(145 days)
Focus HD 35 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 generalpurpose diagnostic procedures. The device is not intended for mammography or dental applications.
Focus HD 35 Detector 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: 35cm×43cm.
The sensor plate of Focus HD 35 Detector 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 Focus HD 35 Detector 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.
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 text is a 510(k) summary for the iRay Technology Taicang Ltd. Focus HD 35 Detector. This document primarily focuses on establishing substantial equivalence to a predicate device (Mars1417X Wireless Digital Flat Panel Detector, K210316) rather than directly presenting a study proving that the device meets specific acceptance criteria related to a diagnostic task or clinical performance.
Medical device 510(k) clearances typically rely on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering and performance testing. They do not usually involve clinical trials or studies like those required for novel AI/diagnostic devices that predict diagnoses or outcomes.
Therefore, many of the requested points regarding acceptance criteria, study details, human reader improvement with AI, standalone performance, ground truth, and training set information are not applicable or not explicitly detailed in this type of submission.
Here's a breakdown of what can be gleaned from the text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here refer to the technical specifications and safety standards required for substantial equivalence, rather than diagnostic performance metrics (e.g., sensitivity, specificity for disease detection). The comparison is primarily against the predicate device's specifications.
| Characteristic | Acceptance Criteria (Predicate Device K210316) | Reported Device Performance (Focus HD 35 Detector) | Met/Not Met | Comments / Justification |
|---|---|---|---|---|
| Intended Use | General radiographic diagnosis for human anatomy (adult & pediatric), replacement for film/screen systems, not for mammography or dental. | Same | Met | Directly comparable Statement. |
| Indications for Use | Same as Intended Use. | Same | Met | Directly comparable Statement. |
| Classification Name | Stationary X-ray system | Same | Met | Directly comparable Statement. |
| Product Code | MQB | Same | Met | Directly comparable Statement. |
| Regulation Number | 21 CFR 892.1680 | Same | Met | Directly comparable Statement. |
| Panel | Radiology | Same | Met | Directly comparable Statement. |
| Classification | Class II | Same | Met | Directly comparable Statement. |
| X-Ray Absorber (Scintillator) | CsI | Same | Met | Directly comparable Statement. |
| Installation Type | Wireless, Portable | Same | Met | Directly comparable Statement. |
| Readout Mechanism | Thin Film Transistor | Same | Met | Directly comparable Statement. |
| Image Matrix Size | 3500 x 4300 pixels | Same | Met | Directly comparable Statement. |
| Pixel Size | 100μm | Same | Met | Directly comparable Statement. |
| ADC Digitization | 16 bit | Same | Met | Directly comparable Statement. |
| Effective Imaging Area | 350.0 mm x 430.0 mm | Same | Met | Directly comparable Statement. |
| Spatial Resolution | Min. 4.3 lp/mm | 5.0 lp/mm | Met (Exceeded) | The proposed device offers higher spatial resolution, indicating improved performance. |
| Modulation Transfer Function (MTF) | 0.65 at 1 lp/mm | Same | Met | Directly comparable Statement. |
| Detective Quantum Efficiency (DQE) | 0.54 at 1 lp/mm (RQA5, 2.5μGy) | Same | Met | Directly comparable Statement. |
| Power Consumption | Max. 19W | Max. 35.5W | Different | This is a difference, but typically evaluated in terms of safety and functionality, not diagnostic performance. Addressed by electrical safety testing. |
| Communications (Wireless functionality) | Wired (Gigabit Ethernet), Wireless (IEEE 802.11a/b/g/n/ac) | Same | Met | Directly comparable Statement. |
| Imaging Protect Plate | Carbon Fiber Plate | Same | Met | Directly comparable Statement. |
| Cooling | Air cooling | Same | Met | Directly comparable Statement. |
| Dimensions | 384 mm × 460 mm × 15 mm | Same | Met | Directly comparable Statement. |
| Detector IP grade | IP56 | Same | Met | Directly comparable Statement. |
| Power input port | 4 pin port | 10 pin port | Different | Main modification from predicate device, but determined substantially equivalent after non-clinical studies. |
| Surface pressure (Uniform load) | 300 kg over whole area | 300 kg over whole area | Met | Directly comparable Statement. |
| Surface pressure (Local load) | 150 kg on 4 cm diameter | 100 kg on 4 cm diameter | Different | Proposed device has a lower local load capacity. The document implies this is acceptable for substantial equivalence without further explanation of the impact. |
| Operation Temperature | +10 ~ +35°C | +5 ~ +35°C | Different | Proposed device supports a wider temperature range, indicating improved or equivalent functionality. |
| Operation Humidity | 5 ~ 90% (Non-Condensing) | Same | Met | Directly comparable Statement. |
| Operation Atmospheric pressure | 70 ~ 106 kPa | Same | Met | Directly comparable Statement. |
