(78 days)
Laborie Urodynamic systems are intended for Urodynamics testing. The traditional equipment performs standard tests including uroflowmeter, cystometry, micturition, electromyography and urethral pressure profiles. The accessory to our standard equipment, Tetra, uses near infrared spectroscopy, for non-invasive testing of bladder activity, aiding in the diagnosis of patients with lower urinary tract symptoms - that is patients who suffer from Urinary Incontinence.
All Urodynamic equipment including the Laborie Urodynamic System with Tetra Accessory are for use under the direction of a licensed physical or health care professional in an office or hospital setting.
The complete device includes traditional Urodynamic system and the Tetra accessory. That is all the standard components, for uroflowmetry and pressure measurement, and the new non-invasive component the Tetra accessory to detect bladder activity.
The provided 510(k) summary for the Laborie Medical Technologies Urodynamic System with Tetra Accessory is for a Class II medical device that measures urodynamic parameters. It's important to note that this submission is primarily focused on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through rigorous clinical trials with specific acceptance criteria in the same way a new drug or a high-risk AI device might.
Therefore, the study information requested regarding acceptance criteria and performance metrics (e.g., sensitivity, specificity, reader improvement with AI) is not applicable in the context of this 510(k) summary. The summary focuses on bench testing and a clinical study to confirm the efficacy of the system and its accessory, as well as safety testing, but these are not described with specific acceptance criteria in terms of diagnostic performance.
Here's an breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the 510(k) summary in the traditional sense of diagnostic performance metrics with defined acceptance criteria. The summary lists technical specifications for the UDS-94 and Tetra Accessory, which are inherent design parameters rather than performance outcomes against a gold standard in a diagnostic context.
| Metric (UDS-94 System) | Reported Performance |
|---|---|
| Uroflow Rate | 0 to 50 ml/s |
| Uroflow Volume | 0 to 1100 ml |
| Pressure | -40 to 350 cm H2O |
| EMG Frequency | 2 to 800 Hz |
| Pump Rate | 5 to 140 ml/min |
| UPP Puller | 0.5 to 3 mm/s |
| Infusion | 0 to 1000 ml |
| T-Doc | -68 to 408 cmH2O |
| Data Conversion Rate | Min 10 Hz up to 1000 Hz (optional up to 5000 Hz) |
| Metric (Tetra Accessory) | Reported Performance |
|---|---|
| Wavelengths | 785 nm, 808nm, 830nm |
| Energy Output | Up to 350 mJ |
| Type of Operation | Pulsed Only, 4 µsec |
| Class of Laser Products | Class I |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The 510(k) summary states "Bench and clinical studies have confirmed the efficacy of the Laborie Urodynamic System with Tetra Accessory," but does not provide details on the sample size, data provenance, or study design (retrospective/prospective) for these studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the 510(k) summary. Since the submission focuses on substantial equivalence for a device measuring physiological parameters, the method of "establishing ground truth" for diagnostic accuracy involving expert consensus would not typically be a primary focus for this type of device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided.
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:
A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable and was not performed. The Tetra Accessory uses near-infrared spectroscopy for non-invasive bladder activity detection; it is a measurement device, not an AI diagnostic tool designed to assist human readers in interpreting complex images or data in a way that would require an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
A standalone algorithm performance study is not applicable as the device is not an AI algorithm. The Tetra accessory is a physical component that uses near-infrared spectroscopy to detect bladder activity. It's a measurement device intended for use by a healthcare professional, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The 510(k) summary does not specify the "ground truth" used for the efficacy confirmation. For a urodynamic system, "efficacy" would likely relate to the accuracy and reliability of its physiological measurements compared to established standards or clinical observations, rather than a diagnostic 'ground truth' like pathology.
8. The sample size for the training set:
As this is not an AI/ML device, there is no training set in the conventional sense.
9. How the ground truth for the training set was established:
As mentioned above, there is no training set and therefore no ground truth establishment for a training set.
In summary:
The provided document describes a 510(k) submission for a medical device that measures physiological parameters. The primary goal of this submission is to demonstrate substantial equivalence to a predicate device, focusing on technical specifications and safety rather than a detailed performance study with diagnostic acceptance criteria. As such, many of the requested details regarding AI/ML device performance validation metrics are not applicable to this submission.
§ 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.