natural rubber latex-based condoms indicated for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs). Durex Patronus CloseFit and Durex Patronus Regular are made of a non-colored natural rubber latex with silicone lubricant and are taper shaft, teat ended smooth shaped condoms. Durex Patronus CloseFit and Durex Patronus Regular have a nominal length of 190 mm and 195 mm, width of 52.5 mm and 56 mm, and thickness of 52 microns and 54 microns, respectively. The condoms are available in regular and extra lubricant varieties with 400 mg and 480 mg silicone lubricant, respectively. The condoms are packaged in individually sealed flexible laminate foils made of polyethylene terephthalate, polyethylene, and aluminum. The foils are packaged in an outer consumer cardboard carton. The number of condoms in the carton may vary. Durex Patronus CloseFit and Durex Patronus Regular condoms are intended for over-the-counter (OTC) use. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.

The provided document is a 510(k) summary for Durex Patronus CloseFit and Durex Patronus Regular condoms. This document describes the device, its intended use, comparison to a predicate device, and a summary of non-clinical performance testing. It is not an AI/ML medical device submission, therefore, much of the requested information regarding AI/ML study design characteristics (e.g., test set sample size, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set sample size, ground truth for training set) is not applicable.

However, I can extract the acceptance criteria and reported device performance for the physical performance testing and shelf-life as described in the document.

Acceptance Criteria and Reported Device Performance

Study Details:

• Sample size used for the test set and the data provenance: Not specified in the provided summary for performance testing. The document states "All samples" for the shelf-life testing, but a specific number is not given. Data provenance is not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is not an AI/ML product requiring expert ground truth for image interpretation or similar tasks.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an AI/ML device that requires MRMC studies.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
• The type of ground truth used: For biocompatibility, the ground truth is established through standardized biological tests. For physical performance, the ground truth is defined by the requirements outlined in international and national standards (ISO 4074:2015 and ASTM D3492-16). For shelf life, the ground truth is based on the device maintaining its performance over time as per 21 CFR 801.435.
• The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."
• How the ground truth for the training set was established: Not applicable.

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The Durex Penck III Regular condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).

Durex Penck III Regular are natural rubber latex-based condoms that completely cover the penis with a closely fitted membrane. Durex Penck III Regular are made of a non-colored natural rubber latex with silicone lubricant and are taper shaft, teat ended smooth shaped condoms. Durex Penck III Regular have a nominal length of 195 mm, width of 56 mm, and thickness of 48 um and are provided in Regular and Extra Lubricant varieties with 400 mg and 480 mg silicone lubricant respectively. The condoms are packaged in individually sealed flexible laminate foils made of polyethylene terephthalate, polyethylene, and aluminum. The foils are packaged in an outer consumer cardboard carton. The number of condoms in the carton may vary. Durex Penck III Regular condoms are intended for over-the-counter (OTC) use. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.

The provided document is a 510(k) Summary for a medical device called "Durex Penck III Regular," which is a male natural rubber latex condom. It describes the device, its intended use, comparison with a predicate device, and a summary of non-clinical performance testing.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that "The Durex Penck III Regular was tested and met all the requirements of ISO 4074:2015 - Natural rubber latex male condoms – Requirements and test methods and ASTM D3492-16 - Standard Specification for Rubber Contraceptives (Male Condoms)."

Therefore, the acceptance criteria are defined by these two international standards. The document also provides specific performance characteristics for the Durex Penck III Regular and compares them to the predicate device.

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

The document does not specify the exact sample sizes for each test (e.g., air burst, physical dimensions, biocompatibility). It states that the device was "tested and met all the requirements."

For biocompatibility, the methods listed (ISO 10993 series) often involve in-vivo (animal) and in-vitro studies. For physical performance (ISO 4074 and ASTM D3492), samples would be taken from production lots.

Data Provenance: The document does not explicitly state the country of origin of the data. Given it's a 510(k) submission to the US FDA, the tests would have been performed by a recognized laboratory, potentially in various locations. The studies are retrospective in the sense that they are performed on manufactured devices and evaluated against established standards.

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

This information is not applicable to this type of device and study. The "ground truth" for condom performance is established by recognized international and national standards (ISO 4074:2015 and ASTM D3492-16). These standards define the test methodologies and acceptance criteria for physical properties and safety. Expert consensus in medical imaging or diagnosis is not relevant here. The experts involved would be those who author and maintain these standards, and laboratory technicians and engineers who perform the tests according to these standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers evaluate medical images or clinical outcomes that might have subjective interpretations. For objective physical and chemical testing of medical devices like condoms, there is no "adjudication" in this sense. The results are quantitative and compared directly to predefined numerical criteria in the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where the performance of human readers, sometimes aided by AI, is evaluated against a ground truth. The Durex Penck III Regular is a physical barrier device, not a diagnostic tool, so an MRMC study is not relevant.

