(168 days)
ViZion Ultra is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion Ultra allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
The ViZion Ultra system represents the straightforward integration of a new digital x-ray receptor panel (K110849) and our previously cleared software. This is a MODIFICATION of our clearances K112661 and K123644 wherein we have changed the supplier of the panel. Therefore a special 510(k) has been submitted. The ViZion Ultra is compatible with Sedecal SHF generators. Some manufacturers rebrand the Sedecal SHF generators, and these generators are compatible as well.
ViZion Ultra is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) ViZion Ultra is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advartages of digital radiography for a filmless environment and improves cost effectiveness. The major funciple of operation of the Viztek PACS and the new receptor panel were not changed. Our main predicate is ViZion + DR, K123644, wherein we combined our OPAL-RAD software with two new digital panels.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Key Takeaway: This 510(k) submission is for a modification to an existing digital X-ray system, specifically changing the supplier of the digital receptor panel. Therefore, the "study" primarily focuses on demonstrating that the new panel performs as well as or better than the previously cleared predicate device, rather than establishing de novo efficacy. The acceptance criteria are implicitly met by achieving substantial equivalence to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate device (Viztek ViZion DR K112661 and ViZion + DR, K123644). | "ViZion Ultra is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion Ultra allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities." (Matches predicate exactly). |
| Image Quality | Equal to or better than predicate devices. | "Clinical images collected demonstrate equal or better image quality as compared to our predicates." |
| Safety | As safe as predicate devices, meeting relevant IEC standards. | "The results of clinical image inspection, bench, and test laboratory results indicates that the new device is as safe and effective as the predicate devices." |
| "Electrical Safety per IEC-60601-1 and EMC per IEC-60601-1-2." | ||
| Effectiveness | As effective as predicate devices. | "The results of clinical image inspection, bench, and test laboratory results indicates that the new device is as safe and effective as the predicate devices." |
| "MTF and DQE measurements were supplied by the panel manufacturer in accordance with the FDA guidance document." | ||
| Technical Parameters | Digital Panel Pixel Size & Resolution: Comparable or improved to predicate panels. | |
| Software: Same. | Digital Panel: Trixell Pixium Rad 4143, 2880 (h) x 2880 (v) pixels, pitch 148 µm (h) x 148 µm (v). (Predicate K123644 panels: 139 µm, 3064x3072 pixels for 17x17; 150 µm, 2288x2800 pixels for 14x17). This indicates comparable technical specifications. | |
| Software: "SAME as K112661, outputs a DICOM image." | ||
| DICOM Compatibility | Yes (same as predicate). | "Yes" |
| Power Source | AC Line (same as predicate). | "AC Line" |
| Risk | Acceptable risks, analyzed per FDA guidance. | "Risk Analysis was conducted in accordance with FDA guidance documents." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the clinical images used in the evaluation. It only states that "Clinical images were acquired."
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) for a minor modification (panel change), it's likely these were prospectively acquired images for comparison purposes, but this is not definitively stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: "a board certified radiologist" (singular, implies one).
- Qualifications of Experts: "board certified radiologist." Specific years of experience are not mentioned.
4. Adjudication Method for the Test Set
- The document states that "a board certified radiologist... concluded the images from the new panel are as good as the images acquired with the predicate panel." This indicates a single-reader assessment rather than a multi-reader adjudication method (like 2+1 or 3+1). There was no additional adjudication process described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The evaluation described involves a single radiologist comparing images from the new panel to those from the predicate panel. The focus was on demonstrating non-inferiority (equal or better image quality) rather than quantifying an improvement in human reader performance with AI assistance. This device is a digital X-ray receptor, not an AI-powered diagnostic aid.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- This question is not applicable in the context of this device. The ViZion Ultra is a digital X-ray receptor panel and associated software for image acquisition. It is not an algorithm designed for interpretation or diagnosis that would typically undergo a standalone performance study in the way AI algorithms are evaluated. Its "performance" is inherently tied to the image it produces for a human reader. The technical parameters like MTF and DQE (mentioned as being supplied by the manufacturer) represent objective standalone measures of the detector's physical performance.
7. Type of Ground Truth Used
- The ground truth for the clinical images was implicitly established by expert consensus/opinion (from the single board-certified radiologist) that the images produced by the new panel were "as good as" those from the predicate panel. There is no mention of pathology, outcomes data, or other objective measures of disease presence as ground truth, as the study's purpose was image quality comparison for substantial equivalence, not diagnostic accuracy.
8. Sample Size for the Training Set
- Not applicable / Not provided. The device described is a hardware component (digital X-ray detector) and associated software for image acquisition and viewing. It is not an AI/Machine Learning algorithm that typically requires a distinct "training set" in the conventional sense for its function. The software is noted as "SAME as K112661," implying that its functionality is established.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, this is not an AI/ML device that requires a training set with established ground truth for learning.
§ 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.