(29 days)
Intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion DR + Wireless allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
The ViZion DR + Wireless system represents the straightforward integration of a modified digital x-ray receptor panel and our previously cleared software. This is a MODIFICATION of our clearance K123644 wherein we have changed panel to a wireless version of the previously cleared panel/software combination. Going wireless (with batterv operation possible) are the ONLY modifications.
ViZion DR + Wireless is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD). ViZion DR + Wireless is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the Viztek PACS and the new receptor panel were not changed. Our predicate is ViZion DR +, K123644. We do not supply the router, but any router meeting the IEEE 802.11 a/b/g/n specifications will work. With the advent of AED (automatic exposure detection) by the panel, integration with or connection to specific generators is no longer required. If the user decides NOT to use AED, wired synchronization with Sedecal Series SHF generators is known to work.
Here's a breakdown of the acceptance criteria and study information for the Viztek ViZion DR + Wireless device based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document provided does not explicitly state formal "acceptance criteria" in a quantitative, measurable sense for the device, beyond equivalence to a predicate device. Instead, it focuses on demonstrating substantial equivalence through a comparison of technical specifications and performance characteristics, some of which could be considered de-facto acceptance criteria derived from the predicate's performance.
| Criterion (Implied/Predicate Based) | Predicate Device Performance (Viztek ViZion + DR K123644) | Vizion DR + Wireless Performance |
|---|---|---|
| Intended Use | General radiographic examinations (skull, chest, shoulders, spine, abdomen, pelvis, extremities), excluding fluoroscopy, angiography, mammography | UNCHANGED (Same) |
| Digital Panel - Pixel size | 150 µm | 150 µm |
| Digital Panel - Pixels | 2288x2800 (6.4 million pixels) | 2304x2800 (6.4 million pixels) |
| Software Output | DICOM image | SAME as K123644 |
| DICOM 3 | Yes | YES |
| A/D Conversion | 14 bit | SAME |
| MTF (0.5 (1/mm) | 0.75 | 0.75 (Essentially the same) |
| DQE (0.5 (1/mm) | 0.23 | 0.27 (Essentially the same) |
| Scintillator | GOS scintillation screen | UNCHANGED |
| Interface | Gigabit Ethernet | Wired: Gigabit Ethernet (1000BASE-T); Wireless: IEEE802.11a/b/g/n |
| Power Source | AC Line | AC Line and/or Rechargeable Lithium Battery (3 hr run time) |
| Electrical Safety | IEC 60601-1 | SAME |
| EMC | IEC 60601-1-2 | SAME, plus complies with FCC Part 15 Rules and Regulations |
| Image Quality | Implied to be acceptable based on predicate clearance | "as good as or better than the images acquired with the predicate panel" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document simply states "Clinical images were acquired" and "bench, and test laboratory results." It does not specify the number of clinical images or cases used for evaluation.
- Data Provenance: The document does not explicitly state the country of origin. Given the submission is to the U.S. FDA, it is likely that the clinical image acquisition was performed in the U.S. The study appears to be prospective in the sense that new images were acquired specifically for this evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: One board-certified radiologist.
- Qualifications: "board certified radiologist." No specific tenure or experience level is mentioned beyond board certification.
4. Adjudication Method for the Test Set
- Adjudication Method: None mentioned. A single radiologist evaluated the images.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. The evaluation was based on a single radiologist's assessment of clinical images from the new panel compared to the predicate, and bench testing.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable / not a software-only algorithm. The device is a digital X-ray receptor panel (hardware) with associated software. The "performance" being evaluated is of the integrated system and its ability to produce diagnostic images. The comparison focuses on the image quality produced by the device, which is inherently designed for human interpretation.
7. Type of Ground Truth Used
- Expert Consensus / Expert Interpretation: The ground truth for image quality was established by the interpretation of a single board-certified radiologist. There is no mention of pathology, outcomes data, or other objective measures for ground truth.
8. Sample Size for the Training Set
- Not applicable / Not explicitly a machine learning model requiring a training set. The device is primarily a hardware modification (wireless panel) to an existing cleared system. While there's "software," the document states "Since no software modifications were required, confirmation testing was performed." This suggests the software itself was not re-trained or developed with a new dataset for this specific submission, but rather integrated with the new wireless panel.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, a distinct "training set" for a machine learning model isn't indicated as part of this device's submission or the testing described.
§ 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.