(21 days)
The PDX-2000 Portable Digital X-Ray System provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
The PDX-2000 Portable Digital X-ray System consists of a Canon X-ray digital camera CXDI-22 retrofit kit, a MinXray Portable Source Generator and Trex proprietary adaptations. The PDX-2000 provides diagnostic images for general radiography with portable table and upright system.
I'm sorry, but I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text. The document is a 510(k) summary for a portable digital X-ray system, which focuses on demonstrating substantial equivalence to predicate devices rather than detailing specific acceptance criteria and a study design with the requested level of detail.
The provided text does not contain:
- A table of acceptance criteria and reported device performance.
- Information on sample sizes for test sets, data provenance, or the number/qualifications of experts for ground truth.
- Details on adjudication methods, MRMC studies, or standalone algorithm performance.
- Specifics on the type of ground truth used for any potential studies mentioned.
- Sample size for training sets or how their ground truth was established.
The 510(k) summary primarily:
- Identifies the device (PDX-2000 Portable Digital X-ray System).
- Lists the submitter, contact, and classification information.
- Describes the device components (Canon X-ray digital camera, MinXray Portable Source Generator, Trex proprietary adaptations).
- States the intended use: "provides digital image capture for conventional film/screen radiographic examinations" and "intended to replace radiographic film/screen systems in all general purpose diagnostic procedures."
- Identifies predicate devices: MinXray HF100H Portable X-ray Generator and Canon CXDI-11/CXDI-22 X-ray Digital Cameras.
- Includes a table of comparison, which simply states that the Trex PDX-2000 uses the "Same" components as the predicate devices (Canon CXDI-11/22 and MinXray HF100H).
The 510(k) process primarily relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, often by showing it has the same technological characteristics and intended use, or that any differences do not raise new questions of safety and effectiveness. It does not typically require the extensive performance study details you are asking for, especially concerning AI/algorithm performance, expert-established ground truth, and MRMC studies, which are more common for AI-driven diagnostic devices today. This document is from 2001, prior to the widespread integration of AI into medical devices and the specific regulatory frameworks for such.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.