(174 days)
The intended use of the AtamA™ System (comprised of two major subsystems: a MR head coil apparatus and a patient stabilization apparatus), in conjunction with a magnetic resonance (MR) imaging system, is the collection of MR data and images of the human brain before, during, and at the end of brain surgery, in a standard operating room, diagnostic MR rooms, or in a MR intra-operative room, while stabilizing the patient's head during neurosurgical procedures and imaging.
The patient head-stabilizing apparatus can also be used for other neurosurgical procedures requiring the patient's head to be stabilized or fixed.
The head coil can also be used as a standard diagnostic head coil for diagnostic MR imaging.
When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
The AtamA"" System is comprised of two subsystems:
- (i) MR Head Coil
- (ii) Patient Stabilization System
These two subsystems have been designed to work independently and in unison to meet the varied needs of neurosurgical procedures utilizing MRI. In addition, the patient head fixation ring subsystem and patient board can also be used for other neurosurgical procedures requiring the patient's head to be stabilized or fixed. Also, the head coil can also be used as a standard diagnostic head coil for diagnostic MR imaging.
Specifically, the AtamA System allows a streamlined workflow for procedures requiring the patient to undergo MRI examination before, during, or after neurosurgical procedures. The AtamA System maintains patient head fixation while providing a patient board for convenient, safe and effective method of moving the patient from an OR table to transport gurney to MRI couch without the need to unpin and re-pin the patient.
This submission clears the use of the additional 3.0 Telsa AtamA Head Coil for use with specific Siemens and Imris 3.0 Telsa MRI Systems, and the expanded labeling of the components of the Patient Stabilization System for their compatibility with both 1.5 Tesla and 3.0 Telsa systems.
This document is a 510(k) Pre-market Notification (K132444) for the Monteris Medical AtamA™ System, seeking to expand its compatibility to 3.0 Tesla MRI systems. This notification is not for an AI device, therefore, the requested information regarding acceptance criteria and studies for AI/algorithm performance is not applicable.
The submission focuses on demonstrating the substantial equivalence of the modified AtamA™ System (specifically, the addition of a 3.0 Tesla MR head coil and expanded labeling for the patient stabilization system) to its predicate device (K110411), which was cleared for 1.5 Tesla MR Systems. The primary form of evidence presented is bench testing for MR compatibility.
Here's an analysis of the information provided, tailored to what is relevant to the 510(k) submission's purpose:
1. Table of acceptance criteria and reported device performance:
The document doesn't explicitly state acceptance criteria in a quantitative table format for performance. Instead, it aims for "substantial equivalence" to the predicate device, particularly concerning safety and efficacy in the 3.0T MRI environment. The "acceptance criteria" here are qualitative for MR compatibility, meaning the device must not introduce new safety concerns or compromise image quality when used with 3.0T MRI.
| Parameter or Characteristic | Predicate AtamA™ System Performance (K110411) | New AtamA™ System Performance (K132444) |
|---|---|---|
| MRI Compatibility of Head Coil | 1.5T Conditional | 1.5T / 3.0T Conditional |
| MRI Compatibility of Stabilization Subsystem | 1.5T Conditional | 1.5T / 3.0T Conditional |
| Safety & Efficacy | Established for 1.5T MR environments | Bench testing demonstrated safe and effective for 1.5T and 3.0T MR environments |
2. Sample size used for the test set and the data provenance:
The document does not detail a "test set" in the context of subject-based performance evaluation as it would for an AI algorithm. The testing described is bench testing (laboratory-based) with the physical device. Therefore, there is no human subject sample size or data provenance in terms of country of origin or retrospective/prospective clinical data for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. There is no "ground truth" to be established by experts in the context of an AI algorithm for this device. The evaluation is based on engineering principles and NEMA standards for MR compatibility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. As this is not a clinical study involving human assessment of results, there is no adjudication method.
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 is not an AI device submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI device submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" equivalent for this type of device is established engineering standards and specifications (e.g., NEMA Standards for MRI compatibility). The device is evaluated against these physical and electrical compatibility requirements, not against clinical outcomes or expert diagnoses.
8. The sample size for the training set:
Not applicable. This is not an AI device; therefore, there is no training set.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for an AI algorithm, this question does not apply.
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the (implied) acceptance criteria of 3.0 Tesla MR Conditional compatibility for both the head coil and the patient stabilization subsystem is summarized as follows:
- Study Type: Bench testing.
- Methodology: The 3.0 Tesla MR Head Coil underwent bench testing "in accordance with NEMA Standards" to demonstrate compatibility with 3.0 Tesla MRI systems. For the Patient Stabilization Subsystem, an "analysis of materials has shown" compatibility with 3.0 Tesla MR environments.
- Conclusion: The bench testing and material analysis concluded that the Monteris Medical AtamA System is safe and effective for use in both 1.5T and 3.0T MRI environments and can be labeled with both 1.5T and 3.0T MR Conditional Compatibility. The submission argues that these tests demonstrate the new device does not raise new issues of safety or efficacy compared to the predicate device.
In essence, this 510(k) submission relies on standard engineering tests for MR safety and compatibility, rather than clinical performance studies typically required for AI or new therapeutic devices.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.