(178 days)
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.
§ 876.1620 Urodynamics measurement system.
(a)
Identification. A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.