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Water-based lubricant is intended for penile, vaginal and/or anal application to moisturize and lubricant, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubricant. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Not Found

The provided FDA 510(k) clearance letter for the "Water-based Lubricant" device (K250142) does not contain the detailed information requested regarding acceptance criteria and the study that proves the device meets those criteria.

This document is a clearance letter, which confirms that the FDA has reviewed the submission and found the device substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and provides contact information but does not typically include the technical details of performance studies.

Therefore, I cannot extract the following information from the provided text:

1. Table of acceptance criteria and the reported device performance: This information is not present in the clearance letter.
2. Sample size used for the test set and the data provenance: This information is not present in the clearance letter.
3. Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present in the clearance letter.
4. Adjudication method for the test set: This information is not present in the clearance letter.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done and any effect size: This information is not present in the clearance letter.
6. If a standalone (algorithm only) performance was done: This information is not present in the clearance letter.
7. The type of ground truth used: This information is not present in the clearance letter.
8. The sample size for the training set: This information is not present in the clearance letter.
9. How the ground truth for the training set was established: This information is not present in the clearance letter.

The clearance letter focuses on the regulatory determination of substantial equivalence, the device's classification, and general regulatory requirements, rather than the specifics of the performance testing. To obtain the requested information, one would need to refer to the actual 510(k) submission document filed by Global Protection Corp. for the Water-based Lubricant.

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Plain water-based lubricant is a water-based 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. This product is not compatible with polyurethane condoms.

Plain Water-based Lubricant

I'm sorry, I cannot fulfill this request. The provided document is an FDA 510(k) clearance letter for a "Plain Water-based Lubricant." This document is a regulatory communication from the FDA to the manufacturer, indicating that the device has been cleared for marketing.

It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or clinical study methodologies (such as MRMC studies or standalone performance). The letter focuses on regulatory compliance and substantial equivalence to a predicate device, not on detailed performance study results.

Therefore, I cannot extract the requested information about device performance and study details from the provided text.

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The Natural rubber latex male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Natural rubber latex male condom

This document is a 510(k) clearance letter from the FDA for a Natural rubber latex male condom. It is not a document about an AI/ML medical device and therefore does not contain any information about acceptance criteria, study data, ground truth, or expert review related to AI/ML performance.

The provided text only addresses the regulatory clearance for a physical medical device (condom) based on substantial equivalence to a predicate device. It details the product name, regulation number, regulatory class, and indications for use. It also outlines general regulatory requirements such as quality system regulations, UDI, and adverse event reporting.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth for an AI/ML device, as this information is not present in the provided document.

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

LubriZenzs is a non-sterile, water-based, over-the-counter personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. Its formulation consists of water, propanediol, cellulose gum, algin, 1,2-hexanediol, sodium hyaluronate, lactic acid, gluconolactone, Tremella fuciformis (mushroom) extract, caprylhydroxamic acid, sodium benzoate, calcium gluconate, sodium hydroxide, xylitylglucoside, anhydroxylitol, glycogen, xylitol, and glucose.

The Lubricant comes in a 100 mL white polypropylene plastic airless pump bottle, with a clear overcap. The lubricant has a shelf-life of 2 years.

Specifications:

• Appearance: Clear, flowable
• Color: Colorless
• Odor: Odorless
• pH: 4.5-5.0
• Viscosity: 10,000 – 25,000 cps
• Osmolality: 135 - 380 mOsm/kg (1:10 dilution)
• Total Microbial Count (TAMC): criteria for category 2. Bacteria: No less than 2.0 log reduction from initial count at 14 days, and no increase from the 14-day count at 28 days. Yeast and Molds: No increase from the initial calculated count at 14 days and 28 days.

The FDA 510(k) clearance letter for LubriZenzs (K242712) pertains to a personal lubricant, not an AI-powered medical device. Therefore, the information requested in points 2, 3, 4, 5, 6, 7, 8, and 9 (related to AI study design, experts, ground truth, and training sets) is not applicable to this submission.

