(99 days)
The Neuromonitoring Kit is indicated for stimulation of peripheral motor nerves, including spinal nerve roots, for localization and identification during surgery.
The Neuromonitoring Kit is designed to use stimulation to locate, identify and monitor peripheral motor nerves and spinal nerve roots during surgery. The kit contains a Probe, Guide Pin Sleeve, and cable electrodes (Guide Pin Cap, and Guide Pin Clip). The Neuromonitoring Kit can be used with the iFuse Implant System.
The design of the Probe is similar to existing stainless steel stimulating instruments. The Probe consists of a stainless steel wire with biocompatible electrical insulation applied to selected portions, and a proximal connector provided to attach the probe to a monopolar stimulator. The distal surface of the Probe is noninsulated stainless steel to provide for tissue stimulation.
The Neuromonitoring Kit meets the requirements of IEC 60601-1:2012 reprint and IEC 60601-1-2:2007 Clause 56.3(c) per 21 CFR 898.12. The Neuromonitoring Kit is sterile (ETO) and for single use only.
The Neuromonitoring Kit (K161893) is a device designed for stimulation of peripheral motor nerves and spinal nerve roots during surgery for localization and identification.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (from predicate comparison) | Reported Device Performance |
|---|---|---|
| Principles of Operation | Monopolar nerve stimulation | Same (Monopolar nerve stimulation) |
| Sterilization Method | EtO Sterilization | Same (EtO Sterilization) |
| Usage | Single Use | Same (Single Use) |
| Biocompatibility | Biocompatible | Same (Biocompatible) |
| Biocompatible Electrical Insulation | PTFE or PVDF | PVDF |
| Distal Stainless Steel Patient Body Contact Surface Material | 316 SS | Same (316 SS) |
| Proximal Stimulator Connector | DIN 42802-1 Touch-proof | Same (DIN 42802-1 Touch-proof) |
| IEC 60601-1 Protected Pin Design | IEC 60601-1 Protected Pin design | Same (IEC 60601-1 Protected Pin design) |
| Shaft Material | 316 SS | Same (316 SS) |
| Handle Material | Acrylonitrile butadiene styrene (ABS) | Same (Acrylonitrile butadiene styrene (ABS)) |
| Maximum Charge Density | Exhibits a range of Charge Densities depending on Probe. Maximum Charge Density is greater than the subject device (Implied acceptance for lower density) | 374 μC/cm2 (This is within the acceptable range as the predicate's maximum is stated to be greater than the subject device) |
| Probe Length | Exhibits a range of probe lengths depending on probe. The probe length is within the range of the subject device (Implied acceptance for being within range) | 225mm (This is stated to be within the range of the predicate device) |
| Cable/Lead Wire Length | Exhibits a range of Cable/Lead wire lengths depending on probe. The Cable/Lead Wire Length is within the range of the subject device (Implied acceptance for being within range) | 2.5m (This is stated to be within the range of the predicate device) |
| Uncoated Conducting Surface Area | Exhibits a range of Conducting Surface Areas. Smallest Conducting Surface Area is less than the subject device (Implied acceptance for being within range) | 27mm2 (This is within the acceptable range as the predicate's smallest is stated to be less than the subject device, suggesting the subject device's area is not excessively small) |
| Tip Diameter/Exposure | Exhibits a range of Tip Diameter/Exposures depending on probe. The Tip Diameter/Exposure is within the range of the subject device (Implied acceptance for being within range) | 3.0mm (This is stated to be within the range of the predicate device) |
| Electrical Safety | Meets IEC 60601-1:2012 reprint and IEC 60601-1-2:2007 Clause 56.3(c) | Demonstrated that the Neuromonitoring Kit meets the requirements of IEC 60601-1:2012 reprint and IEC 60601-1-2:2007 Clause 56.3(c) per 21 CFR 898.12. |
| Electromagnetic Compatibility (EMC) | Meets IEC 60601-1:2012 reprint and IEC 60601-1-2:2007 Clause 56.3(c) | Demonstrated that the Neuromonitoring Kit meets the requirements of IEC 60601-1:2012 reprint and IEC 60601-1-2:2007 Clause 56.3(c) per 21 CFR 898.12. |
| Mechanical Performance | Performance similar to predicate (implied by substantial equivalence claim) | Mechanical performance data were provided and test results demonstrate that the subject Probe is substantially equivalent to the predicate. (Specific criteria not detailed, but overall equivalence established). |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states that Electrical safety, electromagnetic compatibility and mechanical performance data were provided in support of the substantial equivalence determination. However, it does not specify the sample size used for these tests. There's no mention of a test set in the context of clinical data or patient-specific information. The testing seems to be focused on device-level performance (electrical, EMC, mechanical).
Regarding data provenance, since these are device performance tests (rather than clinical trials involving patients), the data provenance would be from laboratory or engineering testing. Neither country of origin nor retrospective/prospective nature is specified, as these terms are more applicable to patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
No information is provided regarding experts establishing ground truth. The acceptance criteria and performance data are based on engineering standards (IEC 60601 series) and comparison to a predicate device's specifications. This type of device does not involve expert interpretation or diagnostic "ground truth" in the way a medical imaging AI would.
4. Adjudication Method for the Test Set:
Not applicable. There's no mention of a test set requiring adjudication in the context of expert review or clinical outcomes. The device performance is assessed against engineering standards and specifications.
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:
Not applicable. This device is a surgical nerve stimulator/locator, not an AI-powered diagnostic or interpretive tool that assists human readers. Therefore, an MRMC study and effect size of human reader improvement with AI assistance are not relevant.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not a standalone algorithm. Its function relies on being used by a surgeon during a procedure for nerve stimulation and localization.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance appears to be based on:
- Compliance with international electrical safety and electromagnetic compatibility standards (IEC 60601-1:2012 and IEC 60601-1-2:2007).
- Engineering specifications and characteristics that are compared to a legally marketed predicate device (Rhythmlink International Monopolar Stimulating Instrument K072736) to establish substantial equivalence.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/machine learning model, so there is no training set in the conventional sense.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set.
§ 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.