(30 days)
Mars 1717XF-GSI Wireless Digital Flat Panel Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This device is not intended for mammography or dental applications, pediatric, pregnant women and fluoroscopy.
Mars1717XF-GSI Wireless Digital Flat Panel Detector is a kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT (Thin Film Transistor)/PD (Photo Diode) image sensor flat panel of active area: 42.48cm×42.54cm. The sensor plate of Mars1717XF-GSI Wireless Digital Flat Panel Detector is coated with Gd2O2S (GOS) scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface. The major function of the Mars1717XF-GSI Wireless Digital Flat Panel Detector is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This detector is the key component of DR system, enables to complete the digitalization of the medical X-ray imaging with the DR system software.
The provided document is a 510(k) summary for the iRay Technology Taicang Ltd. Wireless Digital Flat Panel Detector (Mars1717XF-GSI). It compares the proposed device to a predicate device (Mars1417XF-GSI, K182550) to demonstrate substantial equivalence.
Based on the content, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" for clinical performance as would be seen for an AI-powered diagnostic device. Instead, it focuses on demonstrating substantial equivalence by comparing the technical specifications of the proposed device to the predicate device. The implicit "acceptance criteria" here are that the performance metrics of the proposed device are comparable to or better than the predicate device, or within acceptable tolerances for the intended use.
Here's a table focusing on the comparative technical specifications presented, which serve as the "performance" data for establishing equivalence:
| Item | Predicate Device: Mars1417XF-GSI Wireless Digital Flat Panel Detector | Proposed Device: Mars1717XF-GSI Wireless Digital Flat Panel Detector |
|---|---|---|
| Functional/Technical Specs | ||
| X-Ray Absorber (Scintillator): | Gd2O2S (GOS) | Same (Gd2O2S (GOS)) |
| Installation Type: | Wireless, Portable | Same (Wireless, Portable) |
| Readout Mechanism: | Thin Film Transistor | Same (Thin Film Transistor) |
| ADC Digitization | 16 bit | Same (16 bit) |
| Spatial Resolution: | Min. 3.3lp/mm | Same (Min. 3.3lp/mm) |
| Communications: (Wireless functionality) | Wireless: IEEE 802.11a/b/g/n (2.4 GHz / 5 GHz) | Same (Wireless: IEEE 802.11a/b/g/n (2.4 GHz / 5 GHz)) |
| Imaging protect Plate: | Carbon Fiber Plate | Same (Carbon Fiber Plate) |
| Cooling: | Air cooling | Same (Air cooling) |
| Software | iRay SDK (include iDetector) | Same (iRay SDK (include iDetector)) |
| Performance Metrics | ||
| Image Matrix Size: | 2336 × 2836 pixels | 2832 × 2836 pixels |
| Pixel Pitch: | 150μm | Same (150μm) |
| Effective Imaging Area: | 350.4 mm × 425.4 mm | 424.8 mm × 425.4 mm |
| Modulation Transfer Function (MTF) | 0.45 at 1 lp/mm | 0.44 at 1 lp/mm |
| Detective Quantum Efficiency (DQE) (RQA5, 3.2µGy) | 0.22 at 1 lp/mm | 0.23 at 1 lp/mm |
| Power Consumption: | Max. 19W | Max. 20W |
| Dimensions: | 384 mm × 460 mm × 15 mm | 460 mm × 460 mm × 15 mm |
Note: The primary difference highlighted and addressed in the document is the "panel dimension" which impacts "Image Matrix Size," "Effective Imaging Area," "MTF," "DQE", "Power Consumption", and "Dimensions". The submission argues that non-clinical information is sufficient to support substantial equivalence despite these changes.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical testing rather than a clinical study with a "test set" of patient data in the typical sense of AI/diagnostic device trials (i.e., analyzing images of patients to assess diagnostic accuracy). The "study" here refers to:
- Electrical Safety and EMC testing: Performed according to IEC/ES 60601-1 and IEC/EN 60601-1-2.
- Biological Evaluation: Evaluated with ISO 10993-1 for materials contacting operators' skin.
- Non-clinical Considerations: Performance comparisons, likely quantitative measurements of detector characteristics (MTF, DQE, spatial resolution), and electromagnetic compatibility. This would involve a sample of the manufactured devices, not patient data.
- Clinical Consideration: The submission states that a clinical consideration (study with patient data) was not necessary because the modification from the predicate device to the proposed device is primarily the "panel dimension." It claims "non-clinical information is sufficient to support the substantial equivalence."
Therefore, there is no patient-based "test set" sample size or data provenance (country, retrospective/prospective) relevant to clinical performance assessment mentioned because a clinical study was explicitly deemed unnecessary by the manufacturer, and presumably accepted by the FDA for this direct predicate comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since no clinical study with a patient imaging test set was conducted (as per point 2), there were no experts used to establish ground truth for a clinical test set. The ground truth in this submission is established through:
- Standardized technical measurements: For parameters like MTF, DQE, spatial resolution, which are objective physical properties of the detector.
- Compliance with international standards: For electrical safety, EMC, and biological compatibility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no patient-based clinical "test set" requiring adjudication of diagnoses 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 a digital flat panel detector (hardware), not an AI-powered diagnostic software. Its purpose is to capture X-ray images, not to interpret them or assist human readers in diagnosis. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a hardware device (X-ray detector), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained in point 3, the "ground truth" for the performance evaluation in this 510(k) submission is based on:
- Objective physical measurements (e.g., MTF, DQE, spatial resolution) using phantoms and calibrated equipment.
- Adherence to international safety and performance standards (e.g., IEC/ES 60601-1, IEC/EN 60601-1-2, ISO 10993-1).
- Demonstration of equivalence to a legally marketed predicate device based on these technical and safety characteristics.
8. The sample size for the training set
Not applicable. This is a hardware device, not an AI model that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a hardware device.
§ 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.