(113 days)
The ZIEHM VISION product Family is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures and procedures such as, vascular, cardiac, anglographic, cholangiography, endoscopic, urologic, orthopedic, neurological, critical cate, and emergency room procedures. Radiographic film examinations can be made with an accessory cassette device when attached to the Image Intensifier. At the discretion of a physician the device may be used for other imaging applications.
ZIEHM VISION with option VARIO is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intented for use in visualizing complex anatomical structures and procedures such as, vascular, cardiac, anglographic, cholangiography, endoscopic, urologic, orthopedic, neurological, critical care, and emergency room procedures and whenever the clinician benefits from variable Iso-centric positioning. Radiographic film examinations of a pharising than accessory cassette device when attached to the Image Intensifier. At the discretion of a physician the device may be used for other intaging applications.
ZIEHM VISION " with option FD is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in isualizing complex anatomical structures and procedures such as, vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurological, critical care, and emergency room procedures and where higher accuracy in image geometry is required in and around high magnetic fields. At the discretion of a physician the device may be used for other imaging applications.
ZIEHM VISION with option 3D is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures and procedures such as, vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurological, critical care, and emorgency room procedures and Whenever the clinician benefits from variable Iso-centric positioning and/or intraoperatively generated 3D imaging of high contrast objects (bones and joints), complex anatomical structures such as cervical, thoracic, and lumber regions of the spines and joint fractures of the upper and lower extremities, and where digital image and c-arm positioning data is required for computer aided surgery procedures. Radiographic film examinations can be made with an accessory cassete device when attached to the Image Intensifier. At the discretion of a physician the device may be used for other imaging applications.
The ZIEHM VISION product Family is a mobile C-am x-ray system intended for fluoroscopic imaging and is a modified version of our present ZIEHM VISION digital mobile c-arm K011292. The modified ZIEHM VISION incorporates additional new innovative technologies from two of our other legally marketed devices Ziehm Vision FD, and Ziehm Vario 3D. The base system includes highvoltage x-ray generator, and control, x-ray tube, image intensifier, touch control user interface and monitor cart/workstation with line power matching, Vision II 2D video image of seem with display, CAN bus control system, and internal and external image storage capabilities. The device includes, functional options such as Endoscopic monitor display interface, 3D imaging, NaviPort digital image exchange interface, SSXI/Flat Panel Detector, and Vario Iso-centric operation. There optigns will be identified by extensions to the product name ZIEHM VISION as Vario, FD, 3D, FD, 3D,
The ZIEHM VISION 2 product includes high-voltage x-ray generator and control, x-ray tube, image intensifier, and monitor cart/workstation with 2D image display and optional 3D digital image processing. Device provides internal and external image storage capability, and supports conventional spot-film capability with the Image intensifier option only. Optional monitor cart/workstation with NaviPort digital image exchange interface for Surgical Navigation Devices. Optional SSXI solid sate Varia ISO Contrio model in the imaging of critical anatomical structures. Optional Vario ISO-Centric mechanics work with the 3D maging or stand alone as a method for track anatomical structures in both LAT and AP projections.
The ZIEHM VISION has two main units, Mobile Stand and Monitor Cart workstation.
The Mobile Stand C-arm consists of a High frequency generator and x-ray tube assembly with active VicionCantor uses to collination assembly, 9" or 12" image intensifier (image receptor), VisionCenter user touch control interface, and CCD camera, mechanical C-Profile supporting the generator, image receptor and integrated laser light localizers. The c-profile in conjunction with the other mechanics of the mobile stand allow manual rotational, linear and vertical movements for positioning the c-arm at various and distances for visualization of patient's anatomical structures.
Mobile stand optional functionality includes, VARIO ISO-Centric motorized movement, VARIO-3D recepted in available as a voluning for 3D imaging and Flat Panel Detector/SSXI (Image receptor) is available as a replacement for the trailer beechords on the mobile stand
Monitor Cart workstation consists of a mechanical assembly supporting dual flat panel LCD display monitors, line matching power supply, and Vision II digital image memory device. Optional functionality includes VisionCenter touch control, Vario 3D control and image processing, Ziehm NAVI PORT digital image exchange interface, Endoscopic monitor displays, external image storage and video connection for attachment of external monitor displays
The provided text is a 510(k) summary for the ZIEHM VISION2 product family, which is a mobile C-arm x-ray system. The document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a de novo study with explicit acceptance criteria and performance data. Therefore, the information requested in the prompt regarding acceptance criteria, specific study details, and performance metrics in the format of a table cannot be fully extracted as such a study is not part of this 510(k) submission.
This 510(k) relies on showing that the new device does not raise new questions of safety or effectiveness compared to existing, legally marketed predicate devices.
Here's an analysis of the available information in relation to your request:
Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria and reported device performance in the context of a specific study for the ZIEHM VISION2 device. Instead, it states that the ZIEHM VISION2 product family does not raise new questions of safety or effectiveness and is substantially equivalent to the following current legally marketed devices:
The assertion of substantial equivalence implies that the device inherently meets the performance standards of these predicate devices, which would have undergone their own validation processes. The specific performance metrics of the new device are not explicitly detailed in a comparative table.
Detailed Study Information (Not Applicable for this 510(k) Summary)
The provided text does not describe a standalone study (like an MRMC or standalone AI performance study) with human readers, training sets, test sets, or ground truth establishment for the ZIEHM VISION2 device. This 510(k) submission is for an imaging device, not an AI/CADe system. Therefore, most of the requested points are not applicable.
Here's what can be inferred or explicitly stated based on the document:
- Sample size used for the test set and the data provenance: Not applicable. No specific test set of images for performance evaluation is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for image interpretation in a performance study is not discussed.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant to this submission.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This device is an imaging system, not a standalone algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Standards Met
The document lists several standards that the ZIEHM VISION Family of mobile x-ray devices "will be tested and be shown to meet... prior to being marketed." These standards act as a form of acceptance criteria for the device's design and operation, ensuring safety and basic functionality. However, they do not quantify diagnostic performance in the way a clinical study might.
Relevant Standards (acting as indirect "acceptance criteria" for design/safety):
- Federal Performance Standard for Diagnostic X-ray Systems 21 CFR 1020.30, 21 CFR 1020.31 and 21 CFR 1020.30
- 93/42/EEC - Annex II of EC directive of the Medical Devices Directive (MDD)
- IEC 60601-1-3: Medical Electrical Equipment, Radiation Protection in Diagnostic Xray Equipment
- IEC 60601-1-4: General requirements for safety, Programmable electrical medical systems.
- IEC 60601-2-7: Medical Electrical Equipment, Safety of HV/X-ray Generators
- IEC 60601-2-28: Medical Electrical Equipment Part 2: Particular Requirements for the Safety of X-Ray Source Assemblies and X-Ray Tube Assemblies for Medical Diagnosis
- IEC 60601-2-32: Medical Electrical Equipment, Safety of Associated X-ray Equipment
- IEC60601-2-43: Particular requirements for the safety of X-Ray equipment for interventional procedures.
- IEC 60825-1: Safety of laser products, Equipment Safety, requirements, and user guide
Conclusion:
This 510(k) submission establishes substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a detailed clinical performance study with explicit acceptance criteria and corresponding performance data for the new device as an AI/CADe system would. The "study" here is the comparison to predicate devices and adherence to relevant safety and performance standards for x-ray equipment.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.