(37 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 two cleared devices: ViZion DR, K102123 and K102587, the Samsung Digital Flat Panel. ViZion DR is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) (K102587, Samsung Flat-Panel X-Ray Detector), made by 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 as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a film less. environment and improves cost effectiveness. The major functions and principle of operation of the Viztek PACS and Samsung FPD were not changed.
This is a 510(k) premarket notification for a new version of the Viztek ViZion DR, a Digital Radiography (DR) system. The submission focuses on replacing the digital flat panel detector (FPD) with a new model while maintaining the existing software and overall functionality. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in terms of demonstrating substantial equivalence to a predicate device, rather than proving a specific diagnostic accuracy against a clinical ground truth.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the demonstration of substantial equivalence to the predicate device, specifically regarding safety and effectiveness, and the absence of new indications for use or technological differences that would raise new questions of safety or effectiveness. The reported performance is a comparison to the predicate.
| Characteristic | Acceptance Criteria (Implicitly, as per Predicate) | Reported Device Performance (New Device) |
|---|---|---|
| Intended Use | Same as Viztek ViZion DR K102123: Digital image capture in general radiographic examinations (excluding fluoroscopy, angiography, mammography), imaging skull, chest, shoulders, spine, abdomen, pelvis, and extremities. | SAME (Matches predicate exactly) |
| Digital Panel | Samsung LTX240AA01-A (K090742) with Pixel size 143 µm, 3072 x 3072 pixels, 9 million pixels. | Samsung LLX240AB01 (K102587) with Pixel size 143 µm, 3072 x 3072 pixels, 9 million pixels. |
| Software | Employs OPAL-RAD PACS image viewing and acquire interface software technology, K063337. | SAME (Matches predicate exactly) |
| Electrical Safety | Electrical Safety per IEC-60601. UL listed. | SAME (Matches predicate exactly) |
| Safety and Effectiveness | As safe and effective as predicate devices. | "The results of clinical image inspection, bench, and test laboratory indicates that the new device is as safe and effective as the predicate devices. Clinical images collected demonstrate equal or better image quality as compared to our predicates." |
| Technological Differences | No new technological differences that raise new questions of safety or effectiveness. | "have few technological differences" (only change is the FPD) and "no new indications for use, thus rendering it substantially equivalent". |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Clinical images collected demonstrate equal or better image quality as compared to our predicates." However, it does not specify the sample size for this clinical image inspection, nor does it provide details about the data provenance (e.g., country of origin, retrospective or prospective nature). Given the nature of a 510(k) for a component change (the FPD), this might have been a limited comparative study rather than a large-scale clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document mentions "clinical image inspection" but does not provide any information on the number of experts involved in this inspection or their qualifications.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. It only mentions "clinical image inspection."
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
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a digital X-ray detector system, not an AI-assisted diagnostic tool. The comparison is between the new detector and a previous detector system, with the focus on image quality and equivalence, not reader performance improvement with AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an algorithm's performance without human intervention. Since the device is a digital X-ray detector system (hardware), not a diagnostic algorithm, this concept does not apply. The "standalone performance" for this device would relate to its hardware specifications and image acquisition capabilities, which are covered by bench and laboratory testing.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The available information suggests that the "ground truth" for the comparison was based on "clinical image inspection" and possibly "bench, and test laboratory" results, comparing the image quality of the new device to that of the predicate device. This implies a subjective assessment of image quality by potentially experts, but the specifics are not detailed. It is unlikely to involve pathology or outcomes data for this type of 510(k) submission.
8. The Sample Size for the Training Set
This submission is for a digital X-ray detector system, not an AI algorithm that requires a training set. Therefore, there is no training set in the context of this device.
9. How the Ground Truth for the Training Set was Established
As there is no training set for this hardware device, this question is not applicable.
§ 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.