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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).

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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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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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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 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 am sorry, but the provided text is a 510(k) clearance letter for a medical device (ONE Nitrile Condom). This document does not contain the specific information needed to answer your request regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies for a device's performance.

The letter confirms the device's clearance for marketing and provides regulatory information, but it does not delve into the technical validation studies that would include acceptance criteria and performance data.

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Polyisoprene Extra Large Condoms are used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STIs).

The Polyisoprene Extra Large Condom is a male contraceptive prophylactic device made from synthetic polyisoprene rubber latex with a lubricant coating containing silicone gel with fragrance oil. The fragrance oil acts as a masking agent to minimize odor originated from the condom substrate. The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 200 ± 10mm, width 60 ± 2mm, and thickness 0.070 ± 0.01mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 5-year shelf-life.

The provided text pertains to the 510(k) premarket notification for a medical device (Polyisoprene Extra Large Condom) and does not describe AI/ML device performance or the specific criteria and studies typically associated with such devices (e.g., studies involving human readers, ground truth establishment by experts, or training set details). The document focuses on demonstrating the substantial equivalence of the new condom to a predicate device, primarily through non-clinical performance testing and leveraging clinical testing from the predicate device.

Therefore, I cannot extract the information required to populate a table of acceptance criteria and reported device performance or answer questions regarding MRMC studies, standalone AI performance, and specifics of training/test sets as these concepts do not apply to the provided medical device submission for a condom.

The document discusses:

• Acceptance Criteria for the condom: Primarily adherence to ISO standards (ISO 23409:2011, ISO 4074:2015) for physical properties (dimensions, tensile strength, air burst, etc.), biocompatibility, barrier properties, package integrity, and shelf life.
• Performance Testing for the condom: Non-clinical tests were conducted to demonstrate compliance with the above standards and non-inferiority to natural rubber latex condoms in mechanical properties.
• Clinical Performance Testing: Leveraged from the predicate device, which demonstrated non-inferiority in breakage and slippage rates compared to a natural rubber latex condom.

Without information on an AI/ML component, the requested details about acceptance criteria, ground truth, sample sizes for AI training/testing, and expert involvement for ground truth establishment are not present in the provided text.

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The 45 Micron Polyisoprene Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections STIs).

The 45 Micron Polyisoprene Condom is a male contraceptive prophylactic device made from synthetic rubber (Polyisoprene latex) with a lubricant coating containing silicone gel with fragrance oil (Sensual Masking). The fragrance oil acts as a masking agent to minimize odor originated from the condom substrate. The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 190 ± 10mm, width 53 ± 2mm, and thickness 0.045 ± 0.005mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 3-year shelf-life.

The provided document (K231908 510(k) Summary for 45 Micron Polyisoprene Condom) describes the acceptance criteria and the study that proves the device meets those criteria for a condom. This is not a medical imaging device or an AI/ML-enabled device, therefore, many of the requested elements of your prompt are not applicable (e.g., number of experts for ground truth, MRMC study, sample size for training set, etc.).

However, I can extract and present the available information most relevant to your request format, making it clear what information is and isn't provided in the context of this specific regulatory submission for a condom.

Acceptance Criteria and Device Performance for 45 Micron Polyisoprene Condom

1. Table of Acceptance Criteria and Reported Device Performance

For a condom, "performance" is primarily assessed through physical integrity, barrier properties, and clinical failure rates (breakage/slippage). The document refers to meeting various ISO standards and FDA guidance rather than listing specific numerical acceptance criteria (e.g., a "pass/fail" for an imaging diagnostic would have specific sensitivity/specificity targets).

