(88 days)
The SmartView Option for HiSpeed CT/i is indicated for head and whole body x-ray computed tomography applications. This option is a modifications which can be added to the existing family of HiSpeed CT/i Systems. The option provides almost "real time" reconstruction (SmartView) with a display latency of less than one second. An in-room monitor provides an image display with 6 frame/sec display of up to ninety, one second rotation, scans. Controls are provided for the control of the table and gantry by a physician or their assistant during procedures that require imaging.
The SmartView Option for HiSpeed CT/i is an x-ray computed tomography scanner based on the HiSpeed CT/i platform consisting of a gantry, patient table, console, computer and associated accessories.
The provided document is a 510(k) summary for the GE Medical Systems SmartView Option for HiSpeed CT/i. It focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed study proving performance against defined acceptance criteria. Therefore, most of the requested information cannot be extracted from this document, as it describes a clearance process based on equivalence for a modification to an existing device, not a performance study for a novel device.
However, based on the limited information, here's what can be gathered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Display latency | Less than one second |
| Image display frame rate | 6 frames/sec for up to ninety, one-second rotation, scans |
| Safety | No new potential safety risks compared to predicate devices; performs as well as or better than currently marketed devices regarding safety. Adherence to UL and IEC standards. |
2. Sample size used for the test set and the data provenance
Not applicable. The document does not describe a clinical study with a test set of images or patients. It focuses on demonstrating safety and effectiveness through substantial equivalence and compliance with existing standards for a device modification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No test set requiring expert ground truthing is described in this document.
4. Adjudication method for the test set
Not applicable. No test set adjudication is described.
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 applicable. This device is a modification to a CT scanner that provides "real-time" reconstruction and display for procedural guidance. It is not an AI-assisted diagnostic tool that would typically undergo an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The SmartView Option is an integrated component of a CT system designed to provide real-time image feedback to a physician during procedures. It's not a standalone algorithm in the typical sense.
7. The type of ground truth used
Not applicable as there is no described performance study for a diagnostic task. The "ground truth" for the device's functionality would be its ability to display images within the specified latency and frame rate, which appears to be based on engineering specifications and testing rather than a clinical ground truth.
8. The sample size for the training set
Not applicable. This document describes a hardware/software modification to an existing CT system, not an AI model requiring a training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable. As above, no training set for an AI model is described.
§ 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.