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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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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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The Trojan™ Ultra Ribbed Ecstasy latex condom with silicone lubricant (Trojan™ Ultra Ribbed Ecstasy) is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).

The Trojan™ Ultra Ribbed Ecstasy latex condom with silicone lubricant (Trojan™ Ultra Ribbed Ecstasy) is made of a natural rubber latex sheath, which covers the penis with a fitted membrane. A silicone-based lubricant is applied directly to the condom during packaging. The condom is a bulbous shaped condom with 7 rows of continuous ribs on the shaft and 9 rows of continuous ribs on the bulb. The condom meets the specifications of ASTM D3492-16. The condom has a nominal length of 200 mm, a nominal thickness of 0.095 mm, nominal flat widths of 53 mm measured 30 mm from the open end and 71 mm at the bulbous, closed end, and 800 mg of silicone lubricant per condom. The condoms are packaged in individually sealed laminate (plastic inner layer, foil middle layer, and cellophane outer layer). The foils are packaged in an outer consumer cardboard carton.

This document is a 510(k) Premarket Notification from the FDA regarding a condom. It does not describe an AI/ML device or its performance studies. Therefore, it is impossible to answer the request for information on acceptance criteria and study details for an AI/ML device based on the provided text.

The request asks for:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

None of this information is contained within the provided document, as it pertains to a physical medical device (condom) and not a software or AI/ML device. The document focuses on physical characteristics, biocompatibility, and adherence to established standards for condoms.

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0.04 Zero Zero Four Male Latex Condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

The 0.04 ZERO ZERO FOUR Male Latex Condom is a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The subject condom is smooth surfaced with a reservoir tip, silicone lubricated, with a nominal length of 180 mm, nominal flat width of 54 mm, and nominal thickness of 0.042 mm. This condom conforms to current established national standard ASTM D3492: 2016.

The provided text describes information for a K243584 submission of a male latex condom. However, it does not contain information regarding an AI/ML device or studies proving its performance against acceptance criteria. The acceptance criteria and studies described relate to the physical properties, shelf-life, and biocompatibility of the condom itself, not an AI system.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI device meets the acceptance criteria using the provided text.

Here's what the document does discuss regarding acceptance criteria and performance of the condom:

While the document does not relate to an AI device, here's a breakdown of the condom's acceptance criteria and performance based on the provided text:

1. A table of acceptance criteria and the reported device performance (for the condom):

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

• Physical Testing (Airburst, Water Leakage): "Three (3) lots" of condoms were tested. The specific number of condoms within each lot is not provided.
• Shelf Life: Not explicitly stated as a sample size for a test set, but stability was established from "physical testing data" over a 5-year period.
• Biocompatibility: The sample sizes for the specific biocompatibility tests (cytotoxicity, irritation, sensitization, systemic toxicity) are not provided in the summary.
• Data Provenance: Not specified, but generally, such testing is conducted by the manufacturer or a contract lab. The country of origin for the data is not mentioned. The data is retrospective in the sense that it's reported after the tests were performed.

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 is not applicable as the studies relate to physical and biological testing of a condom, not the performance of an AI system where expert-established ground truth would be required. The "ground truth" here is objective measurements against established international and national standards.

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

• Not applicable as this is not an AI/ML study involving human readers.

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 as this is not an AI/ML comparative effectiveness study.

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

• Not applicable as this is not an AI/ML device.

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

• For physical tests (Air Burst, Water Leakage), the ground truth is established by objective measurements against quantitative specifications defined in standards like ASTM D3492-16.
• For biocompatibility tests, the ground truth is established by the in vitro and in vivo biological responses observed in standardized tests, interpreted against the criteria of ISO 10993 series standards.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML product. There is no "training set" for a physical device like a condom.

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

• Not applicable as this is not an AI/ML product.

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The LifeStyles NRL Textured Condom is used for contraception and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

The LifeStyles® NRL Textured Condom is indicated for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections). The condom is a single use device made of a noncolored natural rubber latex sheath that covers the penis with a closely fitted membrane. The condom is textured with dots along its straight shaft, includes a reservoir tip at the closed end to contain semen, and is coated with a silicone lubricant. The LifeStyles® NRL Textured Condom has a nominal length of 190 mm, width of 53 mm, and thickness of 0.08 mm. Each condom is packaged individually in laminate foils that are secondarily packaged in cardboard shelf boxes.

