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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 TROJAN SIS Synthetic Latex Condom with Silicone Lubricant is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).

The TROJAN SIS Synthetic Latex Condom with Silicone Lubricant is made of a styrene-isoprene-styrene copolymer sheath, which covers the penis with a fitted membrane, and a silicone lubricant applied directly to the exterior of the condom. The condom is straight-walled, smooth, and has a nipple end. The condom has a nominal length of 185 mm, a nominal flat width of 55 mm, a nominal thickness of 0.065 mm, and conforms to the requirements of ISO 23409:2011(E).

The provided text is related to the FDA 510(k) summary for a condom device (TROJAN SIS Synthetic Latex Condom). It details the device's characteristics, comparison to a predicate device, and summaries of non-clinical and clinical performance testing. However, the request asks for information pertaining to an AI/Software as a Medical Device (SaMD), specifically regarding its acceptance criteria and the study proving it meets these criteria.

The document discusses physical testing and a clinical trial for a physical medical device (condom), not an AI/SaMD. Therefore, many of the requested elements (e.g., number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable to the content provided.

Based on the provided text, I can extract the acceptance criteria and study results for the condom's clinical performance, but it will not align with the implied AI/SaMD context of the questions.

If we interpret the request strictly for the provided information (condom device), here's the breakdown:

The document describes a clinical study (NCT05370196) to evaluate the performance of the TROJAN SIS Synthetic Latex Condom with Silicone Lubricant.

Acceptance Criteria and Device Performance (for the Condom)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The reported performance values in the table are the upper bounds of the one-sided 95% confidence intervals for the difference in failure rates between the subject device (SIS) and the control (NRL). The primary objective was non-inferiority, meaning the SIS condom rate should not be significantly worse than the NRL control by more than the specified margin.

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

• Test Set (Clinical Study Population):
  • Couples enrolled: 300
  • Couples completed study: 289
  • Total condom uses contributing to analysis: 1,129 SIS condom uses and 1,130 NRL control condom uses.
• Data Provenance: Clinical trial conducted in California, USA. The study is described as a "randomized crossover clinical trial". This indicates a prospective data collection design.

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

This concept is not applicable to this study. The "ground truth" for condom failure (breakage, slippage) was established by self-reports from the study participants (couples) during actual use, not by expert review of data/images.

4. Adjudication method for the test set:

Not applicable in the context of this condom study, as outcomes were self-reported failures rather than 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:

Not applicable. This was a study comparing two physical condom types, not an AI-assisted interpretation study.

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

Not applicable. This refers to an AI algorithm's performance, which is not relevant to this device.

7. The type of ground truth used:

• Based on: Clinical self-reports of condom breakage and complete slippage during actual use by couples. This is a form of outcomes data from a user perspective.

8. The sample size for the training set:

• Not applicable. This device is a physical product (condom), not an AI algorithm that requires a training set. The study was a clinical performance evaluation.

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

• Not applicable, as there is no training set for a physical device.

In summary, the provided document details the performance testing and clinical study for a physical condom device, not an AI/Software as a Medical Device. Therefore, many of the questions related to AI/SaMD specific methodologies (like expert adjudication, MRMC, training sets, etc.) are not addressed in the text.

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

The FAMA Male Latex Condoms are single-use, non-sterile condoms made of a natural rubber latex sheath, which covers the penis with a closely fitted membrane. The condoms have a smooth, dotted or ribbed surface and have a straight-walled nipple-end (SWNE) style within specifications listed in ASTM D3492-16, Standard Specification for Rubber Contraceptives (Male Condoms are lubricated with no colorants and fragrances added. The product is made of natural rubber latex, additives are sulfur, zinc oxide, promoter PX, promoter ZDC, antioxidant 264, stabilizer casein, and silicone oil as lubricant. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.

The provided text is a 510(k) summary for the FAMA Male Latex Condoms, a medical device. This document details the device's technical specifications, intended use, and its comparison to a predicate device to establish substantial equivalence for FDA clearance.

Crucially, the request asks for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML medical devices, specifying aspects like sample size for test/training sets, expert ground truth establishment, MRMC studies, and standalone performance.

However, the FAMA Male Latex Condoms are not an AI/ML medical device. They are a physical product (condoms) whose performance is evaluated based on physical and biological properties (e.g., length, width, thickness, burst pressure/volume, biocompatibility, shelf-life), not on an algorithm's diagnostic or predictive capabilities.

