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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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The TROJAN SUPRA® 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).

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, nontextured, nipple-end condom with a nominal length of 190 mm and an nominal flat-width of 58 mm.

The provided document describes the premarket notification (510(k) submission) for the TROJAN SUPRA® Lubricated Polyurethane Male Condom, outlining its characteristics, intended use, and the studies conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the studies performed, structured according to your request:

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Clinical In-Use Slip/Break Study:

  • Sample Size: Over 290 couples.
  • Data Provenance: Not explicitly stated, but typically such studies for US FDA submissions are conducted within regulated clinical environments, often in the US, though international sites are possible. The document does not specify the country of origin.
  • Retrospective/Prospective: The phrasing "was conducted" implies a prospective study design.

• Physical Testing Data (Tensile, Air Burst, Water Leakage, Tear, Package Integrity, Viral Penetration, Shelf-life):

  • Sample Size: Three (3) lots of the 510(k)-subject condom, with an additional fourth lot tested for viral penetration at FDA's request.
  • Data Provenance: Not explicitly stated, but typically conducted in manufacturing or testing facilities. The information states the device will be made in Japan, so some testing might originate from there.
  • Retrospective/Prospective: These are typically laboratory tests performed prospectively on manufactured lots.

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

• For the Clinical In-Use Slip/Break Study: The "ground truth" (breakage and slippage events) would have been observed directly by the study participants (couples) and reported, likely verified by clinical staff/investigators. The document does not specify the number or qualifications of experts involved in establishing this ground truth, beyond the general oversight expected in a clinical study.
• For Physical and Barrier Properties: The "ground truth" is based on the objective measurements according to standardized test methods (ASTM, ISO). Experts would be the laboratory personnel performing these tests, qualified in analytical testing and materials science, but their specific number and qualifications are not detailed.

4. Adjudication Method for the Test Set

• Clinical In-Use Slip/Break Study: The document does not explicitly state an adjudication method (e.g., 2+1 or 3+1) for breakage and slippage events. These events are generally observed and recorded by the users themselves and then confirmed by study personnel.
• Physical and Laboratory Tests: Adjudication is not typically required for these objective, quantitative tests. Results are derived directly from measurements.

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 male condom, not an AI-powered diagnostic or screening tool that involves human readers interpreting cases. Therefore, an MRMC study or AI assistance effect size is not relevant to this submission.

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

• Not Applicable. As mentioned above, this device is a condom, not an algorithm. Standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Clinical In-Use Slip/Break Study: The ground truth for breakage and slippage was based on direct observation and reporting by the study participants (couples) as outcomes data (events of breakage or slippage during use).
• Physical and Barrier Properties Studies: The ground truth was based on objective laboratory measurements according to international standards (e.g., ASTM, ISO), representing the intrinsic physical properties and barrier effectiveness of the product.
• Biocompatibility and Safety Studies: Ground truth was based on established biological and chemical safety endpoints and adverse effect observations, in part outcomes data from in vitro and in vivo models.

8. The Sample Size for the Training Set

• Not Applicable. This device is a physical product, not a machine learning model. There is no concept of a "training set" in this context. The manufacturing process and quality control ensure consistency, but this is distinct from training an algorithm.

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

• Not Applicable. No training set was used.

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The TROJAN SUPRA® Lubricate Polyurethane Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases, STDs).

The TROJAN SUPRA® Lubricated Polyurethane Condom is a male condom consisting of a sheath of polyurethane with a lubricant coating. The condom is a straight-walled, nipple-end condom with a nominal length of 190 mm and an approximate flatwidth of 58 mm.

This document describes a 510(k) premarket notification for the TROJAN SUPRA® Lubricated Polyurethane Male Condom. The acceptance criteria and the study that proves the device meets those criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Users/Cases): 206 couples.
• Data Provenance: Prospective, conducted in France.

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

This information is not explicitly provided in the document. The study involved "an In-Use Study" following an FDA guidance, and the outcomes were "clinical breakage rate" and "clinically significant slippage." It's customary for such clinical studies to involve medical professionals in assessing and recording these events, but the specific number and qualifications of experts are not detailed.

4. Adjudication Method for the Test Set

This information is not explicitly provided. Clinical studies often have adjudication committees for adverse events or endpoint assessment, but the document does not specify if one was used or the method (e.g., 2+1, 3+1).

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

No, an MRMC comparative effectiveness study was not conducted as this is a medical device (condom) and not an imaging-based diagnostic or AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

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

No, a standalone algorithm performance study was not done. The device is a physical medical device (condom) and does not involve AI algorithms.

7. The Type of Ground Truth Used

The ground truth used was clinical observation and user reporting of objective outcomes, specifically:

• Clinical Breakage Rate: Direct observation/reporting of condom breakage during intercourse.
• Clinically Significant Slippage Rate: Direct observation/reporting of condom slippage during intercourse.

8. The Sample Size for the Training Set

No training set information is applicable or provided as this is a physical medical device, not an AI-based system.

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

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

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