(28 days)
Mars 1417X 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.
Mars1417X Wireless Digital Flat Panel Detector is a wireless digital flat panel detector that supports single frame mode. Its key component is a TFT/PD image sensor flat panel with an active area of 35cm×43cm. The sensor plate has a direct-deposited CsI scintillator to convert X-ray to visible photon. These visible photons are transformed to electron signals by a diode capacitor array within the TFT panel, which are composed and processed by connecting to scanning and readout electronics, forming a panel image transmitted to a PC through the user interface. The main function is to convert X-ray to digital image for high resolution X-ray imaging. It is a key component of a DR system, enabling the digitalization of medical X-ray imaging with DR system software. iRay SDK (including iDetector) provides an API interface for DR system manufacturers to control the detector.
The provided text describes a 510(k) premarket notification for the Mars 1417X Wireless Digital Flat Panel Detector. This document primarily focuses on demonstrating substantial equivalence to a predicate device (Mars1417V-TSI) rather than presenting a standalone clinical study with detailed acceptance criteria and performance data.
Therefore, the information required to answer most of your questions (especially those related to a clinical study, reader performance, and ground truth establishment) is not present in the provided text. The document states that "clinical consideration may not necessary for changes in the dimensions of the image receptor with otherwise identical materials if non-clinical information is sufficient to support the substantial equivalence." This implies that a formal clinical study, as you've outlined, was likely not conducted or required for this 510(k) clearance.
However, I can extract the acceptance criteria and performance related to the device's technical specifications and non-clinical testing as presented in the document, comparing the proposed device (Mars1417X) to its predicate (Mars1417V-TSI).
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating equivalence or improvement over the predicate device's technical specifications. The "reported device performance" refers to the specifications of the proposed device, Mars1417X.
| Acceptance Criteria (Predicate: Mars1417V-TSI) | Reported Device Performance (Mars1417X) | Notes on Equivalence / Improvement |
|---|---|---|
| Image Matrix Size: 2304 x 2800 pixels | 3500 x 4300 pixels | Improved: Higher resolution |
| Pixel Size: 150μm | 100μm | Improved: Smaller pixel size, contributing to higher resolution |
| ADC Digitization: 16 bit | Same (16 bit) | Equivalent |
| Effective Imaging Area: 345.6 mm × 420.0 mm | 350.0 mm × 430.0 mm | Improved: Slightly larger imaging area |
| Spatial Resolution: Min. 3.3lp/mm | Min. 4.3lp/mm | Improved: Higher spatial resolution |
| Modulation Transfer Function (MTF) at 1 lp/mm: 0.68 | 0.65 | Slightly lower, but likely within acceptable range for overall equivalence given other improvements. No explicit acceptance range is provided, and the device was deemed substantially equivalent. |
| Detective Quantum Efficiency (DQE) at 1 lp/mm (RQA5, 2.5μGy): 0.36 | 0.54 | Improved: Higher DQE, indicating better signal-to-noise ratio and dose efficiency. |
| Detector IP Grade: IPX1 | IP56 | Improved: Higher ingress protection. |
| Surface Pressure (Uniform load): 150 kg over whole area | 300 kg over whole area | Improved: More robust. |
| Surface Pressure (Local load): 100 kg on 4 cm diameter of center | 150 kg on 4 cm diameter of center | Improved: More robust. |
| Communications (Wireless functionality): IEEE 802.11a/b/g/n/ac (2.4 GHz / 5 GHz) | Same | Equivalent |
| X-Ray Absorber (Scintillator): CsI | Same | Equivalent |
| Image Protect Plate: Carbon Fiber Plate | Same | Equivalent |
| Cooling: Air cooling | Same | Equivalent |
| Dimensions: 384 mm × 460 mm × 15 mm | Same | Equivalent |
| Operating Temperature: +5 ~ +35°C | +10 ~ +35 °C | Slightly narrower operating temperature range, but still deemed substantially equivalent. |
| Operating Humidity: 10 ~ 90% (Non-Condensing) | 5 ~ 90% (Non-Condensing) | Slightly wider lower humidity tolerance. |
| Operating Atmospheric Pressure: 70 ~ 106 kPa | 70 ~ 106 kPa | Equivalent |
| Storage/Transportation Temp: -20 ~ +55°C | Same | Equivalent |
| Storage/Transportation Humidity: 5 ~ 95% (Non-Condensing) | Same | Equivalent |
As for the other points, based on the provided text:
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Sample size used for the test set and the data provenance: Not applicable in the context of clinical reads for performance testing. The "test set" here refers to the physical device's specifications being evaluated against the predicate. Data provenance is not described for any clinical study. The device manufacturer is iRay Technology Taicang Ltd. in China. The submission is for a 510(k) Pre-Market Notification, which relies on demonstrating substantial equivalence, often through non-clinical performance data and comparison to an existing device, rather than new clinical trials.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical diagnostic performance using expert consensus or pathology is not mentioned, as a clinical performance study of this nature was likely not performed.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. There is no mention of adjudication for a clinical test set.
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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: No, an MRMC study was not done, and this device is a digital flat panel detector, not an AI diagnostic algorithm. Its primary function is to convert X-rays to digital images, not to provide AI assistance to human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm but a hardware device. Its performance is measured by its raw imaging capabilities (e.g., spatial resolution, DQE).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the specified improvements (e.g., spatial resolution, DQE), the ground truth is established through physical measurements and standardized imaging tests as per industry standards (e.g., lp/mm, ISO standards for DQE measurement). For safety aspects, compliance with standards like IEC/ES 60601-1 and ISO 10993-1 establishes "ground truth" for electrical safety, EMC, and biological evaluation.
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The sample size for the training set: Not applicable. This is a hardware device, not an AI algorithm requiring a training set.
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How the ground truth for the training set was established: Not applicable.
§ 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.