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510(k) Data Aggregation
(144 days)
The KrystalRAD (ATAL8) 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 (ATAL8) 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 (ATAL8) device differs from traditional Xray systems in that, instead of exposing a film and chemically processing it to create a hard convenial 71 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.
The provided text describes the KrystalRAD (ATAL8) System, a flat-panel digital X-ray detector, and its 510(k) submission (K102285) for market clearance. The submission relies on demonstrating substantial equivalence to a predicate device, the DRTech FLAATZ 750 (K080064). The acceptance criteria and supporting study are primarily focused on this comparison and general safety/effectiveness rather than a detailed clinical performance study with specific acceptance criteria for a diagnostic task.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly or explicitly based on comparing the KrystalRAD (ATAL8) System's technical specifications and performance metrics directly against its predicate device, the DRTech FLAATZ 750 (K080064). The goal is to demonstrate "substantial equivalence," meaning that the new device is as safe and effective as the legally marketed predicate.
| Metric / Characteristic | Acceptance Criteria (from predicate K080064) | Reported Device Performance (KrystalRAD (ATAL8) System) |
|---|---|---|
| Indication for Use | General radiographic images of human anatomy; replaces film/screen in general diagnostic procedures (excluding fluoroscopic, angiographic, mammographic) | Same as predicate. |
| User Interface | Software Driven Touch Panel LCD + remote control unit + remote console | Same as predicate. |
| Software | ECOM OmniVue | OmniVision |
| Panel Shape | Square | Square Panel |
| Detector Size | 42.9 x 42.9 cm | 43 x 43 cm |
| Dimensions (W x L x H) | 482 x 482 x 35 mm | 500 x 500 x 40 mm |
| Pixel Pitch | 168 µm | 143 µm |
| Image Size | 3072 x 3072 pixels | 3072 x 3072 pixels |
| Selenium Thickness | 500 µm | no selenium |
| Weight (Detector) | 6.2 kg | 12.7 kg |
| Materials | Amorphous Selenium (a-Se) Detector | Amorphous Silicon (a-Si) |
| DQE | 48.5% @ 0.5 lp/mm | 68% @ 0.5 lp/mm |
| MTF | 78% @ 3.5 lp/mm | 52.5% @ 3.5 lp/mm |
| Resolution | 3.6 lp/mm | 3.5 lp/mm |
| Ghosting | <1% @ RQA5 Condition | <1% @ RA5 condition |
| Anatomical Sites | General Radiography | General Radiography |
| Power Requirement | 100 | 90V - 260V, 47/63 Hz, 3.15A, Single Phase |
Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is described as a combination of bench testing, electrical safety testing, and performance testing against established standards and direct comparison to the predicate device's specifications. The document states:
- "Bench testing and electrical safety further substantiate equivalence to the predicate."
- "Electrical, mechanical safety and performance testing according to standard EN/IEC 60601-1, EN/IEC 60601-1-1, EN/EC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28 and EN/IEC 60601-2-23 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2202. All test results were satisfactory."
- The "Substantial Equivalence Table" explicitly lists the performance metrics of the KrystalRAD (ATAL8) against the predicate, indicating that these measurements were taken for the new device.
The "Conclusion" states: "The results of all testing demonstrate that the KrystalRAD (ATAL8) does not raise any new significant issues of safety, effectiveness or performance of the device when compare to the existing predicate devices." This confirms that the device was deemed to meet the "acceptance criteria" of being substantially equivalent to the predicate.
2. Sample Size for the Test Set and Data Provenance
The document does not detail a specific "test set" in the context of clinical images or patient data for evaluating diagnostic performance. The evaluation is primarily technical and comparative against a predicate device. The "performance testing" mentioned refers to engineering and physics measurements like DQE, MTF, resolution, and ghosting, which are conducted in a lab setting, not typically on patient images from a specific provenance.
Therefore, this information is not provided in the given text.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable as the submission is for substantial equivalence of a general X-ray system based on technical and safety specifications, not a diagnostic AI algorithm that requires expert-established ground truth for clinical performance evaluation on a test set.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
This information is not applicable. The KrystalRAD (ATAL8) System is a digital X-ray detector, not an AI-powered diagnostic algorithm designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed or described.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable. The device is an X-ray imaging system, not a standalone diagnostic algorithm. Its performance is evaluated based on image quality metrics and safety standards, as detailed in the substantial equivalence comparison.
7. Type of Ground Truth Used
The "ground truth" in this context refers to the established technical specifications and performance characteristics of the predicate device, and the general safety and electrical standards (EN/IEC 60601 series). The KrystalRAD (ATAL8) System's performance was measured against these engineering and physics-based "truths."
There is no mention of clinical ground truth like pathology, expert consensus on disease, or outcomes data, as this is not a diagnostic AI device requiring such validation for a specific clinical task.
8. Sample Size for the Training Set
This information is not applicable. The KrystalRAD (ATAL8) System is not an AI algorithm that undergoes "training" on a dataset. It is a hardware device (digital X-ray detector) with associated software for image control and management.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reasons as point 8.
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