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510(k) Data Aggregation
(27 days)
ArtPIX DRF
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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