(224 days)
The Urovations Nerve Stimulator is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.
The Urovations Nerve Stimulator is indicated for use in the stimulation of the cavernosal nerves during open prostatectomy (surgical) procedures, aiding the surgeon in locating these nerves. The device is designed as an adjunct to current open prostatectomy procedures in which a nerve sparing technique is used. The Nerve Stimulator is not designed to replace the surgeon's expertise in mapping out the vascular bundles. Each surgeon's skill determines whether these nerves are spared regardless of any aid.
The Urovations Nerve Stimulator is a electrical Nerve Stimulator designed for use during open prostatectomy (surgical) procedures. The stimulator provides a biphasic current pulse with variable amplitude between 1 - 20mA, a constant pulse width of 800usec/phase, and a constant frequency of 16Hz. The stimulation is applied to the body by the surgeon in order to locate and test the excitability of the cavernosal nerves.
Here's an analysis of the provided text regarding the Urovations Nerve Stimulator, focusing on acceptance criteria and supporting studies:
It's important to note that the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against pre-defined acceptance criteria in the same way a de novo or PMA submission might. Therefore, the "acceptance criteria" here are implicitly tied to the performance characteristics of the predicate devices and general safety/effectiveness standards for the device type.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Predicate Equivalence and Test Summary) | Reported Device Performance (from "Pre-clinical and Clinical Testing" and "Summary") |
|---|---|
| A. Safety: | |
| 1. Electrical Safety Standards Conformance | Meets UL-544, AAMI ES1-1993, and IEC-601 standards. |
| 2. Biocompatibility | Extensive biocompatibility testing conducted; materials demonstrated to be biocompatible, suitable, and safe for intended use. |
| 3. Absence of Adverse Events | "No reported adverse events were associated with device use" in the clinical study. |
| B. Effectiveness/Functionality: | |
| 1. Provides Electrical Stimulation | Provides a biphasic current pulse with variable amplitude (1-20mA), constant pulse width (800usec/phase), and constant frequency (16Hz). |
| 2. Locates and Identifies Nerves | Clinical study indicates the device "provides an electrical charge to stimulate the cavernosal nerves." |
| 3. Tests Nerve Excitability | Clinical study indicates the device "elicits a visible and measurable response in tumescence." |
| 4. Substantial Equivalence to Predicate Devices | "Substantially equivalent to legally marketed devices" and "substantially equivalent to these devices with respect to its performance, safety and effectiveness." |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text. The clinical study is mentioned in the singular, implying a single cohort, but the number of patients/procedures is not given.
- Data Provenance: The document is a 510(k) summary submitted to the FDA in the USA, so the study was likely conducted in the USA. It is a prospective clinical study, as it "was conducted to determine if the Urovations Nerve Stimulator provides electrical stimulation..."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The study focused on the device's ability to stimulate nerves and elicit a response, which would likely be observed intra-operatively by the operating surgeon. The "ground truth" here is the physical response to electrical stimulation rather than an interpretation of an image or signal by an expert off-line.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided. Given the nature of observing a direct physiological response during surgery, formal adjudication methods like 2+1 or 3+1 are typically not applicable. The surgeon observing the response acts as the primary "interpreter."
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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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a nerve stimulator, not an AI-powered diagnostic tool, so "human readers" and "AI assistance" are not relevant concepts in this context. The study focused on the device's ability to directly stimulate nerves and elicit a physiological response during surgery.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the clinical study essentially functions as a standalone performance assessment of the device (not an algorithm) in its intended use. The device directly stimulates nerves, and its performance is measured by its ability to achieve this and elicit a response. While a surgeon operates the device, the study aims to show the device's inherent capability to perform its function.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth was based on direct physiological response/observation during surgery. The text states the study indicated the device "provides an electrical charge to stimulate the cavernosal nerves and elicits a visible and measurable response in tumescence." This visible and measurable response serves as the ground truth for successful nerve stimulation.
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The sample size for the training set:
- This device is an electromechanical nerve stimulator, not an AI/machine learning model. Therefore, there is no "training set" in the context of an algorithm.
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How the ground truth for the training set was established:
- As there is no AI/machine learning component, there is no training set ground truth to establish.
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.