(23 days)
Focus 43C and TRIMAX 43C 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. These two devices are not intended for mammography, dental applications.
Focus 43C Detector and TRIMAX 43C Detector (Hereinafter referred to as Focus 43C and TRIMAX 43C) 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: 427mm x 427mm. Two models TRIMAX 43C and Focus 43C are totally same except for label and trademark. The sensor plate of Focus 43C and TRIMAX 43C 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 43C and TRIMAX 43C 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.
The provided text describes a 510(k) premarket notification for the "Focus 43C Detector" and "TRIMAX 43C Detector". The submission focuses on demonstrating substantial equivalence to a predicate device, the "Wireless Digital Flat Panel Detector (Mars1717XF-CSI, K183713)".
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner. Instead, it compares the technical characteristics of the proposed device to the predicate device to demonstrate substantial equivalence. The performance metrics are generally presented as improvements or minor changes compared to the predicate.
| Characteristic | Predicate Device (Mars1717XF-CSI) | Proposed Device (Focus 43C / TRIMAX 43C) | Evaluation/Comment (Implied Acceptance) |
|---|---|---|---|
| Intended Use | Same as proposed | Same as predicate | Substantially equivalent. Indications for use explicitly include adult and pediatric patients. |
| Classification Name | Stationary x-ray system | Same | Substantially equivalent. |
| Product Code | MQB | Same | Substantially equivalent. |
| Regulation Number | 21 CFR 892.1680 | Same | Substantially equivalent. |
| X-Ray Absorber | CsI | Same | Substantially equivalent. |
| Installation Type | Wireless, Portable | Same | Substantially equivalent. |
| Readout Mechanism | Thin Film Transistor | Same | Substantially equivalent. |
| Image Matrix Size | 2832 × 2836 pixels | 3072 × 3072 pixels | Improved (higher resolution), considered substantially equivalent as improvement. |
| Pixel Pitch | 150 µm | 139 µm | Improved (smaller pixel size), considered substantially equivalent as improvement. |
| ADC Digitization | 16 bit | Same | Substantially equivalent. |
| Effective Imaging Area | 424.8 mm × 425.4 mm | 427 mm × 427 mm | Slightly larger, considered substantially equivalent. |
| Spatial Resolution | 3.3 lp/mm | 3.6 lp/mm | Improved (higher resolution), considered substantially equivalent as improvement. |
| Modulation Transfer Function (MTF) @ 1 lp/mm | 0.49 | 0.61 | Improved, considered substantially equivalent as improvement. |
| Detective Quantum Efficiency (DQE) @ 1 lp/mm (RQA5, 2.5µGy) | 0.40 | 0.46 | Improved, considered substantially equivalent as improvement. |
| Power Consumption | Max. 20W | Max. 20W | Substantially equivalent. |
| Communications (Wireless functionality) | IEEE 802.11a/b/g/n (2.4 GHz / 5 GHz) | IEEE 802.11a/b/g/n/ac (2.4 GHz / 5 GHz) + Wired | Improved wireless standard (added 'ac') and wired option, considered substantially equivalent as an enhancement. |
| Imaging Protect Plate | N/A (not specified but presumed) | Carbon Fiber Plate | Specified, likely similar or improved over predicate. |
| Cooling | Air cooling | Same | Substantially equivalent. |
| Dimensions | 460 mm × 460 mm × 15 mm | 460 mm × 460 mm × 15.2 mm | Minor dimensional change, considered substantially equivalent. |
| Operation Temperature | +5 ~ +30 °C | +5 ~ +35 °C | Slightly wider acceptable range, considered substantially equivalent. |
| Operation Humidity | 10 ~ 80% (Non-Condensing) | 10 ~ 90% (Non-Condensing) | Slightly wider acceptable range, considered substantially equivalent. |
| Storage Temperature | -20 ~ +50 °C | -20 ~ +55 °C | Slightly wider acceptable range, considered substantially equivalent. |
| Storage Humidity | 10 ~ 90% (Non-Condensing) | 5 ~ 95% (Non-Condensing) | Slightly wider acceptable range, considered substantially equivalent. |
| Software (iRay SDK) | "intend to supply API interface for DR system manufacturers... unchanged from the predicate device." | Same | Substantially equivalent. No change to the software API provided to DR system manufacturers. |
The overarching "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, safety, and effectiveness. The document asserts that the proposed devices meet this through direct comparison and noting improvements where applicable.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical images or patient data for evaluating the device's diagnostic performance. The evaluation is primarily focused on non-clinical performance testing and comparison of technical specifications to the predicate device.
- No specific sample size for a test set of images or patient data is mentioned.
- Data provenance (country of origin, retrospective/prospective) is not applicable or provided for such a test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the provided document. The submission does not describe a study involving expert readers establishing ground truth for a diagnostic test set. The evaluation is based on technical specifications and engineering testing.
4. Adjudication Method for the Test Set
This information is not applicable as no diagnostic test set or adjudication process is described in the provided text.
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
No MRMC comparative effectiveness study is mentioned. This device is a digital X-ray detector, not an AI-powered diagnostic tool, so such a study would not typically be performed or described in this type of submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI algorithm. The device is a digital X-ray detector. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" derived from expert consensus, pathology, or outcomes data is not relevant to this submission, as it focuses on the technical performance specifications of the X-ray detector rather than its diagnostic accuracy in interpreting images. The "ground truth" for the device's performance characteristics (e.g., spatial resolution, MTF, DQE) would be established through physical measurements and standardized test phantoms according to industry standards.
8. The Sample Size for the Training Set
No training set is mentioned as this device is an X-ray detector, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned or relevant for this device.
Summary of Device Performance Demonstration:
The submission demonstrates substantial equivalence primarily through:
- Comparison of Technical Specifications: A detailed table comprehensively compares various technical characteristics, showing that the proposed device is either similar to or improved upon the predicate device (e.g., higher image matrix size, smaller pixel pitch, better spatial resolution, MTF, and DQE).
- Non-Clinical Performance Testing:
- Electrical Safety and EMC testing: Performed according to IEC/ES 60601-1 and IEC 60601-1-2, with results meeting standard requirements.
- Biological Evaluation: Materials contacting skin evaluated per ISO 10993-1, with results assuring safety "the same as the predicate device."
- Other Non-Clinical Considerations: These studies showed that non-clinical considerations mentioned in the "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" are substantially equivalent to the predicate. This likely includes aspects like image quality, dose performance, and environmental testing.
- Clinical Consideration: The document explicitly states that "clinical consideration may not necessary for changes in the pixel size and resolution with the same x-ray detection material and may not necessary for changes in the wireless functionality if non-clinical information is sufficient to support the substantial equivalence." It also states, "There was no significant difference between the images of the Focus 43C/TRIMAX 43C and those of the predicate device." This implies that while no formal clinical study is presented, the technical improvements are not expected to negatively impact clinical performance, and the output images are comparable.
§ 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.