(45 days)
The ArtPix Mobile EZ2GO, is intended for use in general radiographic examinations by qualified/trained doctors or technicians, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography.
ArtPix Mobile EZ2GO allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
The modified ArtPix Mobile EZ2GO is a flexible high-resolution Digital Radiography (DR) system that is designed to provide fast and smooth radiography examinations of sitting, standing or lying patient Imaging. The modified ArtPix Mobile EZ2GO consists of the following components: Tablet Computer, Flat Panel Detectors, Detector Removable batteries & Charger, and other optional components such as External Monitor for Docking Station, USB HUB, Bluetooth DAP device and Fix Room Access Point Support. Images may be transferred via a network using DICOM protocol for printing and storage in PACS.
The modified ArtPix Mobile EZ2GO can be used in combination with any conventional analog radiography system currently using film screen or CR, fixed or mobile, or other system capable of producing general radiography exposures.
The modified Artpix Mobile EZ2GO detector can be shared between multiple Artpix Mobile EZ2GO systems.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text.
Based on the provided document, the device described is ArtPix Mobile EZ2GO, an X-ray system. The document is a 510(k) summary for a Special 510(k) submission, indicating modifications to a previously cleared predicate device, PrestoDR 4143 [K110849](https://510k.innolitics.com/search/K110849).
It's important to note that this document is a 510(k) submission summary, which primarily aims to demonstrate substantial equivalence to a predicate device rather than providing a detailed report of a new clinical trial. Therefore, information regarding certain aspects like "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," and "MRMC comparative effectiveness study" are not typically part of a 510(k) summary for this type of device and are not present in the provided text. These elements are more common for AI/CADe devices or those requiring de novo classification with novel claims.
The "study" proving the device meets the acceptance criteria is primarily a verification and validation (V&V) process focused on demonstrating that the modified device's performance is equivalent to or better than the predicate device and that it meets established engineering and functional requirements, without raising new safety or effectiveness concerns.
1. A table of acceptance criteria and the reported device performance
The document focuses on comparing the modified device (ArtPix Mobile EZ2GO) to its predicate (PrestoDR 4143 [K110849](https://510k.innolitics.com/search/K110849)) across various technical specifications and performance characteristics rather than explicitly stating acceptance criteria in table form for each parameter and then listing the observed performance. Instead, it provides a comparative table and a general conclusion of acceptance.
However, we can infer some "acceptance criteria" from the comparison table (Section 1.9.2) and the V&V section (1.10). The primary acceptance criterion for this 510(k) is substantial equivalence to the predicate device in terms of fundamental scientific technology, indication for use, safety, and effectiveness.
Here's an inferred table based on the provided comparison:
| Characteristic | Inferred Acceptance Criteria (Based on Predicate Performance) | ArtPix Mobile EZ2GO Reported Performance |
|---|---|---|
| Detectors (CsI) | ||
| Pixel Pitch | ~148 µm | 144 µm / 148 µm (depending on model) |
| Active Image Area | ~41 x 42.5 cm (2775 x 2874 pixels) | Varies by model: e.g., 34.1x 43.2 cm (2372 x 3000 pixels), 33.7 x 41.4 cm (2280 x 2800 pixels) |
| Dynamic Range | 16 bits | 16 bit |
| DQE (0 lp/mm) | 64% | 66% (for some models) |
| DQE (1 lp/mm) | 52% | 51% (for some models) |
| DQE (2 lp/mm) | 42% | 39% / 40% (for some models) |
| DQE (3 lp/mm) | 25% | 23% / 24% (for some models) |
| Weight | 11.5 Kg | Lighter: 4.7 Kg, 2.8 Kg, 3.0 Kg, 3.2Kg, 1.6 Kg (depending on model) |
| Detectors (Gadox) | ||
| Pixel Pitch | 148 µm | 148 µm |
| Active Image Area | 41 x 42.5 cm (2775 x 2874 pixels) | Varies by model: e.g., 33.7 x 41.4 cm (2280 x 2800 pixels), 22.2 x 28.4 cm (1500 x 1920 pixels) |
| Dynamic Range | 16 bits | 16 bit |
| MTF (0 lp/mm) | 37% | 37% |
| MTF (1 lp/mm) | 25% | 25% |
| MTF (2 lp/mm) | 17% | 17% |
| MTF (3 lp/mm) | 7% | 7% |
