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510(k) Data Aggregation
(104 days)
The B5 S is a mobile digital X-ray diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning operations in trauma surgery, orthopedics, spine surgery, and chest surgery. It is not intended to be used in interventional procedures.
The B5 S 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.
The B5 S is a mobile digital X-ray 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 B5 S is comprised of control unit and G-Arm, the control unit and G-Arm include below primary components.
Control Unit Major Component: Viewing monitor (2), Exposure lamp (2), Control monitor (1), Keyboard (1), Footswitch subassembly (1), Printer(optional) (1).
G-Arm Major Component: Image intensifier assembly (2), X-Ray tube assembly (2), Laser light indicator(optional) (2), Steering unit (optional) (1).
The provided document is a 510(k) premarket notification for the MultiScan G-Arm System, which is an Image-intensified fluoroscopic x-ray system. The document focuses on demonstrating substantial equivalence to a predicate device and provides information on non-clinical testing for safety and performance standards. It does not contain information about acceptance criteria for a device's diagnostic performance, a study to prove it meets those criteria, or details regarding ground truth establishment, expert-based evaluation, or AI integration.
Therefore, many of the requested items cannot be extracted from this document.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted. This document reports on compliance with safety and performance standards relevant to an x-ray system (e.g., electrical safety, EMC, radiation safety), not on diagnostic performance metrics like sensitivity, specificity, or AUC which would typically be associated with acceptance criteria for a device that provides diagnostic interpretations.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted. This document describes non-clinical testing against standards. There is no "test set" of patient data in the context of diagnostic performance. The tests performed are on the device itself (e.g., electrical measurements, radiation output).
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)
- Cannot be extracted. There is no "ground truth" establishment in the context of diagnostic imaging outcomes mentioned in this document, as it focuses on the engineering and safety performance of the X-ray system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be extracted. Not applicable as there is no diagnostic test set or expert evaluation described.
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
- Cannot be extracted. This document describes an X-ray fluoroscopic imaging system, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI performance metrics are included.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be extracted. Not applicable as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be extracted. Not applicable as this document pertains to the physical and electrical performance of an X-ray system, not diagnostic accuracy.
8. The sample size for the training set
- Cannot be extracted. Not applicable as this is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Cannot be extracted. Not applicable as this is not an AI algorithm.
Summary of available information from the document:
The provided document details the non-clinical testing performed on the MultiScan G-Arm System (B5 S) to demonstrate its safety and effectiveness for substantial equivalence to a predicate device (K151280).
Acceptance Criteria and Reported Device Performance (Non-clinical Standards Compliance):
The device was tested for compliance with several accepted safety and performance standards. The "acceptance criteria" in this context are the requirements of these standards, and the "reported device performance" is that the device "Pass"ed all these tests.
| Testing Item Category | Standard Reference | Result |
|---|---|---|
| Electrical Safety & Mechanical Stability | AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 | Pass (for all 33 listed items, including power input, leakage currents, dielectric strength, instability tests, mechanical strength, etc.) |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 Edition 3:2007-03 | Pass (for all 7 listed items, including mains terminal continuous disturbance voltage, radiated emission, electrostatic discharge, RF electromagnetic field immunity, fast transients, injected current, surges, variations of power frequency) |
| Radiation Protection in Diagnostic X-ray | IEC 60601-1-3 Edition 2.1 2013 | Pass (for all 3 listed items: Half-value layer, Leakage radiation in the loading state, Leakage radiation when not in the loading state) |
| Specific Requirements for X-ray Equipment | IEC 60601-2-54 Edition 1.0 2009-06 | Pass (for all 4 listed items: Test for dosimetric information, Accuracy of X-ray tube voltage, Accuracy of X-ray tube current, Determining the attenuation of residual radiation) |
| Digital Imaging Communications | DICOM | Meets the provisions |
Study Description (Non-clinical Testing for Substantial Equivalence):
The study was a non-clinical testing process designed to show conformance to recognized safety and performance standards. This is not a clinical study involving patient data for diagnostic accuracy.
- Sample Size for Test Set / Data Provenance: Not applicable. The "tests" were conducted on the device hardware itself against predefined engineering and safety specifications, not on a set of patient cases.
- Number of Experts / Qualifications / Adjudication: Not applicable. Evaluation was against technical standards, not diagnostic interpretation by human experts.
- MRMC / Standalone / AI: Not applicable. The device is a traditional X-ray fluoroscopic system, not an AI-driven diagnostic tool.
- Ground Truth Type: Not applicable in the diagnostic sense. The "ground truth" for the tests performed is the adherence to the specified technical parameters and safety limits defined by the IEC/AAMI standards.
- Training Set Size / Ground Truth for Training Set: Not applicable. The device is a hardware system, not a machine learning model.
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(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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