(179 days)
ViZion DR is intended for digital image capture use in general radiographic examinations for adult and pediattic, 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 intearation of two cleared devices. ViZion DR is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) K090742 (Samsung Flat-Panel X-Ray Detector), Samsung Mobile Display Co., Ltd. (this is the 510(k) for the flat panel detector) and Viztek's proprietary OPAL-RAD PACS image viewing and acquire interface software technology, (K063337) which incorporates state of the art object-oriented software and connectivity. ViZion is designed to perform digital radiographic examinations in replacement for conventional film. This integrated platform provides the benefits of PACS with the 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 Samsung FPD were not changed.
The provided text is a 510(k) summary for the Viztek ViZion DR, a digital flat panel X-Ray detector system. It describes the device, its intended use, and states that bench and test laboratory results indicate the new device is as safe and effective as predicate devices, with clinical images demonstrating equal or better image quality.
However, the document does not contain specific acceptance criteria, detailed study results, sample sizes for test or training sets, ground truth establishment methods, information about expert involvement, adjudication methods, or MRMC study details. The 510(k) summary is a high-level comparison to predicate devices, focusing on substantial equivalence rather than a detailed performance study with quantifiable acceptance criteria.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or stated based on the text provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Clinical images demonstrate equal or better image quality as compared to predicate devices. |
| Not specified in document | Device is as safe and effective as predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified. The document only states "Clinical images collected."
- Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or from which country.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified. The document does not mention the involvement of experts in establishing ground truth or evaluating the clinical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified. No adjudication method is mentioned.
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 specified. The document does not mention an MRMC study or any AI assistance. The device is a digital X-ray detector system, not an AI-powered analysis tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not specified. The device is a digital X-ray detector system, not an algorithm, so the concept of "standalone" performance for an algorithm isn't directly relevant in the context of this document. The document focuses on the image quality produced by the detector.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. The document only states "Clinical images collected demonstrate equal or better image quality." It does not elaborate on how "image quality" was objectively assessed or against what ground truth.
8. The sample size for the training set
- Not applicable/Not specified. This device is an imaging hardware system. It does not appear to involve machine learning models that would require a "training set" in the conventional sense. The "training" here would refer to engineering and calibration, not data-driven model training.
9. How the ground truth for the training set was established
- Not applicable/Not specified. (See point 8).
§ 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.