(91 days)
The MAGNETOM Spectra is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.
Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Spectra may also be used for imaging during interventional procedures when performed with MR compatible devices such as inroom display and MR-safe biopsy needles.
MAGNETOM Spectra (3T) is similar to the previously cleared MAGNETOM Skyra and MAGNETOM Verio, utilizing a superconducting magnet design. The open bore, whole body scanners are designed for increased patient comfort. They focus on ergonomics and usability to simplify the MR workflow.
The MAGNETOM Spectra systems will be available in a fixed configuration.
The provided text is a 510(k) summary for the Siemens MAGNETOM Spectra 3T System. It describes the device, its intended use, and argues for substantial equivalence to predicate devices. However, this document does not contain acceptance criteria for specific device performance metrics or the details of a study involving such criteria.
Instead, it lists general performance and safety parameters that were measured to demonstrate equivalence to predicate devices, and that the device conforms to NEMA, IEC, and ISO standards. It does not provide the specific numerical acceptance criteria or the results of those measurements for the MAGNETOM Spectra, nor does it describe a study specifically designed to prove the device meets predefined acceptance criteria in the way you've outlined.
Therefore, I cannot populate the table or answer many of your questions as the requested information is not present in the provided text.
Here is what can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document lists "Performance: Specification Volume, Signal to Noise, Image Uniformity, Geometric Distortion, Slice Profile. Thickness and Gap, High Contrast Spatial Resolution" as parameters that were measured, but it does not give specific acceptance criteria (e.g., "SNR > X") or the reported performance values for the MAGNETOM Spectra against those criteria. It only states that performance measurements were done and that the MAGNETOM Spectra is equivalent to predicate devices.
2. Sample size used for the test set and the data provenance:
This information is not provided in the document. No specific "test set" of patient data or phantoms is described with sample sizes or provenance for demonstrating performance. The evaluation seems to be based on engineering measurements against standards and comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. There is no mention of a "test set" requiring expert ground truth establishment. The intended use indicates that images are "interpreted by a trained physician," but this pertains to clinical use, not a study evaluating the device's performance against expert consensus.
4. Adjudication method for the test set:
This information is not provided in the document. As no test set requiring expert ground truth is described, no adjudication method is mentioned.
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:
This information is not provided in the document. This is a submission for a Magnetic Resonance Diagnostic Device (an MRI machine), not an AI algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided in the document. This is an MRI system, not a standalone algorithm.
7. The type of ground truth used:
This information is not provided in the document. The document focuses on technical performance metrics as evaluated against industry standards and predicate devices, rather than clinical ground truth (like pathology or outcomes data) from a patient study.
8. The sample size for the training set:
This information is not provided in the document. There is no mention of a "training set" as this is not an AI/machine learning device submission.
9. How the ground truth for the training set was established:
This information is not provided in the document. As there is no training set mentioned, no establishment of ground truth for it is discussed.
§ 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.