(27 days)
Mars1717X wireless digital flat panel detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental applications.
Mars1717X Wireless Digital Flat Panel Detectors (Hereinafter referred to as Mars1717X) is a kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 42.67cm×42.67cm.
The sensor plate of Mars1717X is direct-deposited with CsI 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 Mars1717X is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. Both kinds of detectors are the key component of DR system, enable to complete the digitalization of the medical X-ray imaging with the DR system software.
iRay SDK(include iDetector) is intended to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to be used directly by other users beside DR system manufacturers.
The provided document is a 510(k) Summary for the Mars1717X Wireless Digital Flat Panel Detector by iRay Technology Taicang Ltd. This document primarily focuses on demonstrating substantial equivalence to a predicate device (Mars1717V-VSI, K201043) rather than detailing a specific study to prove the device meets acceptance criteria regarding clinical performance.
The document states that clinical consideration may not be necessary for changes in image receptor dimensions if non-clinical information is sufficient to support substantial equivalence. This implies that a dedicated clinical study to evaluate the device against specific performance acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity for detecting conditions) was likely not performed or considered necessary by the FDA for this 510(k) clearance due to the nature of the device as an X-ray detector and the comparison to a predicate.
Therefore, many of the requested details about a study proving device performance against acceptance criteria for diagnostic capability cannot be extracted from this document, as such a study does not appear to be the basis for this 510(k) clearance. The "acceptance criteria and reported device performance" primarily relate to technical specifications and equivalence.
However, I can extract information regarding technical performance metrics and how they compare between the proposed device and the predicate. These comparisons serve as the "evidence" for substantial equivalence.
Here's the breakdown based on the provided text, focusing on the technical and non-clinical aspects:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" in the format of a clinical performance study. Instead, it compares the technical specifications and performance characteristics of the proposed device (Mars1717X) to its predicate (Mars1717V-VSI). The "acceptance criteria" can be inferred as being at least equivalent to or better than the predicate device for relevant technical specifications to demonstrate substantial equivalence.
| Characteristic / "Acceptance Criteria" | Predicate Device (Mars1717V-VSI, K201043) | Proposed Device (Mars1717X, K210314) | "Met Acceptance Criteria" (Inferred) | Notes |
|---|---|---|---|---|
| Indications for Use | Same | Same | Yes | Crucial for demonstrating substantial equivalence. |
| Image Matrix Size | 3072 x 3072 pixels | 4267 x 4267 pixels | Improved | Higher resolution. |
| Pixel Size | 139 µm | 100 µm | Improved | Smaller pixel size generally means higher spatial resolution. |
| ADC Digitization | 16 bit | Same | Yes | Maintained high data depth. |
| Effective Imaging Area | 427 mm x 427 mm | 426.7 mm x 426.7 mm | Same (regarded as) | Minor difference, considered substantially equivalent. |
| Spatial Resolution | Min. 3.6 lp/mm | Min. 4.3 lp/mm | Improved | Higher spatial resolution. |
| Detective Quantum Efficiency (DQE) | 0.40 at 1 lp/mm (RQA5, 2.5µGy) | 0.54 at 1 lp/mm (RQA5, 2.5µGy) | Improved | Higher DQE indicates better image quality for a given dose. |
| Power Consumption | Max. 30W | Max. 19W | Improved | Lower power consumption. |
| Communications | Wired (Gigabit Ethernet), Wireless (IEEE 802.11a/b/g/n/ac) | Same | Yes | Maintained connectivity options. |
| Imaging Protect Plate | Carbon Fiber Plate | Same | Yes | Maintained material. |
| Cooling | Air cooling | Same | Yes | Maintained cooling method. |
| Dimensions | 460 mm x 460 mm x 15.3 mm | 460 mm x 460 mm x 15 mm | Improved | Slightly thinner. |
| Detector IP grade | IPX1 | IP56 | Improved | Higher protection against ingress (solids and liquids), making it more robust. |
| Surface Pressure (Uniform load) | 150 kg over whole area | 300 kg over whole area | Improved | Increased durability. |
