(87 days)
The HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems is indicated for head and whole body x-ray computed tomography applications.
The HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems consists of a gantry, patient table, console, computer and associated accessories.
The provided text is a 510(k) summary for the GE Medical Systems HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems. This document is a premarket notification to the FDA for a medical device and typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria.
Based on the provided text, the following information can be extracted regarding acceptance criteria and performance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state numerical acceptance criteria and a detailed table of device performance against those criteria in the way a clinical study report would. Instead, the submission relies on demonstrating substantial equivalence to existing, legally marketed Computed Tomography (CT) X-ray Systems.
- Acceptance Criterion (Implicit): Substantial equivalence to currently marketed Computed Tomography X-ray Systems regarding design, material composition, energy source, radiation characteristics, and safety.
- Reported Device Performance (Implicit): The HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems perform "as well as or better than devices currently on the market" and do not introduce "any new potential safety risks." This is a qualitative statement of performance relative to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not mention any specific test set, sample size, or data provenance (e.g., country of origin, retrospective or prospective) for a performance study. The evaluation appears to be based on system verification and validation to specifications, rather than a clinical trial with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The document does not describe a test set or ground truth established by experts.
4. Adjudication Method for the Test Set:
Not applicable. There is no mention of a test set or an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. The document does not indicate that an MRMC comparative effectiveness study was performed. The focus is on demonstrating substantial equivalence to existing devices, not on comparing reader performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
The device described is a CT scanner system, not an AI algorithm. Therefore, a standalone algorithm-only performance study is not relevant in this context. The evaluation is for the entire hardware and software system.
7. The Type of Ground Truth Used:
Not applicable. The document does not describe a performance study involving ground truth derived from clinical data (like pathology or outcomes data). The "ground truth" for the substantial equivalence claim is the performance and safety profile of the predicate devices.
8. The Sample Size for the Training Set:
Not applicable. This document describes a CT imaging system, not an AI model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, the device is a CT imaging system, not an AI model.
In summary, this 510(k) submission is for a new generation of CT scanners demonstrating substantial equivalence to previously cleared devices. It relies on internal verification and validation against specifications and adherence to standards rather than detailed clinical performance studies with specific acceptance criteria, ground truth, and expert evaluation to prove performance in the context of advanced diagnostic algorithms.
§ 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.