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510(k) Data Aggregation
(48 days)
The SKR 3000 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in general-purpose diagnostic procedures.
The SKR 3000 is not indicated for use in mammography, fluoroscopy and angiography applications.
The digital radiography SKR 3000 performs X-ray imaging of the human body using an Xray planar detector that outputs a digital signal, which is then input into an image processing device, and the acquired image is then transmitted to a filing system, printer, and image display device as diagnostic image data.
- This device is not intended for use in mammography
- This device is also used for carrying out exposures on children.
The Console CS-7, which controls the receiving, processing, and output of image data, is required for operation. CS-7 implements the following image processing; gradation processing, frequency processing, dynamic range compression, smoothing, rotation, reversing, zooming, and grid removal process/scattered radiation - correction (Intelligent-Grid). The Intelligent-Grid is cleared in K151465.
This submission is to add new flat-panel x-ray detectors (FPDs), P-82 and P-85, into the SKR 3000. The P-82 and P-85 employ the same surface material infused with Silver ions (antibacterial properties) as the predicate device. The only difference between the P-82 and P-85 is the number of Li-ion capacitors. The P-85 has two Li-ion capacitors and the P-82 has one. These new P-82 and P-85 are not applicable to the serial radiography which acquires multiple frames of radiography image serially.
The FPDs used in SKR 3000 can communicate with the image processing device through the wired Ethernet and/or the Wireless LAN (IEEE802.11a/n and FCC compliant). The WPA2-PSK (AES) encryption is adopted for a security of wireless connection.
The SKR 3000 is distributed under a commercial name AeroDR 3.
The provided text describes the Konica Minolta SKR 3000, a digital radiography system, and seeks 510(k) clearance by demonstrating substantial equivalence to a predicate device (K210619), which is also an SKR 3000 model. The submission focuses on adding new flat-panel x-ray detectors (FPDs), P-82 and P-85, to the existing system.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines "acceptance criteria" by comparing the specifications and performance of the subject device (SKR 3000 with P-82/P-85 FPDs) against its predicate device (SKR 3000 with P-65 FPD). The acceptance criteria are essentially the performance levels of the predicate device, which the new FPDs must meet or exceed.
| Feature / Performance Metric | Acceptance Criteria (Predicate P-65) | Reported Device Performance (Subject P-82/P-85) | Meets Criteria? |
|---|---|---|---|
| Indications for Use | Same as Subject | Generates radiographic images of human anatomy, replaces film/screen in general diagnostic procedures, not for mammography, fluoroscopy, angiography. | Yes |
| Detection method | Indirect conversion method | Indirect conversion method | Yes |
| Scintillator | CsI (Cesium Iodide) | CsI (Cesium Iodide) | Yes |
| TFT sensor substrate | Glass-based TFT substrate | Film-based TFT substrate | N/A (difference accepted, no new safety/effectiveness issues) |
| Image area size | P-65: 348.8×425.6mm (3,488×4,256 pixels) | P-82/P-85: 348.8×425.6mm (3,488×4,256 pixels) | Yes |
| Pixel size | 100 µm / 200 µm / 400 µm | 100 µm / 200 µm | Yes (smaller range still includes acceptable sizes) |
| A/D conversion | 16 bit (65,536 gradients) | 16 bit (65,536 gradients) | Yes |
| Max. Resolution | P-65: 4.0 lp/mm | P-82/P-85: 4.0 lp/mm | Yes |
| MTF (1.0 lp/mm) | (Non-binning) 0.62, (2x2 binning) 0.58 | (Non-binning) 0.62, (2x2 binning) 0.58 | Yes |
| DQE (1.0 lp/mm) | 56% @ 1mR | 59% @ 1mR | Yes (exceeds) |
| External dimensions | P-65: 384(W)×460(D)×15(H)mm | P-82/P-85: 384(W)×460(D)×15(H)mm | Yes |
| IP Code (IEC 60529) | IPX6 | IP56 | N/A (minor difference, presumed acceptable) |
| Battery Type | Lithium-ion capacitor | Lithium-ion capacitor | Yes |
| Number of batteries | P-65: Two | P-82: One, P-85: Two | N/A (difference in configuration, performance evaluated) |
| Battery duration in standby | P-65: Approx. 13.2 hours | P-82: Approx. 6.0 hours, P-85: Approx. 13.2 hours | Yes (P-85 meets, P-82 is different but acceptable for its configuration) |
| Surface Material | Surface infused with Silver ions (antibacterial properties) | Surface infused with Silver ions (antibacterial properties) | Yes |
| Communication I/F | Wired and Wireless | Wired and Wireless | Yes |
| Operator console (Software) | CS-7, AeroDR3 interface for P-65 (CTDS) | CS-7, AeroDR3 interface for P-82 and P-85 (CTDS) | Yes |
| Image Processing | Same complex image processing algorithms | Same complex image processing algorithms | Yes |
| Serial radiography | Applicable | Not applicable | N/A (difference in feature, not an "acceptance criterion" in this context as new FPDs don't support it) |
Note: The acceptance criteria are largely implied by the claim of substantial equivalence. The document primarily focuses on demonstrating that new FPDs (P-82 and P-85) either match or improve upon the predicate's performance for critical imaging parameters. Differences in the TFT substrate material, pixel size options, number of batteries, and serial radiography capability are noted but explained as not raising new safety or effectiveness concerns.
2. Sample size used for the test set and the data provenance:
The document states: "The performance tests according to the 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices' and the other verification and validation including the items required by the risk analysis for the SKR 3000 were performed and the results demonstrated that the predetermined acceptance criteria were met."
This indicates that specific performance tests were conducted. However, the document does not explicitly state the sample size used for the test sets (e.g., number of images, number of phantom studies, number of human subjects, if any) nor the data provenance (e.g., country of origin, retrospective or prospective nature of clinical data if used). Given the type of device (X-ray system component) and the nature of the submission (adding new FPDs to an existing cleared system), the "performance data" presented is primarily technical specifications and phantom-based measurements, not typically large-scale clinical trials with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention the use of experts to establish ground truth. As this is a technical performance comparison of imaging hardware (FPDs), ground truth would likely be established through objective physical measurements and established technical standards (e.g., imaging phantoms, dosimeters) rather than expert human interpretation of medical images for diagnostic accuracy.
4. Adjudication method for the test set:
Since there is no mention of human experts or clinical image interpretation studies, there is no adjudication method described.
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:
The document does not mention an MRMC study, nor does it refer to AI or AI-assisted improvements for human readers. This device is a digital radiography system (hardware), and the submission focuses on its technical performance compared to a predicate, not on AI algorithms or their impact on reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device described is an X-ray imaging system, not an algorithm. Therefore, a standalone algorithm-only performance study is not applicable in this context. The performance evaluated is that of the hardware components (FPDs) within the system.
7. The type of ground truth used:
The ground truth for the performance parameters (e.g., Max. Resolution, MTF, DQE) would be established through objective physical measurements using standardized phantoms and test procedures as per industry standards (e.g., "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices"). For other specifications like battery life or dimensions, ground truth is based on engineering measurements and design specifications.
8. The sample size for the training set:
The document does not refer to a training set. This is because the submission is for hardware components (FPDs) for an X-ray system, not for a machine learning or AI-based diagnostic algorithm that would require training data.
9. How the ground truth for the training set was established:
As there is no mention of a training set, there is no information on how its ground truth would be established.
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