(27 days)
1717FCC is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.
1717FCC is a digital solid state X-ray detector that is based on flat-panel technology. This radiographic image detector and processing unit consists of a scintillator coupled to amorphous silicon (a-Si) / Indium Gallium Zinc Oxide (IGZO) on TFT sensor. This device is connected to the user PC via wired LAN (ethernet cable) and it needs to be integrated with a radiographic imaging system. It does not operate as an X-ray generator controller but can be utilized to capture and digitalize X-ray images for radiographic diagnosis. The RAW files can be further processed as DICOM compatible image files by separate console SW(Xmaru RF) for a radiographic diagnosis and analysis.
The provided text describes a 510(k) summary for the Rayence 1717FCC Digital Flat Panel X-Ray Detector, claiming substantial equivalence to predicate devices (1717SCC, K171420) and a reference device (DRF 4343, K080859). The performance claims primarily revolve around demonstrating equivalent or better image quality and technical specifications compared to these predicate devices, rather than establishing acceptance criteria against a specific clinical performance threshold.
Therefore, the typical structure for answering questions about acceptance criteria and clinical study results for a new AI/CAD device (which usually involves specific metrics like sensitivity, specificity, AUC, human reader improvement, etc.) is not directly applicable to this document. This submission is for a hardware device (a digital X-ray detector), not an AI algorithm, and the primary method of demonstrating "acceptance" is through showing substantial equivalence to existing hardware rather than meeting specific clinical performance metrics.
However, I can interpret the request in the context of this 510(k) submission for a hardware device and extract relevant information to address the spirit of your questions as much as possible.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For this hardware device, "acceptance criteria" are based on demonstrating equivalent or superior technical performance and image quality compared to a legally marketed predicate device, rather than diagnostic accuracy metrics.
| Characteristic | Acceptance Criteria (Equivalent/Better than Predicate/Reference) | Reported Device Performance (1717FCC) | Relationship to "Acceptance" |
|---|---|---|---|
| Indications for Use | Same as predicate (general radiographic system, not mammography) | "1717FCC is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to... replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography." | Met (Same) - The core "intended use" is identical to the predicate, forming a foundational aspect of substantial equivalence. |
| Detector Type | Similar to predicate (Amorphous Silicon (a-Si) TFT) | Amorphous Silicon (a-Si) TFT + PIN type photodiode; IGZO TFT + PIN type photodiode (option) | Met (Similar, with enhancement) - The change to IGZO TFT is noted as an option, but the fundamental technology (flat panel, TFT) is similar. The document doesn't indicate this as a failing point; rather, an innovation. |
| Scintillator | Same as predicate (CsI:Tl) | CsI:Tl | Met (Same) - Explicitly stated as the same, which is a key component for image generation. |
| Imaging Area | Similar to predicate (17 x 17 inches) | 17 x 17 inches | Met (Same) - Physical size is the same. |
| Pixel Matrix/Pitch | Similar pixel matrix/pitch to predicate (e.g., 140 μm) | 140 type: 3000 x 3000 (Full resolution), 140 μm / 280 μm/ 420 μm/ 560 μm | Met (Similar, with enhancements/options) - While offering different pixel options (280/420/560 μm, and associated binning), the 140 μm is comparable to the predicate. The document states "The pixel matrix and pixel pitch sizes are different imaging areas but the differences do not raise new concerns for the safety and effectiveness of the subject device." |
| A/D Conversion | Same as predicate (14 bit / 16 bit) | 14 / 16 bit | Met (Same) |
| MTF (Image Sharpness) | Equivalent or better than predicate | a-Si TFT: 1.0 lp/mm, Typ. 0.535; 2.0 lp/mm, Typ. 0.220; 3.0 lp/mm, Typ. 0.099; 3.5 lp/mm, Typ. 0.073. | |
| IGZO TFT: Comparison to predicate not directly given for IGZO, but implied as strong performance. | Met (Equivalent or Better) - "1717FCC demonstrated equivalent or better performance in terms of MTF... compared to 1717SCC, the predicate device, at all spatial frequencies." | ||
| DQE (Image Quality/Dose Efficiency) | Equivalent or better than predicate | a-Si TFT: Typ. 0.751 (at 0 lp/mm). | |
| IGZO TFT: Typ. 0.766 (at 0 lp/mm). | |||
| Predicate 1717SCC was Typ. 0.740 (at 0 lp/mm). | Met (Equivalent or Better) - "1717FCC demonstrated equivalent or better performance in terms of... DQE as well as NPS compared to 1717SCC, the predicate device, at all spatial frequencies." | ||
| NPS (Noise Power Spectrum) | Equivalent or better than predicate | (Specific values not detailed, but comparison mentioned) | Met (Equivalent or Better) - "1717FCC demonstrated equivalent or better performance in terms of... NPS compared to 1717SCC, the predicate device, at all spatial frequencies." |
| Preview Time | Same as predicate ( |
§ 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.