(190 days)
The NL4000 BodyTom is intended to be used for non-contrast x-ray computed tomography applications for anatomy that can be imaged in the 85cm aperture.
The NL4000 BodyTom is essentially a larger bore version of our predicate NL3000 CereTom CT system. It is a high resolution, multi row, 85 cm bore, 60cm field of view, x-ray computed tomography system. The lightweight translating gantry consists of a rotating disk with a solid state x-ray generator, solid state detector array, collimator, control computer, communications link, power slip-ring, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation), and stepper drive system (translation). The power system consists of batteries which provide system power while unplugged from the charging outlet. The system software is based upon the CereTom software, however, does not contain application specific software for contrast imaging. In addition, the system has the necessary safety features such as emergency stop switch, x-ray indicators, interlocks, patient alignment laser, and 110 percent x-ray timer. The gantry has retractable rotating caster wheels and electrical drive system so the system can be moved easily to different locations.
The provided text is a 510(k) Summary for the NeuroLogica Corporation NL4000 BodyTom Computed Tomography System. It describes the device and claims substantial equivalence to predicate devices. However, it does not contain a study or acceptance criteria related to a specific AI algorithm's performance.
The document focuses on the physical device (CT scanner) and its technical specifications, safety, and equivalence to other CT scanners, not on an AI algorithm that processes images from the scanner. Therefore, I cannot extract information about acceptance criteria and a study proving an AI device meets these criteria as requested in the prompt.
The information present in the document is about the CT scanner itself and its regulatory approval process.
Here's a breakdown of why I cannot fulfill your request based on the provided text:
- No AI Algorithm: The document describes a "Computed Tomography X-ray System" (NL4000 BodyTom™), which is a hardware device for acquiring CT images. It does not mention any AI or software algorithm designed to interpret or analyze these images.
- No Performance Metrics for AI: Consequently, there are no acceptance criteria, reported device performance (in terms of AI metrics like sensitivity, specificity, AUC), sample sizes for test sets, ground truth establishment, or MRMC studies for an AI component.
- Substantial Equivalence, not Performance Study: The entire document is a submission for "Substantial Equivalence" to legally marketed predicate CT devices. This means the manufacturer is arguing that their new CT scanner is as safe and effective as existing ones, based on comparable technological characteristics, not on superior performance of an AI application.
If you have a different document that details an AI algorithm's performance for a medical device, I would be happy to analyze it according to your requested format.
§ 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.