(15 days)
The LightSpeed Plus CT Scanner System is indicated for head and whole body X-ray computed tomography applications. It can be operated in a mobile as well as a fixed site environment.
The GE LightSpeed Plus Mobile CT Scanner System 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 Plus CT Scanner System and are compliant with UL2601-1, IEC 60601-1 and associated collateral standards, and applicable sections of 21 CFR Subchapter J.
This 510(k) pertains to the GE LightSpeed Plus Mobile CT System, which is described as a modification of the predicate device, the GE LightSpeed Plus CT System (K000300). The submission focuses on demonstrating substantial equivalence rather than presenting a study for new performance claims. Therefore, the information requested in your prompt regarding acceptance criteria, reported performance, and a detailed study description is not present in the provided document.
Here's an breakdown based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The document does not specify quantitative acceptance criteria for device performance. Instead, it relies on demonstrating that the modified device has "the same technological characteristics," "comparable in key safety and effectiveness features," "uses the same basic design, construction, and materials," and has "the same intended use" as the predicate device.
- Reported Device Performance: The document does not provide specific performance metrics (e.g., sensitivity, specificity, accuracy) for the LightSpeed Plus Mobile CT System. It broadly states that "The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards."
2. Sample Size Used for the Test Set and Data Provenance:
- This information is not provided in the document. The submission focuses on design and safety equivalence rather than clinical performance evaluation with a test set of data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not provided in the document, as there was no test set data requiring expert ground truth establishment.
4. Adjudication Method for the Test Set:
- This information is not provided in the document, as there was no test set to adjudicate.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was mentioned or performed. This submission is for a modification of an existing device, focusing on substantial equivalence rather than a new clinical effectiveness claim.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No standalone performance study was performed or mentioned. This device is a CT imaging system, not an AI algorithm.
7. Type of Ground Truth Used:
- This information is not applicable as there was no clinical study involving ground truth establishment for diagnostic performance. The ground truth in this context would implicitly be the established safety and performance of the predicate device.
8. Sample Size for the Training Set:
- This information is not applicable as this is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable as this is not an AI/machine learning device.
Summary of Study (as per the document):
The "Summary of Studies" section in the 510(k) states:
"The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards."
Conclusion drawn from the document:
The 510(k) is a Special 510(k), indicating a modification to an existing cleared device. The focus is on demonstrating that the changes do not raise new questions of safety or effectiveness and that the modified device remains substantially equivalent to the predicate. The "study" mentioned is conformity to safety and performance standards, not a clinical trial with specific performance metrics.
§ 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.