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EXTRON Series are a mobile fluoroscopic X-ray system with high output capacity, high thermal capacity and high resolution image processing system, which provides X-ray images of the patient's anatomy during surgery or treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, neurosurgery surgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis.

Examples of a clinical application may include: Neurosurgery, Orthopedics, Anesthesiology, Urology, Gynecology, Internal Medicine

(※ This device is not intended for mammography applications.)

EXTRON Series are mobile fluoroscopic X-ray systems with high output capacity, high thermal capacity, and high-resolution image processing systems that provide X-ray images of the patient's anatomical structures during surgery or treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, neurosurgery surgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis.

The EXTRON Series are composed of a C-arm main body and a monitor cart. The C-arm main body is composed of an X-ray tube, a flat panel detector, a collimator, a generator, a touch panel, foot switch, hand switch and an XConsoleOP program, while the monitor cart is composed of a monitor, a thermal transfer printer, a mouse, a keyboard and an XConsole program.

The operating principle of the device is designed to expose the patient to X-ray beams. The range of X-ray irradiation are adjusted by the collimator.

X-rays can penetrate into the human body through a two-step conversion process.

X-ray photons are converted into light. The light is then converted into electrical signals through the sensor. The electrical charges are transmitted as the sensor output and converted into signals. These signals are digitized and captured by memory. The captured images are processed and displayed on the monitor. The displayed images can be saved or transmitted to an external storage device, such as a network printer.

Here's a breakdown of the acceptance criteria and the study information for the DRTECH Corporation EXTRON Series, based on the provided FDA 510(k) clearance letter.

It's important to note that this document is a 510(k) summary, which often emphasizes equivalence to a predicate device rather than presenting a novel clinical study with explicit acceptance criteria for a new device's performance. The "performance" here refers to demonstrating equivalence to the predicate, primarily through non-clinical testing and image quality assessment.

Acceptance Criteria and Device Performance for DRTECH Corporation EXTRON Series

Based on the provided 510(k) summary, the device's "acceptance criteria" are implied by its demonstration of substantial equivalence to predicate devices through compliance with established international and FDA-recognized consensus standards and a comparison of technological characteristics. The study primarily relies on non-clinical performance and a qualitative assessment of image quality.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a numerical sample size for a "test set" in the traditional sense of a clinical trial. Instead, it states: "Sample clinical images using anthropomorphic phantoms representative of the indicated anatomies and populations have been taken for both the proposed devices (EXTRON 3/5/7) and the predicate devices (Veradius Unity and OEC 9900 ELITE)."
• Data Provenance: The data primarily comes from non-clinical testing using anthropomorphic phantoms. There is no mention of human subject data (clinical images from patients). The provenance of the phantoms themselves (e.g., manufacturer) or the exact location where these phantom images were acquired is not stated, but the manufacturer is based in South Korea. The study is retrospective in the sense that the comparison is made against existing predicate devices, but the image acquisition for the subject device is new. It is explicitly stated that "Clinical studies were not performed."

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

• Number of Experts: The document states: "These images have been reviewed and compared by qualified clinical experts." The exact number of experts is not specified.
• Qualifications of Experts: The experts are described as "qualified clinical experts." No specific qualifications (e.g., radiologist with X years of experience, board certification) are provided in this summary.

4. Adjudication Method for the Test Set

• Adjudication Method: The document states that the phantom images "have been reviewed and compared by qualified clinical experts." It does not specify a formal adjudication method (e.g., 2+1, 3+1 consensus). It appears to be a comparative review rather than a ground truth establishment process requiring formal adjudication for diagnostic accuracy.

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

• No MRMC study was done. This device is an X-ray imaging system, not an AI software intended to assist human readers in diagnosis. The study focused on demonstrating the image quality equivalence of the X-ray system itself. Therefore, the question about human reader improvement with/without AI assistance is not applicable.

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

• Not applicable. This device is an X-ray system, not an algorithm. The "standalone performance" implicitly refers to the performance of the X-ray system in producing images, which was assessed through non-clinical tests and qualitative image comparisons with predicate devices.

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

• For the image quality comparison, the "ground truth" for the phantom images is the inherent physical properties of the anthropomorphic phantoms themselves, as imaged by both the subject and predicate devices. The "qualified clinical experts" then assessed if the images produced by the subject device were "clinically comparable" to those from the predicate devices. There is no mention of pathology, outcomes data, or a formal expert consensus to establish a diagnostic ground truth in the traditional sense, as these were phantom images, not patient images.

8. The Sample Size for the Training Set

• Not applicable. This device is an X-ray imaging hardware system, not an AI/machine learning model that requires a training set.

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

• Not applicable, as there is no training set for an AI/machine learning model.

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