(34 days)
Focus 35C and TRIMAX 35C are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. This device is not intended for mammography or dental applications. There are no differences between the 2 models except the model name and trade mark.
Focus 35C Detector and TRIMAX 35C Detector (Hereinafter referred to as Focus 35C and TRIMAX 35C) are a kind of wireless digital flat panel detectors. They support the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 34.56cm×42.00cm. Two models TRIMAX 35C and Focus 35C are totally same except for label and trademark. The sensor plate of Focus 35C and TRIMAX 35C detectors are 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 Focus 35C and TRIMAX 35C detectors are to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This kind of detector is the key component of DR system, enables to complete the digitalization of the medical X-ray imaging with the DR system software. iRay SDK(include iDetector) is intend to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to use directly by other users beside DR system manufacturers. The iRay SDK is unchanged from the predicate device.
The provided text describes the 510(k) premarket notification for the iRay Technology Taicang Ltd. Focus 35C Detector and TRIMAX 35C Detector. This submission asserts substantial equivalence to a predicate device (Mars1417XF-CSI, K182551). For devices like X-ray detectors, acceptance criteria often revolve around physical performance specifications and safety, rather than diagnostic accuracy as would be the case for an AI diagnostic device. The study described focuses on demonstrating that the proposed devices meet these technical and safety standards, and are substantially equivalent to the predicate.
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 provided text does not explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance" in the way one might typically expect for a diagnostic AI device (e.g., Sensitivity, Specificity, AUC). Instead, it presents a comparison of technological characteristics between the proposed device (Focus 35C / TRIMAX 35C) and its predicate device (Wireless Digital Flat Panel Detector, Mars1417XF-CSI). The acceptance is implied by demonstrating that the proposed device performs at least as well as or better than the predicate for key technical specifications, and meets relevant industry standards.
Here's a table compiled from the "Technological Characteristic" section comparing the proposed device to the predicate device, which implicitly serves as the baseline for performance acceptance:
| Item | Predicate Device (Mars1417XF-CSI) | Proposed Device (Focus 35C / TRIMAX 35C) | Implied Acceptance: Proposed device meets or exceeds predicate performance standards. |
|---|---|---|---|
| Image Matrix Size | 2336 × 2836 pixels | 2304 × 2800 pixels | Similar, minor difference |
| Pixel Pitch | 150 µm | 150 µm | Same |
| ADC Digitization | 16 bit | 16 bit | Same |
| Effective Imaging Area | 350.4 mm × 425.4 mm | 345.6 mm × 420.0 mm | Similar, minor difference |
| Spatial Resolution | Min. 3.3 lp/mm | Min. 3.3 lp/mm | Same |
| Modulation Transfer Function (MTF) | 0.5 at 1 lp/mm | 0.61 at 1 lp/mm | Better than predicate |
| Detective Quantum Efficiency (DQE) | 0.37 at 1 lp/mm (RQA5, 2.5 µGy) | 0.42 at 1 lp/mm (RQA5, 2.5 µGy) | Better than predicate |
| Power Consumption | Max. 19W | Max. 18W | Better than predicate (lower) |
| Communication (Wireless functionality) | Wireless: IEEE 802.11a/b/g/n (2.4 GHz / 5 GHz) | Wired: Gigabit Ethernet (1000BASE-T); Wireless: IEEE 802.11a/b/g/n/ac (2.4 GHz / 5 GHz) | Better than predicate (includes 'ac' standard and wired option) |
| Operation Temperature | +5 ~ +30 °C | +5 ~ +35 °C | Slightly wider range |
| Operation Humidity | 10 ~ 80% (Non-Condensing) | 10 ~ 90% (Non-Condensing) | Slightly wider range |
| Storage/Transportation Humidity | 10 ~ 90% (Non-Condensing) | 5 ~ 95% (Non-Condensing) | Wider range |
Study Proving Acceptance:
The study proving acceptance is primarily a non-clinical performance study and safety testing demonstrating that the proposed devices (Focus 35C and TRIMAX 35C) are substantially equivalent to the predicate device.
- Electrical Safety and EMC Testing: "Electrical, mechanical, environmental safety and performance testing according to IEC/ES 60601-1 was performed, and EMC testing was also conducted in accordance with IEC 60601-1-2. All test results are meet the standard requirements."
- Biological Evaluation: "The materials of the detector which contact operators' or patient's skin have been evaluated with the ISO 10993-1. And the evaluation results and test result assured the safety the same as the predicate device."
- Non-clinical Considerations: "The non-clinical studies have been performed and the results have shown that sections of the non-clinical consideration mentioned in the 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices' are substantially equivalent to the non-consideration of predicate devices on the Market (Mars1417XF-CSI, K182551)."
- Clinical Consideration: "There was no significant difference between the images of the Focus 35C/TRIMAX 35C and those of the predicate device." This suggests an informal comparison of image quality, likely by engineers or qualified personnel during the non-clinical evaluation.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The studies were non-clinical performance and safety tests, not clinical studies involving patient data in the typical sense for evaluating diagnostic performance. The comparisons were primarily based on technical specifications and output image quality (likely using phantoms or test targets, rather than a "test set" of patient images with ground truth diagnoses).
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)
This information is not applicable and not provided. This device is an X-ray detector, not an AI diagnostic algorithm. Ground truth, in the context of diagnostic accuracy, is not relevant for this type of device submission. The "ground truth" for its technical performance would be the specifications and measurements from calibration and performance tests. The statement "There was no significant difference between the images of the Focus 35C/TRIMAX 35C and those of the predicate device" implies an informal assessment of image quality, likely by qualified personnel (engineers, physicists, or potentially radiologists if consulted for image perception) rather than a formal expert consensus for a diagnostic task.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable and not provided. This is not a study requiring adjudication of diagnostic findings.
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 and not provided. This is an X-ray detector, not an AI-powered diagnostic tool, so 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 and not provided. This is an X-ray detector, not an AI algorithm. Its performance is measured by its physical and technical capabilities to produce an image.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the typical sense. For this device, the "ground truth" for its performance evaluation comes from:
- Engineering specifications and measurements (e.g., spatial resolution, MTF, DQE).
- Compliance with international safety and electromagnetic compatibility standards (IEC/ES 60601-1, IEC 60601-1-2).
- Biocompatibility testing against a standard (ISO 10993-1).
- Comparison of image characteristics to the predicate device, likely using phantoms or standard test patterns.
8. The sample size for the training set
Not applicable and not provided. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable and not provided. This is not an AI device that requires 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.