(79 days)
To control the X-Ray on time exposure
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to IED, Inc. regarding X-Ray Timer Models #IED7881, IED7888, and IED #B7641D. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as typically found in a clinical study report or performance evaluation.
The letter confirms the device is substantially equivalent to legally marketed predicate devices for controlling X-ray on-time exposure. It discusses regulatory classifications, general controls provisions, and refers to GMP regulations, but does not detail any specific performance metrics, test methodologies, or study results.
Therefore, I cannot provide the requested information from the given text.
To answer your request, I would need a document that describes a performance study for the X-ray Timer, including:
- Acceptance criteria: Specific thresholds the device needed to meet (e.g., accuracy of timing within a certain percentage).
- Study design: Details of how the device was tested.
- Results: The actual performance data obtained from the study.
- Ground truth establishment: How the "true" values for comparison were determined.
§ 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.