(76 days)
The Siemens Symbia VA10A Family is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging 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 or additional uses.
SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques: planar imaging, whole body imaging, and tomographic imaging for isotopes with energies up to 588 keV.
CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes taken at different angles.
SPECT+CT: The SPECT and CT components used together acquire SPECT/CT images. The SPECT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images.
Software: The SPECTsyngo software is an acquisition, display and analysis package intended to aid the clinician in the assessment and quantification of pathologies in images produced from SPECT, PET, CT, and other imaging modalities.
The Siemens Symbia VA10A Family consists of Single-Photon Emission Computed Tomography (SPECT) scanner and integrated hybrid x-ray Computed Tomography (CT) and SPECT scanner.
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 stand-alone diagnostic imaging devices.
Siemens Symbia VA10A Family maintains the same intended use and indications for use as the commercially available Intevo Bold System of Symbia 6.7 (K200474).
Symbia VA10A Family introduces hybrid modality imaging systems comprised of two separate but integrated components: a gamma camera (SPECT) and a CT. The gamma camera is based on hardware and software features that generate nuclear medicine images based on the uptake of radioisotope tracers in a patient's body. The CT system (spiral CT) is designed 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.
The combination of SPECT and CT in a single device has several benefits. The SPECT subsystem images biochemical function while the CT subsystem images anatomy. The combination enables scans that not only indicate function, e.g. how active a tumor is, but precise localization, e.g. the precise location of that tumor in the body.
In addition, CT can be used to correct for the attenuation in SPECT acquisitions. Attenuation in SPECT is an unwanted side effect of the gamma rays scattering and being absorbed by tissue. This can lead to errors in the final image. The CT directly measures attenuation and can be used to create a 3D attenuation map of the patient which can be used to correct the SPECT images. The SPECT-CT scanner can be used to image and track how much dose was delivered to both the target and the surrounding tissue.
The systems consist of display equipment, data storage devices, patient and equipment supports and component parts and accessories.
The Symbia VA10A project will integrate the aCTivate platform within this release.
"Symbia VA 10A" is the product name for a new line of Siemens MI SPECT-CT products. The Symbia VA10A Family devices are based on the Symbia Intevo Series. The difference lies in the new name and updated CT. The Intended Purpose, Indications for Use and fundamental scientific technology remains unchanged. The changes included in this submission do not affect the safety and effectiveness of the device.
The provided text is a 510(k) summary for the Siemens Symbia VA10A Family of SPECT/CT systems. It describes the device, its intended use, and claims substantial equivalence to a predicate device (Symbia Intevo Bold).
Unfortunately, this document does not contain the detailed information required to answer your specific questions about the acceptance criteria and the study that proves the device meets those criteria, especially regarding AI/algorithm performance.
The document discusses performance testing for the CT subsystem (citing IEC 60601-2-44 and US regulations) and general SPECT performance (citing NEMA NU-1). However, it does not mention any specific acceptance criteria for AI or algorithmic performance, nor does it describe a study design that would evaluate such performance with quantitative metrics like sensitivity, specificity, or AUC, or MRMC studies.
The "Software" section under "Indications for Use" states: "The SPECTsyngo software is an acquisition, display and analysis package intended to aid the clinician in the assessment and quantification of pathologies in images produced from SPECT, PET, CT, and other imaging modalities." This is a general statement about software functionality but doesn't detail any specific AI-driven analysis or how its performance would be measured against defined criteria.
The information provided suggests that the submission focuses on the hardware and core software functionalities of a SPECT/CT system, rather than a novel AI-driven diagnostic or assistive algorithm for which detailed performance studies would typically be required for a 510(k) clearance seeking to demonstrate substantial equivalence for that specific AI feature.
Therefore, based solely on the provided text, I cannot fill out the requested table or answer most of your detailed questions regarding acceptance criteria and AI performance studies.
Here's a breakdown of what can be extracted and what is missing:
Acceptance Criteria and Study for AI/Algorithm Performance (Information NOT available in the provided text)
The document primarily focuses on demonstrating substantial equivalence of the new SPECT/CT system (Symbia VA10A Family) to a predicate device (Symbia Intevo Bold) based on hardware components and existing functionalities. It explicitly states: "The Intended Purpose, Indications for Use and fundamental scientific technology remains unchanged. The changes included in this submission do not affect the safety and effectiveness of the device." This suggests that no novel AI algorithms requiring new performance studies were part of this specific 510(k) submission.