Therefore, the specific information requested regarding AI/ML device testing (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance, and adjudication methods) is not applicable to this document. The "studies" mentioned in the document are physical and biological performance tests, not AI model evaluations.

Summary of Device Performance and Acceptance Criteria (as applicable to a physical device):

The document provides acceptance criteria and performance data for the FAMA Male Latex Condoms based on physical and biological testing to meet established standards.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document states that "The FAMA Male Latex Condoms were tested at baseline 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)."
• For Biocompatibility, "Biocompatibility studies... were performed in accordance with... ISO 10993-1, -5, -10, -11."
• For Shelf-Life, "accelerated stability evaluations conducted as required in 21 CFR 801.435."
• Specific sample sizes for each test are not detailed in this 510(k) summary. These details would typically be found in the full test reports referenced by the standards (e.g., how many condoms were burst-tested).
• Data Provenance: The manufacturing entity is "Shanghai Personage Hygiene Products Co.,Ltd." located in Shanghai, China. The testing was conducted by or on behalf of this company, presumably according to international standards. The nature of the physical and stability testing is inherently prospective in the sense that the manufactured devices are subjected to these tests to evaluate their properties.

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

• Not Applicable. This is a physical device. "Ground truth" for physical and biological properties is established by adherence to validated test methods and measurement protocols defined in international standards (ISO, ASTM, FDA regulations), not by expert consensus on interpretations of complex data like medical images.

4. Adjudication method for the test set:

• Not Applicable. As a physical device, testing involves quantitative measurements (e.g., length, burst pressure) and standardized biological assays, 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:

• Not Applicable. This is not an AI device.

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

• Not Applicable. This is not an AI device.

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

• For physical properties (length, width, thickness, burst pressure/volume): The "ground truth" is defined by the objective, measurable parameters specified in the ASTM and ISO standards, measured using calibrated equipment and standardized test methods.
• For biocompatibility: The "ground truth" is established by the results of validated biological assays (e.g., cytotoxicity, sensitization, irritation, systemic toxicity tests) as per ISO 10993 series. These tests have defined endpoints and criteria for determining toxicity.
• For shelf-life: The "ground truth" is established through stability testing that demonstrates the device maintains its performance and safety characteristics over time under specified conditions, according to 21 CFR 801.435.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. This is not an AI/ML device, so there is no "training set."

In conclusion, the document successfully demonstrates that the FAMA Male Latex Condoms meet the required physical and biological acceptance criteria by adhering to recognized international standards and FDA regulations for medical devices, thereby establishing substantial equivalence to the predicate device. The detailed questions regarding AI/ML device performance are not relevant to this product.

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The TROJAN™ Her Pleasure Warming natural rubber latex condom with warming lubricant is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).

The TROJAN™ Her Pleasure Warming natural rubber latex condom with warming lubricant is made of a natural rubber latex sheath, which completely covers the penis with a fitted membrane and has a warming lubricant applied directly to the condom to create a perception of warming. The condom is a bulbous shaped condom with 11 rows of continuous ribs on the shaft and 9 rows of continuous ribs on the bulb. The TROJAN™ Her Pleasure Warming natural rubber latex condom with warming lubricant 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.

While the provided text describes the performance testing and safety testing conducted for the TROJAN™ Her Pleasure Warming male natural rubber latex condom, it does not explicitly use the term "acceptance criteria" in a structured table or provide a detailed study that directly proves the device meets specific acceptance criteria in the way a clinical trial or AI model validation study would.

Instead, the document details a 510(k) Premarket Notification for a medical device seeking substantial equivalence to a legally marketed predicate device. In this context, "acceptance criteria" are implicitly met by demonstrating that the device performs equivalently to established standards (ASTM D3492-16, ISO 4074:2015) and passes various safety evaluations (biocompatibility).

