(140 days)
EXTRON5 and EXTRON 7 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, 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, Internal Medicine (※ This device is not intended for mammography applications.)
EXTRON 5 and EXTRON 7 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 5 and EXTRON 7 are composed of a C-arm main body and a monitor cart. The Carm 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.
The provided text describes a medical device submission (K230871) for the EXTRON 5 and EXTRON 7 mobile fluoroscopic X-ray systems. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/ML powered device submission.
This document is a 510(k) summary for a traditional medical imaging device (X-ray system), not an AI/ML diagnostic or prognostic tool. Therefore, many of the requested criteria in your prompt (e.g., sample size for test set, data provenance, ground truth experts, adjudication methods, MRMC studies, standalone performance, training set sample size) are not applicable or not provided in the context of an AI device.
The study described is a non-clinical study to demonstrate "substantial equivalence" to a predicate device, focusing on technical specifications and image quality of the X-ray system itself, not on the performance of an AI algorithm.
Here's a breakdown of the available information in relation to your request:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for an X-ray system affirming substantial equivalence to a predicate, the "acceptance criteria" discussed are primarily around meeting recognized consensus standards for safety and performance, and demonstrating comparable image quality to the predicate device.
| Acceptance Criteria (Implied for X-ray System Equivalence) | Reported Device Performance |
|---|---|
| Compliance with International & FDA-Recognized Consensus Standards for Medical Electrical Equipment, Radiation Protection, Software, and Cybersecurity | The EXTRON 5 and EXTRON 7 comply with: - ISO 14971:2019 (Risk Management) - ANSI AAMI ES60601-1:2005/(R)2012 (Basic Safety & Essential Performance) - IEC 60601-1-2 Ed 4.1:2020 (Electromagnetic Disturbances) - IEC 60601-1-6 Ed 3.1:2013 (Usability) - IEC 62366-1 Ed 1.1:2020 (Usability Engineering) - IEC 60601-1-3 Ed 2.1:2013 (Radiation Protection) - IEC 60601-2-28 Ed 3.0:2017 (X-ray Tube Assemblies) - IEC 60601-2-54 Ed 1.2:2018 (Radiography & Radioscopy) - IEC 60601-2-43 Ed 2.2:2019 (Interventional Procedures) - IEC 62304 Ed 1.1:2015 (Medical Device Software) - ANSI UL 2900-1 First Ed 2017 (Software Cybersecurity) |
| Equivalent Image Quality to Predicate Device (Veradius Unity K142708) | Phantom images of various body parts for both EXTRON 5/7 and the predicate device were reviewed and compared by qualified clinical experts. It was confirmed that EXTRON 5 and EXTRON 7 devices provide equivalent image quality to the predicate device. |
| Substantial Equivalence based on Technological Characteristics | The device has the same fundamental scientific technologies as the predicate. Minor technological differences (Max. Output Power, Radiographic Mode, Fluoroscopic Mode, Dimension, Detector pixels) do not give rise to novel concerns or negatively impact the product's use, and in some cases offer greater convenience (e.g., wider range of movement). |
Study Details (as provided for an X-ray system, not an AI algorithm)
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated as a numerical sample size of patient data. The evaluation involved "phantom images of various body parts." The number of phantoms or images is not quantified.
- Data Provenance: Not applicable in the traditional sense of patient data. The images were generated using the subject devices and the predicate device. No country of origin for patient data as it was phantom-based. The study was "non-clinical."
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):
- Number of Experts: "qualified clinical experts" (number not specified).
- Qualifications of Experts: Not specified beyond "qualified clinical experts."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. The text simply states "These images have been reviewed and compared by qualified clinical experts."
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, an MRMC comparative effectiveness study was not done. This type of study is typically done for AI-assisted diagnostic devices to measure the impact of AI on human reader performance. This submission is for a classic X-ray system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this device is not an algorithm that would have standalone performance. It is an X-ray imaging system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the image quality comparison, the "ground truth" was essentially the visual assessment and comparison of images from the subject devices against images from an established predicate device by qualified clinical experts, validating that the new device produces images of equivalent quality.
8. The sample size for the training set:
- Not applicable. This device is a hardware X-ray system, not an AI/ML algorithm that requires a training set of data.
9. How the ground truth for the training set was established:
- Not applicable. No training set data or ground truth establishment relevant to AI/ML.
In summary, the provided document details the regulatory submission for a mobile fluoroscopic X-ray system where the primary "study" is a non-clinical comparison of technical specifications and image quality between the new devices and a predicate device to establish substantial equivalence. It does not describe an AI/ML powered device or a clinical study in the conventional sense of establishing performance metrics for an autonomous or AI-assisted diagnostic tool.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.