(67 days)
The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult patients and pediatric patients aged 12 and over.
Not Found
The provided text does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), or training set information for an AI/ML medical device.
The document is an FDA 510(k) clearance letter for the Carestream Health, Inc. OnSight 3D Extremity System. It states that the device is substantially equivalent to legally marketed predicate devices.
Specifically, the document provides:
- Device Name: OnSight 3D Extremity System
- Regulation Number/Name: 21 CFR 892.1750, Computed tomography x-ray system
- Regulatory Class: II
- Product Code: JAK
- Indications for Use: X-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult patients and pediatric patients aged 12 and over.
To answer your request, information regarding the performance study (e.g., clinical validation, technical validation) of the device would be required, which is typically found in the 510(k) summary or detailed submission documents, not in the clearance letter itself. Therefore, I cannot describe the acceptance criteria and the study that proves the device meets them based on the given text.
§ 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.