(54 days)
The CT/e Computed Tomography system is intended for head and whole body x-ray computed tomography applications.
The CT/e Computed Tomography system consist of a gantry, patient support, operator console, computer and associated accessories.
The provided text is a 510(k) Summary of Safety and Effectiveness for the GE CT/e Computed Tomography scanner system. This document is focused on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving performance against specific acceptance criteria for a new, novel AI-enabled device.
Therefore, many of the requested details about acceptance criteria, specific studies, sample sizes, expert involvement, and ground truth establishment are not present in this type of submission. This document predates the widespread use of AI in medical imaging devices and the specific regulatory guidance around its validation.
Here's an analysis based on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of an ordinary 510(k) submission for a conventional CT scanner. The submission's goal is to demonstrate substantial equivalence, not to meet pre-defined performance metrics for a novel algorithm.
2. Sample size used for the test set and the data provenance
Not applicable. This is not a study validating an AI algorithm with a test set of images. The "test" here refers to system verification and validation against specifications and regulatory requirements, not performance on a clinical image dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth establishment with experts is typical for AI/ML device validation. This document describes a conventional CT scanner submission.
4. Adjudication method for the test set
Not applicable.
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 is not an AI-enabled device and therefore no MRMC study was performed in relation to AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used
Not applicable in the context of validating performance on a clinical dataset. The "ground truth" for this conventional device would be its adherence to established engineering specifications, regulatory standards (e.g., 21 CFR Subchapter J, IEC 60601-1), and the performance of the predicate devices.
8. The sample size for the training set
Not applicable. This device is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of what is present and relevant in the document:
- Device Type: Conventional CT scanner (CT/e Computed Tomography scanner system)
- Regulatory Pathway: 510(k) clearance, demonstrating "substantial equivalence."
- Predicate Device: HiSpeed LX/i, FX/i and DX/i (K980169)
- Performance (as stated for substantial equivalence):
- "The CT/e Computed Tomography system is of comparable type and substantially equivalent to currently marketed computed tomography systems that comply with the same or equivalent standards and have the same intended uses."
- "It is the opinion of GE Medical Systems that the CT/e Computed Tomography system is of comparable type and substantially equivalent to currently marketed head and whole body x-ray computed tomography systems with respect to design, material composition, energy source and radiation characteristics."
- "It will comply with the x-ray performance standards of 21 CFR as well as the safety requirements of the IEC 60601-1 series of standards."
- "System verification and validation to insure performance to specifications, regulatory requirements and user requirements."
- "Adherence to Industry and International Standards (UL/IEC/CSA)"
- "Use of the CT/e Computed Tomography system does not result in any new potential safety risks and performs as well as, or better than devices currently on the market."
In essence, this document demonstrates that the CT/e system meets its "acceptance criteria" by being substantially equivalent to existing, legally marketed CT systems and by complying with relevant safety and performance standards for such devices. The "study" for this type of submission is the comprehensive engineering design, manufacturing adherence, and verification/validation activities typical for conventional medical devices.
§ 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.