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The CT3000Pro is intended for urodynamic testing. The equipment performs standard tests including uroflowmeter, cystometry, micturition, electromyography and urethral pressure profiles. The non-invasive option utilizes a penile cuff (UroCuff-Classic or UroCuff-DC) for non-invasive testing of bladder activity, by assessing the pressure necessary to interrupt urine flow.

The CT3000Pro is intended for use under the direction of a licensed physician or health care professional in an office or hospital setting.

The CT3000Pro system is an urodynamics testing system which combines an all-in-one touchscreen PC with the CT3000Pro console. Patient information and all data from the tests are stored on the PC's hard disk and the printer enables the user to print a hard copy report of the recorded data. It features a scale to record urine flow, as well as a pump for cystometrogram and urethral pressure profile studies.

The CT3000Pro PC software runs three types of tests: (a) catheterized urodynamics, (b) non- invasive urodynamics, and (c) uroflow studies.

The provided text describes the acceptance criteria and study proving the CT3000Pro's performance, but it primarily focuses on substantial equivalence for regulatory clearance rather than a detailed AI model performance study. The text does not describe an AI/ML-driven device.

From the provided text, the CT3000Pro is a urodynamics measurement system. The performance data section describes standard device verification and validation activities, software validation, and clinical data from literature regarding the UroCuff for non-invasive urodynamic studies. There is no mention of an AI/ML algorithm or related performance metrics like sensitivity, specificity, or AUC. Therefore, a direct answer to the acceptance criteria and study of an AI/ML device is not possible based on the provided document.

However, I can extract information related to the device's functional performance and the clinical evidence presented for its substantial equivalence, interpreting "acceptance criteria" as meeting regulatory standards for a non-AI medical device.

Based on the provided document, here's an interpretation of the requested information, acknowledging the absence of AI/ML specifics:

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

Since this is a non-AI device application, the "acceptance criteria" are not related to typical AI performance metrics (like sensitivity, specificity, or AUC). Instead, they are related to the device's functional and safety characteristics, and its equivalence to a predicate device. The document implies compliance with relevant standards and successful completion of verification and validation.

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

• Test Set (Clinical Data for Non-invasive Uroflow): The clinical performance for the non-invasive uroflow measurement technique (UroCuff) was demonstrated through published literature. A specific study mentioned involved over 50,000 UroCuff patients.
• Data Provenance: The explicit provenance of this large patient dataset is "103 US hospitals and urology offices." The study is described as having been published in the Journal of Urology by authors practicing at Mayo Clinic, Mount Sinai Hospital, and Chesapeake Urology. The data collection would be retrospective as it's based on clinical experiences that have already occurred and been published.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document describes a urodynamics measurement system, not an AI model requiring ground truth established by experts for image or signal interpretation. The "ground truth" for this device's performance is the accurate measurement of physiological parameters (e.g., urine flow, pressure, EMG signals) during urodynamic testing and the clinical outcomes for UroCuff use. The validity of these measurements and clinical outcomes is established through standard medical practice and the rigor of published clinical studies. Experts (physicians) use the device and interpret its output in the clinical setting; their qualification would be "licensed physician or health care professional." For the clinical studies referenced, the "experts" are the authors and clinicians from institutions like Mayo Clinic, Mount Sinai Hospital, and Chesapeake Urology, who "utilize UroCuff." No specific number of "experts" for establishing ground truth in the context of an AI test set is relevant here.

4. Adjudication method for the test set:

Not applicable, as this is not an AI/ML performance study requiring adjudication of expert interpretations. The clinical data cited from literature represents clinical experience and measured outcomes.

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/ML device that assists human readers.

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

Not applicable. The CT3000Pro is a medical device, not a standalone AI algorithm. Its function is to perform physiological measurements for diagnosis, always with a human healthcare professional in the loop.

7. The type of ground truth used:

For the device's functional performance, the "ground truth" is adherence to engineering specifications, accuracy of measurements, and compliance with electrical safety and EMC standards. For the UroCuff clinical performance, the "ground truth" is outcomes data and clinical experience from a large patient cohort, as reported in peer-reviewed literature, demonstrating the effectiveness and safety of the non-invasive measurement technique in assessing bladder activity.

8. The sample size for the training set:

Not applicable, as 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, as this is not an AI/ML device that requires a training set.

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