(22 days)
The Siemens MR-PET system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.
These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders.
The MR is intended to produce transverse, sagittal, coronal and oblique crosssectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR-safe biopsy needles.
The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.
The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.
The Biograph mMR systems are combined Maqnetic Resonance Imaging and Positron Emission Tomography scanners. The Biograph mMR systems provide registration and fusion of high-resolution metabolic, physiologic and anatomic information from the two major components of each system (PET and MR) acquired simultaneously and isocentrically.
The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely alianed MR and PET image coordinate systems.
Software syngo MR B20P is a new software version for the Siemens Biograph mMR systems that were previously cleared under K103429 (running software version syngo MR B18P).
New scanners will be manufactured with syngo MR B20P; existing scanners can be upgraded to this software version. The new software version includes new software features, coil modifications and other modified hardware for the Biograph mMR systems.
This 510(k) submission (K133226) from Siemens for "Software syngo MR B20P for Biograph mMR" is a special 510(k), indicating modifications to an already cleared device. As such, the focus of the submission is on demonstrating that the new software and hardware features do not introduce new issues of safety or effectiveness and that the device remains substantially equivalent to its predicate.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly provide a table of quantitative acceptance criteria with corresponding performance metrics for the software changes in the way one might expect for a novel AI algorithm. Instead, the acceptance criteria are implicitly defined by standard engineering and regulatory practices for medical device modifications. The reported device performance is demonstrated through various tests designed to ensure the modified coils and software functions as intended and meet established standards.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| New Hardware (Coils): | |
| - Maintain/improve image quality (SNR, uniformity) | - Coils were tested for SNR, image uniformity. (No specific quantitative values provided, but implied to be acceptable, demonstrating "performs as intended"). |
| - Ensure user safety (heating) | - Coils were tested for heating. (Implied to be acceptable). |
| - Proper functionality in hybrid mode | - Coils were tested for hybrid mode. (Implied to be acceptable). |
| New Software Features: | |
| - Correct implementation and functionality (Verification/Validation) | - All software features were verified and validated. (Implied to be bug-free and function as designed across all new additions: reconstruction improvements, usability improvements, quality control improvements, new sequences, Multi-Nuclear Spectroscopy). |
| - Accurate PET performance (NEMA NU:2 compliance) | - PET performance testing in accordance with NEMA NU:2. (This implies meeting established industry standards for PET image quality, quantification, and system performance). |
| - Accurate MNO Spectroscopy (phantom testing) | - The performance parameters of MNO Spectroscopy were phantom-tested. (Implied to be accurate and reliable when used with phantoms, indicating proper system calibration and data acquisition/processing for this specific application). |
| General Safety and Effectiveness: | |
| - Compliance with regulatory standards | - Adherence to recognized and established industry standards, such as IEC 60601-1 series, ISO 14971:2007, and applicable FDA recognized and international IEC, ISO and NEMA standards as recommended by the respective MR FDA Guidance Document. (Demonstrates compliance with fundamental safety and performance benchmarks for medical devices). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of AI performance evaluation. The non-clinical tests involved:
- Testing of coils (SNR, image uniformity, heating, hybrid mode).
- Phantom testing for MNO Spectroscopy.
- Verification and validation of all software features.
- PET performance testing in accordance with NEMA NU:2.
The data provenance for these tests is implicitly from Siemens' internal testing environment and phantoms, as no patient data (retrospective or prospective) is mentioned as being used for the testing of the modified features to demonstrate conformance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission does not describe a study involving expert-established ground truth on a test set (e.g., for diagnostic accuracy). The evaluation focuses on engineering performance and regulatory compliance for modified features.
4. Adjudication Method for the Test Set
Not applicable, as no expert adjudication of images or data to establish ground truth is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "There were not any clinical tests conducted to support the subject device and the substantial equivalence argument..." This is a software and hardware update, not a new diagnostic AI algorithm requiring such a study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable in the typical sense for a diagnostic AI algorithm. The software features are enhancements to an existing imaging system, not a standalone diagnostic algorithm. The "standalone" performance here relates to the technical functionality of the new features (e.g., whether the new sequences produce images correctly, whether MNO spectroscopy works on phantoms). These functional tests were performed in a standalone manner (without a human interpreting findings for diagnostic purposes).
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests was based on:
- Physical measurements and engineering specifications: For coil performance (SNR, uniformity, heating, hybrid mode).
- Phantom studies: For MNO Spectroscopy, where the phantom's known characteristics serve as the ground truth.
- NEMA NU:2 standards: For PET performance, adherence to these published standards serves as the ground truth for system performance.
- Software engineering requirements and specifications: For the verification and validation of all software features, ensuring they meet their design intent.
8. The Sample Size for the Training Set
Not applicable. This submission is for modifications to an existing MR-PET system software and hardware. The new software features described (e.g., reconstruction improvements, new sequences, usability improvements) are not typically "trained" in the machine learning sense from a large dataset but rather developed through traditional software engineering and signal processing methods.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a "training set" in the context of machine learning for this device modification.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.