(178 days)
The EVOX Electro Diagnostic Device is intended for the testing of sacral reflexes, pudendal nerve terminal motor latency (PNTML) studies. electromyography (EMG), and cerebral pudendal somatosensory evoked potential (SEP).
The EVOX Electro-Diagnostic Device utilizes Laborie Urodynamic equipment 510(k) exempt under section § 876.1620 or with another microprocessor that is compatible with the required capability.
The Laborie EVOX Electro Diagnostic Device will help diagnose and perform evaluation tests for urinary and fecal incontinence as well as other neurological and physiological assessment, including:
Pudendal Nerve Terminal Motor Latency with St Marks Electrodes Anal Sphincter CN EMG
Cerebral Pudendal Somatosensory Evoked Potential
Sacral Reflexes
Calculations will include: latency, peak, duration, conduction velocity and area.
The equipment includes the Evox Electro-diagnostic Software and the hardware required to perform the stated tests which include:
- Laborie 94-based Hardware with Integrated Electrodiagnostic Stimulation .
- . Ring/Bar Stimulation Electrodes
- Needle/Cup/Patch EMG/ECG Electrodes .
- St. Mark's Electrode and Cable .
- EMG/ECG Cabling .
The provided 510(k) summary for the KOR2614 Laborie EVOX Electro Diagnostic Device does not contain the detailed study results, acceptance criteria, or performance data typically found in a comprehensive clinical or performance study report.
Instead, this document focuses on establishing substantial equivalence to predicate devices through technical characteristics and intended use. The "Testing" section explicitly states that "Bench studies have confirmed the efficacy of the EVOX Electro Diagnostic Device. Safety testing included electrical safety testing and electromagnetic compatibility testing to recognized standards." This indicates that the device's efficacy was confirmed via bench testing, not through a clinical study with human subjects, ground truth, or expert review in the way a diagnostic AI/ML device would be evaluated.
Therefore, many of the requested categories cannot be populated from the provided text.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Efficacy (via bench testing) | Confirmed by bench studies (details not provided) |
| Electrical Safety | Complies with IEC 60601-1 and IEC 60601-2-10 standards. |
| Electromagnetic Compatibility | Complies with recognized standards (details not provided). |
| Technical Characteristics | Detailed in the "Summary of the Technical Characteristics" table, showing the Laborie EVO's specifications against predicate devices. The implicit acceptance criterion here is that the technical specifications are comparable to, or better than, the predicate devices for achieving the intended use. (See full technical table in the original document for specific values like Common Mode Rejection, Noise, etc.) |
2. Sample size used for the test set and the data provenance
Not applicable. The document states "Bench studies have confirmed the efficacy," implying a technical verification rather than a clinical test set from patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical test set or human ground truth described.
4. Adjudication method for the test set
Not applicable. No clinical test set or human ground truth described.
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 MRMC study was done. This device is an electro-diagnostic tool and not an AI-assisted diagnostic software in the context of this 510(k) summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a standalone electro-diagnostic device. Its performance is inherent in its technical capabilities for signal acquisition and processing. The "bench studies" mentioned would represent this standalone performance, although specific metrics are not detailed in this summary.
7. The type of ground truth used
For efficacy, the ground truth would have been established by comparing the device's output signals and measurements (e.g., latency, peak, duration, conduction velocity, area) against known, accurate electrical stimuli and reference measurements in a laboratory setting (bench testing).
For safety, the ground truth is established by the specified electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-2-10).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set of data.
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).