(248 days)
The Circon Endotek OM-4 Urodynamics Monitoring System is indicated for urodynamic diagnostic procedures only. It is to be operated only be qualified physicians or qualified personnel under the direction and supervision of a physician trained in urodynamic monitoring techniques.
The Circon Endotek OM-4 H2O Cystometry Pump is used to pressurize the filling media during water cystometry diagnostic procedures. The device is designed to be used with the Circon Endotek OM-4 Urodynamic Monitoring System.
The Circon Endotek OM-4 H2O Cystometry Pump is a peristallic pump used with the The Olicon Endotek OM-4 Urodynamic Monitoring System for pressurizing the filling media during cystometry measurements.
The provided document is a 510(k) premarket notification for the Circon Endotek OM-4 Cystometry Pump. This type of submission is for establishing substantial equivalence to existing devices, not for demonstrating novel performance or conducting advanced clinical studies. Therefore, many of the requested elements for AI/ML device studies (like MRMC studies, specific performance metrics against an established ground truth, or details on sample sizes for training/test sets for AI models) are not applicable to this 1997 medical device submission.
This document describes a device used for measuring during cystometry, not an AI-powered diagnostic tool. The "performance criteria" described are typically related to the functional specifications and safety of the pump itself, rather than diagnostic accuracy metrics.
Here's an attempt to answer the questions based only on the provided text, indicating when information is not present or not applicable for this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the format of specific numerical performance targets for diagnostic accuracy or device output error rates that would be typical for an AI/ML device.
Instead, the submission focuses on meeting voluntary standards and demonstrating substantial equivalence to predicate devices. The implicit "acceptance criteria" for a 510(k) of this nature are that the device is safe and effective for its intended use and performs comparably to legally marketed predicate devices.
The document states:
- "The OM-4 H₂O Cystometry Pump is designed to meet the following voluntary standards:" (However, the list of those standards is not provided in the excerpt.)
For this type of device, performance would typically relate to its ability to accurately pressurize the filling media, its flow rate, pressure consistency, safety features, and reliability. Specific numerical performance data for these aspects are not included in the provided excerpt.
2. Sample size used for the test set and the data provenance
Not Applicable (N/A) / Not Provided. This document describes a new hardware device (a pump) for cystometry, not an AI/ML diagnostic tool that would typically involve a "test set" of patient data in the modern sense. The submission would have involved engineering tests and perhaps a limited clinical evaluation for safety and basic functionality, but not "test sets" for diagnostic performance in the way AI/ML devices do.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable (N/A). As this is not an AI/ML diagnostic device, there would be no "ground truth for a test set" related to diagnostic outcomes or classifications.
4. Adjudication method for the test set
Not Applicable (N/A). See explanation for question 3.
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
No. This device is a pump, not an AI system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance would have been conducted or is applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable (N/A). This is a hardware pump, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not Applicable (N/A). No "ground truth" as typically understood for AI/ML diagnostic performance was established for this pump. The device's performance would be evaluated against its technical specifications (e.g., pressure accuracy, flow rate stability) and safety standards.
8. The sample size for the training set
Not Applicable (N/A). This is a hardware device submission, not an AI/ML algorithm requiring a "training set."
9. How the ground truth for the training set was established
Not Applicable (N/A). See explanation for question 8.
§ 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.