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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 |
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(27 days)
The ArtPIX DRF is a digital image acquisition system to be used with integrated solid state detector, during radiography or fluoroscopy x-ray examination, to capture digitalize, review images according to DICOM protocol to be sent through network connection.
This device is not intended for mammography use.
The modified ArtPIX DRF is a dynamic digital radiography system including fluoroscopy and radiography capabilities.
The system application is based on Windows 10 operating system. The object-oriented software performs real-time image processing (based on parallel computing), and full procedures storage. The DICOM 3.0 IHE compliant connectivity provides the tools to transmit patient demographics, examinations and image data in digital format.
Parameters for X-ray exposure, review, post-processing operations and filming can be set up from a single console, significantly increasing clinical efficiency.
The modified ArtPix DRF operates in connection with the dynamic Pixium 2121, 3030, 4343 flat panel detectors and 2430, 3543 portable flat panel detectors (made by Thales of Moirans, France).
The modified ArtPix DRF is intended for OEMs and Integrators that will integrate the product with their R&F table as a digital supplement.
The provided text describes a Special 510(k) submission for the ArtPIX DRF, which is a modification of a previously cleared device, the Duet DRF (K103038). This type of submission focuses on demonstrating that the modified device remains substantially equivalent to the predicate device, implying that extensive, new clinical studies for acceptance criteria may not be performed if the changes do not introduce new safety or effectiveness concerns.
Based on the provided information, I can extract the following:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly present a table of acceptance criteria with corresponding performance metrics in a way you might expect for a new device submission. Instead, it details that the modified ArtPIX DRF's performance and technological characteristics are substantially equivalent to its predicate device, the Duet DRF K103038. The acceptance criteria for the modified device are implicitly inferred from the performance characteristics of the predicate device and the new, integrated components, as well as adherence to various industry standards.
Here's an attempt to infer and present the acceptance criteria and device performance based on the comparison:
| Acceptance Criteria (Inferred from Predicate's Performance/Standards) | Reported Device Performance (ArtPIX DRF) |
|---|---|
| Intended Use | |
| Digital image acquisition system for radiography/fluoroscopy, not for mammography. | Identical. |
| Detector Characteristics (Dynamic) | |
| Pixel Pitch (e.g., 148 µm for Pixium RF 4343) | Varies by integrated FPD model (e.g., 148 µm for Pixium 4343 FL, 154 µm for Pixium 3030S-A). All are within acceptable ranges for prior cleared devices. |
| Active Image Area (e.g., 42.5 x 42 cm for Pixium RF 4343) | Varies by integrated FPD model (e.g., 42.5 x 42 cm for Pixium 4343 FL, 30.1 x 30.1 cm for Pixium 3030S-A). All are within acceptable ranges for prior cleared devices. |
| Dynamic Range: 16 bits | 16 bits (for all listed dynamic FPDs). |
| X-ray generator voltage range: 40-150 kVp | 40-150 kVp (for all listed dynamic FPDs). |
| Maximum Frame Rate (Cont. fluoroscopy): Up to 30 FR/sec | Varies by integrated FPD model (e.g., 16 FR/sec for Pixium 4343 FL; 30 FR/sec for Pixium 4343 FL Models 4; 25 FR/sec for Pixium 2121S-A). |
| DQE (Detective Quantum Efficiency) @ 0 lp/mm (e.g., 65% for Pixium RF 4343) | Varies by integrated FPD model (e.g., 65% for Pixium 4343 FL; 73% for Pixium 4343 FL Model 4; 77% for Pixium 3030S-A). |
| DQE @ 2 lp/mm (e.g., 35% for Pixium RF 4343) | Varies by integrated FPD model (e.g., 32% for Pixium 4343 FL; 35% for Pixium 4343 FL Model 4; 30% for Pixium 3030S-A). |
| Detector Characteristics (Static - Portable) | |
| Pixel Pitch (e.g., 148 µm for Pixium Portable 3543EZ-C) | Varies by integrated FPD model (e.g., 148 µm for Pixium Portable 3543EZ-C; 160 µm for Pixium Portable 3543DR-CS). All are within acceptable ranges for prior cleared devices. |
| Active Image Area (e.g., 34.4 x 42.1 cm for 3543EZ-C) | Varies by integrated FPD model. All are within acceptable ranges for prior cleared devices. |