1. A table of acceptance criteria and the reported device performance
- Not explicitly provided for AI/algorithmic performance. The document lists detector specifications for SPECT (Intrinsic spatial resolution, Intrinsic spatial linearity, Intrinsic energy resolution, Intrinsic flood field uniformity) and general CT performance standards (21 CFR 1020.30, 1020.33, etc.), but these are for the imaging system itself, not a specific AI-driven diagnostic or analytical tool.
2. Sample size used for the test set and the data provenance
- Not provided. No details on a test set for AI/algorithm performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not provided. No details on ground truth establishment for AI/algorithm performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided.
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
- Not provided/Applicable. The document does not describe any MRMC study for AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not provided/Applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not provided.
8. The sample size for the training set
- Not provided.
9. How the ground truth for the training set was established
- Not provided.
Information that is available in the provided document, but pertains to the overall system, not specific AI algorithms:
- Device Name: Symbia VA10A Family
- Manufacturer: Siemens Medical Solutions USA, Inc.
- Product Code: KPS (Emission Computed Tomography System), JAK (Computed Tomography X-Ray System)
- Regulatory Class: Class II
Performance Testing (General System):
- CT Subsystem: Performance testing was included in the original premarket notification for the CT subsystems (K200524). Tested against:
- 21 CFR 1020.30 (a), (b)(36)(iii)-(v), (b)(58)-(62), (h)(3)(vi)-(viii)
- 21 CFR 1020.33 Computed Tomography (CT) equipment
- 21 CFR 1040.10 Laser Products
- 21 CFR 1040.11 Specific purpose laser products
- IEC 60601-2-44
- SPECT System:
- Performance testing is conducted according to NEMA NU-1.
- All Performance testing met the predetermined acceptance values.
- Specific Detector Specifications (for Tc99m):
- Intrinsic spatial resolution (FWHM in CFOV: ≤3.8 mm, FWHM in UFOV: ≤3.9 mm; FWTM in CFOV: ≤7.5 mm, FWTM in UFOV: ≤7.7 mm)
- Intrinsic spatial linearity (Differential in CFOV: ≤0.2 mm, Differential in UFOV: ≤0.2 mm; Absolute in CFOV: ≤0.4 mm, Absolute in UFOV: ≤0.7 mm)
- Intrinsic energy resolution (FWHM in CFOV: ≤9.9%)
- Intrinsic flood field uniformity (uncorrected) (Differential in CFOV: ≤2.5%, Differential in UFOV: ≤2.7%; Integral in CFOV: ≤2.9%, Integral in UFOV: ≤3.7%)
- States that NEMA detector and collimator performance specifications do not change, and there are no changes in system design impacting SPECT performance.
Software Specifics:
- "The SPECTsyngo software is an acquisition, display and analysis package intended to aid the clinician in the assessment and quantification of pathologies in images produced from SPECT, PET, CT, and other imaging modalities."
- "Verification and validation of Siemens software is performed in accordance with documented procedures, test plans and specifications. Traceability of the requirements specified in the requirement specifications and functional specifications is ensured during component integration, software verification, and system testing."
- "System and System Integration testing (validation) was carried out for all features of the project, and all planned test cases were executed."
- Verification and Validation aims to: ensure functionality, quality, risk mitigation, identify issues, and ensure specifications meet intended use.
Cybersecurity:
- Mentions cybersecurity controls to prevent unauthorized access, modifications, misuse, or denial of use, and unauthorized use of information. Adheres to FDA Guidance (Oct 2, 2014).
In conclusion, the provided FDA 510(k) summary focuses on demonstrating the substantial equivalence of updated hardware and general software functionalities of a SPECT/CT system to a predicate device, rather than the performance of a distinct AI/algorithmic component with specific diagnostic claims. Therefore, the detailed questions about AI acceptance criteria and study design cannot be answered from this document.
§ 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.