(93 days)
The URONIRS 2000 device is intended to be used in conjunction with commercially available uroflowmeters and bladder ultrasound systems for noninvasive testing of bladder activity, aiding in the diagnosis of urinary incontinence and lower urinary tract symptoms. The device is used under the direction of a licensed physician or health care professional.
The URONIRS 2000 device is indicated for non-invasive testing of bladder activity in an office or hospital setting.
The URONIRS 2000 is an active medical device indicated for non-invasive testing of bladder activity in an office or hospital setting.
The device consists of a medical grade Tablet PC running the URONIRS application software, a URONIRS base station for data acquisition, a custom designed cable with an optical sensor end and a single use, disposable patch.
The base station provides the laser output and accepts NIRS data input from the sensor via the sensor cable and charges the Tablet PC when plugged in. The base station communicates with the tablet PC via Bluetooth.
During bladder voiding, URONIRS 2000 measures concentration changes in oxygenated haemoglobin (HbO2), de-oxygenated haemoglobin (Hb) and cytochrome (Cyt) while a commercial uroflowmeter simultaneously measures uroflow data (flow and volume). The data is sent to the tablet PC via Bluetooth connection for display to the clinical users.
The URONIRS 2000 device focuses on non-invasive bladder activity testing by measuring changes in oxygenated hemoglobin, de-oxygenated hemoglobin, and cytochrome during voiding while simultaneously record uroflow data (flow and volume). The provided document states that performance validation using actual clinical data showed that the URONIRS 2000 has the same performance as the predicate device (Urodynamic System Tetra Accessory cleared under K073552). However, it does not provide a table of specific acceptance criteria or reported device performance metrics against those criteria.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them, based on the input:
1. A table of acceptance criteria and the reported device performance
Unfortunately, the provided text does not include a table of specific quantitative acceptance criteria or detailed reported device performance metrics. It broadly states: "Performance Validation using actual clinical data showed that the URONIRS 2000 has the same performance as the predicate device." This is a statement of equivalence rather than a detailed breakdown of performance against predefined targets.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Performance Validation using actual clinical data" but does not specify the sample size used for this test set, its country of origin, or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not provide any information regarding the number of experts used to establish ground truth for the test set or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method used for the test set.
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
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a measurement system and not described as providing AI assistance to human readers in its stated intended use.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the URONIRS 2000 as a system that "measures concentration changes... while a commercial uroflowmeter simultaneously measures uroflow data... The data is sent to the tablet PC via Bluetooth connection for display to the clinical users." This implies that the device provides data to clinicians for interpretation, rather than issuing a diagnosis autonomously. Therefore, the concept of a "standalone (algorithm only)" performance study, as typically understood for diagnostic AI, does not directly apply here in the context of replacing human interpretation. Its performance is validated against a predicate device, which is also a measurement system for bladder activity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document broadly states "Performance Validation using actual clinical data." While this implies a comparison to a known clinical state, the specific type of ground truth used (e.g., expert consensus on urodynamic parameters, pathology findings, or long-term clinical outcomes) is not detailed. Given that it's comparing performance to a predicate urodynamic system, the ground truth would likely involve established urodynamic measurements or clinical diagnoses made using conventional methods.
8. The sample size for the training set
The document does not provide any information about a specific training set or its sample size. This suggests that the validation was focused on confirming equivalence to the predicate device, rather than training a novel AI algorithm from scratch.
9. How the ground truth for the training set was established
As no training set is described, no information is provided on how its ground truth might have been established.
§ 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.