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To acquire EMG signals for display and analysis by, or under the direction of a health care professional, to assess neurogenic sacral dysfunction such as urinary incontinence and fecal incontinence.

The UroVal BRS System is used to record and display electromyogram (EMG) signals. In addition, the BRS System will determine latency time intervals of the bulbocavernous reflex (BCR). The UroVal BRS System also has report generation capabilities. The UroVal BRS System uses a probe, with a single use disposable tip to evoke a BCR response, and activate recording and timing of EMG signals. The UroVal BRS System uses pregelled surface electrodes to monitor the muscle activity.

The UroVal BRS System is used to record and display electromyogram (EMG) signals and determine latency time intervals of the bulbocavernous reflex (BCR).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria for the UroVal BRS System's performance in terms of specific EMG signal parameters or BCR latency measurements. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through conformity with recognized standards and a comparative clinical trial.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "a clinical trial" but does not provide the number of participants or cases included in this trial.
• Data Provenance: The study was a "clinical trial," which implies prospective data collection. The country of origin for the data is not specified.

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

This information is not provided in the document. The study focuses on comparing the device's performance to a predicate device, not on establishing a new ground truth based on expert consensus. The "ground truth" implicitly would be the measurements obtained from the predicate device (CTS 2000).

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of comparing device measurements, a formal adjudication process involving multiple experts to resolve discrepancies in the test set ground truth would likely not be relevant, as the predicate device's output serves as the reference.

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

• Was an MRMC study done? No, the document describes a clinical trial comparing the UroVal BRS System to the CTS 2000 ("The UroVal BRS System performance was compared to the CTS 2000 in a clinical trial"). This is a device-to-device comparison, not an MRMC study evaluating human reader performance with and without AI assistance.
• Effect size of human readers improving with AI vs. without AI assistance: Not applicable, as this was not an MRMC study with AI assistance.

6. Standalone (Algorithm Only) Performance:

• Was standalone performance done? Yes, the clinical trial compared the UroVal BRS System (algorithm/device only) directly against the predicate device (CTS 2000), which can be considered a standalone assessment of its measurement capabilities. The comparison concluded that the UroVal BRS System "performs safely and effectively, and is substantially equivalent to the predicate devices."

7. Type of Ground Truth Used:

The ground truth used for the comparison was the performance of a legally marketed predicate device, specifically the CTS 2000. This implies that the measurements (EMG signals, BCR latency) obtained from the CTS 2000 were considered the reference "truth" against which the UroVal BRS System's measurements were compared.

8. Sample Size for the Training Set:

This information is not provided. The document describes a medical device, not a machine learning or AI algorithm that would typically have a separate training set. The UroVal BRS System itself performs the measurements.

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

Not applicable, as there is no mention of a separate training set for an AI algorithm. The device's underlying principles are based on established physiological measurements and comparisons to existing, validated devices.

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