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The Direct Digitizer, REGIUS MODEL 170 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 filing device, and other image reproduction devices.

REGIUS MODEL 170 is used to obtain image data of long areas of anatomy such as the whole spine or the whole lower leg.

REGIUS MODEL 170 is also used to obtain image data to verify the position for a radiotherapy location.

It is designed intended to use in a clinic, a radiology department in a hospital and in other medical facilities.

It is not intended for use with digital mammography system.

The Direct Digitizer, REGIUS MODEL 170 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 the REGIUS MODEL 170. By means of laser scan and photoelectric method, the 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. The signal processing is made to the digital image data such as the digital filtering, the gain-offset correction and the shading collection. Then the REGIUS MODEL 170 is capable of transferring 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 filing device, and other image reproduction devices.

The modifications are 1) Applicable cassette size is increased. 2) Read-Only cassettes are added, 3) Exposure-Only cassettes are added, and 4) Function of a reader console is upgraded.

The purpose of modification is to enable to use of multiple cassettes to obtain images of long areas of anatomy and then to present the images as a single composite image (Long Length Imaging feature), and to obtain images to verify the position for a radiotherapy location.

This 510(k) summary describes a device modification to the Direct Digitizer REGIUS MODEL 170, and as such, it focuses on the changes and their intended use rather than a comprehensive study to establish its primary performance characteristics. The document explicitly states that the "Risk analysis is the same as our current REGIUS MODEL 170, K023061" and "Software information is also the same as current REGIUS MODEL 170, K023061." This suggests that the fundamental performance characteristics established for the original device are considered applicable, and no new studies are presented to re-evaluate those core metrics for the modified device.

However, based on the provided text, we can infer some aspects related to acceptance criteria for the new functionalities:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a device modification submission, the document doesn't present new quantitative performance metrics for the device as a whole. Instead, the "acceptance criteria" are implicitly met by demonstrating the device's ability to implement the new functionalities as intended and ensuring consistency with the predicate device.

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

The provided 510(k) summary does not describe a clinical study or a specific test set with a defined sample size for the evaluation of the device modifications. The submission relies on the established performance of the predicate device and the design documentation for the new features. It is therefore implicitly assumed that standard engineering and quality assurance practices for device functionality testing were conducted during development, but no specific data or provenance is detailed in this regulatory document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

No information is provided regarding experts or ground truth establishment for a test set. This type of detail is typically found in clinical validation studies, which are not described here given the nature of this submission focused on device modification and substantial equivalence.

4. Adjudication Method for the Test Set

Not applicable, as no dedicated test set or clinical study requiring expert adjudication is described in this document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC study is mentioned or implied. The submission is based on modifications to an existing device, and the focus is on maintaining equivalence and functionality of the new features rather than demonstrating improved human reader performance with AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This device is an X-ray image reader. Its function is to digitize X-ray images for subsequent viewing by human operators, not to provide diagnostic algorithms or standalone interpretations. Therefore, a standalone algorithm performance study is not relevant to this device.

7. The Type of Ground Truth Used

Not applicable. As described in points 2 and 3, there's no mention of a clinical or expert-reviewed test set for this modification. The device's performance is demonstrated through its ability to accurately digitize images, a technical rather than interpretative function. The implicit ground truth for the core device functionality would be the accurate digital representation of the analog X-ray image on the phosphor plate.

8. The Sample Size for the Training Set

Not applicable. This device is an image digitizer and does not employ AI or machine learning algorithms that would require a training set.

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

Not applicable, as no training set is used by this device.

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