The provided text describes the 510(k) premarket notification for a medical device, specifically a condom. It details the device's characteristics, comparison to a predicate device, and non-clinical performance testing. However, the request asks for information related to a study proving a device meets acceptance criteria for an AI/algorithm-based medical device, including details like sample sizes, expert ground truth establishment, MRMC studies, and training set information.

The provided document does not contain any information about an AI/algorithm-based medical device study. The "LifeStyles® NRL Textured Condom" is a physical medical device, not an AI or algorithm-driven one. Therefore, I cannot extract the requested information from the given text as it is not present.

The document discusses:

• Device Name: LifeStyles® NRL Textured Condom
• Regulation: 21 CFR § 884.5300 Condom, Class II
• Performance Testing: Biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity), Physical Property Testing (conformance to ASTM D3492-16 and ISO 4074:2015 for parameters like lubricant quantity, length, width, thickness, burst volume, burst pressure), and Shelf-Life (5 years based on accelerated stability).

These are all standard tests for a physical condom and do not relate to the evaluation of an AI or algorithm.

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SKORE Male Natural Rubber Latex Condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

The subject SKORE Male Natural Rubber Latex Condoms are made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane and used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted infections. The subject device in this submission consists of SKORE Smooth, Dotted &Thin Condoms, SKORE Bulbous Condoms, and SKORE Benzocaine Condoms.

The provided text describes the 510(k) summary for SKORE Male Natural Rubber Latex Condoms. It details the device, its intended use, comparison to a predicate device, and performance testing data.

Here's the requested information structured for acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size:
  • For Mechanical Performance Testing: "Three lots of subject devices, SKORE Male Natural Rubber Latex Condoms" were tested.
  • For Biocompatibility and Shelf Life: The sample sizes are not explicitly stated, but the tests were performed on "SKORE Male Natural Rubber Latex Condoms."
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be conducted by the manufacturer, TTK Healthcare Ltd., which is based in India. The studies are prospective in nature, as they are conducted to demonstrate compliance of the device before market entry.

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 the evaluation of condoms. The ground truth for condom performance is established through adherence to recognized international and national standards (e.g., ISO 4074, ASTM D3492) and laboratory testing, rather than expert consensus on interpretive data.

4. Adjudication method for the test set

Not applicable. The tests are objective and quantitative, based on physical and chemical properties measured against established standards. There is no subjective 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 device is a medical product (condom), not an AI-based diagnostic or assistive technology for human readers.

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

Not applicable. This is not an algorithm-based device. Performance is determined through physical and biological testing.

7. The type of ground truth used

The ground truth used for this device is based on established international and national standards (ISO 4074:2015, ASTM D3492-16, ISO 10993 series, 21 CFR 801.435) for material properties (natural rubber latex), physical integrity (air burst pressure/volume), dimensions, biocompatibility, and shelf-life.

8. The sample size for the training set

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

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 TROJAN™ Fire & Ice male natural rubber latex condom with lubricant is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).

The TROJAN™ Fire & Ice lubricated male natural rubber latex condom is made of a natural rubber latex sheath, which completely covers the penis with a fitted membrane, and a lubricant applied directly to the exterior of the condom that creates a perception of warming and cooling. The condom is bulbous shaped and smooth (no ribs) with a reservoir tip and meets the specifications of ASTM D3492-16. The condom has a nominal length of 185 mm and a nominal flat width of 54 mm, measured 30 mm from the open end. The bulbous part at the closed end of the condom has a flat width of 65 mm.

This document is a 510(k) Pre-Market Notification from the FDA regarding a new condom (TROJAN™ Fire & Ice lubricated male natural rubber latex condom). It is not a medical AI/software device and therefore does not contain information on acceptance criteria and validation studies for AI/ML algorithms.

The request asks for information relevant to the validation of a medical device software/AI, such as acceptance criteria, study methodologies, sample sizes for training and testing, ground truth establishment, expert qualifications, and MRMC studies. This type of information is found in clearances for AI/ML medical devices, which the provided document is not.

Therefore, I cannot fulfill the request using only the provided text. The document details the clearance of a physical medical device (a condom) and its non-clinical performance testing (physical testing, shelf-life, biocompatibility), which are entirely different from the validation of a software algorithm.

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