(13 days)
The GE BrightSpeed Delight Series Computed Tomography X-ray system is intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, patient for all ages, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. 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. Further the images can be post processed to produce additional imaging planes or analysis results.
The GE BrightSpeed Delight Series CT Scanner System is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.
The GE BrightSpeed Delight Series CT Scanner System (aka GE BrightSpeed Elite, BrightSpeed Elite Select, BrightSpeed Edge Select, and BrightSpeed Excel Select) is composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. The GE BrightSpeed Delight Series CT Scanner System is an evolutionary modification to StarSpeed Series CT system (K052855). It is developed from the hardware platform of StarSpeed system by adding new application features that involve changes in hardware, software, firmware, recon, and scan mode.
The GE BrightSpeed Delight Series CT Scanner System is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and similar Indications for Use. Materials and construction are equivalent to our existing marketed products, which are compliant with UL 60601-1, IEC 60601-1 and associated collateral and particular standards, and 21CFR Subchapter J.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the GE BrightSpeed Series CT Scanner System:
The provided document is a 510(k) summary for a GE BrightSpeed Series CT Scanner System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or specific performance metrics with clinical studies of the type described in the prompt. Therefore, much of the requested information regarding acceptance criteria, specific device performance, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in this document.
The document focuses on demonstrating that the new device, the GE BrightSpeed Delight Series CT Scanner System, is an "evolutionary modification" of a previously cleared device (GE StarSpeed Series CT Scanner System K052855) and performs "as well as or better than devices currently on the market," without introducing new safety risks.
Here's a breakdown of what can be extracted and what is explicitly not available from the provided text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: No new potential safety risks compared to predicate. | Device designed and manufactured under 21CFR820. Potential hazards identified and controlled via system verification/validation, adherence to industry standards (UL/CSA, IEC), and compliance with 21CFR Subchapter J. |
| Effectiveness/Functionality: Performs as well as or better than predicate. | Evolutionary modification with new application features (hardware, software, firmware, recon, scan mode). Uses same basic fundamental operating principles and similar Indications for Use as predicate. |
| Compliance: Certified to applicable X-ray, safety, and quality standards. | Certified to 21CFR1020.30, 21CFR1020.33 (X-ray requirements); UL 60601-1, IEC 60601-1 (safety requirements); and associated collateral and particular standards. |
| Substantial Equivalence: Comparable type, similar intended uses, and compliant with same or equivalent standards as predicate. | Directly compared to GE StarSpeed Series CT Scanner System (K052855). Stated to be "of comparable type and substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. A 510(k) for an evolutionary modification typically relies on technical comparisons, design verification, and adherence to standards rather than new clinical testing on a "test set" of patient data for performance claims.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided as a formal "test set" with expert-established ground truth as you describe for AI performance evaluation is not detailed in this type of submission. The evaluation is primarily against engineering specifications and predicate equivalency.
4. Adjudication Method for the Test Set
This information is not provided for the same reasons as above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study is not mentioned or described in this 510(k) summary. This type of study (comparing human readers with and without AI assistance to quantify improvement) is typically associated with AI/CADe (Computer-Aided Detection) or CADx (Computer-Aided Diagnosis) devices, which aim to aid in interpretation. This document describes a CT scanner system, an image acquisition device, not a diagnostic aid algorithm in that sense.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. The device in question is a Computed Tomography X-ray system, which is inherently a hardware and software system used by humans to acquire images. It does not perform a standalone diagnostic algorithm in the way an AI CADe/CADx device might.
7. The Type of Ground Truth Used
The concept of "ground truth" as it pertains to clinical outcomes or definitive diagnoses for evaluating an algorithm's performance is not directly applicable or detailed in this 510(k). The "truth" in this context is adherence to engineering specifications, safety standards, and functional equivalence to the predicate device.
8. The Sample Size for the Training Set
This information is not provided and is not relevant for this type of device submission. CT scanners do not typically have a "training set" in the machine learning sense to learn to perform their primary function of image acquisition and reconstruction. While there are internal development and testing processes, they are not described as a formal "training set" for an algorithm in this document.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not relevant for this type of device submission for the reasons outlined in point 8.
§ 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.