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

• Biocompatibility: Leveraged from predicate device submission, with additional specific tests on the subject device. Sample sizes not explicitly stated for each test, but standard for biocompatibility studies.
• Physical Performance: Not explicitly stated for each test, but testing was "for compliance" with standards.
• Package Integrity: 3 lots of the subject device.
• Barrier Properties/Permeability: 3 test lots of the subject polyisoprene condom, one lot of the commercially available predicate device, and a natural rubber latex condom comparator.
• Shelf Life: "All samples" met criteria, specific number not stated.
• Clinical In-Use Slip/Break: Over 267 couples were included in the study.
• Data Provenance: The submission is from Suretex Limited, located in Thailand. The study details (where it was conducted, retrospective/prospective) are not explicitly stated, but clinical performance studies for regulatory submissions are typically prospective and conducted under Good Clinical Practice (GCP) guidelines. The document states it "followed a protocol prepared to meet the FDA guidance".

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

• This question is not applicable as this is a physical medical device (condom) and not a medical imaging or AI diagnostic device. "Ground truth" for condom performance is established through objective physical and chemical testing, and clinical observation of real-world use rather than expert interpretation of images.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in imaging studies where interpretations from multiple readers need to be reconciled. For a condom, performance is measured objectively (e.g., breakage, slippage, physical properties).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• This question is not applicable as this is not an AI/ML-enabled medical device.

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

• This question is not applicable as this is not an AI/ML-enabled medical device.

7. The Type of Ground Truth Used

• For physical properties (tensile strength, air burst, etc.): Objective measurements against predefined ISO and ASTM standards.
• For biocompatibility: Laboratory testing results against established limits for toxicity, irritation, and sensitization.
• For barrier properties: Laboratory viral penetration testing.
• For clinical in-use performance (breakage/slippage): Direct observation of events (breakage or slippage) during actual use by participating couples. Non-inferiority was established by statistical comparison to a control latex condom.

8. The Sample Size for the Training Set

• This question is not applicable as this is a physical medical device and not an AI/ML-enabled device. There is no concept of a "training set" in this context.

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

• This question is not applicable as this is a physical medical device and not an AI/ML-enabled device.

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The Okamoto 002 Lubricated Polyurethane Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).

This condom is made of a polyurethane sheath, which completely covers the penis with a closely fitted membrane. This device is a smooth-surfaced, straight-walled, silicone-lubricated condom with nominal length 180 ± 10 mm, nominal width 57 ± 2 mm, and nominal thickness of 0.028 ± 0.008 mm with dimensions evaluated per ISO 23409-2011, Male condoms - Requirements and test methods for condoms made from synthetic materials. This condom also conforms to ASTM D6324-11 (2017) Standard Test Methods for Male Condoms Made from Polyurethane. This product has a shelf life of 5 years.

1. Table of Acceptance Criteria and Reported Device Performance:

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

   • Biocompatibility: The specific sample sizes for each test (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity) are not explicitly stated in the provided text.
   • Physical Performance Testing: The sample sizes for these tests are not explicitly stated. The tests were performed to comply with ASTM D6324-11 (2017) and ASTM D624-00 (2020), which would dictate standard sample sizes.
   • Package Integrity: Three (3) lots of the subject device were used.
   • Barrier Properties/Permeability (Viral Penetration Study): Three (3) test lots of the subject polyurethane condom, one lot of the commercially available predicate device, and a natural rubber latex condom comparator.
   • Shelf Life: "All samples" in accelerated stability evaluations. The exact number of samples is not specified.
   • Clinical In-Use Slip/Break: The study was conducted using the predicate device with a standard natural rubber latex condom serving as control. The specific number of participants or condoms used in this clinical study (relying on predicate data) is not provided in this document.

   Data Provenance:

   • The studies were conducted by Okamoto U.S.A. Inc. or their commissioned laboratories.
   • The clinical in-use slip/break data was leveraged from testing done on the predicate device (Trojan Supra Lubricated Polyurethane Male Condom, K100767). The origin of this predicate data (e.g., country) is not specified.
   • The studies appear to be prospective as they were conducted to demonstrate compliance for the subject device or leveraged from a previous prospective study of the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications: Not applicable. These tests are primarily objective performance evaluations based on established standards, not expert consensus on interpretations of complex data like medical images.

