(17 days)
The Siemens Symbia series 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 and interventional radiology procedures.
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, 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 take at different angles.
SPECT+CT: The SPECT and CT components used together acquire SPECT/CT 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 syngo MI Applications software is a 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 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 provided document is a 510(k) Pre-market Notification from Siemens Medical Solutions, USA, Inc. to the FDA for their Symbia 6.5 device. This document primarily focuses on establishing substantial equivalence to a predicate device (Symbia 6.0) rather than presenting a detailed clinical study for a novel AI/software component, which is what the prompt's questions imply by asking for "human readers improve with AI vs without AI assistance" or "stand alone (i.e. algorithm only without human-in-the-loop performance)."
The document discusses updates to the Symbia device, including upgraded software and the integration of commercially marketed CT software and a viewing application. The "syngo MI Applications software" is described as a display and analysis package intended to aid clinicians. However, the performance testing section does not describe a clinical study of an AI algorithm in the way the prompt specifies. Instead, it focuses on physical performance characteristics of the SPECT/CT system, specifically quantitative accuracy using phantoms, and refers to electrical, mechanical, and radiation safety standards.
Therefore, many of the requested details about acceptance criteria and study design for an AI-powered diagnostic device are not present in this document. The document describes performance testing for a medical imaging system, not a specific AI-driven diagnostic or assistive algorithm for image interpretation that would involve human readers or ground truth established by experts.
Given the information provided in the document:
Acceptance Criteria and Reported Device Performance
The acceptance criteria and performance reported relate to the quantitative accuracy of the SPECT system, not a specific AI diagnostic algorithm.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Absolute quantification accuracy of the system shall be within 10% in phantoms for objects larger than three times the system resolution when acquired for count rates up to 160 kcps. | Pass (Deviation from true |
§ 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.