(14 days)
The NewTom QR-DVT 9000 Computed Tomography X-ray System is a dedicated X-Ray imaging device that acquires a 360-degree rotational X-Ray sequence for use in diagnostic support in odontoiatric radiology (with a particular reference to patient chaghestion and the monitoring of implantations) and in the field of maxillofacial surgery. This is the same intended use as previously cleared for the NewTom QR-DVT 9000 Computed Tomography X-ray System, [510 (k) #K003787].
The NewTom 3G is a dedicated X-Ray imaging device that uses an X-Ray imaging system and a patient table. The NewTom 3G acquires a 360-degree rotational X-Ray sequence, reconstructs a three-dimensional matrix of the examined volume and produces two-dimensional views of this volume, displaying both two- and three-dimensional images. The NewTom 3G can measure distances and thickness on two-dimensional images.
Images produced by the NewTom 3G can be printed or exported on magnetic and optical media.
The NewTom 3G is designed for use in diagnostic support both in odontoiatric radiology, with a particular reference to "planning" and to monitoring of implantations, and in the field of maxillofacial surgery.
The Newlom 3G hardware, including a patient table and a gantry (comprised of an X-ray Source, image chain and a motorized arm) facilitates the acquisition of a full X-Ray sequence by the device's software. The NewTom software runs either in a Windows 2K or Windows XP workstation.
The NewTom 3G is an X-Ray imaging device that constructs a three-dimensional model from images taken during a rotational X-Ray sequence. The NewTom 3G is optimized for bone morphology analysis on the maxillofacial region.
The NewTom 3G reconstructs a three-dimensional model for X-Ray images similar to the three-dimensional model obtained using the original NewTom X-Ray system.
The provided text is a 510(k) summary for the NewTom 3G model QR-DVT 9000 Computed Tomography X-ray System. It asserts substantial equivalence to a predicate device, the NewTom model QR-DVT 9000. The document explicitly states that the determination of substantial equivalence was based on a comparison of machine specifications, not on clinical and/or non-clinical performance data. Therefore, it does not contain the detailed information requested regarding acceptance criteria, study design, or performance metrics.
Here's a breakdown of why the requested information cannot be extracted from this document:
- No Acceptance Criteria or Device Performance: The document does not define any specific acceptance criteria for performance, nor does it present any data on the device's performance against such criteria.
- No Performance Study: The text directly states: "The determination of substantial equivalence of the predicate device has been based upon the comparison of machine specifications and not upon clinical and/or nonclinical performance data, thus 21 C.F.R. Part 807.92(b) does not apply." This means no standalone performance study, MRMC study, or any other type of study involving patient data or expert interpretation was conducted for the purpose of demonstrating equivalence.
- No Sample Sizes, Data Provenance, Experts, Adjudication, Ground Truth, Training Set Information: Since no performance study was conducted, there are no details about sample sizes, data provenance, expert involvement, adjudication methods, or how ground truth would have been established.
In summary, the provided document focuses solely on demonstrating substantial equivalence based on technical specifications and intended use comparison to a predicate device, rather than through clinical performance data.
§ 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.