(133 days)
The BSD4343 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.
BSD4343 is a digital X-ray flat panel detector which intercepts x-ray photons and the scintillator (Gadox:Tb type) 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.
The acceptance criteria and study proving the device meets them are described below for the BSD4343 Digital Flat Panel X-ray Detector.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative "acceptance criteria" for performance metrics in a pass/fail format. Instead, it demonstrates substantial equivalence to a predicate device (LLX240AB01) by showing similar or better performance in key imaging characteristics and adherence to safety standards. The "Reported Device Performance" below is derived from the comparison table and the "Non-clinical study" section, relative to the predicate.
| Characteristic | Acceptance Criteria (Implied: Substantially Equivalent to Predicate) | Reported Device Performance (BSD4343) |
|---|---|---|
| Intended Use | Same as Predicate LLX240AB01 | Same as Predicate: General radiographic system for human anatomy, not mammography. |
| Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT |
| Scintillator | Gadolinium Oxysulfide | Gadolinium Oxysulfide |
| Imaging Area | 17 x 17 inches | 17 x 17 inches |
| Pixel matrix | 3072 x 3072 (9.4 million) | 3072 x 3072 (9.4 million) |
| Pixel pitch | 143 μm (Predicate) | 140 μm |
| Resolution | 3.5 lp/mm | 3.5 lp/mm |
| A/D Conversion | 14 bit (Predicate) | 16 bit |
| Grayscale | 16384 (14bit) | 16384 (14bit) |
| Data output | RAW, convertible to DICOM 3.0 | RAW, convertible to DICOM 3.0 |
| Dimensions | 500 x 496.6 x 45 mm (Predicate) | 460 x 460 x 15 mm |
| Application | General Radiology system, with upright stand, table, universal stand | General Radiology system, with upright stand, table, universal stand |
| Performance (DQE, MTF, NPS) | Basically equivalent to Predicate LLX240AB01 | Similar or better resolution performance than LLX240AB01 at 0 ~ 3.5lp/mm spatial frequencies. More efficient in utilizing input image signal (DQE). |
| Electrical Safety | Compliance with IEC 60601-1 | Complies with IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) |
| EMC | Compliance with IEC 60601-1-2 | Complies with IEC 60601-1-2: 2007 |
| Risk Management | Compliance with ISO 14971 | Complies with ISO 14971 (Risk management file generated) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention a "test set" in the context of a clinical study with patient data. The "non-clinical study" section refers to physical values for comparison (DQE, MTF, NPS) with the predicate device. These are typically measured on phantoms or test objects, not human subjects, and therefore do not involve patient-specific sample sizes or data provenance in the clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no clinical "test set" with patient data requiring expert ground truth is described, this information is not applicable. The basis for comparison is the technical specifications and measured performance of the device against a predicate, typically using engineering metrics and standards.
4. Adjudication Method for the Test Set
Not applicable, as no clinical "test set" requiring adjudication or expert consensus for ground truth is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission relies on non-clinical performance data and substantial equivalence to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance testing described is standalone, focusing on the inherent technical capabilities of the device (such as DQE, MTF, NPS) and its compliance with safety and electrical standards. These are measures of the device's technical performance, independent of human interpretation in a clinical setting.
7. The Type of Ground Truth Used
For the non-clinical performance metrics (DQE, MTF, NPS), the "ground truth" would be established through highly controlled measurements using calibrated equipment and phantoms according to industry standards. These are objective physical measurements, not subject to expert consensus, pathology, or outcomes data in the traditional sense of medical image evaluation. For regulatory compliance, the "ground truth" is defined by the requirements of the standards (e.g., IEC 60601-1).
8. The Sample Size for the Training Set
This information is not applicable. This device is a digital X-ray detector, which is hardware, not an AI algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as the device is not an AI algorithm and therefore does not have a "training set."
§ 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.