(54 days)
The SIGNA PET/MR 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. MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional 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. 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 GE SIGNA PET/MR system is a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner. The system is designed for whole body oncology, neurology and cardiology examinations. The SIGNA PET/MR system provides simultaneous acquisition of high-resolution metabolic and anatomic information from the two major components of each system (MR and PET). Additional components of the system include: a patient table and both the acquisition and processing workstations with associated software. The SIGNA PET/MR includes a 3.0T superconducting magnet, gradient coil and body coil. The system includes dual drive capabilities. The SIGNA PET detectors are integrated into the MR bore. This allows for simultaneous, precisely aligned whole body MR and PET acquisition. The PET subsystem supports Time of Flight (ToF). The SIGNA PET/MR software is used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.
Here's an analysis of the provided text to extract the requested information regarding acceptance criteria and the study proving device performance for the SIGNA PET/MR system (K163619).
Important Note: The provided document is a 510(k) premarket notification summary for a modification to an existing device (SIGNA PET/MR, K142098). Therefore, the information primarily focuses on demonstrating substantial equivalence of the modified features (MR Attenuation Correction) rather than a complete de novo study of the entire PET/MR system. As such, some specific details typically found in studies for novel devices, such as comprehensive stand-alone performance or MRMC studies for improved human reading, are not explicitly provided or may not be applicable in the same way.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Defined for Modified Software Features) | Reported Device Performance (Summary from Non-Clinical and Clinical Tests) |
|---|---|
| Compliance with AAMI/ANSI 62304 (Medical Device Software - Software lifecycle processes) | Software features comply with AAMI/ANSI 62304 |
| Compliance with AAMI/ANSI ES60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance) | Software features comply with AAMI/ANSI ES60601-1 |
| Compliance with IEC 60601-2-33 (Medical electrical equipment - Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis) | Software features comply with IEC 60601-2-33 |
| Passing results for detailed Pass/Fail criteria defined in test cases for: | Testing completed with passing results per defined criteria for: |
| - Risk Analysis | - Risk Analysis (applied during development) |
| - Requirements Reviews | - Requirements Reviews (applied during development) |
| - Design Reviews | - Design Reviews (applied during development) |
| - Unit-level testing (Module verification) | - Testing on unit level (Module verification) |
| - Integration testing (System verification) | - Integration testing (System verification) |
| - Safety testing (Verification) | - Safety testing (Verification) |
| - Simulated use testing (Validation) | - Simulated use testing (Validation) |
| Substantial equivalence of modified MR Attenuation Correction to predicate MR Attenuation Correction technology regarding clinical images, qualitative, and quantitative comparisons. | Sample clinical images, qualitative and quantitative comparisons confirm substantial equivalence of modified features to predicate MR Attenuation Correction technology. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions "Sample clinical images" were used for qualitative and quantitative comparisons. However, a specific numerical sample size for this test set is not explicitly stated in the provided text.
- Data Provenance: Not explicitly stated. The document refers to "clinical images," but does not specify the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) for a medical device company, it's generally assumed to be clinical data relevant to human use, potentially from multiple sites.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not explicitly stated. The document does not detail how ground truth was established for the "sample clinical images" used for comparison, nor does it mention the number or qualifications of experts involved in this specific aspect of the testing for the modified features.
4. Adjudication Method for the Test Set
- Not explicitly stated. The document focuses on demonstrating compliance with quality assurance measures and comparative testing. It does not mention an adjudication method for a test set in the context of expert review or consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study is not mentioned. The submission describes "clinical tests" involving "sample clinical images, qualitative and quantitative comparisons compared to the predicate MR Attenuation Correction technology." This implies a comparison against the existing technology, but not necessarily an MRMC study with human readers assessing improvement with human-AI assistance. The focus is on the performance of the attenuation correction modification itself.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The reported performance relates to the "software-only features" and their engineering verification and validation ("Testing on unit level," "Integration testing," "Safety testing," "Simulated use testing"). The "qualitative and quantitative comparisons" of the modified MR Attenuation Correction also refer to the algorithmic performance in generating these corrections, independent of a human interpreting the final images. The comparative aspects focus on the technical output of the algorithm.
7. The type of ground truth used
- Regarding the "clinical tests" for the modified MR Attenuation Correction, the "ground truth" seems to be established through comparison to the predicate device's MR Attenuation Correction technology. The document states, "Sample clinical images, qualitative and quantitative comparisons compared to the predicate MR Attenuation Correction technology are included in this submission to support substantial equivalence of the modified features." This indicates the predicate's performance serves as the reference point for evaluating the new system's attenuation correction. It does not explicitly mention pathology or direct outcomes data being used as ground truth for this specific software modification.
8. The sample size for the training set
- Not explicitly stated. The document describes a software modification to an existing device. It discusses the development process using "Risk Analysis," "Requirements Reviews," and "Design Reviews" and then verification and validation testing. There is no mention of a separate "training set" in the context of machine learning model development. The focus is on demonstrating that the modified software behaves as intended and is substantially equivalent to the predicate.
9. How the ground truth for the training set was established
- N/A. As no explicit "training set" for a machine learning model is mentioned, there is no information on how its ground truth was established. The document describes a development and testing process for software features, not the training of an AI model in the typical sense with labeled data.
§ 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.