(66 days)
A1417MCW / A1717MCW / F1417MCW (Digital Flat Panel X-Ray Detector) are indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy targeting both adult and children. It is intended to replace film based radiographic diagnostic systems. Not to be used for mammography.
The A1717MCW/A1417MCW/F1417MCW is wired or wireless digital flat panel detectors that have been designed for faster, more streamlined approach to digital radiography systems. The A1717MCW/A1417MCW/F1417MCW detector utilize a combination of propriety TFT and scintillator (Csl), and those and electronics are housed in one package. The detectors support an auto-trigger signal sensing technology that allows the detectors to be used without generator integration. The flat panel sensors of the A1717MCW/A1417MCW/F1417MCW/ are fabricated using thin film technology based on amorphous silicon technology. Electronically, the sensors are much like conventional photodiode arrays. Each pixel in the array consists of a light-sensing photodiode and a switching Thin Film Transistor (TFT) in the same electronic circuit. Amorphous silicon photodiodes are sensitive to visible light, with a response curve roughly comparable to human vision. The sensitivity of amorphous sillcon photodiodes peaks in green wavelengths, well matched to scintillators such as Csl. The response has the excellent linearity of a charge-integrating-biased photodiode. SDK-MCW is the software of Detector that performs image acquisition, image correction, and preprocessing.
The provided document is a 510(k) premarket notification for a Digital Flat Panel X-Ray Detector (A1417MCW/A1717MCW/F1417MCW). It does not describe an AI/ML device or its acceptance criteria and study as per your request. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K213497) based on technological characteristics and non-clinical performance tests.
Therefore, I cannot extract the information you requested regarding acceptance criteria, study details for AI/ML device performance, sample sizes, expert qualifications, or adjudication methods from this document.
The document only states that:
- Indications for use: "A1417MCW / A1717MCW / F1417MCW (Digital Flat Panel X-Ray Detector) are indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy targeting both adult and children. It is intended to replace film based radiographic diagnostic systems. Not to be used for mammography."
- Non-Clinical Test Summary: The device complies with voluntary standards for electrical safety, electromagnetic compatibility, and its software (SDK-MCW) has a "moderate level of concern" and was validated. Imaging performance tests were conducted according to IEC 62220-1.
- Clinical Test Summary: "Clinical images were provided; these images were not necessary to establish substantial equivalence based on the differences from the predicate (note TFT technology with Csl scintillator that is identical to the predicate image plate) but they provide further evidence in addition to the laboratory performance data to show that the subject digital detector works as intended."
The document does not include specific acceptance criteria tables, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or details on how ground truth was established for training sets, as it is a submission for a hardware device (X-ray detector) and not an AI/ML diagnostic software.
§ 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.