Here's an attempt to structure the information according to your request, acknowledging that some details, especially regarding a "study that proves the device meets acceptance criteria" in the context of AI or specific clinical efficacy endpoints, are not present for this type of device (a condom):

Acceptance Criteria and Device Performance for TROJAN™ Her Pleasure Warming Condom

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Physical Testing (Airburst): "Three (3) lots" of condoms were tested. No specific number of individual condoms per lot is provided.
• Shelf Life: The stability was established through "physical testing data using a protocol that followed 21 CFR §801.435 and met the requirements of both ASTM D3492-16 and ISO 4074:2015." The sample size (number of condoms tested over time) is not explicitly stated.
• Biocompatibility: The text lists several specific tests (e.g., Rabbit Vaginal Irritation, Guinea Pig Maximization Sensitization). The "sample size" for these biological tests typically refers to the number of animals or cell cultures used, which is not detailed in this summary.
• Data Provenance: Not explicitly stated, but given these are standard tests for medical device approval in the US, it's implied they were conducted in a controlled lab environment. It is not specified if the data is retrospective or prospective, but testing for device approval is inherently prospective relative to market entry.

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

This type of information is generally not applicable to the evaluation of a condom for physical and biological safety. The "ground truth" for condom performance is established by adherence to internationally recognized standards (ASTM D3492-16, ISO 4074:2015) and standard biocompatibility testing protocols, not by expert consensus on clinical readings or interpretations. Labs performing these tests are accredited to do so.

4. Adjudication Method for the Test Set:

Not applicable in the context of objective physical and biological tests. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where expert consensus is needed to establish a "ground truth" for complex diagnostic or treatment outcomes, often involving subjective interpretation (e.g., imaging reads). Here, results are pass/fail based on objective measurements and established thresholds.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study is typically performed for diagnostic devices (like AI-assisted imaging software) to evaluate how AI impacts human reader performance. The device here is a physical contraceptive/prophylactic, not a diagnostic tool requiring human interpretation.

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

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

7. The Type of Ground Truth Used:

The "ground truth" for the performance of this device is based on:

• Objective Standards: Adherence to established international and national standards for rubber contraceptives (e.g., ASTM D3492-16, ISO 4074:2015) for physical properties like airburst and stability.
• Standardized Biocompatibility Protocols: Results from well-defined biological evaluations (ISO 10993 series) for cytotoxicity, irritation, sensitization, and acute systemic toxicity.

8. The Sample Size for the Training Set:

Not applicable. As a physical product, there is no "training set" in the machine learning sense. The development of the condom involves engineering, material science, and manufacturing processes, not algorithm training.

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

Not applicable, as there is no training set in the context of this device. The development and verification processes for condoms rely on established scientific and engineering principles, material specifications, and regulatory standards rather than machine learning ground truth establishment.

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

The Microthin Natural Rubber Latex Condom is a male contraceptive made of natural rubber latex that completely covers the penis with a closely fitted membrane sheath. The condom is provided lubricated with silicone oil. The condom is straight-walled, with a smooth surface and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 170mm ± 10mm, width 52 ± 2mm, and thickness 0.035mm ± 0.005mm. The condom conforms to the recognized standards ASTM D3492-16 Standard Specification for Rubber Contraceptives (male condoms) and ISO 4074:2015 Natural Rubber Latex Condoms - Requirements and test methods. The condom has a 5-year shelf-life.

The provided text is related to a 510(k) premarket notification for a medical device (Microthin Natural Rubber Latex Condom). It details the device's characteristics, comparison to a predicate device, and summaries of non-clinical performance testing. However, it does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML powered medical device, which is what your request is specifically asking for.

The request asks for details about:

• A table of acceptance criteria and reported device performance (in the context of AI performance metrics like sensitivity, specificity, AUC).
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth establishment.
• Adjudication method for the test set.
• MRMC comparative effectiveness study details.
• Standalone performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

None of this information is present in the provided document, as it is describing a physical product (a condom) and not an AI/ML device.

The document does mention "acceptance criteria" in the context of a physical product's performance validation (e.g., airburst specifications, biocompatibility), but these are not the kind of acceptance criteria you are asking for (which are relevant to AI/ML performance).

Therefore, I cannot fulfill your request for information related to an AI/ML powered medical device study based on the provided text.

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

Not Found

I am sorry, but the provided text does not contain information about the acceptance criteria for a device, nor does it describe a study proving a device meets any such criteria.

The document is an FDA 510(k) clearance letter for a "Male Latex Condom" (K203536). It states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing. It also outlines regulatory requirements such as registration, labeling, and good manufacturing practices. The "Indications for Use" section specifies that the condom is for contraception and prophylactic purposes.

Therefore, I cannot provide the requested information, including:

• A table of acceptance criteria and reported device performance
• Sample sizes and data provenance
• Number and qualifications of experts for ground truth
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone algorithm performance
• Type of ground truth used
• Training set sample size and ground truth establishment

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