| Weight | 11.5 Kg | Lighter: 2.8 Kg, 1.6 Kg (depending on model) |
| Workstation Computer | ||
| Processor (min) | i3-540 | i5-4310U (Improved) |
| Memory (min) | 2GB, DDR3, 1333 MHz RAM | 8GB (Improved) |
| Operating System | Windows XP | Windows 7 (Updated) |
| Display | 17"/19" LCD Touch Screen, 1280x1024 | 10.1" LCD 10-Point Multi Touch (Optional 24" with docking station) 1920x1200 (Different form factor, higher res optional) |
| Disk Storage | 500 GB (15,000 images) | 250 GB SSD (7,500 images) (Smaller capacity, but deemed sufficient for temporary storage) |
| Dimensions | 36 x 18.3 x 42 cm (10.1 Kg) | 27 x 18.8 x 2 cm (1.09 Kg) (Smaller and lighter) |
| Preview Image Time | 6-7 seconds | 4 seconds (Improved) |
| Max Power | 700VA | 92VA (Lower power consumption) |
| Functional Equivalence | All basic functions, intended use, and principle of operation should be unchanged. | The device maintains the same basic functions, intended use, and principle of operation. |
| Safety & Effectiveness | No new safety or effectiveness concerns should be raised. | V&V indicated no critical, safety, efficacy or blocking issues. |
| Compliance with Standards | Adherence to relevant IEC, ISO, NEMA, CFR standards. | List of 12 standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 14971, CFR 1020.30/31) met. |
Conclusion from the document: "The modified ArtPix Mobile EZ2GO system passed its acceptance criteria and is recommended for release."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "sample size" in terms of patient data or images for testing the device's diagnostic performance, as it is a technical modification to an existing X-ray system rather than a new AI/CAD device. The "test set" in this context refers to the device itself being subjected to engineering verification and validation.
- Sample Size for Test Set: Not applicable in the context of patient data or clinical images. The testing refers to the system hardware and software.
- Data Provenance: Not applicable. The V&V focused on the device's technical specifications and functionality.
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)
This information is not provided and is generally not required for a 510(k) summary concerning technical modifications to an X-ray imaging system. Establishing ground truth by experts is relevant for assessing diagnostic accuracy, which is not the primary focus of this type of submission (since the diagnostic capability relies on the predicate's established performance and the fundamental imaging physics).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not typically relevant for this type of 510(k) submission. Adjudication methods are used in clinical trials, particularly for diagnostic algorithms, where there might be disagreement among reviewers regarding the ground truth.
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 or reported. This type of study is specific to devices, especially AI/CAD, that assist human readers in making diagnoses. The ArtPix Mobile EZ2GO is an X-ray imaging system itself, not an AI software. The submission focuses on demonstrating that the new hardware and software components maintain diagnostic image quality and system functionality equivalent to the predicate.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done or reported. The device is an integral imaging system requiring human operation (qualified/trained doctors or technicians). The submission does not claim any autonomous algorithmic diagnostic capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Since this is not a diagnostic AI/CAD device but an imaging system, the "ground truth" concept in the traditional sense (e.g., pathology for disease detection) is not directly applicable to the V&V described. The V&V focused on:
- Expected performance of software functions ("pass/fail" based on test protocols).
- Correctness of system integration.
- Measured image quality metrics (DQE, MTF) against expected engineering specifications which are themselves proxies for producing diagnostic quality images.
- Adherence to safety and electrical standards.
So, the "ground truth" essentially refers to engineered specifications and functional requirements.
8. The sample size for the training set
Not applicable. The ArtPix Mobile EZ2GO is an X-ray imaging device, not an AI/machine learning algorithm that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable. (See point 8).
§ 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.