(152 days)
The ddRElement is a Digital Radiography system developed to be used for Medical General Radiography examinations on standing, seated and supine patients.
The ddRElement is a Digital Radiography system.
The provided text is a dated FDA clearance letter and an "Indications for Use Form" for a device called "ddR Element," a Digital Radiography system. It does not contain specific information about acceptance criteria for a study, reported device performance metrics, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training sets.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes and data provenance for the test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Information on multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- A standalone performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is solely an FDA letter granting substantial equivalence for a medical device based on its indications for use, without detailing specific performance studies or their methodologies.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.