4. Adjudication Method for the Test Set: Not applicable, as there is no mention of expert review or consensus in the context of adjudication for these performance tests. The results are from direct measurement and laboratory analysis against predefined criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This type of study is relevant for medical imaging or diagnostic devices where human interpretation is involved. The reported studies are for the physical and biological performance of a condom.

6. Standalone Performance: Yes. All the non-clinical performance tests (Biocompatibility, Physical Performance Testing, Package Integrity, Barrier Properties/Permeability, Shelf Life) and the leveraged clinical in-use slip/break data represent the standalone performance of the device (or its predicate for clinical performance) against defined criteria. There is no mention of a human-in-the-loop component for these evaluations.

7. Type of Ground Truth Used:

   • Biocompatibility: Established scientific standards and protocols (ISO 10993 series).
   • Physical Performance: Established industry standards (ASTM D6324-11, ASTM D624-00, ISO 23409-2011) and FDA guidance documents.
   • Package Integrity: Established industry standard (ASTM D6324-11).
   • Barrier Properties/Permeability: Established scientific protocols and industry standards (ISO 23409:2011).
   • Shelf Life: Regulatory requirements (21 CFR 801.435) and industry standard (ASTM D6324-11).
   • Clinical In-Use Slip/Break: Clinical outcome data (breakage and slippage rates) from a study following FDA guidance documents ("Clinical Testing Guidance for New Material Male Condoms").

8. Sample Size for the Training Set: Not applicable. This refers to the training of machine learning algorithms. The device is a physical product (condom), not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established: Not applicable (see point 8).

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Synthetic Polyisoprene Lubricated Male Condom - 5 Senses is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STI's).

The Synthetic Polyisoprene Lubricated Male Condom – 5 Senses is a male contraceptive and prophylactic device made from synthetic rubber polyisoprene latex with a lubricant coating containing silicone gel with flavor and sensate. The subject condom is provided in a variety pack which includes three variants; Cooling, Tingling, and Warming.

The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 190±10mm, width 53±2mm, and thickness 0.065-0.075mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 3-year shelf-life.

The provided text is related to the FDA 510(k) premarket notification for a medical device: "Synthetic Polyisoprene Lubricated Male Condom - 5 Senses." It describes the device, its intended use, comparison to a predicate device, and performance data.

However, the document does not contain any information about an AI/ML device, nor does it mention anything related to acceptance criteria for an AI/ML model, a study proving an AI/ML device meets acceptance criteria, sample sizes for test or training sets for AI, expert involvement in ground truth establishment for AI, or MRMC studies for AI.

Therefore, I cannot fulfill your request for information related to an AI/ML device's acceptance criteria and study data based on the provided text.

The closest relevant information from the document pertains to device performance testing for a physical medical device (condom):

• Performance Testing Standards: ISO 23409:2011 ("Male Condoms - Requirements and test methods for condoms made from synthetic materials") and the FDA Guidance Document, "Testing guidance for Male Condoms Made from New Material (Non-Latex)."
• Performance Results: "Results of testing showed that the mechanical properties of the subject device were equivalent to the predicate device."
• Shelf-life testing: Demonstrated a three-year shelf-life, including assessment of mechanical burst properties.
• Biocompatibility Testing: Conducted in accordance with ISO 10993-1, including Cytotoxicity, Sensitization, Irritation (Dermal, Vaginal, Penile in Rabbits), and Acute Systemic Toxicity tests.

This information is for a physical product, not a software or AI/ML device.

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Skyn Original Polyisoprene Lubricated Male Condom - Flavored is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STI's).

The Skyn Original Polyisoprene Lubricated Male Condom – Flavored is a male contraceptive and prophylactic device made from synthetic rubber Polyisoprene latex with a lubricant coating containing silicone gel with flavor oil provides a pleasant aroma/flavor for the end user. The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 190±10mm, width 53±2mm, and thickness 0.065-0.075mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 3 year shelf-life.

