(76 days)
The MAGNETOM Systems with the Numaris 4 VA15A are indicated for use as magnetic resonance diagnostic devices (MRDD's) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, based upon 'H and "P metabolites, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM systems with the new Numaris 4VA15A is substantially equivalent to the predicate MAGNETOM Systems with Numaris 4VA12A. The MAGNETOM Systems which will be affected will be: The MAGNETOM 1.5 Tesla Sonata system, The MAGNETOM 1.5 Tesla Symphony system, The MAGNETOM 1.0 Tesla Harmony system, The MAGNETOM 0.2 Tesla Concerto system. This includes Siemens upgrades of currently used MAGNETOM Impact/Expert, Vision, and Open (Viva) systems to systems described above. Siemens Medical Systems is adding an upgrade in software and hardware to the currently available MAGNETOM Systems. The MRI systems are exactly the same as what was described and cleared in the predicate premarket notifications.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Numaris 4VA15A:
This document is a 510(k) summary for a software and hardware upgrade to existing Magnetic Resonance Diagnostic Devices (MRDDs) manufactured by Siemens. The core premise of the submission is that the upgrade, Numaris 4VA15A, does not significantly alter the safety or performance of the existing predicate devices. Therefore, the provided text does not contain a study specifically designed to establish new acceptance criteria or prove device performance through a clinical trial or a detailed bench test against new, specific metrics for the Numaris 4VA15A itself.
Instead, the submission argues for substantial equivalence by stating that the safety and performance parameters remain unchanged from the already cleared predicate devices.
Let's break down the information based on your requested points:
-
A table of acceptance criteria and the reported device performance
There are no new acceptance criteria or reported device performance metrics specifically for the Numaris 4VA15A upgrade. The submission states that the safety and performance parameters are exactly the same as those described and cleared in the 510(k)s for the predicate devices.
The document lists the following parameters as having no significant effect due to the Numaris 4VA15A upgrade:
Category Parameter Reported Performance (for Numaris 4VA15A) Acceptance Criteria (for Numaris 4VA15A) Note Safety Maximum Static Field (Implicitly unchanged from predicate) (Implicitly unchanged from predicate) These values are stated to be "exactly the same as described in the 510(k)s for these systems." Rate of Change of Magnetic Field (Implicitly unchanged from predicate) (Implicitly unchanged from predicate) RF Power Deposition (Implicitly unchanged from predicate) (Implicitly unchanged from predicate) Acoustic Noise Level (Implicitly unchanged from predicate) (Implicitly unchanged from predicate) Performance Specification Volume (Implicitly unchanged from predicate) (Implicitly unchanged from predicate) Signal to Noise (Implicitly unchanged from predicate) (Implicitly unchanged from predicate) Image Uniformity (Implicitly unchanged from predicate) (Implicitly unchanged from predicate) Geometric Distortion (Implicitly unchanged from predicate) (Implicitly unchanged from predicate) Slice Profile, Thickness and Gap (Implicitly unchanged from predicate) (Implicitly unchanged from predicate) High Contrast Spatial Resolution (Implicitly unchanged from predicate) (Implicitly unchanged from predicate)
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No specific test set or data provenance is detailed for the Numaris 4VA15A as a new device requiring performance validation. The submission relies on the existing clearance of predicate devices, stating that "the MRI systems are exactly the same as what was described and cleared in the predicate premarket notifications." "Laboratory testing were performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to safety and effectiveness," but no details on these lab tests (sample size, data provenance) are provided.
-
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. No new ground truth establishment for a test set is described for the Numaris 4VA15A.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set is described.
-
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-assisted device, and no MRMC study is mentioned.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an MRI system upgrade, not a standalone algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for new ground truth establishment by this submission. The devices, when interpreted by a "trained physician," yield information that may assist in diagnosis, implying that clinical diagnosis (likely based on various inputs, including expert interpretation, potentially pathology, and patient outcomes) would form the ultimate ground truth for the predicate devices' diagnostic capabilities.
-
The sample size for the training set
Not applicable. This document describes an upgrade to existing hardware/software, not a new algorithm that requires a training set.
-
How the ground truth for the training set was established
Not applicable. No training set is mentioned.
§ 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.