(16 days)
The LightSpeed Ultra CT Scanner System with Wide - View is indicated for head and whole body X-ray computed tomography applications.
The GE LightSpeed Ultra CT Scanner System with Wide - View is composed of a gantry, patient table, image acquisition hardware and software, an operator console, and associated accessories. Materials and construction are equivalent to the LightSpeed Ultra CT Scanner System and are compliant with UL2601-1, IEC 60601-1 and associated collateral standards, and applicable sections of 21 CFR Subchapter J.
The provided text describes a 510(k) premarket notification for a medical device, the GE LightSpeed Ultra CT System with Wide-View. However, it does not contain information about acceptance criteria, specific performance metrics, or a study designed to prove the device meets such criteria in the way typically expected for an AI/CADe device.
This document is a regulatory submission for a modification to an existing CT scanner (adding a "Wide-View" option). The submission focuses on demonstrating substantial equivalence to the predicate device, not on proving new performance characteristics through a clinical study with detailed acceptance criteria.
Therefore, for many of your points, the answer will be that the information is not provided or not applicable based on the type of submission.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. This 510(k) submission for the LightSpeed Ultra CT System with Wide-View does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) for a new clinical performance study. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (the GE LightSpeed Ultra CT System, K000300). The "Summary of Studies" section only states: "The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards." It does not provide quantitative performance metrics against specific acceptance thresholds in a clinical context.
2. Sample Size Used for the Test Set and Data Provenance
Not Provided. No information regarding a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective) is included in this 510(k) submission. The submission focuses on safety and performance standard conformity and substantial equivalence, not a new clinical performance study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not Provided. Since no specific clinical test set or ground truth establishment process is described for device performance, information about experts or their qualifications is not present.
4. Adjudication Method for the Test Set
Not Provided. No test set or related adjudication method is mentioned in this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not Done. The document does not describe an MRMC comparative effectiveness study, nor does it mention AI or human-in-the-loop performance. This device is a CT scanner, not an AI/CADe system.
6. Standalone (Algorithm Only) Performance Study
Not Applicable. This is a hardware modification to a CT scanner, not a standalone algorithm. Therefore, no such study was performed or described.
7. Type of Ground Truth Used
Not Applicable. For the purpose of this 510(k) submission, the "ground truth" focused on ensuring the modified device met safety standards and maintained performance comparable to its predicate. This is assessed through engineering testing, compliance with standards (e.g., UL2601-1, IEC 60601-1, 21 CFR Subchapter J), and a review of the design and manufacturing process (21 CFR 820, ISO 9001/ EN 46001). There isn't a clinical ground truth (like pathology or outcomes data) established for a new clinical performance claim in this document.
8. Sample Size for the Training Set
Not Applicable. This document describes a CT scanner modification, not an AI/ML algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As no training set is relevant to this device submission, this information is not provided.
§ 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.