(171 days)
The Konica Direct Digitizer, REGIUS MODEL 350 is an X-ray image controller which uses a stimulative phosphor as X-ray detector and controls and manages digital X-ray image file processing.
The Konica Direct Digitizer, REGIUS MODEL 350 is an X-ray image controller which uses a stimulative phosphor as X-ray detector and controls and manages digital X-ray image file processing. The system consists of an operator console, an image buffer section (hard disk) and control section. The operator consists of an operation CRT display that has a touch panel function, and a keyboard for entering text. An image file received from an industry-standard X-ray film cassette is processed using automatic tonal processing and is then transferred to an externally connected device including a host computer or CR printer.
The provided 510(k) summary for the Konica Direct Digitizer REGIUS MODEL 350 primarily focuses on demonstrating substantial equivalence to a predicate device (Konica Direct Digitizer REGIUS MODEL 330) based on device description, intended use, and general specifications. It does not contain information regarding detailed acceptance criteria for diagnostic performance or a specific study proving the device meets expert-defined criteria.
This type of submission often relies on demonstrating that the new device performs fundamentally the same as a previously cleared device, rather than requiring a new clinical performance study against established ground truth.
Given the information provided, here's what can be extracted and what is explicitly not available:
1. Table of Acceptance Criteria and Reported Device Performance
No specific acceptance criteria related to diagnostic accuracy (e.g., sensitivity, specificity, AUC) are mentioned in this 510(k) summary. The comparison is primarily focused on technical specifications and functionality with the predicate device.
| Item | Acceptance Criteria (Not explicitly stated for diagnostic performance) | Reported Device Performance (Comparison to Predicate) |
|---|---|---|
| Device Type | X-ray image controller using stimulative phosphor (same as predicate) | X-ray image controller using stimulative phosphor |
| Configuration | Reading unit + control unit (same as predicate) | Reading unit + control unit |
| Principle of Operation | Exposure -> Reading -> Erase using stimulable phosphor plate (same as predicate) | Exposure -> Reading -> Erase using stimulable phosphor plate |
| Cycle Time | Max. 25 sec. or less (for predicate) | Max. 17 sec. or less (Improved from predicate) |
| Exposure Size | 5 sizes (for predicate) | 6 sizes (Improved from predicate) |
| Maximum Pixels (Read) | Max. 4096 x 4924 pixel (for predicate) | Max. 4860 x 4860 pixel (Improved from predicate) |
| Sampling Pitch | 9 types (for predicate) | 2 types (Changed from predicate) |
| Gray Levels | 4096 (same as predicate) | 4096 |
| Laser Source | Laser Diode 780nm (for predicate) | Laser Diode 690nm (Changed from predicate) |
| Laser Power | 200mW (for predicate) | 60mW (Changed from predicate) |
| Elevation Stroke | 575mm or more (for predicate) | 750mm or more (Improved from predicate) |
| Intended Use | Control and manage digital X-ray image file processing (same as predicate) | Control and manage digital X-ray image file processing |
2. Sample size used for the test set and the data provenance
- Not provided. This submission does not detail a specific diagnostic performance test set. The evaluation focuses on technical specifications and functional equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not provided. No explicit test set with ground truth established by experts is mentioned in this document.
4. Adjudication method for the test set
- Not provided. As no dedicated test set for diagnostic performance is described, 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
- No, an MRMC comparative effectiveness study was not done. This device is a digitizer, transforming X-ray images into digital format. It is not an AI-powered diagnostic tool that assists human readers directly. Therefore, improvement metrics with or without AI assistance are not applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not an algorithm for diagnostic interpretation. The device's function is to convert X-ray film data into digital signals. The concept of "standalone performance" for diagnostic interpretation does not apply to this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. Since no diagnostic performance study against ground truth is described, no type of ground truth is mentioned. The evaluation is centered on the device's ability to digitize images effectively and its technical specifications compared to a predicate.
8. The sample size for the training set
- Not applicable. This device is an imaging hardware component (a digitizer), not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As the device is not an AI/ML algorithm, it does not have a training set or associated ground truth.
Summary Explanation:
The 510(k) submission for the Konica Direct Digitizer REGIUS MODEL 350 focuses on establishing substantial equivalence to its predicate device (REGIUS MODEL 330) based on its technical specifications, intended use, and operational principles. The document highlights improvements in cycle time, exposure size, maximum pixels, and elevation stroke, while noting changes in sampling pitch, laser source, and laser power. Crucially, as a digitizer (a device that converts analog X-ray images to digital format), its primary function is not to perform diagnostic interpretations or assist human readers in clinical decision-making. Therefore, the typical performance metrics associated with AI/ML-driven diagnostic devices (like sensitivity, specificity, AUC, MRMC studies, or training/test sets for algorithms) are not part of this 510(k) submission. The "study" proving it meets acceptance criteria is implied through the detailed comparison of its engineering specifications against its predicate device, demonstrating that it functions robustly and safely for its intended purpose, which is to digitize X-ray images.
§ 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.