(95 days)
The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.
The DRX-Revolution Mobile X-ray System (also referred to as the DRX-Revolution) is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. The DRX-Revolution 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. The DRX-Revolution system incorporates a flat-panel detector that can be used wirelessly for exams such as in-bed chest projections. The system can also be used to expose CR phosphor screens or film.
The provided text is a 510(k) Summary for the Carestream DRX-Revolution Mobile X-ray System. It describes the device, its intended use, and a comparison to a predicate device. It also briefly mentions testing performed. However, it does not contain specific acceptance criteria, a detailed study description with performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC study results.
The only study mentioned is a "concurrence study of clinical image pairs" (also referred to as a "Reader Study") conducted in accordance with "Guidance for the Submission of 510(k)'s for Solid State Imaging Devices" to demonstrate diagnostic capability. The outcome was that the DRX-Revolution system was "statistically equivalent to or better than that of the predicate device."
Therefore, based only on the provided text, I cannot fill in most of the requested information.
Here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text. | "statistically equivalent to or better than that of the predicate device" (for diagnostic capability) |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The study is referred to as a "concurrence study of clinical image pairs" and a "Reader Study," implying a set of images was used.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication method: Not specified.
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
- A "Reader Study" was done comparing the DRX-Revolution system to a predicate device. This implies human readers were involved. However, it was not an MRMC comparative effectiveness study involving AI assistance vs. without AI assistance. The study compared two different imaging systems.
- Effect Size: Not specified.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The "Reader Study" assessed diagnostic capability by human readers using the system. It does not mention a standalone algorithm-only performance assessment.
7. The type of ground truth used
- The text describes a "concurrence study of clinical image pairs" to demonstrate "diagnostic capability." This suggests that the ground truth would likely be based on a clinical diagnosis or expert interpretation against which the images from both systems were compared. However, the specific type of ground truth (e.g., expert consensus, pathology, outcomes data) is not explicitly stated.
8. The sample size for the training set
- No training set is mentioned as this device is an X-ray system, not typically an AI/machine learning device that requires a training set in the conventional sense for its core function described here.
9. How the ground truth for the training set was established
- Not applicable; no training set mentioned.
§ 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.