(103 days)
The GE LightSpeed Xtra CT Scanner System is indicated for head and whole body Xray Computed Tomography applications.
The system is capable of generating images for the guidance of minimally invasive procedures such as biopsy and ablation of tumors and pathology.
The system allows imaging of obese patients, up to and including the morbidly obese population (BMI > 40).
When used in the LightSpeed RT Pro16 configuration:
The system acquires CT anatomical images that are clinically useful in the simulation and planning of radiation therapy for the treatment of cancer.
The LightSpeed Xtra CT Scanner System is composed of a gantry, patient table, operator console, power distribution unit (PDU), and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.
The system generates images through the computer reconstruction of data acquired at different angles of the same axial plane. The gantry can rotate at up to 0.5 seconds per rotation, and can acquire up to 16 slices of data with a maximum total coverage of 20mm in the axial direction. The system may be operated in both axial and helical scan modes.
The system features an 80cm diameter wide bore to accommodate large patients and radiation therapy planning immobilization devices, to allow easy access during interventional procedures, and for ease of patient positioning.
The LightSpeed Xtra system is also available as the LightSpeed RT ProJ6, which features a unique accessory package designed to assist planning of radiation therapy procedures.
The provided text is a 510(k) summary for the GE LightSpeed Xtra CT Scanner System. This document is primarily focused on demonstrating substantial equivalence to a predicate device and discussing the device's technical specifications and intended use. It does not contain information about specific acceptance criteria for device performance, nor details of a study that proves the device meets such criteria in terms of clinical accuracy or diagnostic efficacy.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: The document does not define specific performance metrics or acceptance criteria for clinical outcomes or diagnostic accuracy. It focuses on technical specifications and safety standards.
- Sample size used for the test set and the data provenance: No test set data or provenance is mentioned for device performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment for a clinical test set is not described.
- Adjudication method for the test set: No test set adjudication method is mentioned.
- 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: No MRMC study, AI component, or human improvement metrics are discussed.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance is discussed as this is a CT scanner, not an AI diagnostic algorithm.
- The type of ground truth used: No ground truth for clinical performance or diagnostic accuracy is described.
- The sample size for the training set: No training set information is provided.
- How the ground truth for the training set was established: No training set information is provided.
The document states:
- "LightSpeed Xtra is an evolutionary modification to the LightSpeed 5.0 scanner (K030420), does not result in any new potential safety risks, and performs as well as or better than devices currently on the market." This is a general claim of equivalence and performance, not a report of specific acceptance criteria met.
- "LightSpeed Xtra will be certified to comply with the X-ray requirements of 21CFR1020.30 and 1020.33, as well as the safety requirements of UL 60601-1, and IEC 60601-1 and associated collateral and particular standards." These are safety and technical compliance standards, not clinical performance acceptance criteria.
To obtain the information you are requesting, you would typically need a clinical study report or performance evaluation document, which is not included in this 510(k) summary.
§ 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.