However, I can extract the acceptance criteria and the summary of performance testing for the LubriZenzs device as described in the provided text.

Acceptance Criteria and Device Performance for LubriZenzs

1. Table of Acceptance Criteria and Reported Device Performance

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

• Biocompatibility: The document does not specify the exact sample sizes for each biological test (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity). The provenance of the data (e.g., country of origin, retrospective/prospective) is not mentioned.
• Condom Compatibility: The document does not specify the sample size of condoms or lubricant used for testing. The provenance of the data is not mentioned.
• Shelf-Life Testing: The document does not specify the number of samples or batches tested for real-time stability. The provenance of the data is not mentioned.
• Other Device Specifications (Appearance, Color, Odor, pH, Viscosity, Osmolality, Microbial Counts): The document does not specify sample sizes for these tests or data provenance.

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 lubricant, and its performance is assessed via standardized chemical, physical, and biological tests, not expert interpretation of diagnostic images or clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Performance is based on objective measurements against predefined specifications using established test methods.

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, not an AI-assisted 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, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device is based on compliance with predefined physical, chemical, and biological specifications established by relevant industry standards (e.g., USP, ASTM, ISO) and regulatory guidance. For example:

• Chemical/Physical properties (pH, viscosity, osmolality): Measured against numerical ranges.
• Microbiological purity: Measured against limits for colony-forming units and absence of specific pathogens.
• Biocompatibility: Assessed through in-vitro and in-vivo tests designed to detect cytotoxic, sensitizing, irritating, or toxic effects.
• Condom compatibility: Tested according to a specific ASTM standard (ASTM D7661-18) which defines compatibility criteria.

8. The sample size for the training set:
Not applicable. This is a physical product (lubricant), not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established:
Not applicable. As above, no training set is involved.

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Water Solubility Human Body Lubricant is a personal lubricant for penile, anal 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.

Water Solubility Human Body Lubricant is a clear, colorless, odorless and semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene, and is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal, 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 sold as an over-the-counter (OTC) product in 120 mL size provided in clear polyethylene terephthalate (PET) bottle. The bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process. The device is composed of Hyaluronic acid, Lubrajel CG, Lubrajel oil, Panthenol, Trimethyl glycine, Pentanediol, Hydroxyacetophenone, Ethylene glycol, Glycerol, Purified water.

This FDA clearance letter is for a Water Solubility Human Body Lubricant, which is regulated as a condom accessory (personal lubricant). The information provided is standard for a 510(k) submission for such a device and focuses on biocompatibility, shelf-life, and condom compatibility.

Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-based medical device (like those requiring MRMC studies, ground truth establishment by experts, training/test sets) does not apply to this product.

The document discusses performance testing, but these tests are for physical, chemical, and biological properties of the lubricant itself, not for an AI algorithm's diagnostic or assistive performance.

Here's why the AI-related questions cannot be answered based on the provided text:

• No AI/Algorithm: The device is a "Water Solubility Human Body Lubricant," a physical product, not an AI software or algorithm.
• No Diagnostic/Clinical Performance: The device's function is lubrication, not diagnosis, image analysis, or any task typically performed by an AI in healthcare.
• No Human Readers/Experts for AI Ground Truth: Since there's no AI, there's no need for human readers to establish ground truth or conduct MRMC studies.

Instead, I can summarize the performance criteria and the studies conducted for this specific medical device (the lubricant):

Device Category: Personal Lubricant (regulated under Condom, Product Code NUC)

The acceptance criteria and studies for the Water Solubility Human Body Lubricant are focused on its physical, chemical, microbiological properties, biocompatibility, shelf-life, and compatibility with condoms, as is standard for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes used for each physical, chemical, or microbiological test (e.g., how many units were tested for viscosity or pH, or how many animals for biocompatibility). These are typically standard laboratory sample sizes for quality control and testing.
• Data Provenance: The tests were conducted according to recognized international and US standards (USP, ISO, ASTM). The manufacturer is "Dongguan Yanxuan Biotechnology Co., Ltd." in China, and the studies were performed as part of their 510(k) submission to the US FDA. The studies are prospective tests performed on the manufactured product to demonstrate compliance.

