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510(k) Data Aggregation
(144 days)
The KrystalRad 560 (FLAATZ 560) Digital X-Ray System is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammography applications).
The KrystalRad 560 (FLAATZ 560) System is a flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire X-ray film or an image plate as an image capture medium. The KrystalRad 560 (FLAATZ 560) device differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector Panel is used to capture the image in electronic form.
Once the system captures a radiographic image and subsequently displaying and storing an image, radiologists or physicians can adjust the image electronically to optimize the view of the desired anatomy at a work station. The system enables a user to duplicate images without having to take additional exposures so that the user can easily transmit a duplicate to the second physician who needs the duplicate image through the network. Hardcopy images can also be made from digital printers, optimizing for the user's preference. The system can have DICOM-compliant output to ensure compatibility with existing imaging network infrastructure.
Here's a breakdown of the acceptance criteria and study information for the KrystalRad 560 (FLAATZ 560) System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes the KrystalRad 560 (FLAATZ 560) as "substantially equivalent" to a predicate device (DRTech FLAATZ 750 system). Acceptance criteria are not explicitly stated as pass/fail thresholds for clinical performance but rather by demonstrating that the new device's performance characteristics (technical specifications) are comparable to or better than the predicate device. The study presented is a comparison to the predicate device, not a standalone clinical trial with specific performance metrics for disease detection.
| Criteria (Technical Specification) | Predicate Device (DRTech FLAATZ 750) Performance | KrystalRad 560 (FLAATZ 560) Performance (Reported Device Performance) |
|---|---|---|
| Panel Shape | Square | Rectangle |
| Detector Size | 42.9 x 42.9 (cm) | 35x43 cm |
| Dimensions (W x L x H) | 482 x 482 x 35 (mm) | 383 X 460 X15mm |
| Pixel Pitch | 168 (um) | 139 um |
| Image Size | 3072 x 3072 (pixels) | 3072 x 2560 pixels |
| Selenium Thickness | 500 (µm) | 500 (µm) |
| Weight (Detector) | 6.2 (kg) | 3.8kg |
| DQE @ 0.5lp/mm | 48.5% | 52.5% |
| MTF @ 3.5lp/mm | 78% | 77% |
| Resolution | 3.6lp/mm | 3.5lp/mm |
| Ghosting @ RQA5 Condition | <1% | <1% |
| Anatomical Sites | General Radiography | General Radiography |
| Power Requirement | 100 | 100 |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not describe a test set in the context of a clinical performance study with human images. The "acceptance criteria" and "study" are based on technical specifications and performance metrics of the device itself, comparing them to a predicate device. Therefore, there is no sample size of patients or images for a test set, nor information about data provenance in that sense. The comparison is between the technical specifications of two devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable. As noted above, there is no clinical test set for which ground truth would be established by experts. The performance metrics (DQE, MTF, Resolution, Ghosting) are engineering measurements of the device's imaging capabilities.
4. Adjudication Method for the Test Set:
Not applicable. There is no clinical test set requiring adjudication.
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 applicable. This submission is for a digital X-ray detector, which replaces film/screen systems. It is not an AI-powered diagnostic tool, and therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The KrystalRad 560 (FLAATZ 560) System is a medical imaging device, not an algorithm, so standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The evaluation relies on engineering and physical performance measurements (e.g., DQE, MTF, Resolution, Ghosting) of the detector panel, compared against equivalent measurements of a legally marketed predicate device.
8. The Sample Size for the Training Set:
Not applicable. This is a medical device (hardware and basic software for image acquisition/display) and not an AI/ML algorithm that would typically require a training set of images with established ground truth.
9. How the Ground Truth for the Training Set was Established:
Not applicable, for the same reasons as point 8.
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