(133 days)
The Digital X-ray detector, EXPD-N Series, is designed for use in digital imaging solutions for general radiographic diagnosis of human anatomy. This device is intended for use in all general diagnostic procedures, replacing film or screen-based radiographic systems for both adult and paediatric patients. It is not intended for use in mammography.
In comparison to existing devices, the new detectors incorporate a Flexible a-Si in the TFT material within the panel. The primary difference from the conventional glass a-Si panel is that the electronic circuits, such as silicon, are deposited on a plastic substrate instead of a glass substrate during the manufacturing of the TFT panel. Since only the material of the substrate on which the silicon is deposited changes, the overall image performance remains unaffected. Another difference is the pixel pitch. While existing products feature only a pixel pitch of 140μm, the new models include an option with a pixel pitch of 100um. The resolution of an X-ray detector has a significant impact on MTF (Modulation Transfer Function) and sensitivity.
This medical device submission is for an X-ray detector, not an AI/ML device. Therefore, the typical acceptance criteria and study requirements for AI/ML devices, such as those related to multi-reader multi-case studies, standalone performance, and ground truth establishment with expert consensus or pathology, are not applicable here.
The submission focuses on establishing substantial equivalence to a predicate device based on technical characteristics and physical performance, confirming it is suitable for general radiographic diagnosis.
Here's a breakdown of the provided information, tailored to the context of a non-AI X-ray detector:
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device in terms of technical characteristics and performance metrics relevant to X-ray image quality. The table below compares the subject device's performance to the predicate device, highlighting where performance is similar or improved.
| Item | Acceptance Criteria (Implied by Predicate Device K193017 Performance) | Subject Device (EXPD-N Series) Reported Performance |
|---|---|---|
| Intended Use | General radiographic diagnosis, replaces film/screen-based systems, adult & pediatric, Not for mammography. | General radiographic diagnosis, replaces film/screen-based systems, adult & pediatric, Not for mammography. (Same) |
| Anatomical Sites | General Radiography | General Radiography (Same) |
| Dimensions (mm) | EVS 3643W/WG/WP: 460(W) x 386(L) x 15(H) | |
| EVS 4343W/WG/WP: 460(W) x 460(L) x 15(H) | EXPD 3643N/NP/NU/N1/U1: 460(W) x 386(L) x 15.5(H) | |
| EXPD 4343N/NP/NU/N1/U1: 460(W) x 460(L) x 15.5(H) (Slight difference in thickness, otherwise similar) | ||
| Pixel Pitch | 140 μm | 140 μm (for N/NP/NU models) |
| 100 μm (for N1/U1 models) (Improved resolution option added) | ||
| Image Size (pixels) | EVS 3643W/WG/WP: 2,560 x 3,072 | |
| EVS 4343W/WG/WP: 3,072 x 3,072 | EXPD 4343N/NP/NU: 3,072 × 3,072 (Same) | |
| EXPD 3643N/NP/NU: 2,560 × 3,072 (Same) | ||
| EXPD 4343N1/U1: 4,302 × 4,302 (Improved with 100μm pixel pitch) | ||
| EXPD 3643N1/U1: 3,534 × 4,302 (Improved with 100μm pixel pitch) | ||
| Active Area (mm) | EVS 3643W/WG/WP: 430 x 358 | |
| EVS 4343W/WG/WP: 430 x 430 | EXPD 4343N/NP/NU: 430.2mm × 430.2mm (Similar) | |
| EXPD 3643N/NP/NU: 353.4mm × 430.2mm (Similar) | ||
| EXPD 4343N1/U1: 430.08mm × 430.08mm (Similar, adapted for 100μm pixel pitch) | ||
| EXPD 3643N1/U1: 358.4mm × 430.08mm (Similar, adapted for 100μm pixel pitch) | ||
| TFT Material | a-Si, IGZO | a-Si, Flexible a-Si, IGZO (New Flexible a-Si material introduced, otherwise similar) |
| Cycle Time |
§ 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.