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

N/A - This device is a physical product (lubricant), not an AI/algorithmic device that requires expert-established ground truth for performance evaluation. The "ground truth" here is the result of the standardized laboratory tests meeting predefined physical, chemical, and biological specifications.

4. Adjudication Method for the Test Set

N/A - Not applicable for this type of product testing. Results are quantitative measurements or qualitative observations based on direct testing according to established standards.

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

N/A - MRMC studies are for evaluating the performance of diagnostic devices, especially those involving human interpretation (e.g., radiologists reading images) sometimes with AI assistance. This device is a lubricant.

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

N/A - There is no algorithm for this device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective laboratory measurements and tests against pre-defined specifications from recognized standards (e.g., USP monographs, ISO biocompatibility standards, ASTM condom compatibility standards).

8. The Sample Size for the Training Set

N/A - Not applicable. There is no AI model to train.

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

N/A - Not applicable. There is no AI model to train.

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Sutil Rich Personal Lubricant is a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. The product is not compatible with polyurethane condoms.

Sutil Rich Personal Lubricant is a non-sterile, water-based personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. Its formulation consists of purified water, propanediol, hyaluronic acid, gluconolactone, sodium benzoate, Nelumbo Nucifera Root Water, Horny Goat (Epimedium Sagittatum) Herb, Siberian Ginseng (Eleuthero) Std. Extract, Jujube (Zizyphus Jujuba) Fruit Powder Extract. The device is provided in tube containers composed of low-density polyethylene (LDPE) with flip-top caps made of high-density polyethylene (HDPE). The packaging configurations range from 0.34 FL OZ (10 mL) to 8 FL OZ (240 mL), depending on the device. The personal lubricant is non-sterile and intended for over-the-counter (OTC) use.

This document is a 510(k) clearance letter for a personal lubricant, not a medical device involving AI or complex clinical studies for diagnosis or treatment. Therefore, many of the typical acceptance criteria and study designs you've asked about (e.g., MRMC studies, expert ground truth establishment for AI, effect size of human readers with AI assistance) are not applicable to this product.

The acceptance criteria here concern physical, chemical, and biological properties of the lubricant, as well as its compatibility with condoms, to ensure it is safe and performs as intended.

Here's an analysis based on the provided text for the Sutil Rich Personal Lubricant:

Device Name: Sutil Rich Personal Lubricant
Device Type: Personal Lubricant (OTC)
Regulatory Class: II
Product Code: NUC (lubricant, personal)

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (e.g., number of batches, number of units) used for each specific test (e.g., pH, viscosity, microbiological assays, biocompatibility, or condom compatibility). It states "samples" were used for shelf-life testing and that "the subject devices" were evaluated for condom compatibility.

• Sample Size: Not explicitly quantified for each test. General reference to "samples" or "the subject devices".
• Data Provenance: The document does not specify the country of origin of the data. The studies performed are laboratory-based and simulated use (e.g., shelf-life, condom compatibility, biocompatibility). These are prospective tests performed on the manufactured product to demonstrate its properties. There is no indication of retrospective data analsysis.

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

• This device clearance is for a personal lubricant, not an AI-powered diagnostic device.
• Ground Truth Establishment: The "ground truth" for the performance of this device is established through standardized laboratory test methods (e.g., USP, ASTM, ISO standards) and adherence to predefined specifications. These methods are analytical and rely on measurements and observations, not on expert consensus or interpretation in the way one would for medical image analysis.
• Experts: The tests are conducted by trained technicians or scientists in specialized laboratories (e.g., chemistry, microbiology, toxicology labs). The document does not specify the number or qualifications of individuals who performed or interpreted these specific lab tests, but it's implied they adhere to the requirements of good laboratory practice (GLP) and the specific test methodologies.

