(313 days)
The Neural Navigator is a neuronavigation system indicated for accurate positioning of the treatment coil of the CloudTMS Therapy System with respect to target brain regions based on data obtained from MRI measurements. Specifically, the Neural Navigator is indicated for use with the following CloudTMS Therapy System coils manufactured by Neurosoft Ltd: AFEC-02-100 and AFEC-02-100-C.
The Neural Navigator combines MRI-based, 3-D localization of cortical motor areas of the brain with non-invasive TMS and simultaneous EMG measurement to locate areas of the brain that are capable of evoking muscle responses when stimulated, and to locate the target area for depression therapy. The Neural Navigator software is used to import a patient's MR image slices through standard DICOM communication protocols, and automatically generates an accurate 3-D model of the patient's head, and a custom automatic tissue segmentation routine to reveal anatomical structures of the brain surface in 3D.
The provided text describes the 510(k) premarket notification for the Neural Navigator device. While it asserts substantial equivalence based on performance testing, it does not explicitly define "acceptance criteria" in a quantitative table with specific thresholds as would be typical for a detailed study report. However, it implicitly presents performance metrics and their comparison to predicate devices, which serve as the basis for acceptance.
Here's an attempt to extract and rephrase the information to fit the requested format, acknowledging the limitations of the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present explicit acceptance criteria with defined pass/fail thresholds. Instead, it compares the Neural Navigator's performance to its predicate devices, implying that performance comparable to or better than the predicate is considered acceptable.
| Parameter | Implicit Acceptance Criterion (Compared to Predicate) | Reported Neural Navigator Performance |
|---|---|---|
| Tracking System Accuracy |
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).