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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. The CS-7 is a software with Moderate level of concern. 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. The CS-7 modifications have been made for a wireless serial radiography.

The SKR 3000 is distributed under a commercial name AeroDR 3.

This submission is to introduce a wireless serial radiography into the SKR 3000 system. The wireless serial radiography function of P-65 / P-75 used with Phoenix was cleared under K221803. These detectors are wireless and their serial radiography functions are not being controlled by the x-ray generator. Hence no detector integration testing is necessary.

The provided text is a 510(k) Summary for the Konica Minolta SKR 3000 device, which is a digital radiography system. This document focuses on demonstrating substantial equivalence to a predicate device (K213908), rather than presenting a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, expert involvement, or statistical analysis.

The document states that the changes made to the SKR 3000 (specifically the addition of wireless serial radiography for P-65 and P-75 detectors) did not require clinical studies. Therefore, the information requested about a study demonstrating the device meets acceptance criteria regarding clinical performance is not available in this filing. The "Performance Data" section primarily addresses compliance with electrical safety and EMC standards.

However, based on the information provided, here's what can be extracted and inferred regarding "acceptance criteria" in the context of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Given that no clinical study specific to this submission's modifications is presented, the "acceptance criteria" here relate to general regulatory and technical compliance rather than clinical performance metrics (e.g., sensitivity, specificity for a particular pathology). The "reported device performance" is essentially a statement of compliance.

Note: This table reflects the nature of a 510(k) submission focused on substantial equivalence rather than a clinical performance study.

Here's the breakdown for the other requested information, based on the limitations of the provided document:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document states that "The results of risk management did not require clinical studies to demonstrate the substantial equivalency of the subject device modifications." This indicates that no clinical "test set" with patient data was used for this specific submission. The performance assessment was based on non-clinical testing (e.g., engineering verification, validation testing to internal specifications and regulatory standards).

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)

• Not applicable. As no clinical study or test set with patient data was conducted or analyzed, there were no experts establishing ground truth for performance metrics like diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No clinical test set.

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

• Not applicable. This submission is for a digital radiography system, not an AI-powered diagnostic aide. No MRMC study was performed or is relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is an imaging system, not an algorithm for standalone diagnosis. The "performance tests" mentioned are related to the hardware and software functionality of the imaging system itself (e.g., image quality specifications, electrical safety, EMC), not an algorithm's diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. For the purpose of this 510(k) filing for device modifications, the "ground truth" for performance was implicitly defined by the compliance with engineering specifications, safety standards (AAMI/ANSI ES 60601-1, IEC 60601-1-2), and the functional equivalence to the predicate device. No clinical ground truth (e.g., pathology, outcomes) was established for this submission.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the sense of patient data for learning.

9. How the ground truth for the training set was established

• Not applicable. No training set for an AI/ML algorithm.

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