4. Adjudication Method for the Test Set

• Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies where human interpretation of data is subjective (e.g., reading medical images).
• For this device, the "adjudication" is inherent in the objective, quantitative nature of the tests. Results are compared directly against the pre-defined numerical or descriptive specifications. Any deviation would lead to a failure to meet the acceptance criteria, not a need for adjudication.

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

• No, an MRMC study was NOT done. MRMC studies are designed to compare the diagnostic performance of human readers, often with and without AI assistance, on a set of cases. This is not relevant to a personal lubricant.

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

• This question is applicable to AI algorithms.
• No, a standalone algorithm performance study was NOT done because this is not an AI/software device. The performance of the lubricant is intrinsic to its formulation and physical/chemical properties, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this product is based on defined scientific standards and objective measurements from various laboratory tests (chemical analysis, physical properties testing, microbiological analysis, biocompatibility testing, condom compatibility testing).
• It is not based on expert consensus, pathology, or outcomes data in a clinical sense. For example, the "ground truth" for pH is a specific range measured by a pH meter against a standard, not a subjective interpretation.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" as this is not a machine learning or AI device. The product formulation is developed through research and development, and then tested against established industry standards.

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

• This question is not applicable. As there is no training set (being a non-AI product), there is no ground truth for a training set to be established.

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The ONE Nitrile Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections).

Not Found

I apologize, but the provided FDA 510(k) clearance letter for the ONE Nitrile Condom does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found for AI/medical imaging devices.

The document primarily focuses on regulatory approval, substantial equivalence to a predicate device, and general controls for medical devices. It outlines:

• The FDA's determination of substantial equivalence for the ONE Nitrile Condom (K243967).
• Regulatory classifications (Class II, Product Code MOL).
• Applicable regulations (e.g., Quality System regulation, UDI Rule).
• General information about FDA oversight of medical devices.
• The intended use of the device (contraception and STI prevention).

Therefore, I cannot extract the detailed information requested in your prompt (e.g., acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) because it is not present in this specific FDA clearance letter for a condom.

These types of details are typically found in regulatory submissions for AI-enabled medical devices or diagnostic tools, which undergo rigorous performance validation studies. A condom, while a medical device, is evaluated based on different performance metrics (e.g., burst strength, freedom from holes, dimensions) that are validated through standard tests rather than AI-specific evaluations.

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The Joylux Intimacy Gel is a water-based personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, 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.

Joylux Intimacy Gel is a non-sterile, water-based, clear gel personal lubricant. It contains Water, Hydroxyethylcellulose, Polyquaterium-5, Propylene Glycol, PEG-45, Aloe Vera 200x Powder, Sodium Hyaluronate, Geogard Ultra (gluconolactone & sodium benzoate). The lubricant is compatible with natural rubber latex and polyisoprene condoms. The lubricant is not compatible with polyurethane condoms.

The lubricant is packaged in a 4oz / 120mL flip-top 5-layer polyethylene tube made up of 70% LDPE and 30% HDPE.

The provided document is a 510(k) summary for the Joylux Intimacy Gel (PG3100), a water-based personal lubricant. It describes the device, its intended use, comparison to a predicate device, and the non-clinical performance testing conducted to demonstrate substantial equivalence.

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

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 typical "test set" sample sizes in the way one might for an AI/ML device. Instead, the testing described is analytical and performance testing for a personal lubricant.

• Biocompatibility: The sample size for animals or cell cultures used in these tests (Cytotoxicity, Guinea Pig Maximization, Vaginal Irritation, Acute Systemic Toxicity) is not explicitly stated.
• Shelf Life: Not specified, but standard aging study protocols typically involve multiple units tested at various time points.
• Condom Compatibility: The specific number of condoms or lubricant samples tested is not provided, but it would adhere to the ASTM D7661-18 standard method.

The data provenance is from non-clinical performance testing conducted on the Joylux Intimacy Gel device itself, likely performed in laboratories according to recognized international standards (ISO, USP, ASTM). It is prospective in the sense that the testing was conducted specifically for this submission. The country of origin of the data is not specified but is implicitly from testing labs adhering to these international standards.

