(58 days)
The PaxScan 4030 Medical Digital Imaging System is intended for use in generating radiographic images of human anatomy. It is intended to replace film/screen or computed radiography in extremity and general-purpose procedures appropriate to the input field of view. This device is intended for use by qualified medical personnel trained in radiology
The PaxScan 4030 Medical Digital Imaging System is composed of an amorphous silicon flat planel imager, Pentium based computer, road runner card, trigger board, imaging software and a power supply. The digital imager uses a large-area amorphous silicon sensor array with a gadolinium oxysulfide scintillator. The 40 x 30 cm panel will display high quality images in approximately five seconds over a wide range of dose settings.
The provided text describes a 510(k) premarket notification for the PaxScan 4030 Medical Digital Imaging System. This is a submission to demonstrate substantial equivalence to already legally marketed devices, rather than a clinical study establishing new acceptance criteria or proving effectiveness of an AI-powered device. Therefore, much of the requested information regarding acceptance criteria, study design for AI devices, and ground truth establishment is not present in this document.
However, based on the provided text, we can infer some "acceptance criteria" through comparison to predicates and the nature of a 510(k) submission. The "study" here is primarily a technical comparison and performance testing against industry standards and predicate devices, rather than a clinical trial in the traditional sense for AI.
Here's an attempt to answer the questions based only on the provided document, acknowledging its limitations:
Acceptance Criteria and Device Performance
Since this is a 510(k) submission for a medical imaging device and not an AI-powered diagnostic tool, the "acceptance criteria" are related to technical performance specifications and substantial equivalence to predicate devices, rather than diagnostic accuracy metrics like sensitivity or specificity. The device is accepted if it performs comparably or better than existing approved devices for its intended use.
| Acceptance Criteria (Inferred from Predicate Comparison) | Reported Device Performance (PaxScan 4030 Medical Digital Imaging System) |
|---|---|
| Detector Material and Type | Amorphous Silicon Sensor Array with Gadolinium Oxysulfide Scintillator |
| Dimensions (Input Field of View) | 16" x 11.5" |
| Pixel Size | 127 x 127 microns |
| Detector Element Matrix | 2232 x 3200 |
| Dynamic Range | 12 bits |
| Spatial Resolution | 3.94 lp/mm |
| External Connectivity | DICOM 3.0 Compatible |
| Image Processing Time | 5 Seconds per Image |
Note: These are comparisons to predicate devices to demonstrate substantial equivalence, not necessarily strict "acceptance criteria" that must be met in a standalone clinical trial for an AI device. The general acceptance criterion for a 510(k) is that the device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics, or if it has different technological characteristics, the information submitted demonstrates that the device is as safe and effective as the legally marketed predicate device.
Study Details (Based on 510(k) Submission)
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a "test set" in the context of an algorithmic performance study. The 510(k) submission primarily relies on technical specifications and comparisons to predicate devices. It is highly likely that internal technical performance testing (e.g., image quality assessment, dose response) was conducted on the physical device, but the number of "images" or "patients" constituting a test set is not specified.
- Data Provenance: Not specified. As this is a technical submission, any testing would likely be internal to Varian Medical Systems.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to this 510(k) submission. Ground truth establishment by experts is typical for studies assessing diagnostic accuracy of AI algorithms. This submission focuses on the performance of a digital imaging system itself, not an interpretive AI.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring adjudication of diagnostic interpretations.
-
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 study was done, as this is for a standalone digital imaging system, not an AI-assisted interpretation device. Therefore, no effect size for human reader improvement is reported.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense, the primary "study" is a demonstration of the standalone technical performance of the imaging system. The performance metrics listed in the table (spatial resolution, dynamic range, image processing time) are inherent properties of the PaxScan 4030 system itself, independent of human interaction beyond operating the device. This is not an algorithm in the AI sense, but rather the performance of the hardware and associated software for image acquisition.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the technical specifications, the "ground truth" would be established using physics-based measurements and engineering standards. For example, spatial resolution would be measured using standard test patterns (e.g., line pair phantoms), dynamic range by measuring signal response to varying X-ray exposures, and image processing time by timing the system. There would be no pathology or expert consensus on clinical findings involved at this stage of device approval.
-
The sample size for the training set:
- Not applicable. This is not an AI algorithm requiring a training set.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI algorithm mentioned.
§ 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.