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The TheyFit male condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

The TheyFit Male Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The condom is shaped with a reservoir end and is flat with a cylindrical shape. TheyFit condoms are available in 34 sizes, of different length/width combinations. TheyFit Condoms are provided pre-lubricated with a silicone-based lubricant. TheyFit condoms are not provided with spermicide. The user must use a fitting kit (FitKit) to select the appropriate size TheyFit Condom.

The provided text describes the 510(k) summary for the TheyFit Male Condom, detailing its performance data and substantial equivalence to a predicate device. Here's an analysis to extract the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: 203 condom use surveys (for the clinical performance study).
• Data Provenance: The study was a "customer survey clinical study" with participants "recruited from TheyFit customers who had ordered a condom in the eligible size range." This indicates a prospective, real-world usage study, likely originating from TheyFit's customer base, which would be international given the global nature of product sales but no specific country of origin is mentioned.

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

• Number of Experts: Not applicable. The clinical performance study was a self-report survey conducted by customers.
• Qualifications of Experts: Not applicable. The data was based on user self-reports.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable in the traditional sense of expert adjudication. The study relied on customer self-reports. However, there was an interpretation of the self-reported data regarding slippage during withdrawal (whether to count it as clinical or user error), referencing ISO/DIS 29943-1:2014 guidance. This could be considered a form of interpretation or categorization based on a standard, rather than expert adjudication of individual cases.

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:

• MRMC Study: No, this type of study was not conducted. The device is a male condom, not an AI-powered diagnostic or interpretive tool.

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

• Standalone Performance: Not applicable. The device is a physical medical device (condom), not an algorithm. The clinical performance study evaluated the device's physical function in human use.

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

• Ground Truth: For clinical performance, the ground truth was based on self-reported outcomes data from users regarding breakages and slippages during actual use.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. The document describes studies for a physical medical device (condom), not a machine learning model that would require a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device and study.

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The TheyFit male condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

The TheyFit Male Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The condom is shaped with a reservoir end and is flat with a cylindrical shape. TheyFit condoms are available in 22 sizes, of different length/width combinations. TheyFit Condoms are provided pre-lubricated with a silicone-based lubricant. TheyFit condoms are not provided with spermicide. The user must use a fitting kit (FitKit) to select the appropriate size TheyFit Condom.

This is a summary of the acceptance criteria and study information for the TheyFit Male Condom, based on the provided 510(k) summary (K122219).

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary leverages a published clinical study for clinical performance data.

• Sample Size: Not specified in the 510(k) summary. The summary refers to the publication "Reece M, Herbenick D, Sanders SA et al, Breakage, slippage and acceptability outcomes of a condom fitted to penile dimensions. Sex Transm Infect 2008; 84(2):143-149." To find the exact sample size, the full published study would need to be consulted.
• Data Provenance: The 510(k) summary does not explicitly state the country of origin. The study is cited in "Sex Transm Infect 2008; 84(2):143-149," which is a journal published by the British Medical Journal (BMJ) group, but this doesn't confirm the study's geographic location. It is also not specified whether the study was retrospective or prospective, though clinical performance studies are typically prospective.

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 clinical study for condoms involves user performance and outcomes (breakage, slippage, and acceptability), not interpretation by experts.

4. Adjudication Method for the Test Set

This information is not applicable, as ground truth was not established via expert consensus requiring adjudication. Clinical outcomes were directly observed and reported by users in the clinical study.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic imaging devices where multiple readers interpret cases. The clinical study cited here focuses on user-reported outcomes of condom performance. There is no mention of comparing human readers' performance with and without AI assistance, as this is not an AI-enabled device.

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

No, a standalone algorithm performance study was not done. This device is a medical device (condom), not a software algorithm or AI. The clinical performance study assessed the device's function in real-world use.

7. The Type of Ground Truth Used

For the clinical performance, the "ground truth" was based on user-reported outcomes regarding breakage, slippage, and acceptability during actual use. This aligns with standard clinical evaluation for such devices.

For the other performance data (Airburst, Water Leak, Freedom from Holes, Dimensional Analysis), the "ground truth" was established by meeting specified engineering and safety standards (ASTM D3492-08 and ISO 4074:2002).

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical medical device (condom) and does not involve AI or machine learning algorithms that require a "training set."

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

This information is not applicable, as there is no "training set" for this device.

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