(223 days)
The Urodynamic Analysis Module is a software program that has been designed to analyze pressure, volume and flow data recorded from the urological tract in pediatric and adult populations. The Urodynamic Analysis Module includes the following analyses: Uroflow analysis. Cystometry analysis, Pressure/flow voiding analysis, Urethral Pressure Profile. The program is to be used on a personal computer analyzing patient data in the hospital environment under supervision of a trained physiclan. The analyzed data can be viewed on the computer screen or printed out on a separate paper.
The Polygram Software for Windows (KD46322) was designed to record and handle/store physiological parameters. After a recording, the user is able to review the tracings on the computer screen and print the signal tracings or just parts of them. When reviewing the data on the computer screen, the user is able to mark certain segments and calculate certain parameters from the selected signal segments. These parameters include minimum and maximum values. length of selection. By adding the Urodynamic Analysis Module to the Polygram Software for Windows, the user can also have all the pressure, flow and volume data analyzed In terms of physiological properties, comparison with normal values, etc. The analyzed data can thereafter be viewed on screen or printed out on a separate paper. The analysis report includes sections such as patient demographics: interpretation and comment (for user to insert); procedure summary; Urodynamic tracing; analyses (as specified below); and physician signature section.
The provided text describes the Urodynamic Analysis Module, a software program for analyzing urological data. However, it does not contain any specific acceptance criteria or details of a study that proves the device meets such criteria.
The section titled "Performance Testing" indicates that "alpha testing in terms of integration testing has been performed and documented and beta testing in terms of hospital site testing has been done and documented." It further states that "It has been concluded that the alpha and beta testing has meet and passed the specified objectives and should therefore be released to the market."
This statement is a high-level summary and lacks the detailed information required to fill out the requested table and answer the specific questions.
Here's an explanation of why the requested information cannot be extracted from the provided text:
- Table of Acceptance Criteria and Reported Device Performance: This information is entirely absent. There are no measurable criteria (e.g., accuracy percentages, error rates, precision targets) or reported numerical performance data.
- Sample Size Used for Test Set and Data Provenance: The document mentions "beta testing in terms of hospital site testing," suggesting real-world data was used. However, it does not specify the sample size (number of patients, number of cases), the country of origin, or whether the study was retrospective or prospective.
- Number of Experts Used to Establish Ground Truth and Qualifications: This information is not provided. We don't know who established the "specified objectives" mentioned or how the ground truth for the testing was determined.
- Adjudication Method: Not mentioned.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned. There is no indication of human reader comparisons, with or without AI assistance, or any effect size.
- Standalone Performance Study: The document describes the software's analytical capabilities but doesn't detail a standalone performance study with specific metrics, only generalized "alpha and beta testing."
- Type of Ground Truth Used: The document doesn't specify how ground truth was established for the "specified objectives."
- Sample Size for Training Set: Not applicable as the text describes a system that analyzes data, not one that uses machine learning models that require a training set in the conventional sense. The "training" here would likely refer to the software's development and internal validation, not a machine learning training phase.
- How Ground Truth for Training Set was Established: Not applicable for the same reason as point 8.
In summary, the provided 510(k) summary focuses on describing the device's functionality and its equivalence to an older DOS-based version. It only offers a very general statement about performance testing, without the specific details required for a robust analysis of acceptance criteria and proven performance.
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510(k) Summary
DRAERD 510(K)
Summary of Safety and Effectiveness Information
| Submitter'sname | Synectics Medical ABRenstiernos gata 12S-116 28 StockholmSweden | Synectics Medical Inc3850 Victoria Street NorthMail Stop V215Shoreview, MN 55126 2978 |
|---|---|---|
| Contact: Anna Pettersson | Contact: Keith Jung | |
| Name of device | Urodynamic Analysis Module | |
| Name ofequivalentdevice | Poly Uro Polygram Software (DOS environment)(included in 924383 - PolyUro) | |
| The Urodynamic Analysis Module is identical, in function and types of analysesthat can be performed, to the PolyUro Polygram Software (DOS). The maindifference is that the PolyUro Polygram Software (DOS) is written for the DOSenvironment and the Urodynamic Analysis Module is written for the Windowsenvironment. Poly Uro Polygram Software (DOS) works in the DOS environmentand the Urodynamic Analysis Module works in the Windows environment. | ||
| Description ofdevice | The Polygram Software for Windows (KD46322) was designed to record andhandle/store physiological parameters. After a recording, the user is able toreview the tracings on the computer screen and print the signal tracings or justparts of them. When reviewing the data on the computer screen, the user is ableto mark certain segments and calculate certain parameters from the selectedsignal segments. These parameters include minimum and maximum values.length of selection. | |
| By adding the Urodynamic Analysis Module to the Polygram Software forWindows, the user can also have all the pressure, flow and volume data analyzedIn terms of physiological properties, comparison with normal values, etc. Theanalyzed data can thereafter be viewed on screen or printed out on a separatepaper. | ||
| The analysis report includes sections such as patient demographics:interpretation and comment (for user to insert); procedure summary; Urodynamictracing; analyses (as specified below); and physician signature section. | ||
| Analyses: | Uroflow analysis: position, subjective grading, residual volume, numericaluroflow analysis, voided volume, bladder capacity, maximum flow (Qmax),average flow, voiding time, flow time, Tim to maximum flow, volume atmaximum flow, urethral conductance, flow index.Cystometry analysis: position, infusion rate, infused volume, residualvolume before procedure, maximum cystometric capacity, first sensation.compliance, detrusor activity, leakage during filling, catheter via, infusionstopped because, infusion time, diuresis, squeezing, sensation levels, leakpoint pressure analysis, pressure/infused volume graph.Pressure/flow voiding analysis: position, subjective grading, residualvolume, voided volume, vesical capacity, maximum flow rate (Qmax).average flow rate, voiding time, flow time, time to maximum flow, volume atmaximum flow, vesical pressure at Qmax, detrusor pressure at Qmax, urethral | |
| minimum operating pressure, urethral resistance, pressure/flow graph,nomograms in the P/Q graph, filter in the P/Q loop, curve adaption in the P/Qloop, pressure minimal urethral opening (Pmuo).• Urethral pressure profile: static UPP, Pucp graphs, maximum closingpressure, urethral functional length, closure area, pull speed, cough profiles,Pucp graphs, Pvcs amplitude, closure pressure, transmission tactor, relativelength, pull speed, transmission graph. | ||
| The analysis report can then serve as a tool for the physician's diagnosis and posttreatment cvaluation. | ||
| PerformanceTesting | The Urodynamic Analysis Module has been thoroghly tested during thedevelopment phase, that is, alpha testing in terms of integration testing has beenperformed and documented and beta testing in terms of hospital site testing hasbeen done and documented. | |
| It has been concluded that the alpha and beta testing has meet and passed thespecified objectives and should theretore be released to the market. | ||
| Statement ofIntendeduse/indicationfor use | The Urodynamic Analysis Module is a software program that has been designedto analyze pressure, volume and flow data recorded from the urological tract inpediatric and adult populations. | |
| The Urodynamic Analysis Module includes the following analyses:Uroflow analysis. Cystometry analysis, Pressure/flow voiding analysis, UrethralPressure Profile | ||
| The program is to be used on a personal computer analyzing patient data in the |
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hospital environment under supervision of a trained physiclan. The analyzed data can be viewed on the computer screen or printed out on a separate paper.
UROSUMM.DOC
§ 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.