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

No, a standalone "algorithm only" study was not done. This concept applies to AI/ML-driven devices. The Durex Penck III Regular is a physical medical device whose performance is assessed through physical, chemical, and biological testing as per established standards, not through algorithmic evaluation.

7. The Type of Ground Truth Used

The "ground truth" for the Durex Penck III Regular device is based on established international and national standards and regulatory requirements.

• Physical Performance: ISO 4074:2015 (Natural rubber latex male condoms – Requirements and test methods) and ASTM D3492-16 (Standard Specification for Rubber Contraceptives (Male Condoms)). These standards specify the test methods and the acceptable ranges/thresholds for properties like dimensions, air burst pressure/volume, and integrity.
• Biocompatibility: ISO 10993-1:2009/R 2014, ISO 10993-5:2009/R 2014, ISO 10993-10:2010/R 2014, and ISO 10993-11:2017. These standards define the acceptable biological responses for device materials.
• Shelf Life: 21 CFR 801.435 for accelerated stability evaluations.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" is relevant for machine learning algorithms. The Durex Penck III Regular is a physical medical device, not an AI/ML algorithm. Its performance is validated through defined physical, chemical, and biological tests, not by training a model on a dataset.

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

This information is not applicable for the same reasons as #8. There is no training set for this type of device.

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The Durex Condom with Benzocaine is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).

The Durex Condom with Benzocaine is a natural rubber latex-based condom used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs). This is a textured condom with a silicone-based lubricant. Durex Condom with Benzocaine has a nominal length of 195 mm and width of 56 mm with a thickness of 65 um. The Durex Condom with Benzocaine is packaged with 480 mg of silicone lubricant. In addition, the Benzocaine male genital desensitizer paste on the condom helps in temporarily prolonging the time until ejaculation. This condom is a surface device that comes into contact with skin and mucosal membranes. Durex Condom with Benzocaine is packaged in individually sealed flexible laminate foils made of polyethylene terephthalate, polyethylene, and aluminum. The foils come packaged in an outer consumer cardboard carton. The Durex Condom with Benzocaine is intended for over-the-counter (OTC) use. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.

The provided document is a 510(k) summary for the Durex Condom with Benzocaine, which is a medical device. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving effectiveness in the same way a clinical trial for a drug or a novel medical device would.

Therefore, the study described here is about confirming that the condom meets specific performance standards and is biocompatible, rather than conducting a comparative effectiveness study with human readers or standalone algorithm performance.

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

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the exact sample sizes (number of condoms) used for each specific test (e.g., air burst, dimensions, biocompatibility assays). It generally states "All samples met predefined acceptance criteria" for shelf-life testing and that the device "was tested and met all the requirements" of the specified standards.

Data provenance is not detailed in terms of country of origin or whether it was retrospective/prospective. These are standard performance tests for condom manufacturing and regulatory submission.

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

This type of information is not relevant to the evaluation of a condom's physical and biological performance tests. The "ground truth" here is defined by the established international and national standards (ASTM D3492-16, ISO 4074:2015, ISO 10993 series). The tests are objective and measurable, not based on expert interpretation of complex data like medical images.

4. Adjudication Method for the Test Set

Not applicable. The performance criteria are objective measurements against defined physical and biological specifications in recognized standards. There is no subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This device is a condom, and the studies described are performance and safety (biocompatibility) tests against industry standards, not studies involving human readers or comparative effectiveness in a clinical diagnostic sense. The concept of "human readers improve with AI vs without AI assistance" does not apply here.

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

Not applicable. This is not an AI-powered diagnostic or interpretive device.

7. The Type of Ground Truth Used

The "ground truth" is established by:

• International and National Standards: Specifically, ISO 4074:2015 and ASTM D3492-16 for physical performance, and the ISO 10993 series for biocompatibility.
• Defined Specifications: The specific nominal dimensions, lubricant quantities, and benzocaine quantities (e.g., 56 ± 2 mm nominal width, 480 ± 50 mg lubricant).
• Regulatory Guidance: FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and 21 CFR 801.435 for shelf life.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set." The tests are empirical and based on physical and chemical properties.

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

Not applicable, as there is no training set in this context.

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Durex Patronus Wide condoms are used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).

