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510(k) Data Aggregation
(113 days)
The Platinum dRF Imaging System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including: general radiology and diagnostic fluoroscopy examinations, conventional linear tomography and pediatrics examinations.
The Platinum dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from, but not limited to, gastrointestinal, cranial, skeletal, thoracic, lung and urogenital tract examinations.
It may also be used in: lymphography, endoscopy, myelography, venography and arthrography.
The Platinum dRF may also be used for outpatient or emergency services, as well as for mobile transport examinations (wheelchair and bed).
The Platinum dRF is not indicated for use in interventional radiology.
The subject of this Special 510(k) application is the change to the imaging software system to the ADAM Imaging System. As the resources are now available, Apelem-DMS Group was able to develop their own Imaging System called the ADAM Imaging System. The ADAM Imaging System will now be developed by Apelem-DMS Group. The predicate device (K160301) had an Off the Shelf Software Imaging System called DUET DRF Imaging System which was developed by Thales.
The ADAM Imaging System is a digital image acquisition system to be used in conjunction with a detector during radiography or fluoroscopy X-ray examinations to acquire, display, process and export images according to DICOM protocol via a network connection.
The ADAM Imaging System software interfaces with an X-Ray detector to acquire raw pixel data and image processing algorithms which transform raw pixel data into images and image sequences to help medical professionals with viewing images to for patient diagnosis.
The Duet DRF requires the use of the THALES RF4343 FL detectors, whereas ADAM Imaging System requires the use of the VIEWORKS VIVIX-D 1717G detector. Both detectors employ the same state-of-the-art indirect conversion technology based on CsI scintillator and photo-diodes. The detector Vivix-D 1717G is connected to the x-ray system by cable. The integration with the PLATINUM dRF system has been established and appears adequate. The VIEWWORKS VIVIX-D 1717G detector is only compatible with the ADAM Imaging System.
The Duet DRF and ADAM Imaging System are designed to support general radiography (excluding mammography) and fluoroscopy imaging procedures.
The Apelem-DMS Group ADAM Imaging System is not a stand-alone device. It is integrated into the Platinum dRF Imaging System and functions as a platform for FDA cleared or registered components (i.e. generator, panel detector, detector collimator, X-ray tube and software imaging packages), that are installed with a Apelem-DMS Group manufactured radiological examination table, control panel with system controller software, and electrical panel.
The Platinum dRF remote controlled table is a radiologic table equipped with a flat panel electronic detector. This table is used to perform general digital radiological, fluoroscopy and peripheral angiography.
The provided document is a 510(k) summary for the Platinum dRF Imaging System and does not contain detailed information about acceptance criteria or a study proving that the device meets those criteria. The document states that the new ADAM Imaging System component changes the internal imaging software and detector, but it does not include performance data or explicit acceptance criteria for image quality, diagnostic accuracy, or clinical effectiveness.
The submission focuses primarily on demonstrating substantial equivalence to a predicate device (K160301) by comparing technical specifications and highlighting that the proposed changes do not raise new questions of safety or effectiveness. It mentions compliance with various IEC and ISO standards related to medical electrical equipment, software, and risk management, which are general safety and performance standards rather than specific acceptance criteria for a diagnostic imaging study.
Therefore, most of the requested information regarding acceptance criteria and performance study details cannot be extracted from this document.
However, based on the available information, here's what can be inferred:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics for a diagnostic study. The document primarily focuses on demonstrating that the performance of the new detector (VIEWORKS VIVIX-D 1717G) is "similar enough" or "sufficient" compared to the predicate's detector.
- Reported Device Performance: The document provides technical specifications of the new detector and compares them to the predicate's detector, implying these are the performance characteristics considered.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (ADAM Imaging System Detector) | Reported Predicate Performance (DUET Imaging System Detector) | Comment |
|---|---|---|---|---|
| Scintillator | Same as predicate | CsI | CsI | Same |
| Pixel Pitch | Similar to predicate; smaller is generally better | 140µm | 148µm | ADAM Imaging System's detector has a smaller pixel pitch which means better detail detectability. |
| Pixel Matrix | Similar to predicate; larger is generally better | 3072 x 3072 pixels | 2874 x 2840 pixels | Adam Imaging System's detector has a larger pixel matrix which means a larger detection field. |
| Image Size | Same as predicate | 17" x 17" | 17" x 17" | Same |
| Grayscale | Same as predicate | 16 bits | 16 bit | Same |
| Resolution | Performance similar enough (>3%) for indicated procedures | 3.5 linepairs/mm | 3.4 linepairs/mm | The performance of both detectors are similar enough (>3%) for the procedures indicated. |
| Modulation Transfer Function (MTF) | Performance of both detectors sufficient for general radiographic procedures | MTF IEC 0.5 lp/mm: Minimal 78%, Typical 83% MTF IEC 1 lp/mm: Minimal 50%, Typical 55% MTF IEC 2 lp/mm: Minimal 20%, Typical 25% MTF IEC 3 lp/mm: Minimal 5%, Typical 10% | MTF IEC 0.5 lp/mm: Minimal 79%, Typical N/A MTF IEC 1 lp/mm: Minimal 55%, Typical 66% MTF IEC 2 lp/mm: Minimal 25%, Typical 35% MTF IEC 3 lp/mm: Minimal 10%, Typical 19% | Performance of both detectors are sufficient for general radiographic procedures. (Predicate listed MTF IEC Nyquist as 7% Minimal, 15% Typical) |
| Detective Quantum Efficiency (DQE) | DQE difference <5% considered equivalent, and small clinical significance (<10% variation) in required dose. | 75% | 78% (if shot noise only)60-65% (0.5 lp/mm) | Difference low enough to be considered equivalent; <10% variation in required dose, <5% DQE difference might be error margins. |
| Dimensions | Not increase, ideally smaller for easier installation | 471 x 471 x 35 mm | 500 x 490 x 45.5 mm | VIEWORKS detector is smaller than the predicate which will enable easier installation. |
| Weight | Differences with no impact | 10 kg | 9.1 kg | VIEWORKS detector is heavier than the predicate but as the difference is less than 1 kg there is no impact. |
2. Sample size used for the test set and the data provenance
- This information is not provided in the document. The submission focuses on technical specifications of the components rather than a clinical performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. No clinical or diagnostic performance study with expert adjudication is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided in the document. No adjudication method is described as no clinical performance study is detailed.
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
- This information is not applicable/not provided. The device is an imaging system (hardware and software for image acquisition and display), not an AI-assisted diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This information is not applicable/not provided. The device is a complete imaging system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- This information is not provided. The submission relies on technical specifications and compliance with standards, not on a clinical ground truth for diagnostic accuracy.
8. The sample size for the training set
- This information is not provided. As no AI/machine learning component for diagnosis is indicated, a 'training set' in that context is not relevant to this submission. The software changes are for image acquisition, display, and processing.
9. How the ground truth for the training set was established
- This information is not provided. See point 8.
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