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 in the context of this device. The ground truth for the performance of a personal lubricant is established through objective laboratory testing against defined physical, chemical, and biological specifications, not through expert consensus on interpretation of data like in medical imaging.

4. Adjudication method for the test set

Not applicable. As described above, the determination of meeting specifications is based on objective laboratory measurements and adherence to test standards, not on subjective expert 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

Not applicable. This is not an AI/Machine Learning device or an imaging device requiring human readers or AI assistance.

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

Not applicable. This is not an AI/Machine Learning device. The performance testing is for the physical and chemical properties of the lubricant itself.

7. The type of ground truth used

The ground truth for this device is based on:

• Established industry standards and methods: USP (United States Pharmacopeia) for pH, viscosity, osmolality, and microbial limits; ISO 10993 series for biocompatibility; ASTM D7661-18 for condom compatibility, and ASTM F1980-21 for accelerated aging.
• Pre-defined specifications: The specific quantitative and qualitative acceptance criteria listed in Table 1 for parameters like pH, viscosity, microbial counts, appearance, and odor.

8. The sample size for the training set

Not applicable. This is not an AI/Machine Learning device, 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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The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

It is a straight walled textured condom with a nipple end and made of natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. It has a nominal length of 190 ± 10 mm, nominal width of 54 ± 2 mm and nominal thickness of 0.06 ± 0.01 mm.

Lelo Hex Lubricated Natural Rubber Latex Condom is packaged in individually sealed flexible laminate foils which is then packaged into an outer consumer cardboard carton. The Lelo Hex Lubricated Natural Rubber Latex Condom is 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 regulatory clearance of a medical device, the Lelo Hex Lubricated Natural Rubber Latex Condom, and references its performance testing. However, it does not explicitly define acceptance criteria in a structured table or detail a specific study proving the device meets these criteria in the way typically required for AI/ML-based diagnostic devices.

The document focuses on demonstrating substantial equivalence to a predicate device for FDA clearance. The "acceptance criteria" can be inferred from the standards the device claims to meet and the types of tests performed.

Here's an interpretation based on the provided text, structured as requested, but with caveats about the specificity of the "acceptance criteria" as defined in this context:

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

Note: The details of the specific quantitative acceptance criteria (e.g., exact tensile strength values, specific acceptable defect rates) from ISO 4074 or ASTM D3492 are not provided in this document, only that the device met these standards.

Regarding the study proving the device meets the acceptance criteria:

The document summarizes the performance testing conducted, which serves as the "study" proving the device meets the inferred acceptance criteria.

The following information is largely not applicable (N/A) or not available (N/A – not provided) because this is a submission for a physical medical device (condom) and not an AI/ML-based diagnostic device. The questions about test sets, experts, adjudication, MRMC studies, standalone algorithm performance, and training sets are directly relevant to AI/ML device evaluations.

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

• Sample size: Not explicitly stated for each test, but implied to be sufficient to meet the statistical requirements of the referenced ISO and ASTM standards.
• Data provenance: Not explicitly stated, tests were presumably performed by laboratories in a controlled environment to standard specifications.

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

• N/A. This question is for AI/ML diagnostics. For a physical device like a condom, "ground truth" refers to the objective measurement against established physical standards.

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

• N/A. This question is for AI/ML diagnostics.

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. This question is for AI/ML diagnostics.

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

• N/A. This question is for AI/ML diagnostics. The device is a physical product.

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

• Objective measurement against recognized international and national standards. For biocompatibility, it's the results from standardized biological tests. For physical performance, it's direct measurements (e.g., dimensions, burst pressure, tensile strength) compared to numerical thresholds defined in ISO 4074:2015 and ASTM D3492-16.

8. The sample size for the training set:

• N/A. This question is for AI/ML diagnostics. There is no "training set" for a physical device like this in the context of this submission. The device is developed through manufacturing processes and then tested against standards.

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

• N/A. This question is for AI/ML diagnostics.

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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).

Not Found

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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