(13 days)
SPECT: To detect or image the distribuītion of SPECT: radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
CT: The CT component is intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data from either the same axial place taken at different angles or spiral planes taken at different angles.
SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.
The Siemens Enhanced Imaging System is an improved version of the e.cam gamma camera that now incorporates 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 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 Siemens Enhanced Imaging System is intended to allow healthcare facilities to carry out SPECT and CT studies using the same instrument.
The Siemens Enhanced Imaging System has been modified to include upqraded electrical, computer, software and mechanical performance features that produce nuclear medicine images and CT-based attenuation corrected images in order to identify regions of interest in the patient's anatomy.
The device includes updated display equipment, data storage devices, patient and equipment supports and component parts and accessories.
Here's an analysis of the provided text regarding the Siemens Enhanced Imaging System, focusing on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific quantitative acceptance criteria and detailed performance metrics are not explicitly stated. The document primarily focuses on demonstrating substantial equivalence to predicate devices through various tests.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Functional Performance (Safety & Effectiveness) | "successfully undergone bench and functional testing" |
| Software Verification & Validation | "successfully undergone... software verification and validation" |
| Electrical Safety | "successfully undergone... electrical safety" |
| Environmental Testing | "successfully undergone... environmental testing" |
| Design Modifications | "demonstrate acceptable performance of the device" |
| No New Safety/Effectiveness Issues | "The test results do not raise any new or additional issues of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for any test set or its provenance (e.g., country of origin, retrospective/prospective). The studies mentioned are described generally as "bench and functional testing" and "software verification and validation."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention using experts to establish ground truth for a test set, nor does it specify their number or qualifications. The nature of the device (an imaging system, not an AI-driven diagnostic tool) suggests that performance was likely evaluated through technical metrics and comparisons to predicate devices, rather than expert-adjudicated diagnostic accuracy studies.
4. Adjudication Method for the Test Set
As no expert-established ground truth or diagnostic test set is described, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
The provided text does not indicate that an MRMC comparative effectiveness study was conducted. The device is a "Siemens Enhanced Imaging System," an improved gamma camera incorporating CT, and the focus of the submission is on its safety and effectiveness compared to predicate devices, not on the improvement of human readers with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device described is an imaging system (hardware and software) that assists clinicians in imaging and localization. It is not an AI algorithm designed to perform diagnostic tasks in a standalone manner. Therefore, a standalone algorithm-only performance study is not applicable and not mentioned. The system provides "attenuation corrected images and to provide registration of anatomical and physiological images," which are tools for human interpretation.
7. The Type of Ground Truth Used
The text does not explicitly state the type of ground truth used, as the studies described are primarily technical validation of the system's performance (e.g., functional, electrical safety, software V&V). For an imaging system, ground truth typically relates to the accuracy of image formation, registration, and attenuation correction, which would be assessed against physical phantoms or established imaging standards/benchmarks, rather than pathology or outcomes data in the context of diagnostic accuracy.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This is consistent with the nature of the device as an enhanced imaging system rather than a machine learning/AI diagnostic algorithm that requires explicit training data to learn patterns.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set for an AI/ML algorithm, the method for establishing its ground truth is not applicable and not mentioned.
§ 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.