| Operation Altitude | Max. 3000 meters | Same | Met | Directly comparable Statement. |
| Storage & Transportation Temperature | -20 ~ +55°C | Same | Met | Directly comparable Statement. |
| Storage & Transportation Humidity | 5 ~ 95% (Non-Condensing) | Same | Met | Directly comparable Statement. |
| Storage & Transportation Atmospheric pressure | 60 ~ 106 kPa | 70 ~ 106 kPa | Different | Proposed device has a slightly reduced range. Implied acceptable for substantial equivalence. |
| Storage & Transportation Altitude | Max. 3000 meters | Same | Met | Directly comparable Statement. |
| Software | SDK (include iDetector) supplies API interface for DR system manufacturers. | Same | Met | Directly comparable Statement. |
| Electrical Safety | Meet IEC/ES 60601-1 | All test results meet standard requirements. | Met | Stated as part of non-clinical testing. |
| EMC Testing | Meet IEC 60601-1-2 | All test results meet standard requirements. | Met | Stated as part of non-clinical testing. |
| Biological Evaluation | Meet ISO 10993-1 | Evaluation and test results assured safety. | Met | Stated as part of non-clinical testing. |
2. Sample size used for the test set and the data provenance
- Sample size used for the test set: Not applicable for a typical 510(k) submission based on technical equivalence. The "test set" here refers to the actual physical device and its components undergoing engineering and safety tests, not a dataset for diagnostic performance evaluation.
- Data provenance: Not applicable. The data is from engineering and safety tests conducted on the physical device and from a comparison of specifications with the predicate. There is no mention of country of origin for clinical or image data, as such data is not the primary basis for this type of submission. The tests were likely conducted by the manufacturer or accredited labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is an X-ray detector, a hardware component. Its clearance is based on technical specifications, safety, and performance as an imaging capture device, not on its ability to produce a specific diagnosis from images or generate ground truth. There is no "ground truth" in the diagnostic sense being established for a test set of images within this submission.
4. Adjudication method for the test set
- Not Applicable. As no clinical diagnostic performance study with images and ground truth is described, there's no adjudication method.
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. This is not an AI-powered diagnostic device. It's a digital X-ray detector. Therefore, no MRMC study comparing human readers with and without AI assistance was performed or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a hardware device (X-ray detector), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For this hardware device submission, "ground truth" relates to physical measurements and compliance with engineering standards (e.g., spatial resolution, DQE, electrical safety standards). There is no clinical ground truth (pathology, expert consensus on images, etc.) associated with this submission.
8. The sample size for the training set
- Not Applicable. This is a hardware device; no "training set" in the context of machine learning or AI is mentioned or relevant to its clearance.
9. How the ground truth for the training set was established
- Not Applicable. As no training set is mentioned, no ground truth for it was established.
Summary of the Study (as described in the 510(k) submission):
The "study" referenced in the document is primarily a technical assessment and comparison to establish substantial equivalence with a legally marketed predicate device (K210316, Mars1417X Wireless Digital Flat Panel Detector).
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Methodology:
- Side-by-side comparison of technical specifications: The document provides tables comparing parameters like intended use, indications for use, physical dimensions, imaging characteristics (spatial resolution, MTF, DQE), environmental operating conditions, and interfaces between the proposed device and the predicate device.
- Non-clinical testing: This included:
- Electrical safety and EMC testing: Performed according to IEC/ES 60601-1 and IEC 60601-1-2 standards.
- Biological Evaluation: Materials contacting operators' or patient's skin evaluated with ISO 10993-1.
- Functional performance testing: The document implies that areas with minor differences (e.g., power consumption, local load capacity, operating temperature range, atmospheric pressure range) were still considered substantially equivalent following non-clinical studies. The improved spatial resolution (5.0 lp/mm vs. Min. 4.3 lp/mm) was presented as a positive difference.
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Conclusion: The manufacturer concluded that the Focus HD 35 Detector is substantially equivalent to the predicate device regarding safety and effectiveness, based on the non-clinical studies and comparison of technical characteristics. The main identified differences (DC input port, power consumption, local load, operating temperature range, storage/transportation atmospheric pressure) were implicitly determined not to raise new questions of safety or effectiveness.
§ 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.