(200 days)
The Neuro-Urodynamics Suite for Duet / Duet MultiP is indicated for electrophysiological testing of the pelvic organs including motor nerve conduction, sacral reflex, and free-run EMG tests.
The Duet version 8.1 is enhanced with a new suite of test programs for EMG and Motor Nerve conduction measurements. The suite is called Neuro Urodynamics Suite and consists of the following predefined testprogram:
- Neuro Free Run EMG
- Neuro Motor Nerve Conduction
- Neuro Sacral Reflex
The Neuro Urodynamic Suite is together with Duet MultiP intended to record a patients urodynamic functions and examination of the motor innervation of the spincters and the pelvic floor and the sensory innervation of pelvic structures.
The whole system includes transducers, devices, tubing, catheters and electrodes. The tests are operated just like the urodynamic and anorectal tests. A license number is required to enable the software for the Neuro Urodynamic Suite.
This 510(k) summary describes a software update (Neuro Urodynamic Suite for Duet / Duet MultiP version 8.1) and does not contain detailed acceptance criteria, performance data from a specific study, information on sample sizes, expert involvement for ground truth, or adjudication methods typically found in studies for new medical devices establishing clinical efficacy. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against predefined acceptance criteria.
However, based on the provided text, here's a breakdown of what can be inferred and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the Neuro Urodynamic Suite. Instead, it relies on demonstrating equivalence to a predicate device. The primary performance claim is that the "enhanced system performs as its predicate system."
| Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Performance | Equivalent to predicate system. | "Verifications results shows that the enhanced system performs as its predicate system." (Section 7) |
| Safety and Effectiveness | No new issues regarding performance or safety compared to predicate. | "This new software version does not raise any new issues regarding performance or safety that can not be tested in-house." (Section 8) |
| Calculated Parameters | Able to calculate a subset of parameters as the predicate device. | "Latency, velocity, response, amplitude and duration" are calculated. (Section 6, Table: Calculated parameters) |
2. Sample Size and Data Provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified. The verification results are mentioned as "in-house" testing (Section 8), implying internal testing rather than external or patient-specific clinical data.
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable/Not specified. The document does not describe the use of experts to establish ground truth for a test set in the context of a new performance study. The evaluation relies on verification of the software's functionality and comparison to a predicate device.
4. Adjudication Method for the Test Set:
- Not applicable/Not specified. No adjudication method is mentioned as there's no described study involving multiple interpretations for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document explicitly states: "Clinical evaluation not performed." (Section 8). Therefore, no MRMC study, human-in-the-loop performance, or effect sizes of AI assistance are reported.
6. Standalone Performance Study (Algorithm Only):
- A standalone performance study was conducted, but it's referred to as "Verifications results" and "in-house" testing (Section 7 and 8). The exact methodology, metrics, and quantitative results of this "verification" are not provided in detail. The claim is that it performs as the predicate system. It's an algorithm-only evaluation as it's a software update.
7. Type of Ground Truth Used:
- The ground truth for the "verification results" is not explicitly defined in terms of clinical outcomes or pathology. Given that it's a software update for electrophysiological testing, the "ground truth" for the verification likely refers to whether the software accurately processes and displays expected electrophysiological signals and calculates parameters correctly, compared to a known good reference or the predicate device's behavior. It's a functional and performance comparison against the predicate, not a clinical diagnostic accuracy assessment.
8. Sample Size for the Training Set:
- Not applicable/Not specified. This device is a software program for signal processing and parameter calculation in electrophysiology, not an AI/ML model that typically requires a training set of data.
9. How Ground Truth for the Training Set Was Established:
- Not applicable/Not specified. No training set is described for this device.
§ 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.