(136 days)
The MAGNETOM Prisms and MAGNETOM Prismalit systems are indicated for use as a magnetic resomance diagnostic device (MRDD) that produces transverse, sagital, coronal and oblique cross sectional 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 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 Prisma and MAGNETOM Prismalit systems may also be imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR Safe biopsy needles.
MAGNETOM Prisma (3 T) and MAGNETOM Prisma" (3 T) are similar to the previously cleared MAGNETOM Skyra (3 T) and MAGNETOM Trio a Tim System (TaTS) (3 T) systems utilizing a superconducting magnet design. The open bore, whole body scanners are designed for increased patient comfort. They focus on ergonomics and usability to reduce complexity of the MR workflow.
The MAGNETOM Prisma will be offered as ex-factory (new production) and the MAGNETOM Prismall will be offered as an upgrade to the currently installed MAGNETOM Trio a Tim System (TaTS) systems.
The provided text is a 510(k) summary for the Siemens MAGNETOM Prisma and MAGNETOM Prisma™ MR systems. It asserts substantial equivalence to predicate devices and describes safety and performance testing. However, it does not contain specific acceptance criteria values, reported device performance metrics against those criteria, or the detailed study design (like sample sizes for test sets, data provenance, expert qualifications, or ground truth establishment) typically associated with such criteria for a medical device's performance.
The document states that the new devices conform to "measurements of safety parameters to the international IEC, ISO and NEMA standards for safety issues with Magnetic Resonance Imaging Diagnostic Devices" and that "performance testing has been completed to show that the performance... is equivalent with respect to the predicate devices." It lists areas of safety and performance evaluated but does not provide quantitative results or explicit acceptance thresholds.
Summary of Missing Information:
The input document does not contain the level of detail required to complete the requested table and study information. Specifically, it lacks:
- Quantitative acceptance criteria values.
- Reported device performance metrics.
- Sample sizes for test sets.
- Data provenance for test sets.
- Number and qualifications of experts for ground truth.
- Adjudication method for test sets.
- Information on MRMC comparative effectiveness studies (effect size of AI improvement).
- Information on standalone algorithm performance.
- Type of ground truth used (beyond implying "equivalence" to predicate devices).
- Sample size and ground truth establishment for the training set.
Based on the provided text, here is what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric (as mentioned or implied) | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Safety | Maximum Static Field | Conforms to IEC, ISO, NEMA standards | Shown to conform to standards and be equivalent to predicate devices |
| Rate of Change of Magnetic Field | Conforms to IEC, ISO, NEMA standards | Shown to conform to standards and be equivalent to predicate devices | |
| RF Power Deposition | Conforms to IEC, ISO, NEMA standards | Shown to conform to standards and be equivalent to predicate devices | |
| Acoustic Noise Levels | Conforms to IEC, ISO, NEMA standards | Shown to conform to standards and be equivalent to predicate devices | |
| Performance | Specification Volume | Equivalent to predicate devices | Shown to be equivalent to predicate devices |
| Signal to Noise | Equivalent to predicate devices | Shown to be equivalent to predicate devices | |
| Image Uniformity | Equivalent to predicate devices | Shown to be equivalent to predicate devices | |
| Geometric Distortion | Equivalent to predicate devices | Shown to be equivalent to predicate devices | |
| Slice Profile, Thickness and Gap | Equivalent to predicate devices | Shown to be equivalent to predicate devices | |
| High Contrast Spatial Resolution | Equivalent to predicate devices | Shown to be equivalent to predicate devices |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document states that "performance testing has been completed," but it does not specify the sample size, data provenance, or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The document does not provide any information regarding the number or qualifications of experts used to establish ground truth for test sets.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not specify any adjudication method for test sets.
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
- The document describes the device as a Magnetic Resonance Diagnostic Device (MRDD), implying it's an imaging system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study regarding "human readers improve with AI vs without AI assistance" is not applicable or mentioned in this context. The focus is on the equivalence of the MR system's performance itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This refers to the performance of the MR system itself. The document confirms that performance testing was completed to show equivalence to predicate devices, which implies standalone performance evaluation of the imaging system. However, specific metrics and methodologies for a "standalone algorithm" performance in the sense of AI are not described, as this device is a hardware imaging system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The document states that performance testing was done "following NEMA or equivalent IEC and ISO standards." This suggests that physical phantoms and standardized measurement techniques, which serve as the "ground truth" for technical imaging specifications, were likely used. However, it does not explicitly state "expert consensus, pathology, or outcomes data" as ground truth for clinical cases. The ground truth for proving substantial equivalence appears to be established by demonstrating that the new system's technical specifications and image quality measurements are comparable to the predicate devices and conform to industry standards.
8. The sample size for the training set
- This document describes a medical imaging device (hardware and core software), not an AI algorithm that undergoes "training." Therefore, the concept of a "training set sample size" is not applicable in this context.
9. How the ground truth for the training set was established
- As per point 8, the concept of a "training set" for AI is not applicable to this device description.
§ 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.