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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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The Uropower is a urine flow and volume measuring system intended for lay use to measure the urine volume and flow of men during the course of normal urination. The device is also intended to be used by health care professionals.

The Uropower is a device intended to measure the urine flow and calculate the volume of males in order to identify micturition disturbances. It is designed to be used by health care professionals and by laymen. The system consists of a base unit, a urinal-flow-transducer and various mount elements. Due to its construction the transducer can be installed in a urinal. The user is guided by instructions shown on the LCD display of the base unit. The urinal flow transducer measures the flow of the urine in accordance with the through-flow-principle, a volume per time measurement. The base unit calculates the total voided volume, maximum flow rate, mean flow rate, total measuring time, time, time to max, flow and medical data like the flow index. All parameters are printed on a thermo card.

The provided document is a 510(k) summary for the Uropower device, a urine flow and volume measuring system. It describes the device, its intended use, and its classification. However, it does not contain details about specific acceptance criteria or a study proving the device meets those criteria, and therefore I am unable to populate the table and other requested information.

The document primarily focuses on establishing substantial equivalence to a predicate device for regulatory clearance, rather than presenting a performance study against predefined acceptance criteria. This is common for 510(k) submissions, which often rely on comparison to existing legally marketed devices rather than de novo clinical trials with explicit acceptance criteria.

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The GRIOUFS is intended to be used to measure urinary flow rates.

Urine flowrate meter used for determining urine flow rate from patients performing normal micturition. The device functions by weighing the voided urine, the weight in grans approximates to the volume in ml the specific gravity of urine varies between 1.002 and 1.006 in infants and 1.025 in adults (95% ranges) and any inaccuracy is therefore no more than 2.5%. The urine is weighed as the urine flows using a straingauged load cell, the signal nutput from which is digitised. The flow volume is differentiated digitally to give the flow rate, which is printed on a paper chart recorder. The flowmeter uses algorithms to calculate the following parameters.

• Total voided volume Volume at maximum flow Maximum Now rate Mcan flow rate Flow time Time of maximum flow
  The recorder is a table-top device connected to the load coll which supports a jug and which fits under either a commode chair or stand.

This document is a 510(k) summary for the Albyn Medical Ltd. GR100F Urine Flowmeter, dated September 19, 1997. It describes the device, its intended use, and claims substantial equivalence to a predicate device, the Browne Medical Systems Inc. "UroFlo".

However, the provided text does not contain any information regarding acceptance criteria, study details, or performance results of the GR100F Urine Flowmeter. The document is a regulatory submission for premarket notification, outlining the device's characteristics and its equivalence claim, but it does not include the results of a study to prove it meets specific performance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and substantial equivalence to a predicate device, not on a detailed performance study with acceptance criteria.

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