(134 days)
The device is designed to perform radiographic x-ray examinations on all pediatric and adult patient treatment areas.
The DRX-Rise Mobile X-ray System is a diagnostic mobile X-ray system utilizing digital radiography technology. The DRX-Rise consists of a self-contained X-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of a standard stationary X-ray room. These components are mounted on a motorized cart that is battery powered to enable the device to be driven from location to location by user interaction. The DRX-Rise system incorporates a flat-panel detector that can be used wirelessly for exams such as in-bed chest projections. The device acquires images using Carestream's clinical acquisition software platform (ImageView) and digital flat panel detectors. ImageView is considered software that is of Moderate Level of Concern and not intended for manipulation of medical images. The DRX-Rise Mobile X-ray System is designed for digital radiography (DR) with Carestream detectors.
The provided document is a 510(k) premarket notification for the DRX-Rise Mobile X-ray System, asserting its substantial equivalence to a predicate device (DRX-Revolution Mobile X-ray System, K191025). The document does not describe a study involving acceptance criteria for an AI/CADe device's performance when assisting human readers or evaluating standalone AI performance.
Instead, the document focuses on demonstrating that the DRX-Rise Mobile X-ray System itself, as a physical medical device, is substantially equivalent to an already cleared device. This is achieved through comparisons of technological characteristics and compliance with consensus standards.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/CADe device's performance (points 2-9) because the submission does not pertain to such a device or study.
Here's a breakdown of what can be extracted from the provided text, related to the device itself:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present acceptance criteria in the typical "performance target" vs. "achieved performance" format for an AI/CADe. Instead, it compares the modified device's specifications to the predicate device's specifications, arguing that any differences do not impact safety or performance.
| Criterion (Feature) | Predicate Device Performance (DRX-Revolution Mobile X-ray System K191025) | Modified Device Performance (DRX-Rise Mobile X-ray System K213568) | Impact Assessment (Implicit Acceptance Criterion) |
|---|---|---|---|
| Indications for Use | The device is designed to perform radiographic X-ray examinations on all pediatric and adult patients, in all patient treatment areas. | Same | Substantially equivalent (Same indications for use is an explicit statement of acceptance) |
| Imaging Device Compatibility | Digital Radiography (DR) | Same | Substantially equivalent |
| Digital Radiography Imaging Device (Detector) | DRX Plus Detectors (K150766), (K153142), (K183245) | Same | Substantially equivalent |
| X-ray Generator Rating | 32kW | Same | Substantially equivalent |
| mAs Range (Generator) | 0.1-320 mAs | 0.1 mAs~630 mAs | The DRX Rise (modified device) provides more power in generator output. No impact to safety/performance. (Implicitly accepted if no safety/performance impact) |
| X-ray Tube Voltage Range | 40-150kV (1kV steps) | 40-125kV (1kV steps) | 40-125kV is the most commonly used kV range in clinical imaging. No impact to safety/performance. (Implicitly accepted if no safety/performance impact) |
| X-ray Tube Model | Canon/XRR-3336X | Canon/E7242 (X / FX / GX) | Same supplier but different tube model is used with the modified device. No impact to safety/performance. (Implicitly accepted if no safety/performance impact) |
| X-ray Tube Focal Spot Size | 0.6mm and 1.2mm | 0.6 mm and 1.5 mm | Small focal spot size is same as predicate. Large focus spot size is 20% larger but within expected range for clinical imaging. No impact to safety/performance or to image quality. (Implicitly accepted if no safety/performance impact or to image quality) |
| System Power for Charging | Single Phase AC: 50/60 Hz, 1440 VA Voltage:100-240V | Same | Substantially equivalent |
| Application System Software (Operator Console X-ray Control) | Carestream ImageView System software with image processing capability (K191025) | Same | Substantially equivalent |
| Collapsible Column | Yes | No | The column is fixed on the modified device. No impact to safety/performance. (Implicitly accepted if no safety/performance impact) |
| Column Height | 2193mm-1390mm | 1930mm (fixed column) | No impact to safety/performance. (Implicitly accepted if no safety/performance impact) |
| Column Rotation Range | +/- 270 degrees | Same | Substantially equivalent |
| Travel Method | Electric motor (battery powered) | Same | Substantially equivalent |
2. Sample sized used for the test set and the data provenance: Not applicable. This submission concerns a hardware medical device, not a performance study on a test set of images. The "test set" in this context refers to the device itself being tested against its specifications and existing standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for image interpretation by experts is not relevant to this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. No AI assistance mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's acceptance is its compliance with recognized consensus standards and its functional equivalence to a predicate device.
8. The sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/ML device submission.
9. How the ground truth for the training set was established: Not applicable.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.