(73 days)
The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaqing, whole body imaging, tomographic imaging for isotopes with energies up to 588keV
CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
SPECT+CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.
Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.
The Siemens Symbia 5.0 systems consist of Single Photon Emission Computed Tomography (SPECT) scanners and integrated hybrid X-Ray Computed Tomography (CT) and SPECT scanners. The SPECT subsystem images and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and integrates CT's anatomical detail for precise reference of the location of the metabolic activity. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The system can be used as an integrated SPECT and CT modality while also enabling independent functionality of SPECT and CT as standalone diagnostic imaging devices.
The Symbia 5.0 consists of Symbia E,.S, T, Intevo Excel and Intevo systems.
- The Symbia E Series and Symbia S are SPECT only systems. s
- The Symbia T Series are SPECT/CT systems.
- The Symbia Intevo Excel is a non-diagnostic SPECT/CT system with CT support for I only attenuation correction and anatomical localization.
- . The Symbia Intevo Series are xSPECT systems. These are SPECT and CT systems integrated through xSPECT technology during image registration and reconstruction. This xSPECT integration enables the use of extra-modal information for high image quality and quantification.
For all systems, a new software version syngo MI Applications VA70 and optional LPHR collimator for I-123 imaging are available.
Here's an analysis of the Siemens Symbia 5.0 510(k) Premarket Notification based on the provided text, focusing on acceptance criteria and study details:
Siemens Symbia 5.0 - Acceptance Criteria and Study Analysis
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the submission focuses on demonstrating substantial equivalence to a predicate device (Symbia 4.0) rather than establishing specific quantitative performance acceptance criteria against a defined benchmark. The performance testing section largely references adherence to recognized standards and qualitative "meeting expected image quality requirements."
| Acceptance Criteria Category | Specific Criteria (if stated) | Reported Device Performance (if stated) |
|---|---|---|
| Performance & Safety | Conformance to applicable FDA recognized and international IEC, ISO and NEMA standards. | Conforms to applicable FDA recognized and international IEC, ISO and NEMA standards. |
| SPECT Detector Performance | NEMA NU2:2007 (for SPECT) | Performance does not change from the predicate device (implies it meets NEMA NU2:2007). |
| CT Performance | NEMA NU2:2007 (for CT) | Performance does not change from the predicate device (implies it meets NEMA NU2:2007). |
| LPHR Performance Testing | NEMA NU-1 :2007 | Conducted according to NEMA NU-1 :2007 (implies it meets the standard). |
| Image Quality (LPHR & xSPECT) | "Expected image quality requirements" (not quantitatively defined). | All image quality testing results meet expected image quality requirements. |
| Risk Management | Compliance with ISO 14971:2007 and IEC 60601-1 series. | Risk analysis in compliance with ISO 14971:2007 and adheres to IEC 60601-1 series. |
| Substantial Equivalence | Same intended use, same fundamental scientific technology, safe/effective/performance substantially equivalent to predicate. | Claims to have the same intended use and fundamental scientific technology as the predicate. Claims to be as safe, effective, and with performance substantially equivalent to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not contain information about a specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective). The performance testing described is primarily focused on adherence to standards rather than a clinical trial or a specific dataset to evaluate a new algorithm's performance against ground truth.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The provided text does not contain information about experts used to establish ground truth or their qualifications. The submission emphasizes technical performance and substantial equivalence based on engineering and physics standards.
4. Adjudication Method for the Test Set
The provided text does not contain information about any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The submission focuses on hardware and software updates, and their adherence to technical standards, rather than evaluating human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The text mentions a "new reconstruction algorithm, xSPECT," and states that "xSPECT enables the use of extra-modal information for high image quality and SPECT quantification." While this implies algorithmic performance, the provided text does not describe a standalone performance study where the xSPECT algorithm's output was evaluated independently against ground truth in a clinical context without human-in-the-loop. The evaluation appears to be integrated into image quality testing against "expected image quality requirements."
7. The Type of Ground Truth Used
The text indicates that "image quality testing is conducted for LPHR and xSPECT features, and all image quality testing results meet expected image quality requirements." This suggests that the ground truth for these tests was likely:
- Phantoms/Calibration Standards: For NEMA standards, phantoms are typically used to measure resolution, sensitivity, uniformity, etc.
- Engineering/Physics Benchmarks: "Expected image quality requirements" would likely be based on established engineering specifications and benchmarks for image characteristics.
There is no mention of ground truth based on expert consensus, pathology, or outcomes data in a clinical setting for evaluating the xSPECT algorithm's diagnostic accuracy.
8. The Sample Size for the Training Set
The provided text does not contain information about the sample size used for any training set.
9. How the Ground Truth for the Training Set Was Established
The provided text does not contain information about how ground truth was established for any training set. Given that the xSPECT algorithm is described as a "new reconstruction algorithm... based on the existing reconstruction algorithm of the predicate device," it's possible it was developed using internal engineering data and simulations, but the document does not elaborate on this.
Summary of Device and Study Focus:
The Siemens Symbia 5.0 510(k) submission primarily focuses on demonstrating substantial equivalence to its predicate device (Symbia 4.0) by ensuring that updates (software version syngo MI Applications VA70, new reconstruction algorithm xSPECT, LPHR collimator, and other improvements) do not negatively impact safety and fundamental performance. The "study" described is a series of performance tests against established industry standards (NEMA, IEC, ISO) and internal image quality requirements, rather than a clinical study evaluating diagnostic accuracy with a specific patient dataset, ground truth, or human reader performance. The lack of detailed clinical study data for the new xSPECT algorithm is typical for devices seeking substantial equivalence on the basis of maintaining core functionality and safety while offering incremental improvements.
§ 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.