| Surface Pressure (Local load) | 100 kg on an area 4 cm diameter | 150 kg on an area 4 cm diameter | Improved | Increased durability. |
| Operating Temperature | +5 ~ +35°C | +10 ~ +35°C | Comparable (Slight change) | Still within expected operating range; considered substantially equivalent for clinical use. |
| Operating Humidity | 5 ~ 95% (Non-Condensing) | 5 ~ 90% (Non-Condensing) | Comparable (Slight change) | Still within expected operating range; considered substantially equivalent for clinical use. |
| Storage Temperature | -10 ~ +55°C | -20 ~ +55°C | Improved | Broader storage temperature range. |
| Battery Model | Battery-KV (10.8V) | Battery-KX (11.55V) | Different (Improved specifications) | New model, likely with improved performance/design, but functionally equivalent. |
| X-ray Exposure Mode | (Implied AED trigger) | AED trigger module | Same principle | Automatic Exposure Detection (AED) is a common feature and is maintained. |
| Electrical Safety & EMC | Complies with IEC/ES 60601-1, IEC 60601-1-2 | Complies with IEC/ES 60601-1, IEC 60601-1-2 | Yes | Standard requirements met for safety. |
| Biological Evaluation | Complies with ISO 10993-1 | Complies with ISO 10993-1 | Yes | Materials contacting skin are safe. |
Regarding a "study that proves the device meets the acceptance criteria":
For this 510(k) submission, the "study" is a comparative technical performance assessment against a legally marketed predicate device (K201043). The conclusion of substantial equivalence means the device meets the regulatory "acceptance criteria" for market clearance based on this comparison. The non-clinical studies performed were used to demonstrate that changes in panel size, structure, IP grade, and surface pressure do not raise new questions of safety or effectiveness and that the performance is substantially equivalent to or better than the predicate.
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: Not applicable in the context of a clinical test set for diagnostic accuracy, as no such clinical study appears to have been conducted for this 510(k). The "test set" would be the device itself undergoing various engineering and performance tests (e.g., DQE measurements, spatial resolution charts, durability tests). The document does not specify the number of units tested.
- Data Provenance: The technical performance data (DQE, spatial resolution, etc.) would be generated from laboratory tests conducted by the manufacturer, iRay Technology Taicang Ltd., in China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable, as no clinical test set with human diagnostic ground truth was used for this 510(k) clearance based on the provided document.
4. Adjudication Method for the Test Set:
- Not applicable, as no clinical test set requiring expert adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not performed according to this document. The submission focuses on technical equivalence to a predicate X-ray detector, not on the diagnostic effectiveness of human readers using the device with and without AI assistance.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):
- Yes, the evaluation is inherently a standalone performance assessment of the device itself (the flat panel detector) in terms of its image acquisition capabilities (spatial resolution, DQE, etc.). There is no AI algorithm being evaluated for diagnostic assistance in this context. The device's performance is measured objectively based on physical and technical specifications, independent of human interpretation.
7. Type of Ground Truth Used:
- For the technical performance aspects, "ground truth" refers to objective physical measurements and standards. For example:
- Spatial resolution is measured using phantoms or line pair gauges with known patterns.
- DQE is measured according to standardized protocols (e.g., IEC 62220-1) using known X-ray spectra and dose levels.
- Durability (surface pressure, IP rating) is tested against engineering specifications and industry standards.
- Safety (electrical, biological) is assessed against international standards (e.g., IEC 60601-1, ISO 10993-1).
8. Sample Size for the Training Set:
- Not applicable, as this is not an AI/machine learning device requiring a training set in the conventional sense. The "training" in manufacturing would refer to quality control and calibration processes during production.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set in the context of an AI algorithm.
§ 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.