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The device is intended for use for medical purpose in a hospital, etc., in order to convert X-ray image data to digital signal and to transfer the converted data to printer, filing system, image display device, etc. Flex DR C30 is not intended for use with FFDM systems.

FlexDR C30 is comprised of a reader and an elevator stand that raises and lowers the reader. The reader is an X-ray image reader with a built-in FPD as an X-ray detector. This reader is linked to the exposure liming of the X-ray generator and starts reading of the X-ray image immediately after exposure. The read images are stored inside, and then they are converted one by one to digital data and sent to Medical Image Working Station, CS-3000, 510(k) cleared, K051523. The operator can manually adjust the height of the reader to match the height of the patient by holding the reader elevation handle at the rear of the reader.

This 510(k) submission for the Konica Minolta FlexDR C30, a Solid State X-ray Imager, focuses on its substantial equivalence to previously cleared predicate devices. Therefore, the submission does not contain a detailed study with specific acceptance criteria and performance metrics for the FlexDR C30 itself, as would be expected for a novel device. Instead, the demonstration of substantial equivalence relies on comparing the technological characteristics of the new device to the predicates.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the given 510(k) summary. Since the submission is for substantial equivalence to predicate devices, a direct study with specific acceptance criteria and detailed performance metrics for the FlexDR C30 itself is not presented. The claim is that its technological characteristics are "basically the same" as the predicates.

2. Sample size used for the test set and the data provenance

This information is not provided as a standalone performance study with a test set was not detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided as a standalone performance study with a test set was not detailed.

4. Adjudication method for the test set

This information is not provided as a standalone performance study with a test set was not detailed.

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

There is no mention of an MRMC study or AI assistance in this 510(k) submission. The device is an X-ray imager, not an AI-powered diagnostic tool.

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

This information is not provided as the device is an imaging hardware system, not an algorithm.

7. The type of ground truth used

This information is not provided as a standalone performance study with a test set was not detailed.

8. The sample size for the training set

This information is not provided. As an imaging hardware device, it would not typically have a "training set" in the context of an AI algorithm.

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

This information is not provided. As an imaging hardware device, it would not typically have a "training set" in the context of an AI algorithm.

Summary of Device and Equivalence:

The FlexDR C30 is a Solid State X-ray Imager intended for converting X-ray image data to digital signals and transferring them. Its substantial equivalence is claimed to the Konica Minolta Direct Digitizer, Regius Model 370 (K051418), and the Canon Inc. Digital Radiography Model CXDI-40C (K031633). The comparison of principal characteristics is referenced in "Section 4" (which is not provided in the excerpt), and the conclusion states that the FlexDR C30 "has basically the same technological characteristic" as the predicate devices. The submission also indicates compliance with safety and electromagnetic compatibility standards (IEC60601-1 and IEC60601-1-2).

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