(227 days)
The Dantec Duet™ system is intended for urodynamics testing. The Duet™ system is intended to assist practitioners in executing specific urodynamics test protocols, collecting data during protocol execution, analyzing collected data, preparing written reports and archiving patient and testing information.
General indications for use include use in patients with lower urinary tract voiding or continence problems, and more specifically incontinent patients, patients with bladder outlet obstructions, patients with neurogenic bladder dysfunction and some children with complex voiding / incontinence problems.
The Dantec Duet™ is a computerized urodynamics measurement system. The system consists of a mobile cart or "trolley" with the following components mounted on it: a 486 based computer, color monitor, printer, dedicated keyboard, digital and analog measurement electronics, Windows™ based application software, transducers for measuring EMG, pressure, flow and weight, infusion stand, puller with arm, CO₂ gas pump, water pump, patient interface module and patient connecting accessories.
The provided text describes a medical device, the Dantec Duet™, a computerized urodynamics measurement system, and its non-clinical testing and conclusion for a 510(k) submission. However, it does not contain the specific information required to complete a table of acceptance criteria, reported device performance, or details about a study to prove the device meets said criteria.
The document primarily focuses on:
- Device Description: What the Dantec Duet™ is and its components.
- Intended Use: For urodynamics testing to assist practitioners.
- Technological Characteristics: How it operates (records electrical signals, data acquisition, signal processing, accessory controls).
- Predicate Devices: Other similar devices on the market.
- Non-Clinical Testing: Mentions development and validation according to written procedures, comparison to predicate devices, in-house validation, and EMC/ESD testing by qualified laboratories.
- Conclusion: States it meets requirements, performs as well or better than marketed products, and is safe and effective.
Therefore, many of the requested sections cannot be filled from the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states "System testing and validation demonstrate that the device meets the requirements of internationally recognized standards, meets its published specifications, performs as well or better than the currently marketed product," but it does not list these specific standards, specifications, or the results of the performance against them.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document only mentions "in house validation" and "EMC and ESD testing." There is no information about test set sample sizes or data provenance.
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)
- Not applicable/Cannot be provided. This device is a measurement system, not one that generates interpretations requiring expert ground truth in the same way an AI diagnostic tool would. Its performance is likely evaluated against known physical standards or by comparison to predicate devices' measurements, not by expert consensus on generated data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Cannot be provided. Similar to point 3, this concept typically applies to subjective interpretations or classifications, not to the performance of a physical measurement system.
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
- Not applicable. The Dantec Duet™ is a measurement system, not an AI diagnostic assistant. Its function is to collect and present data for human interpretation, not to augment human reading with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is described as a "computerized urodynamics measurement system" that "assists practitioners." Its primary function is data acquisition and presentation, not standalone diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be precisely determined from the text. For a measurement device, "ground truth" would typically involve calibrated standards, known physical values, or comparison against established, accurate measurement devices (e.g., predicate devices). The text mentions "in house validation" and comparison to "published specifications" and "currently marketed product," implying such methods, but doesn't detail them as "ground truth."
8. The sample size for the training set
- Not applicable/Cannot be provided. This device is from 1996 and is described as a "computerized urodynamics measurement system" with "Windows™ based application software." While it performs "signal processing," the description does not suggest the use of machine learning algorithms that require a "training set" in the modern sense. Its development involved "written validation procedures," which is standard software engineering, not AI model training.
9. How the ground truth for the training set was established
- Not applicable/Cannot be provided. (See point 8).
Summary of what can be extracted (with caveats):
Study Description:
The document implies a non-clinical study was conducted as part of the validation process. This study involved:
- In-house validation: Likely testing of the system's components and overall function against design specifications.
- EMC (Electromagnetic Compatibility) and ESD (Electrostatic Discharge) testing: Performed by "qualified testing laboratories" to ensure the device operates correctly in its intended electromagnetic environment and is resistant to static electrical discharges.
- Comparison to predicate devices: To establish substantial equivalence in terms of intended use, labeling, and specifications.
Ground Truth (in context of a measurement device):
While not explicitly called "ground truth," the device's accuracy and performance were likely established by:
- Meeting published specifications: Implies comparison to precise physical standards or known values.
- Performing as well or better than the currently marketed product (predicate devices): This suggests comparative testing against existing, accepted devices.
Missing Information:
Crucially, the document lacks quantitative data, specific acceptance criteria values, performance metrics (e.g., accuracy, precision for different measurements), and detailed methodology of any performance study. This is typical for older 510(k) summaries which focused more on substantial equivalence and safety rather than detailed performance data as seen in modern AI/ML device submissions.
§ 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.