(46 days)
ViZion + DR 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 + allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
The ViZion + DR system represents the straightforward integration of a new digital x-ray receptor panel and our previously cleared software. This is a MODIFICATION of our clearance K112661 wherein we have changed the supplier of the panel. ViZion + DR is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) ViZion + 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 main predicate is ViZion DR, K112661, wherein we combined our OPAL-RAD software with a new digital panel. We now also offer two sizes of panels: 14" x 17" and 17" x 17" panels.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Viztek ViZion + DR device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary (K123644) does not outline specific numerical acceptance criteria for image quality metrics. Instead, it relies on a qualitative assessment for substantial equivalence.
| Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Clinical Image Quality | As safe and effective as the predicate devices (Viztek ViZion DR, K112661, and Atlaim ATAL 8, K113812), specifically, image quality should be "equal or better" than the predicates. | "Clinical images were acquired and evaluated by a board certified radiologist who concluded the images from the new panel are as good as or better than the images acquired with the predicate panel." |
| Electrical Safety | Compliance with IEC 60601-1 (for electrical safety) and IEC 60601-1-2 (for EMC). | "Electrical Safety per IEC-60601-1 and EMC per IEC 60601-1-2." |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | "Electrical Safety per IEC-60601-1 and EMC per IEC 60601-1-2." |
| MTF and DQE | No explicit criteria mentioned, but assumed to be comparable to or better than predicate devices, as these are standard metrics for digital imaging systems. | "MTF and DQE measurements... was conducted in accordance with FDA guidance documents." (Results not explicitly provided in the summary, but implied to be acceptable for substantial equivalence). |
| Risk Analysis | Compliance with FDA guidance documents. | "Risk Analysis... was conducted in accordance with FDA guidance documents." |
| Software Validation | Compliance with FDA guidance documents. | "Software validation was conducted in accordance with FDA guidance documents." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Clinical images were acquired," implying a set of images, but the exact number is not provided.
- Data Provenance: The document does not specify the country of origin of the data. It is implied to be retrospective or a limited prospective acquisition for the purpose of the 510(k) submission, as it involves comparison to existing predicate devices. The study is described as a clinical image evaluation, not a large-scale clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: "a board certified radiologist" (singular).
- Qualifications: "board certified radiologist." No further details on years of experience are provided.
4. Adjudication Method for the Test Set
- Adjudication Method: "a board certified radiologist who concluded the images from the new panel are as good as or better than the images acquired with the predicate panel." This indicates a single reader assessment, not a multi-reader adjudication method (like 2+1 or 3+1).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The evaluation was performed by a single board-certified radiologist.
- Effect Size: Not applicable, as no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This device is a digital flat panel X-ray detector system, not an AI algorithm. Therefore, a standalone performance study in the context of an AI algorithm is not applicable. The device itself is the imaging system, and its performance is assessed directly (both technically and clinically).
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the clinical image evaluation was expert opinion/consensus, specifically the judgment of a single board-certified radiologist comparing the new panel's images to those from predicate panels. There is no mention of pathology or outcomes data for establishing ground truth in this submission.
8. The Sample Size for the Training Set
- This submission describes a hardware modification (a new digital panel combined with existing software) and its equivalence to predicate devices, not the development or training of a new AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for an AI algorithm.
§ 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.