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The Glean Urodynamics System is a urodynamics analyzer system that is intended to quantify the pressure and flow characteristics of the lower-urinary tract. The system can be used in adult patients only to perform standard urodynamic tests such as Uroflow, Cystometrogram (CMG), Urethral Pressure Profile (UPP) and Micturition Studies.

The major application of urodynamics is the diagnosis of urine (incontinence), abnormal urinary retention, or neurological cases of micturition disorder. The system is intended to be used as medical diagnostic equipment.

The Glean Urodynamics System (GUS) is a single-channel urodynamic system indicated for standard Urodynamic tests such as Uroflow (UF), Cystometrogram (CMG), Urethral Pressure Profile (UPP), and Micturition Studies (MS).

GUS consists of the following three physical component elements: Sensor, Insertion Tool, and Uroflowmeter, as well as the following three software applications: Glean Mobile App (Clinician), Glean Mobile App (Patient), and Glean Web App. The patient may use the Glean Mobile App as a digital voiding diary, logging fluid input, leakage, urgency, and other urological symptoms. The clinician may use the Glean Mobile App to prepare the Sensor for insertion, log symptoms, and download data. The Glean Web App may be used by clinicians to view and analyze data.

The Sensor can be inserted through the urethra into the bladder using the Insertion Tool. Once inserted, the Sensor has a Removal String that hanss out of the urethra to enable removal of the Sensor may stay in the bladder for the entire duration of monitoring while collecting data. The Sensor stores data that may be wirelessly transmitted to the Glean Mobile App (Clinician) once it is removed from the body.

The Uroflowmeter is used to measure voided volume and flow. The Glean Mobile App (Clinician) wirelessly receives data from the Uroflowmeter after the patient has completed a voiding cycle.

The provided text describes a 510(k) submission for the "Glean Urodynamics System," but it does not contain information related to an AI/ML-driven device or its acceptance criteria and study proving its performance. The document is a traditional medical device 510(k) clearance letter and summary, focusing on non-clinical and clinical testing for a hardware-based urodynamics measurement system.

Therefore, I cannot fulfill the request as it pertains to AI/ML device performance, ground truth, expert adjudication, or MRMC studies. The document discusses:

• Non-clinical testing: Biocompatibility, Electrical Safety, EMC, Software Verification and Validation, Sterilization validation, Cybersecurity, Human Factors Engineering, and an animal safety study. All pre-determined acceptance criteria for these tests were met.
• Clinical testing (for device feasibility, efficacy, and safety): A prospective, open-label, multi-center, interventional study involving 38 participants. The study focused on the device's ability to record vesical pressure, ease of insertion/removal, patient comfort, and clinician interpretation of results compared to conventional urodynamics.

The "acceptance criteria" mentioned in the document refer to the successful completion of these non-clinical and clinical tests, affirming general device performance and safety, not AI/ML-specific metrics like accuracy, sensitivity, or specificity against established ground truth as would be evaluated for an AI algorithm.

If you intended to provide a different document for an AI/ML device, please provide that text.

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The UFM is a urine flow measuring system.

The UFS provides real-time urine flow measurement, in men, by analyzing specific sound areas that are produced by the urine as it impacts the water surface.
The system consists of a laptop with proprietary software and a microphone to capture the sound. Real time urine flow is displayed on the monitor during the test and Maximum Flow; Average Flow; Volume; Time to Maximum and Void Time are calculated and displayed on the monitor upon completion of the test.

The provided document is a 510(k) summary for a Uroflow meter (UFM) by BE Technologies, Inc. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study results, acceptance criteria, or performance metrics that would allow a comprehensive answer to all the questions posed.

Based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The UFM and predicate device have an equivalent accuracy related to flow and volume." and "Performance testing has demonstrated the UFM and the predicate device have equivalent technological characteristic for measuring urine flow. Both devices have the ability to capture flow rates at the maximum limits of male urination."

However, specific numerical acceptance criteria (e.g., within X% of the predicate or gold standard) and detailed reported performance metrics are not provided in this summary. The document only makes a general statement about equivalence.

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

This information is not provided in the document. The document mentions "Performance Data" but does not detail the study design, sample size, or data provenance (e.g., country of origin, retrospective/prospective).

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. For a uroflowmeter, ground truth is typically established by direct measurement (e.g., weighing urine over time), not by expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used for subjectively interpreted data where human experts disagree. A uroflow meter measures physiological parameters, and its performance is validated against a reference measurement, not expert consensus on interpretations.

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

This information is not provided and is not applicable in the context of a uroflowmeter. MRMC studies are used for diagnostic imaging or similar devices where human readers interpret data. A uroflowmeter is an automated measurement device.

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

Yes, based on the description, the UFM is a standalone device. Its performance data refers to the device's ability to measure urine flow independently. The statement "The UFS provides real-time urine flow measurement... by analyzing specific sound areas" and "The system consists of a laptop with proprietary software and a microphone to capture the sound" indicates a standalone algorithm.

7. The Type of Ground Truth Used

The document implicitly suggests that the ground truth for comparison was the predicate device's measurement based on weight. The text states: "The predicate device calculates flow based on weight; the UFM is based on sound, both methods are scientifically sound." This implies that the UFM's sound-based measurements were compared against the weight-based measurements of the predicate device as a reference.

8. The Sample Size for the Training Set

This information is not provided in the document. The document mentions "Performance Data" and "Software Verification and Validation Testing" but does not detail a training set for the algorithm.

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

This information is not provided in the document. If a training set was used for the sound-based algorithm, its ground truth would presumably be established via a reference measurement method (e.g., direct gravimetric measurement of urine flow) corresponding to the sound signatures.

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