(27 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, tomography and angiography applications.
The proposed SKR 3000 is modified to consist of new FPD P-71 and P-81 in addition to previously cleared P-61, Console CS-7 and other peripherals. Additionally, a radiography sequence of AeroSync, non tethered operation mode, is modified to incorporate improved usage that allow user to use a FPD without console CS-7. A user can capture the images and store them in FPD memories until when those readout images are transferred to the console CS-7 by a user.
The system is intended for use replacing a radiographic film/screen system in general-purpose diagnostic procedures of human anatomy. The system can be used in conjunction with current cleared AeroDR FPDs. The P-61, P-71, P-81 and the other compatible FPDs availably used in SKR 3000 are lightweight, mobile FPD and they are formed in compatible size with the cassette of ISO standard size.
The SKR 3000 performs radiography imaging of the human body using an X-ray planar detector (FPD) that outputs a digital signal, which is then input into an image processing device. The acquired image is transmitted to a filing system, printer, and image display device as diagnostic image after applying image processing to the raw data of image by the image processing device, Console CS-7.
The radiography sequences to be synchronized with a trigger timing of Xray irradiation are the same as the way of predicate device that requires the SRM / S-SRM connection between the SKR 3000 and X-ray generator. The AeroSync allows to use a FPD without a wired connection of SRM / S-SRM, the FPD itself begins to acquire an image when it detects X-ray irradiation in this mode. The compatible X-ray system is same as that of previously cleared SKR 3000.
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 designed to comply with the following standards; AAMI/ANSI ES 60601-1 (Ed.3.1), IEC 60601-1-2, and ISO 10993-1.
Based on the provided text, the device in question, the KONICA MINOLTA SKR 3000, is an X-ray imaging system, and the submission is for a modification to an already cleared predicate device (K162504 The original SKR 3000) by adding new Flat Panel Detectors (FPDs) (P-71 and P-81) and a modified radiography sequence (AeroSync).
The crucial point from the document is:
"The concurrence study is not necessary according to the new SSXI Guidance because the proposed P-71 / P-81 have same imaging performance but overall change in the dimensions only. Besides, the results of risk management did not require clinical studies to demonstrate the substantial equivalency of the proposed device."
This statement indicates that the regulatory body determined that a full-fledged clinical study or comparative effectiveness study was NOT required because the new FPDs primarily change in physical dimensions while maintaining the same imaging performance as the already cleared predicate device. Therefore, many of the typical acceptance criteria and study aspects you'd expect for a novel AI or diagnostic device are not detailed in this 510(k) summary because they were not deemed necessary for this specific submission.
However, I can extract information relevant to the general performance testing and the implicit criteria used for this type of device based on what is stated:
Acceptance Criteria and Device Performance (Implicit/Inferred from the document's context)
For this specific 510(k) submission regarding the modification of the SKR 3000, the primary acceptance criteria revolved around demonstrating that the new components (P-71 and P-81 FPDs and the AeroSync modification) do not degrade the established performance of the predicate device and comply with relevant safety standards. The document explicitly states that the new FPDs have the "same imaging performance" as the predicate.
| Acceptance Criteria (Inferred from regulatory context for X-ray systems) | Reported Device Performance (as stated or implied) |
|---|---|
| Imaging Performance Equivalence | "P-71 / P-81 have same imaging performance" as predicate P-61. |
| (e.g., Spatial Resolution, Contrast Resolution, Dose efficiency, DQE, MTF) | (Specific metrics not provided, but equivalence asserted) |
| Safety and Electrical Compliance | "The system is in conformance with the standards described above [AAMI/ANSI ES 60601-1 (Ed.3.1), IEC 60601-1-2]" and "same standards to those of predicate device." |
| Biocompatibility | "All patient contact materials... are identical to those of predicate device, and are evaluated under ISO 10993-1 and determined as acceptable." |
| Mechanical Integrity/Durability | Explicitly stated "overall change in the dimensions" for P-71 and P-81, implies new mechanical properties were evaluated. (No specific performance data given, but assumed within "performance tests") |
| Functional Equivalence (AeroSync) | "The system including a modified radiography sequence has same operational principles and designing as those of the predicate device." "Allows user to use a FPD without console CS-7" (new feature with stated functionality). |
Study Details (as per the provided text for this specific 510(k) modification)
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Sample sizes used for the test set and the data provenance:
- The document mentions "Performance tests" were performed "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."
- No specific sample sizes (e.g., number of images, patients) for the test set are mentioned. This is typical for submissions focused on hardware modifications retaining "imaging performance" rather than proving a new diagnostic capability. The tests would likely involve phantom images and bench testing rather than patient data in large quantities.
- Data provenance is not specified. Given the nature of the tests (bench/phantom), patient data provenance (country, retrospective/prospective) is likely irrelevant for this specific submission, as it's not a clinical performance study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. Since this is primarily a hardware/engineering performance and safety validation (demonstrating equivalence to a predicate system rather than a new diagnostic claim), there is no mention of human experts establishing "ground truth" for diagnostic purposes. The ground truth for engineering tests typically comes from calibrated measurement equipment and reference standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / None specified. No adjudication method is mentioned as there's no diagnostic ground truth established by human readers for comparative or standalone performance in this context.
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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 explicitly NOT done. The document states: "The concurrence study is not necessary according to the new SSXI Guidance because the proposed P-71 / P-81 have same imaging performance but overall change in the dimensions only." This device is a digital radiography system, not an AI-based diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an "algorithm." This device is an X-ray imaging system. The performance tests would be "standalone" in the sense that the device itself is tested for its physical and imaging characteristics (e.g., MTF, DQE, spatial resolution) using phantoms and test procedures, without a human in a diagnostic loop.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering/Physical Ground Truth: The "ground truth" for the performance tests would be based on calibrated measurements against established standards for X-ray imaging performance (e.g., physical properties of test phantoms, known radiation doses, measurements of image quality metrics like spatial resolution and contrast-to-noise ratio). It is not expert consensus, pathology, or outcomes data related to disease diagnosis.
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The sample size for the training set:
- Not applicable / Not mentioned. This device is a traditional X-ray imaging system, not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. As no training set is mentioned, no ground truth establishment for it is relevant.
Summary of Key Takeaways from the Document:
- This 510(k) is for a modification to an existing X-ray system (SKR 3000), primarily introducing new FPDs with different physical dimensions but "same imaging performance."
- Due to the nature of the modification (maintaining imaging performance and primarily changing dimensions), full clinical studies or comparative effectiveness studies (like MRMC) were explicitly deemed unnecessary by the FDA for this submission.
- The "performance tests" focused on ensuring the new components met engineering and safety standards and maintained equivalence to the predicate device's established imaging performance.
- "Ground truth" in this context refers to physical measurements and adherence to technical specifications rather than medical diagnostic outcomes or expert consensus on clinical cases.
§ 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.