(400 days)
The SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image whole organs, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes.
The system is indicated for X-ray Computed Tomography imaging of organs that fit in the scan field of view, including cardiac and vascular CT imaging. The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.
The SpotLight Duo is a multi-slice (192 detector rows), dual tube CT scanner consisting of a gantry, patient table, operator console, power distribution unit (PDU) and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software for operator interface and image handling. As in other CT scanned subject is irradiated by X rays and a detector array measures attenuation data of X rays that have been attenuated by the subject from multiple view angles. This is achieved by rotation source and the detector about the subject while acquiring the attenuation data. A computer is used to reconstruct cross sectional images of the subject from the attenuation data.
The provided text describes the regulatory clearance of a medical device, the "SpotLight Duo," and its substantial equivalence to predicate devices based on non-clinical performance testing. However, it does not include detailed acceptance criteria or the specific results of a study designed to prove the device meets these criteria in the format requested.
Here's a breakdown of the missing information and what can be inferred:
1. A table of acceptance criteria and the reported device performance: This information is not explicitly provided in a table format with specific quantitative criteria and corresponding performance metrics. The document mentions "performance specifications are met" but does not detail what these specifications are.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No information about sample size or data provenance is provided. The testing described is non-clinical performance testing using phantoms, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable, as the testing described is non-clinical performance testing using phantoms. No human expert review for establishing ground truth is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as the testing described is non-clinical performance testing using phantoms.
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: An MRMC comparative effectiveness study was not done. The device is a CT scanner, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done: The document describes non-clinical performance testing of the CT scanner hardware and software. It's essentially a standalone performance evaluation of the imaging system itself, independent of human interpretation for the purpose of demonstrating technical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical performance testing, the ground truth would be established by the known physical properties and configurations of the phantoms used, as well as established metrology and physics principles for evaluating CT image quality and dose.
8. The sample size for the training set: Not applicable. The device is a CT scanner, and the "training set" concept is typically associated with machine learning or AI models, which is not the primary focus of this submission. The software adaptations mentioned are for supporting new detector configurations, reconstruction at larger FOV, and scan modes based on engineering modifications, not machine learning model training.
9. How the ground truth for the training set was established: Not applicable for the reasons stated above.
In summary, the provided text describes a 510(k) premarket notification for a Computed Tomography X-ray System (SpotLight Duo). The "study" proving it meets acceptance criteria refers to a series of non-clinical performance tests using phantoms to demonstrate that the device's technical specifications - regarding image quality (spatial resolution, low contrast detectability, noise, uniformity, CT number accuracy) and dose performance - are met, and that it complies with relevant electrical safety and radiation protection standards.
The document does not contain information about clinical studies with human participants, expert review of images, or AI-specific performance metrics. It focuses on the physical and technical performance of the imaging device itself.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.