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The Direct Digitizer, REGIUS Model 110 is an X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette. It reads the image recorded on the Plate and transfers the image data to an externally connected device such as a host computer, an order input device, an image display device, a printer, an image data fillng device, and other image reproduction devices. REGIUS Model 110 also reads the image data of long areas of anatomy and to verify the position for a radiotherapy location. It is designed and Intended to be used by trained medical personnel In a clinic, a radiology department in a hospital and in other medical facilities. This device is not intended for use with digital mammography system

The Direct Digitizer, REGIUS Model 110 is an X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette, and reads the image recorded on the Plate by inserting a cassette in the entrance slot of this device. By means of laser scan and photoelectric method, this device reads the X-ray Image data created in form of a latent image on the Plate exposed by an external X-ray generating device, and converts the read data into digital. REGIUS Model 110 also reads the image data of long areas of anatomy and to verify the position for a radiotherapy location.

The provided 510(k) summary for the Konica Minolta Direct Digitizer, REGIUS Model 110, primarily focuses on demonstrating substantial equivalence to a predicate device (REGIUS Model 190) rather than providing detailed acceptance criteria and a specific study proving the device meets those criteria.

Therefore, much of the requested information cannot be definitively extracted from the provided text. The document refers to a "Comparison Table" in Section 2 for details on modifications, but this table is not included in the provided text.

Based on the available text, here's what can be inferred and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission is a "Special 510(k)" which implies minor modifications to a previously cleared device. The core argument for substantial equivalence relies on the new device having "the same intended use and basically the same technological characteristic" as the predicate. As such, explicit performance acceptance criteria and a report against them are not detailed in this summary. Instead, the focus is on safety and efficacy being maintained due to the minor nature of the changes and the use of technology from another cleared device.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. As no specific performance study is detailed, there's no mention of a test set, sample size, or data provenance.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided. Ground truth establishment is not discussed as no specific performance study against a ground truth is presented.

4. Adjudication Method for the Test Set

This information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not provided. The document does not describe any studies involving human readers or comparative effectiveness with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

This information is not provided. The device is an X-ray image reader, not an AI algorithm for image analysis. Therefore, a standalone algorithm performance study would not be applicable in this context.

7. Type of Ground Truth Used

This information is not provided.

8. Sample Size for the Training Set

This information is not provided. The device is a hardware component (an image reader), not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not provided. (See explanation for #8).

Summary of what can be extracted related to criteria and proof:

The acceptance criteria and proof of meeting them are implicitly covered by the "substantial equivalence" argument. The manufacturer's assertion is that because the device has:

• The same intended use as the predicate device (REGIUS Model 190).
• Basically the same technological characteristics as the predicate, with minor modifications (compact design) that utilize technology already present in another cleared device (DD341 / REGIUS150).
• Compliance with relevant safety and electromagnetic compatibility standards (IEC60601-1, IEC60601-1-2) and radiation safety (21 CFR 1040.10, IEC60825-1).

Therefore, it is considered safe and effective and meets the implicit "acceptance criteria" of the predicate device. The "study" proving this is the detailed comparison to the predicate and the declaration of compliance with standards rather than a new clinical or performance study with detailed metrics. The FDA's issuance of the 510(k) clearance acts as the confirmation of this substantial equivalence.

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