(77 days)
The MAGNETOM systems described above are 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 systems described above may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR-safe biopsy needles.
The software update syngo MR B17 offers additional and improved applications for MAGNETOM Systems. It includes sequences and image processing functions for oncology, neurology, orthopaedics and cardio-vascular imaging.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Siemens MAGNETOM Systems with software syngo MR B17:
Important Note: The provided document is a 510(k) summary for a software update to an MRI system. Unlike AI/CADe devices, an MRI system itself does not typically have "acceptance criteria" in the sense of a specific performance metric (like sensitivity/specificity) being met by the device's output. Instead, the "acceptance criteria" for a software update to a diagnostic imaging device like an MRI focuses on ensuring the new software maintains the safety and effectiveness of the previously cleared device, does not introduce new risks, and performs as intended without compromising image quality or diagnostic utility. This is primarily done through verification and validation testing, and demonstrating substantial equivalence to a predicate device.
Therefore, the table below reflects what would be considered "performance" and "acceptance criteria" for this type of device submission, rather than a quantifiable diagnostic accuracy metric.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance (Summary of Study Findings) |
|---|---|---|
| Safety and Effectiveness | No significant concerns of safety and efficacy introduced by the software upgrade. | Siemens believes that the MAGNETOM systems with software syngo MR B17 are substantially equivalent to the predicate devices (K072237 and K062454). This implies that the safety and effectiveness are maintained at a level comparable to the cleared predicates. |
| "The introduction of the MAGNETOM systems with software syngo MR B17 has no significant concerns of safety and efficacy." | ||
| Risk Management | Potential hazards identified and controlled via software development, verification, and validation testing. | Risk analysis was performed to identify potential hazards, which were controlled through software development, verification, and validation testing. |
| Compliance to Standards | Conformance to international IEC and ISO standards (where applicable) for safety and performance. | "The MAGNETOM Systems with software syngo MR B17 will conform to the measurement of safety and performance parameters to the international IEC and ISO standards, where applicable." |
| Intended Use | The device continues to fulfill its intended use as a magnetic resonance diagnostic device (MRDD) for imaging various body parts and assisting in diagnosis when interpreted by a trained physician. The new software provides "additional and improved applications for oncology, neurology, orthopaedics and cardio-vascular imaging." | The software update "offers additional and improved applications for MAGNETOM Systems," implying continued and enhanced fulfillment of the stated intended use. The FDA concurred with the stated Indications for Use. (Pages 1 & 5) |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly detail specific clinical test sets, sample sizes (e.g., number of patients/scans), or data provenance (country of origin, retrospective/prospective). For a software update to an MRI system, the "test set" primarily refers to the data used in verification and validation (V&V) testing. This V&V testing typically involves technical performance evaluation, image quality assessment, and functional testing rather than a large-scale clinical study with specific patient data.
The document indicates that risks are controlled "via software development, verification and validation testing," suggesting a comprehensive engineering and quality assurance process was followed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for establishing ground truth for any specific test set related to diagnostic performance. As noted above, the focus here is on substantial equivalence to a predicate device and technical performance, not on demonstrating improved diagnostic accuracy against a specific ground truth for a novel diagnostic claim. The "trained physician" is mentioned in the intended use as interpreting the images to assist in diagnosis, but not as part of a formal ground truth establishment for a clinical study in this submission.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method as it does not present a clinical study requiring such a method for a specific diagnostic outcome.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. This type of study is more common for
AI/CADe devices that directly assist human readers in making diagnostic decisions. This submission is for a software update to an MRI system, aiming to maintain or improve image acquisition and processing capabilities.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to an MRI system software update. An MRI system itself is a diagnostic tool, not an AI algorithm performing a standalone diagnostic task. Its "performance" is inherently tied to image acquisition, processing, and display, which are then interpreted by a human. The software update improves the capabilities of this core diagnostic tool.
7. The Type of Ground Truth Used
Given the nature of the submission (software update for an MRI system), the "ground truth" used in testing would primarily revolve around:
- Technical specifications & engineering standards: Ensuring image fidelity, resolution, contrast, artifact reduction, and adherence to physical parameters.
- Clinical utility assessments: Ensuring the "additional and improved applications" (for oncology, neurology, etc.) align with current clinical practice and provide diagnostically relevant information.
- Comparison to predicate device: The fundamental "ground truth" for substantial equivalence is that the modified device performs as safely and effectively as the previously cleared predicate, producing images of comparable diagnostic quality.
The document does not mention specific pathology, outcomes data, or expert consensus in the context of a clinical study for establishing ground truth for this software update.
8. The Sample Size for the Training Set
The document does not mention a training set as this is not an AI/machine learning device that requires a training set in that context. The "training" for the software development would be based on engineering principles and clinical requirements.
9. How the Ground Truth for the Training Set was Established
As there is no mention of a "training set" in the context of AI/ML, this question is not applicable to the provided document.
§ 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.