(53 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 Monteris medical AtamA™ System is comprised of two major subsystems: (i) a MR head coil functionality, and (ii) a patient stabilization functionality. These two subsystems have been designed to work independently and in unison to meet the varied needs of neurosurgical procedures utilizing MRI. The Head Coil Subsystem is comprised of a novel design of a standard split-array multichannel (8 channel) receive coil in the form of a common Lower Coil and two interchangeable Upper Coils (only one used at any time) and the appropriate coil configuration data, known as "coil files", for the selected MR system to be used. The design of the two-part Head Coil system is such that, in conjunction with the rest of the AtamA System, openings in the two-part coil can be rotated around the patient's head to allow surgical access to essentially any supratentorial aspect of the patient's head, and still allow for the collection of MR data without repositioning the patient or moving the coils within the MR system. This will allow for more expedient collection of high quality MR data, minimize moving the patient, and maintenance of spatial registration (required for or supporting stereotactic procedures). The Stabilization subsystem is comprised of three major components and their accessories. The major components are: A Head Fixation Ring (HFR) apparatus, A Cradle that fixates the HFR and the two-part Coil relative to each other and the MRI system bore, and A patient Board that allows for the effective transport of the patient to and from various procedures and procedure locations while maintaining the stability and spatial registration of the patient.
The provided document describes a medical device, the Monteris Medical AtamA™ System, and its substantial equivalence to predicate devices, rather than a study proving the device meets a specific set of acceptance criteria based on clinical performance metrics. The document explicitly states: "This application does not rely on any clinical investigations or clinical performance testing in support of substantial equivalence to the stated predicate devices."
Therefore, I cannot provide information for many of the requested categories related to clinical performance studies. However, I can extract information regarding non-clinical performance and the device's characteristics.
Here’s a breakdown of what can be inferred or directly stated from the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with corresponding reported device performance metrics in the way one would expect for a clinical performance study (e.g., sensitivity, specificity, accuracy). Instead, it states:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | In compliance with ISO 10993 |
| Bench Testing | In compliance with product specifications, medical community expectations, and product labeling |
| Coil Functionality | Performance testing to recognized standards (NEMA Magnetic Resonance Imaging standards where appropriate) and actual values of predicate devices |
| Technical Characteristics | Materially the same as predicate devices (split array 8-channel MR head coil design, construction, materials, principles of head stabilization/immobilization) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable, as no clinical performance study with a test set was mentioned or conducted. The non-clinical performance data appears to be from bench testing and biocompatibility assessments, not human subject data.
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, as no clinical performance study with a test set was mentioned or conducted.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical performance study with a test set was mentioned or conducted.
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 head coil and stabilization system, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance, the "ground truth" or reference points were:
- ISO 10993 for biocompatibility.
- Product specifications, expectations of the medical community, and product labeling for bench testing.
- Recognized standards (NEMA Magnetic Resonance Imaging standards) and actual/reported values of predicate devices for coil functionality.
8. The sample size for the training set
Not applicable, as no training set for an algorithm was mentioned or used.
9. How the ground truth for the training set was established
Not applicable, as no training set for an algorithm was mentioned or used.
Summary of the study conducted (as per the document):
The document explicitly states that the application for the Monteris Medical AtamA™ System does not rely on any clinical investigations or clinical performance testing in support of substantial equivalence. Instead, the substantial equivalence to predicate devices is supported by:
- Non-Clinical Performance Data:
- Biocompatibility analysis: Demonstrated compliance with ISO 10993.
- Bench testing: Demonstrated compliance with product specifications, the expectations of the medical community, and product labeling.
- Performance testing for Coil functionality: Conducted according to recognized standards (NEMA Magnetic Resonance Imaging standards, where appropriate) and by comparing to actual or reported values of predicate devices.
- Technological Characteristics: The device's technical modes of action and technical principles are materially the same as the predicate devices, including split array 8-channel MR head coil design, construction, functionally similar materials, and the same principles of head stabilization/immobilization. The design differences are in integration and utilization for expediency and convenience.
§ 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.