(59 days)
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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly stated in the document, but implied to be equivalence to predicate in accuracy for flow and volume, and the ability to capture maximum flow rates.) | Demonstrated equivalent accuracy related to flow and volume compared to the predicate device. |
| Demonstrated equivalent technological characteristics for measuring urine flow compared to the predicate device. | |
| Able to capture flow rates at the maximum limits of male urination. |
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.
§ 876.1800 Urine flow or volume measuring system.
(a)
Identification. A urine flow or volume measuring system is a device that measures directly or indirectly the volume or flow of urine from a patient, either during the course of normal urination or while the patient is catheterized. The device may include a drip chamber to reduce the risk of retrograde bacterial contamination of the bladder and a transducer and electrical signal conditioning and display equipment. This generic type of device includes the electrical urinometer, mechanical urinometer, nonelectric urinometer, disposable nonelectric urine flow rate measuring device, and uroflowmeter.(b)
Classification. (1) 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.