(26 days)
The SKR 3000 is indicated for use in generating radiographic images of human anatomy. It is intended to replace a radiographic film/screen system in general-purpose diagnostic procedures.
The SKR 3000 is not indicated for use in mammography, tomography and angiography applications.
The SKR 3000 consisting of new FPD P-61, Console CS-7 and other peripherals 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 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 provided text describes the Konica Minolta SKR 3000, a digital radiography system, and its substantial equivalence to a predicate device (K141271 - AeroDR SYSTEM 2). The document suggests that a formal clinical study was not required to demonstrate substantial equivalence.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
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."
It also mentions a concurrence study: "The concurrence study in a way of comparing images between the proposed device and the predicate device was conducted, and the qualified persons have affirmed and have concluded that both images of proposed P-61 and predicate AeroDR P-51 are equivalent and have sufficient capabilities for the intended purpose of the device."
However, the document does not explicitly list specific quantitative acceptance criteria (e.g., minimum DQE, specific MTF values, contrast-to-noise ratio requirements) or specific performance metrics from the SKR 3000. It merely states that "predetermined acceptance criteria were met" and that images were "equivalent."
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Meet "Guidance for Submission of 510(k)s for Solid State X-ray Imaging Devices" performance tests | Performed, results "demonstrated that the predetermined acceptance criteria were met." |
| Meet other verification and validation tests (including risk analysis requirements) | Performed, results "demonstrated that the predetermined acceptance criteria were met." |
| Image equivalence to predicate device (AeroDR SYSTEM 2) | Concurrence study concluded images from SKR 3000 and predicate are "equivalent and have sufficient capabilities for the intended purpose." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample size for the test set used in the "concurrence study" or the other "performance tests." It also does not provide information on the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
The document states "qualified persons have affirmed and have concluded," but it does not specify the number of experts or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not specify any adjudication method used in the concurrence study or other performance tests.
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 a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a digital radiography system, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable in this context. The study performed was a "concurrence study" comparing images from the new device to the predicate device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device described is a digital X-ray system (hardware and associated image processing), not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance without human-in-the-loop is not directly applicable in the way it would be for an AI diagnostic algorithm. The performance tests would be evaluating the image acquisition and processing capabilities of the system itself. The "concurrence study" did evaluate the images produced by the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the "concurrence study," the ground truth appears to be established by expert judgment that images from the proposed device were "equivalent" and had "sufficient capabilities" compared to the predicate device's images. There is no mention of pathology, outcomes data, or other objective ground truth methods.
8. The sample size for the training set:
The document does not mention a training set, as the SKR 3000 is an imaging acquisition and processing system, not a machine learning model that requires a labeled training set in the conventional sense. The "training" described would be the development and calibration of the image processing algorithms based on engineering principles and potentially internal testing, not a separate labeled dataset.
9. How the ground truth for the training set was established:
As no training set (in the context of machine learning) is explicitly mentioned, there is no information on how its ground truth was established. The "ground truth" for the device's technical specifications and image quality would have been established through engineering design, optical/X-ray physics principles, and quality assurance testing against established imaging standards.
§ 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.