(37 days)
The BSD3543(BT-DA22-IA) detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general-purpose diagnostic procedures. It is not to be used for mammography.
BSD3543(BT-DA22-IA/BT-DB22-IA) is a digital X-ray flat panel detector which intercepts x-ray photons and the scintillator (BT-DB22-IA(Gdos) / BT-DA22-IA(CsI)) emits visible spectrum photons that illuminate an array of photo (a-SI)-detector that creates electrical signals. After the electrical signals are generated, it is converted to digital values, and the images will be displayed on the monitor. This device should be integrated with an operating PC and an X-Ray generator. It can digitalize x-ray images and transfer them for radiography diagnostics. Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, and sharing of image information on network.
Based on the provided text, the device in question is the BSD3543 Digital Flat Panel X-ray Detector. The information describes non-clinical performance testing to demonstrate substantial equivalence to a predicate device (BONTECH BSD4343, K160204), rather than a study proving the device meets specific clinical acceptance criteria for diagnostic accuracy.
Here's a breakdown of the requested information based on the provided text. Please note that several items (like clinical study details, expert qualifications, adjudication methods, and training set information) are explicitly not available because the submission relies on non-clinical testing for substantial equivalence, not clinical studies for efficacy.
Acceptance Criteria and Device Performance for BSD3543 Digital Flat Panel X-ray Detector
The acceptance criteria for the BSD3543 Digital Flat Panel X-ray Detector are based on demonstrating substantial equivalence to its predicate device, BONTECH BSD4343 (K160204), through non-clinical performance testing. The key performance metrics compared are related to image quality and technical specifications.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Proposed BSD3543) | Outcome |
|---|---|---|---|
| Indications for Use | General radiographic system for human anatomy, not for mammography. | General radiographic system for human anatomy, not for mammography. | Same |
| Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT | Same |
| Scintillator | Gadolinium Oxysulfide (Gdos) | BT-DB22-IA(Gdos) / BT-DA22-IA(CsI) | Similar |
| Imaging Area | 17 x 17 inches | 14 x 17 inches | Similar |
| Pixel Matrix | 3072 x 3072 | 2500 x 3052 | Similar |
| Pixel Pitch | 140 μm | 140 μm | Same |
| Resolution | 3.5 lp/mm | 3.5 lp/mm | Same |
| A/D Conversion | 16 bit | 16 bit | Same |
| Grayscale | 16384 (14bit) | 65,536 (16bit) | Similar |
| Data Output | RAW (convertible to DICOM 3.0 by console S/W) | RAW (convertible to DICOM 3.0 by console S/W) | Same |
| Viewing SW | Raw Image Viewer | Raw Image Viewer | Same |
| Dimensions | 460 x 460 x 15 mm | 384 x 460 x 15 mm | Similar |
| MTF (Spatial Resolution) | Predicate: CsI: @1 lp/mm (60%), @2 lp/mm (28.1%), @3.5 lp/mm (12.4%) | Proposed: GDOS: @1 lp/mm (58.7%), @2 lp/mm (27.2%), @3.5 lp/mm (11.2%) (CsI data for proposed not provided but stated as "Similar") | Similar* |
| DQE | Predicate: CsI: @0 lp/mm (70%), @1 lp/mm (59.4%), @2 lp/mm (51.4%), @3.5 lp/mm (28%) | Proposed: GDOS: @0 lp/mm (37.9%), @1 lp/mm (29.7%), @2 lp/mm (22.4%), @3.5 lp/mm (10.8%) (CsI data for proposed not provided but stated as "Similar") | Similar* |
| Power Supply | Input: 100~240 V, 50/60 Hz, Output: 12 V, 6 A | Input: 100~240 V, 50/60 Hz, Output: 12 V, 6 A | Same |
| Application | General Radiology system (upright, table, universal stand) | General Radiology system (upright, table, universal stand) | Same |
The document states that the non-clinical performance testing concluded that "BSD3543(BT-DA22-IA/BT-DB22-IA) offer similar or better resolution performance than BSD4343 at 0 ~ 3.5lp/mm spatial frequencies. Moreover, the ability of BSD3543(BT-DA22-IA/BT-DB22-IA) to utilize the input image signal are more efficient than BSD4343 at same patient exposure as shown in the detective quantum efficiency graph." While the tables provide numerical differences, the overall conclusion is that performance is similar or better. Note that direct comparison of GDOS to CsI is done, and both are offered for the proposed device, suggesting the specific scintillator type impacts the exact values. The table for predicate only lists CsI for MTF/DQE, while proposed lists GDOS.
2. Sample Size Used for the Test Set and the Data Provenance
The submission relies on non-clinical bench testing rather than a clinical test set. The data provenance is described as "bench testing performed to compare the subject devices to the predicate." No patient data or country of origin is mentioned for this testing, as it's not a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. No experts were used to establish ground truth for a clinical test set, as this was a non-clinical performance evaluation focused on physical properties (MTF, DQE, etc.) of the imaging device.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set or adjudication method was used.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an X-ray detector, not an AI-powered diagnostic tool, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an X-ray detector, not an algorithm, so standalone algorithm performance is not relevant. The performance tested is the inherent image quality of the detector.
7. The Type of Ground Truth Used
The "ground truth" for this non-clinical study were the established scientific and engineering performance metrics (e.g., MTF, DQE values, pixel pitch, resolution) obtained through standardized laboratory measurements. These are objective measurements of the device's physical and technical capabilities.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no training set in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See #8).
§ 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.