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510(k) Data Aggregation
(139 days)
The DigiArc 100AU/ 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/ 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/ 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 FDA 510(k) summary describes the "MultiScan G-Arm System" (DigiArc 100AU & DigiArc 100AU+) by Beijing East Whale Imaging Technology Co., Ltd. The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance and safety testing against recognized standards. It does not detail specific acceptance criteria for diagnostic accuracy or device performance in the context of clinical image interpretation or AI-assisted diagnoses, nor does it present a study proving the device meets such criteria. The device is a standard X-ray fluoroscopic imaging system, not an AI-powered diagnostic tool.
Therefore, the requested information regarding acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance is not present in this document. The provided text exclusively covers the device's technical specifications, safety, and compliance with general medical device standards.
However, I can extract the information that is present concerning the device's compliance with safety and performance standards, which are the "acceptance criteria" discussed in this 510(k) submission.
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" in this context are compliance with various recognized safety and performance standards for medical electrical equipment and X-ray systems. The reported device performance for these criteria is consistently "Pass."
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (General Requirements for Basic Safety and Essential Performance of Medical Electrical Equipment) | Pass |
| - Power input | Pass |
| - Humidity preconditioning treatment | Pass |
| - Determination of applied parts and accessible parts | Pass |
| - Legibility of markings | Pass |
| - Durability of markings | Pass |
| - ME equipment for connection to a power source by a plug | Pass |
| - Internal capacitive circuits | Pass |
| - Protective earth connection | Pass |
| - Leakage currents | Pass |
| - Dielectric strength | Pass |
| - Ball pressure test | Pass |
| - Measurement of creepage distance and air clearance | Pass |
| - Cord anchorage | Pass |
| - Gaps | Pass |
| - Instability-overbalance in transport position | Pass |
| - Instability-overbalance excluding transport position | Pass |
| - Instability-overbalance from horizontal and vertical forces | Pass |
| - Audible acoustic energy | Pass |
| - Maximum temperature during normal use | Pass |
| - Spillage | Pass |
| - Ingress of water or particulate matter | Pass |
| - Cleaning | Pass |
| - Interruption of the power supply/supply mains to ME equipment | Pass |
| - Single fault conditions | Pass |
| - Mechanical strength test | Pass |
| - Transformer short circuit | Pass |
| - Transformer overload test | Pass |
| - ME system-leakage measurements | Pass |
| - Half-value layer | Pass |
| - Focal spot to image receptor distance | Pass |
| - Leakage radiation in the loading state | Pass |
| - Leakage radiation when not in the loading state | Pass |
| IEC 60601-1-3 Edition 2.0 2008 (Radiation protection in diagnostic X-ray equipment) | Pass |
| IEC 60601-2-54 Edition 1.0 2009-06 (Specific requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy) | Pass |
| - Test for dosimetric information | Pass |
| - Accuracy of X-ray tube voltage | Pass |
| - Accuracy of X-ray tube current | Pass |
| - Determining the attenuation of residual radiation | Pass |
| IEC 60601-1-2 Edition 3: 2007-03 (Electromagnetic compatibility - Requirements and tests) | Pass |
| - Harmonics on AC mains | Pass |
| - Voltage fluctuations on AC mains | Pass |
| - Mains terminal continuous disturbance voltage | Pass |
| - Radiated emission | Pass |
| - Electrostatic discharge | Pass |
| - RF electromagnetic field immunity test | Pass |
| - Fast transients on AC power line, signal line and interconnecting line | Pass |
| - Injected current into AC power line, signal line and interconnecting line | Pass |
| - Surges to AC power port, signal line and interconnecting line | Pass |
| - Voltage dips and interruptions to AC power port | Pass |
| - Variations of power frequency | Pass |
| Digital Imaging Communications in Medicine (DICOM) provisions | Meets |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is non-clinical performance and safety testing for the device itself, not a study involving patient data or clinical images for diagnostic accuracy assessment.
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)
This information is not provided in the document. This type of information would be relevant for studies evaluating diagnostic performance, which is not the subject of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are used in clinical studies to establish ground truth for diagnostic decisions, which is not applicable to the non-clinical testing presented here.
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
An MRMC comparative effectiveness study was not done. This device is an X-ray imaging system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm was not done. This device is an imaging system, not an algorithm, and the submission does not describe any AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as it relates to diagnostic accuracy is not applicable to the non-clinical performance and safety testing described. The "ground truth" for these tests are the objective pass/fail criteria defined by the respective international and national standards (e.g., specific voltage/current ranges, radiation leakage limits, insulation resistance, etc.).
8. The sample size for the training set
This information is not provided and is not applicable, as this device itself is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not provided and is not applicable, as this device itself is not an AI algorithm.
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(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.
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