(175 days)
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 provided document, a 510(k) Summary of Safety and Effectiveness for the DigiArc 100AU G-Arm MultiScan System, offers limited information regarding specific acceptance criteria and detailed study results for device performance. It primarily focuses on demonstrating substantial equivalence to predicate devices through compliance with recognized standards and general clinical imaging evaluation.
Here's an attempt to extract and infer the requested information based on the provided text, highlighting what is present and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a table format. It states that the device "meets the requirement of intended use and clinical use" and "is as safe and effective as the predicate devices." The primary method of demonstrating compliance is through adherence to relevant IEC standards for X-ray medical electrical equipment and a general assessment of clinical images.
| Acceptance Criteria Category | Specific Criteria (Inferred from text) | Reported Device Performance (Inferred from text) |
|---|---|---|
| Safety | Compliance with IEC 60601-1:2005 | Device passed all tests according to IEC 60601-1:2005. |
| Compliance with IEC 60601-1-2:2007 (EMC) | Device passed all tests according to IEC 60601-1-2:2007. | |
| Compliance with IEC 60601-1-3:2008 (Radiation Protection) | Device passed all tests according to IEC 60601-1-3:2008. | |
| Compliance with IEC 60601-2-28:2010 (X-ray tube assemblies for medical diagnosis) | Device passed all tests according to IEC 60601-2-28:2010. | |
| Compliance with IEC 60601-2-54:2009 (X-ray equipment for radiography and radioscopy) | Device passed all tests according to IEC 60601-2-54:2009. | |
| Effectiveness/Functionality | Generation of X-ray fluoroscopic image for real-time positioning and monitoring in surgical applications (trauma, orthopedics, spine, chest). | "Software validation and images assessment for simultaneous imaging have been done by the manufacturer, and the results demonstrate that the subject device meet the requirement of intended use and clinical use." |
| Imaging concept and fundamental scientific technology comparability to predicate devices. | "employs the same imaging concepts and fundamental scientific technology with the predicate device." | |
| Image Performance | Unspecified; implied to be adequate for diagnostic exposure of spinal column, chest, abdomen, extremities, and other body parts. | "Clinical images evaluation was performed for each X-Ray generator and image intensifier." Results are stated to be satisfactory for intended use. |
| Software Performance | Unspecified; implied to support simultaneous imaging function reliably. | "Software validation... for simultaneous imaging have been done by the manufacturer, and the results demonstrate that the subject device meet the requirement of intended use and clinical use." |
| DICOM Conformance | Compliance with Digital Imaging Communications in Medicine (DICOM) standard. | "the subject device meets the provisions of Digital Imaging communications in Medicine (DICOM)." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Clinical images evaluation was performed," but it does not specify the sample size for this clinical image evaluation (test set). It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the manufacturer's location in Beijing, China, it is plausible the data originated from China, but this is not explicitly stated.
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)
The document states "images assessment for simultaneous imaging have been done by the manufacturer" and "Clinical images evaluation was performed." However, it does not specify the number of experts involved in establishing ground truth, nor does it provide any details about their qualifications (e.g., radiologists, years of experience).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method used for the test set. It simply mentions "images assessment" and "Clinical images evaluation," implying an assessment was made but without detailing the process for resolving discrepancies or establishing a definitive ground truth from multiple readers.
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
The document does not describe an MRMC comparative effectiveness study. The device is an imaging system (fluoroscope), not an AI-assisted diagnostic tool. Therefore, the question of human readers improving with AI assistance is not applicable in this context. The study described focuses on the device's technical performance and image quality compared to predicate devices and standards.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to a standalone algorithm performance. Since the device is a medical imaging system (fluoroscope) and not an AI algorithm, a standalone algorithm performance study is not applicable here. The performance evaluated is that of the hardware and integrated software in generating diagnostic images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not explicitly state the type of ground truth used. Given that it involves "Clinical images evaluation," it is most likely that the "ground truth" was established by expert assessment or clinical diagnosis based on a variety of available clinical information, but this is not detailed. There is no mention of pathology or outcomes data being used as ground truth for the imaging system's performance.
8. The sample size for the training set
The document does not mention a training set or its sample size. This is expected as the DigiArc 100AU is a conventional X-ray fluoroscopy system, not a machine learning or AI-driven device that typically requires a training set.
9. How the ground truth for the training set was established
As there is no mention of a training set, there is no information on how its ground truth was established.
§ 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.