| Dynamic Range: 16 bit | 16 bit (for all listed static FPDs). |
| DQE (typical values) (e.g., 70% at 0 lp/mm for 3543EZ-C) | Varies by integrated FPD model. All are within acceptable ranges for prior cleared devices. |
| System Functionality | |
| PC based workstation, User interactive GUI, 16 Bits digitization, Anatomically programmed protocols, User-selectable display manipulations | Identical. |
| Continuous fluoroscopy rate: Up to 30 fps | Up to 30 fps. |
| Pulsed Fluoroscopy rate: Up to 15 fps | 3.75, 7.5, 15 fps. |
| Fluoro store: 0.5 fps Up to 15 fps | Up to 30 fps. |
| DICOM compatibility (Store, Print, MWL) | DICOM compatibility (Store, MWL, RDSR, Storage Commitment, MPPS). (Note: DICOM Print removed, other functions added). |
| Electrical, Thermal, EMC Safety (IEC 60601-1, 60601-1-2) | Adheres to IEC 60601-1, IEC60601-1-2. |
| New Features Acceptance (e.g., Image Stitching) | User-controlled, requires user approval for saving. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes verification and validation (V&V) activities, which are typically technical assessments rather than extensive clinical studies. It mentions "software unit tests," "software test document," "system bench tests," and "measuring the image quality." It also states, "The (positive /negative) results were documented in the test document."
However, there is no specific sample size mentioned for a test set (e.g., number of patients or images). The data provenance is also not specified, as these appear to be internal design validation activities rather than
a clinical trial. The testing was performed by "CMT Medical Technologies Ltd." which is an Israeli company, so the testing data would likely originate from their facilities. The nature of the changes (integration of new, already cleared FPDs and hardware/software upgrades) suggests that rigorous clinical testing with human subjects was not deemed necessary for substantial equivalence given the predicate.
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)
The document does not mention using experts (e.g., radiologists) to establish ground truth for a test set. This is consistent with a "Special 510(k)" for device modifications where clinical performance is demonstrated via substantial equivalence to a predicate device and technical performance testing, rather than new clinical evaluations requiring expert reads.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No adjudication method is mentioned, as no expert-based ground truthing or clinical study requiring adjudication 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
No MRMC comparative effectiveness study was done. The device is an image acquisition and processing system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is a digital image acquisition system with software for image processing and handling. Its performance is inherently linked to its ability to capture, digitize, review, and format images. The "system performance of the modified ArtPix DRF was validated by measuring the image quality." This would include the performance of the integrated detectors and the processing algorithms. While not explicitly called "standalone algorithm performance," the technical tests on image quality and system functionality without human interpretation are part of the stated V&V.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the verification and validation activities appears to be based on technical performance specifications, industry standards (e.g., DQE, pixel pitch), and expected functional behavior of the system components. For image quality, it would be measured parameters against documented specifications. There's no indication of ground truth established by expert consensus, pathology, or outcomes data, as this was not a clinical efficacy study.
8. The sample size for the training set
The document discusses device modifications and V&V testing, not the development of a machine learning or AI algorithm that would typically require a "training set." Therefore, no training set size is applicable or mentioned.
9. How the ground truth for the training set was established
As there is no mention of a training set or an AI/ML algorithm within the modifications described, this information is not applicable and not provided. The software modifications described primarily relate to supporting new hardware, updating the operating system and user interface, and incorporating previously cleared processing algorithms or standard DICOM functions.
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