The provided text describes a 510(k) premarket notification for a medical device, specifically a flavored male condom. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove a device meets acceptance criteria in the typical sense of diagnostic or AI-driven medical devices. Therefore, much of the requested information regarding AI-specific studies (e.g., test sets, ground truth, expert adjudication, MRMC studies) is not applicable or cannot be extracted from this document.

However, I can provide the acceptance criteria and a summary of the performance data as presented for this specific device based on the 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes for the mechanical property, biocompatibility, or shelf-life tests. It mentions that performance testing was conducted according to ISO 23409:2011 and FDA Guidance Document, "Testing guidance for Male Condoms Made from New Material (Non-Latex)." The provenance of the data is that these were tests conducted by the manufacturer, Ansell Healthcare Products LLC, for their K171172 submission. The tests were likely prospective in nature, specifically designed to support this submission.

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 and not provided. The "ground truth" for condom performance is established through standardized physical, chemical, and biological testing as per international standards (ISO) and FDA guidance, not through expert consensus or interpretation of medical images/diagnoses.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving human interpretation or uncertain clinical outcomes. Condom performance tests rely on objective measurements and pass/fail criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a physical medical device (condom), not an AI-driven diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.

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

This is not applicable as there is no algorithm involved.

7. The type of ground truth used

The "ground truth" for this device's performance is based on objective measurements against established engineering and biological standards (ISO 23409:2011) and regulatory guidance documents from the FDA for condom testing. This includes:

• Physical properties (e.g., dimensions, strength, integrity) confirmed through laboratory testing.
• Chemical properties (e.g., lubricant composition, flavor oil compatibility).
• Biocompatibility assessments based on recognized biological evaluation standards.
• Shelf-life stability data.

8. The sample size for the training set

This is not applicable. This device is not an AI algorithm requiring a training set.

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

This is not applicable as there is no training set for an AI algorithm.

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The Trojan Supra Lubricated Polyurethane Male Condom is intended to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections.

The TROJAN SUPRA™ Lubricated Polyurethane Condom is a male condom consisting of a sheath of polyurethane with a lubricated coating. The condom is a straight-walled, non-textured, nipple-end condom with a nominal length of 190 mm and a nominal flatwidth of 58 mm. This product has a 5-year shelf-life.

The provided text describes a 510(k) submission for a male condom, which is a Class II medical device. The submission focuses on a change to the device's labeling regarding personal lubricant compatibility. This type of device and submission does not fit the typical framework of AI/ML-driven diagnostic devices that would have the requested "acceptance criteria" and "study" details (e.g., test sets, ground truth, expert opinions, MRMC studies).

The information provided pertains to the regulatory review of a medical device (a condom) and its safety and effectiveness. The "performance testing" described is related to the physical properties of the condom and its compatibility with lubricants, not the diagnostic accuracy of an AI algorithm.

Therefore, many of the requested fields cannot be answered from the provided text as they are not applicable to this type of device and submission.

Here's an attempt to answer the applicable parts based on the input:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail table format as one might see for an AI algorithm's performance metrics (e.g., sensitivity, specificity). Instead, it implicitly refers to adherence to standards for condom performance. The primary "performance testing" mentioned is for lubricant compatibility.

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

• Sample size for test set: Not explicitly stated. The document mentions "Condom compatibility testing was performed on Polyurethane condoms (subject device) with current commercial lubricant per ASTM D7661-10." The ASTM standard, if referenced, would contain details on sample size, but it's not provided here.
• Data provenance: Not explicitly stated. Likely laboratory testing of manufactured condoms.

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 and not provided. The testing relates to physical properties (burst, lubricant compatibility) measured against an ASTM standard, not interpretation by human experts.

4. Adjudication method for the test set:

Not applicable and not provided. The testing involves physical measurements, not expert review or 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-assisted diagnostic device.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

The "ground truth" here would be defined by the physical specifications and performance requirements for condoms as established in standards (e.g., ASTM D7661-10) and regulatory guidelines, rather than expert consensus, pathology, or outcomes data in the context of diagnostic algorithms.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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