(11 days)
This device is indicated for use in surgical procedures for patient-connected intraoperative nerve monitoring, i.e. assisting the surgeon in locating and mapping motor nerves through the use of electromyographic (EMG) signals and electrical stimulus of nerves.
NIM PRS is a multi-channel intraoperative neurophysiological monitor capable of connecting various styles of patient monitoring electrodes and supplying electrical stimulus for evoked responses. The monitoring console uses both video and audio output to alert the user of EMG responses during a surgical procedure. EMG responses monitored with the device may originate from operator applied electrical stimulus or from direct mechanical stimulus occurring during the course of the surgery. Acquired data may be stored on various types of durable media, and hard copy may be obtained via an optional printer.
The provided text is a 510(k) summary for the Medtronic Xomed NIM PRS device, which is an intraoperative neurophysiological monitor. This type of regulatory document is typically focused on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving performance against specific acceptance criteria for a new, complex algorithm or AI model.
Therefore, many of the requested items (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment) are not applicable to this type of submission as they relate to analytical or clinical validation studies for novel algorithms, which are not described here.
The document primarily focuses on comparing the new device (NIM PRS) to a predicate device (NIM-4) to show substantial equivalence, especially in terms of features and intended use.
Here's a breakdown of the information that can be extracted or inferred from the provided text, and where the information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly showing substantial equivalence to the predicate device, NIM-4 (K982595), which is already legally marketed. The "performance" is described as having similar features and functionality.
| Characteristic | Acceptance Criteria (Predicate Device K982595 Performance) | Reported Device (NIM-PRS) Performance |
|---|---|---|
| Multi-channel intraoperative neurophysiological monitor | Yes (4 channels) | Yes (8 channels) - Exceeds predicate channel count |
| Indicated for use in surgical procedures for patient-connected intraoperative nerve monitoring, i.e. assisting the surgeon in locating and mapping motor nerves through the use of electromyographic (EMG) signals and electrical stimulus of nerves | Yes | Yes |
| Complies with IEC 60601-1 electrical safety standards | Yes | Yes |
| Capable of connecting various styles of patient monitoring electrodes | Yes | Yes |
| Capable of supplying electrical stimulus for evoked responses | Yes (1 stimulator 0 - 3 mA) | Yes (2 stimulators 0 - 30 mA and 0 - 120 mA) - Exceeds predicate stimulus range/quantity |
| Capable of connecting various styles of patient stimulating electrodes | Yes | Yes |
| Uses both video and audio output to alert the user of EMG responses during a surgical procedure | Yes | Yes |
| Monitors EMG responses originating from operator applied electrical stimulus | Yes | Yes |
| Monitors EMG responses originating from direct or indirect mechanical stimulus | Yes | Yes |
| Acquired data may be printed on hard copy via an optional printer | Yes | Yes (May also be stored on various types of durable media) - Enhanced capability |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This submission relies on substantial equivalence to a predicate device, not on a new clinical performance study with a test set of patient data.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. No test set requiring expert ground truth is described.
- Qualifications: Not applicable.
4. Adjudication method for the test set
- Adjudication method: Not applicable. No test set requiring adjudication is 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
- MRMC Study: No. This device is an intraoperative nerve monitor, not an AI-assisted diagnostic imaging or interpretation tool that would typically undergo an MRMC study.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. This device is a monitoring system intended for human-in-the-loop use during surgery, not a standalone AI algorithm generating interpretations.
7. The type of ground truth used
- Type of Ground Truth: Not applicable. The submission is based on demonstrating functional equivalence to an existing device rather than a new diagnostic claim requiring external ground truth validation. The "ground truth" for this type of submission is the established safety and effectiveness of the predicate device.
8. The sample size for the training set
- Sample Size: Not applicable. This device does not describe an AI/ML component that requires a training set in the conventional sense. Its "training" would be related to its engineering design and validation against electrical safety and performance standards.
9. How the ground truth for the training set was established
- How Ground Truth was Established: Not applicable.
§ 890.1375 Diagnostic electromyograph.
(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).