(38 days)
The current modifications do not change the indications for use. As previously reported and cleared: the DigiArc 100AU+ is a mobile digital X-ray G-Arm diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery, it is not intended to be used in interventional procedures. The DigiArc 100AU+ permits a qualified doctor or technologist to take a range of diagnostic exposures of spinal column, chest, abdomen, extremities, and other body parts on the patients at the age of at least eighteen.
The DigiArc 100AU+ is a mobile digital X-ray G-Arm diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery, it is not intended to be used in interventional procedures.
There are two sets of X-ray tube assemblies and Image Intensifiers which are perpendicularly distributed on the G-Arm, acting as two sets of vertical X-ray source and receptor systems and providing fluoroscopy image of the patient. The two sets of X-ray tube assemblies and Image Intensifiers can operate simultaneously and separately.
The DigiArc 100AU+ includes below primary components.
Control unit
Viewing monitor
Control monitor
Control panel
G-Arm
Image intensifier assembly
X-ray tube assembly
Foot switch subassembly
Laser aimer system
Tracking wheel system
Printer (optional): thermal or laser printer
The medical device in question is the DigiArc 100AU+, a mobile digital X-ray G-Arm diagnostic system. This 510(k) summary focuses on demonstrating that the updated DigiArc 100AU+ is substantially equivalent to its predicate device, the DigiArc 100AU (K131423), and does not delve into detailed clinical performance studies for diagnostic accuracy.
Here's an analysis of the provided information regarding acceptance criteria and supportive studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety & Performance Standards | Compliance with AAMI / ANSI ES60601-1:2005 (Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance) | The updated G-arm has passed all tests according to AAMI / ANSI ES60601-1:2005. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2007 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests) | The proposed device has been tested to compliance. |
| Radiation Protection in Diagnostic X-ray Equipment | Compliance with IEC 60601-1-3:2008 (Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment) | The proposed device has been tested to compliance. |
| X-ray Equipment for Radiography and Radioscopy | Compliance with IEC 60601-2-54:2009 (Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy) | The proposed device has been tested to compliance. |
| Digital Imaging & Communications in Medicine (DICOM) | Compliance with DICOM provisions | The proposed device meets the provisions of DICOM. |
| Laser Aimer System Safety | Compliance with IEC 60950-1:2006 (Information technology equipment - Safety - Part 1: General requirements) and IEC 60825-1:2007 (Safety of laser products - Part 1: Equipment classification and requirements) | The laser aimer system has passed all tests according to IEC 60950-1:2006 and IEC 60825-1:2007. The laser classification of the laser component is 2. |
| Impact of Device Modifications on Safety & Effectiveness | Demonstrating that the "Tracking wheel system" and "Laser aimer system" additions do not adversely affect safety and effectiveness. | The tracking wheel system is a mechanical difference and passed AAMI / ANSI ES60601-1:2005 tests, thus not affecting safety and effectiveness. |
| The laser aimer system does not change fundamental scientific technology, passed IEC 60950-1:2006 and IEC 60825-1:2007 tests, and the updated device passed AAMI / ANSI ES60601-1:2005, thus not affecting safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
This submission does not describe a clinical study with a "test set" in the context of diagnostic accuracy. Instead, the "testing" refers to non-clinical performance testing for compliance with recognized safety and performance standards. Therefore, information on sample size for a test set (e.g., number of patients/images) and data provenance (country of origin, retrospective/prospective) related to clinical diagnostic performance is not applicable and not provided. The testing described is largely hardware-focused, ensuring the device itself meets established engineering and safety benchmarks.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Given that this is a non-clinical 510(k) submission focused on hardware modifications and compliance with engineering standards (not diagnostic accuracy), there is no mention of experts or radiologists establishing ground truth for a test set. The "ground truth" here is the adherence to the specifications of the various IEC and ANSI standards.
4. Adjudication Method for the Test Set
As no clinical test set requiring expert interpretation or ground truth establishment is described, an adjudication method is not applicable and not provided.
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 comparative effectiveness study was done or reported. This device primarily focuses on imaging equipment and its functionality, not AI assistance for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone algorithm performance study was done or reported. This device is an X-ray system, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission is compliance with recognized electrical, safety, and performance standards for medical electrical equipment and laser products (e.g., AAMI / ANSI ES60601-1:2005, IEC 60601-1-2:2007, IEC 60601-1-3:2008, IEC 60601-2-54:2009, IEC 60950-1:2006, IEC 60825-1:2007) and adherence to DICOM provisions.
8. The Sample Size for the Training Set
Not applicable and not provided. As this is a hardware device compliance demonstration, there is no AI algorithm being "trained" on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable and not provided. There is no training set for an AI algorithm in this submission.
§ 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.