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510(k) Data Aggregation
(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.
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