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The UroMed ABC device is intended to prevent or reduce episodes of male urinary incontinence.
The UroMed ABC device is indicated to prevent or reduce episodes of male urinary incontinence.

The UroMed ABC device is a urological clamp designed to significantly reduce the leakage of urine by occluding the urethra. The ABC device is clamped on the glans of the penis to provide less compression, yet the same continence as those urological clamps that are placed on the shaft of the penis.

This K971992 document describes the UroMed Alternative Bladder Control Continence Device (ABC), a Class I urological clamp. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with defined endpoints.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the provided document. The 510(k) submission for the UroMed ABC device does not articulate specific acceptance criteria for performance metrics (such as efficacy in preventing urine leakage or comfort levels) nor does it report device performance against such criteria. The submission primarily relies on demonstrating substantial equivalence to existing predicate devices.

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

This information is not provided for efficacy or clinical performance. The document only mentions "Bench tests were conducted to evaluate the tack force and the peel force of the ABC device adhesive." It does not specify the sample size for these bench tests, nor does it provide details on data provenance beyond stating "on human skin" for the peel force. There is no information about a test set for clinical performance.

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

This information is not applicable/not provided. There is no mention of a clinical test set requiring expert-established ground truth for the UroMed ABC device. The submission relies on bench testing and substantial equivalence to market approval.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. No clinical test set requiring adjudication is described in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done as described in the provided document. The submission focuses on substantial equivalence based on device design and intended use, not on comparing human reader performance with and without AI assistance. The device is a physical medical device, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable/not provided. The UroMed ABC is a physical medical device and does not involve an algorithm or AI. Therefore, a standalone performance study in the context of AI algorithms is not relevant.

7. Type of Ground Truth Used

For the bench tests on adhesive performance, the "ground truth" would be the direct measurements of tack force and peel force. However, for the overall effectiveness of the device in preventing urinary incontinence, the document does not refer to any specific ground truth method applied to a clinical study. Instead, it relies on the established safety and effectiveness of its predicate devices through the substantial equivalence pathway.

8. Sample Size for the Training Set

This information is not applicable/not provided. The UroMed ABC device is not an AI/ML algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

This information is not applicable/not provided. As the device is not an AI/ML algorithm, there is no training set or associated ground truth establishment process.

In Summary:

The K971992 submission for the UroMed ABC device is a Class I 510(k) submission, which typically relies on demonstrating substantial equivalence to legally marketed predicate devices. This type of submission generally does not require extensive clinical trials with detailed performance acceptance criteria, test sets, or ground truth establishment in the same manner as novel, higher-risk devices or AI/ML-driven diagnostics. The provided document details the device's design, intended use, and a summary of bench tests for adhesive properties, with the primary argument being substantial equivalence to existing penile clamps.

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