Durex Patronus Wide are natural rubber latex-based condoms that completely cover the penis with a closely fitted membrane. Durex Patronus Wide is made of a non-colored natural rubber latex with silicone lubricant and is a taper shaft, teat ended smooth shaped condom. Durex Patronus Wide has a nominal length of 200 mm, width of 60 mm, and thickness of 62 um. It will be packaged in individually sealed flexible laminate foils made of polyethylene terephthalate, polyethylene, and aluminum. The foils will come packaged in an outer consumer cardboard carton. The number of condoms in the carton may vary. Durex Patronus Wide condoms are intended for over-the-counter (OTC) use. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.

Here's an analysis of the acceptance criteria and study information provided in the document for the "Durex Patronus Wide" condom.

It is important to note that this document is a 510(k) summary for a condom, not a medical device driven by an algorithm or AI. Therefore, many of the typical questions regarding AI-driven medical devices (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance) are not applicable or will not be found in this type of submission.

Acceptance Criteria and Study Information: Durex Patronus Wide Condom (K213647)

1. Table of acceptance criteria and the reported device performance

The acceptance criteria are generally based on recognized international and national standards for male natural rubber latex condoms. The reported device performance indicates that the Durex Patronus Wide met all requirements of these standards.

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

• Sample Size for Test Set: The document does not specify a distinct "test set" sample size in the way an AI/algorithm study would. Instead, performance testing was conducted according to the specified standards (ISO 4074:2015 and ASTM D3492-16) and biocompatibility test methods (ISO 10993 series). These standards prescribe specific sampling plans and test methods for evaluating parameters like burst pressure, burst volume, dimensions, and biocompatibility. The exact number of units tested for each specific criterion is not provided in this summary but would be detailed in the full test reports.
• Data Provenance: The studies were conducted by the manufacturer (RB Health (US) LLC) or contracted labs as part of the regulatory submission process. This data is generally prospective, generated specifically for the device under evaluation. The country of origin of the data is not explicitly stated but would be derived from the testing facilities used by the applicant.

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

This question is not applicable to a condom's performance evaluation as described. The "ground truth" for condom testing is based on objective physical measurements and biological assays against established, quantitative pass/fail criteria defined in international and national standards. It does not involve expert interpretation or consensus in the way a diagnostic imaging device might.

4. Adjudication method for the test set

Not applicable. Condom testing is based on objective measurements and established standards, not judgmental 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

Not applicable. The Durex Patronus Wide is a physical medical device (condom), not an AI-driven system, and therefore, MRMC studies are irrelevant.

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

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used

The ground truth for physical and biological testing of the Durex Patronus Wide condom is based on:

• Quantitative metrics defined in recognized standards: e.g., minimum air burst pressure, minimum air burst volume, dimensional tolerances (Nominal Width, Length, Thickness).
• Biological assay outcomes: Demonstrating non-cytotoxicity, non-sensitization, non-irritation, and absence of acute systemic toxicity, as per ISO 10993 series standards.

8. The sample size for the training set

Not applicable. There is no "training set" for a physical device like a condom. Manufacturing processes are validated through quality control and process validation, not machine learning training.

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

Not applicable, as there is no training set for this type of device.

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Grosz Play Feel is intended for penile, vaginal and/or anal application to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Grosz Play Feel is compatible with natural rubber latex and polyisoprene condoms. Grosz Play Feel is not compatible with polyurethane condoms.

Grosz Play Feel is a personal lubricant that is non-sterile, water-based, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of Water, Propylene Glycol, Xanthan Gum, Carbomer, Benzoic Acid, and Sodium Hydroxide. Grosz Play feel is packaged in 50 mL bottles composed of High Density Polyethylene (HDPE) and fitted with a Polypropylene (PP) cap. The bottle is packaged in an outer cardboard carton. Grosz Play Feel is a personal lubricant for over-the-counter (OTC) use.

The provided text describes a 510(k) premarket notification for the "Grosz Play Feel" personal lubricant. This document details the device's technical specifications and the testing performed to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Grosz Play Feel personal lubricant are primarily derived from its device specifications and performance testing. The reported device performance is indicated by the results of these tests.

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The Durex Penck Standard Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).

The Durex Penck XL Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).

Durex Penck Standard and Durex Penck XL are natural rubber latex condoms that completely cover the penis with a closely fitted membrane. They are intended to be used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs). These are straight-walled, parallel sided, teat ended, smooth, and non-colored condoms with a silicone-based lubricant. Durex Penck Standard has a nominal length of 190 mm and width of 54 mm with a thickness of 48 microns. Durex Penck XL has a nominal length of 190 mm and width of 57 mm with a thickness of 50 microns. Durex Penck Standard and Durex Penck XL will be packaged in individually sealed flexible laminate foils made of polyethylene terephthalate, polyethylene, and aluminum. The foils will come packaged in an outer consumer cardboard carton. Durex Penck Standard and Durex Penck XL condoms are intended for over-the-counter (OTC) use. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.

The provided text describes the 510(k) summary for the Durex Penck Standard and Durex Penck XL condoms. Here's a breakdown of the acceptance criteria and the studies that prove the devices meet them:

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

Note: For parameters where the subject device specifications differ from the predicate, the document states: "the different technological characteristics of the subject devices do not raise different types of safety and effectiveness questions." This implies that the observed differences are within acceptable limits or are supported by the physical testing results against the recognized standards.

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

The document does not explicitly state the sample size for any of the test sets (biocompatibility or physical testing). It generally refers to "results of this testing" or "all samples."

The data provenance is not explicitly mentioned in terms of country of origin or retrospective/prospective for the described non-clinical testing. These types of tests are typically conducted in a laboratory setting.

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 submission. The device described is a medical device (condom) that undergoes physical and biocompatibility testing against established international and national standards (ISO 4074:2015, ASTM D3492-16, ISO 10993 series). The "ground truth" for these tests is defined by the objective criteria within these standards, not by expert consensus in a medical diagnostic sense.

4. Adjudication method for the test set:

This information is not applicable. As explained above, the assessment is based on objective measurements against predefined criteria in recognized standards, not subjective interpretations 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 information is not applicable to this device. An MRMC comparative effectiveness study is relevant for diagnostic devices (often AI-assisted) where human interpretation is involved. This submission is for a physical barrier contraceptive device.

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

This information is not applicable to this device. This device is not an algorithm or AI-based system. Its performance is assessed through physical and biological testing.

7. The type of ground truth used:

The ground truth used for this device is based on:

• Specifications and criteria defined in recognized international and national standards:
  • ISO 4074:2015 - Natural rubber latex male condoms - Requirements and test methods
  • ASTM D3492-16 - Standard Specification for Rubber Contraceptives (Male Condoms)
  • ISO 10993-1:2009 & 2020 FDA guidance (Biological Evaluation of Medical Devices)
  • ISO 10993-5:2009/R 2014 (Cytotoxicity)
  • ISO 10993-10:2010/R 2014 (Sensitization, Vaginal Irritation)
  • ISO 10993-11:2017 (Acute Systemic Toxicity)
• Established material properties and performance characteristics for condoms.

8. The sample size for the training set:

This information is not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable. As there is no training set for this type of device, this question is irrelevant.

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This product is intended for penile, vaginal and/or anal 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. This product is not compatible with polyurethane condoms.

K Y Grosz Jelly is a water-based personal lubricant intended for penile, vaginal and/or anal 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. Its formulation consists of Water, Propylene glycol, Hydroxyethylcellulose, Benzoic acid, Carbomer, Sodium hydroxide. KY Grosz Jelly may be packaged in 2 oz (57g) and 4 oz (113g) tubes composed of high-density polyethylene (HDPE) and linear low-density polyethylene (LLDPE), sealed with foil and fitted with a polypropylene (PP) cap. The individual tubes may be packaged in an outer cardboard carton. KY Grosz Jelly is a personal lubricant for over-the-counter (OTC) use.

The provided text describes the regulatory review for a personal lubricant (KY Grosz Jelly), not an AI-powered medical device. Therefore, the information required to answer your specific questions about acceptance criteria, study design, expert involvement, and ground truth for an AI device is not present in the document.

The document discusses:

• Product Name: KY Grosz Jelly
• Regulation Number: 21 CFR § 884.5300 (Condom)
• Regulatory Class: Class II
• Intended Use: Penile, vaginal, and/or anal application to moisturize and lubricate, enhance intimacy, and supplement natural lubrication. Compatible with natural rubber latex and polyisoprene condoms, not with polyurethane condoms.
• Predicate Device: KY Banksy Aloe
• Performance Testing: Shelf life, biocompatibility (cytotoxicity, vaginal irritation, sensitization, acute systemic toxicity), and condom compatibility.

No information regarding AI/ML device performance, human reader studies (MRMC), standalone algorithm performance, or the establishment of ground truth for AI model training/testing is available in this document.

Therefore, I cannot populate the table or answer the specific questions related to AI device acceptance criteria and study design based on the provided text.

Ask a specific question about this device