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The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include but are not limited to urologic and endoscopic procedures. The system may be used for other imaging applications at the physician's discretion.

The UroView 2800 is a fluoroscopic x-ray system including a tilting patient-support table with overhead x-ray tube assembly, high-voltage x-ray generator, image intensifier, and video image display. A separate mobile workstation provides digital image processing, image storage capability, and additional video display.

The provided document K993687, concerning the UroView 2800, is a 510(k) summary and not a comprehensive study report. Therefore, it primarily focuses on establishing substantial equivalence to predicate devices and adherence to relevant standards rather than presenting detailed experimental data on acceptance criteria and device performance as one might find in a clinical trial or performance study.

Based on the provided text, a detailed table of acceptance criteria and reported device performance, information on sample sizes, expert qualifications, and adjudication methods for a test set, and specific details about MRMC studies, standalone algorithm performance, or training set ground truth cannot be fully extracted.

The document mainly highlights the device's adherence to various safety and performance standards without explicitly stating "acceptance criteria" through a defined study with quantifiable outcomes against a benchmark. The "performance" described is in the context of meeting general functional requirements and safety standards.

Here's a breakdown of what can be inferred or is missing based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not present a table of specific, quantifiable acceptance criteria alongside reported device performance derived from a dedicated study. Instead, the device's "performance" is implicitly deemed acceptable by its compliance with various recognized industry standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Missing. The document does not describe a "test set" in the context of an AI/algorithm evaluation. This is a medical device (fluoroscopic x-ray system), not an AI algorithm. Its performance is assessed through compliance with engineering and safety standards, not typically by analyzing a dataset of medical images.
• Data Provenance: Not applicable as it's not an AI/data-driven device.

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)

• Missing/Not Applicable. The concept of "ground truth" established by experts for a test set is not relevant for this type of device submission. Its safety and effectiveness are established through adherence to engineering and performance standards, and comparisons to predicate devices, rather than through diagnosis or interpretation of clinical images by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Missing/Not Applicable. Adjudication methods are typically used in clinical studies involving interpretation tasks and expert consensus, which is not the nature of this 510(k) submission.

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

• Not Applicable. The UroView 2800 is a physical medical imaging system, not an AI or computer-aided detection/diagnosis (CAD) system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not have been performed or reported in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable in the traditional sense. The "ground truth" for this device's acceptance is its compliance with established regulatory and industry standards for X-ray systems (e.g., radiation output limits, electrical safety, image quality specifications as defined by the standards).

8. The sample size for the training set

• Not Applicable. The UroView 2800 is a conventional medical device; there is no "training set" as it does not employ machine learning or AI algorithms that require data for training.

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

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The MINI 6800 Digital Mobile C-arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging.

The OEC mobile workstation, which supports image display monitors, image processing and recording devices, is combined with a miniature C-arm to create the MINI 6800 Digital Mobile C-arm.

Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCRs. Video outputs are compatible with RS-170 format for North American markets, CCIR format for international markets, and DICOM 3.0.

The MINI 6800 has the following physical characteristics:

• . All components are contained in one mobile workstation.
• . An articulating arm is attached to the workstation and extends out from the main cabinet to position the x-ray imaging components.
• . All mechanical positioning of the workstation and articulating arm is manual (nonmotorized).
• . The system is powered by a non-detachable power cord.
• Power ratings between 100-240 VAC, 4-6 Amps at 50/60 Hz. .
• . Internal system power is insulated from input power by an isolation transformer.
• Fluoroscopic operation: .
• -- 40 to 80 kVp
• -- 20 to 160 µA (0.020 to 0.160 mA)
• Automatic Exposure Rate Control

Major components of the system include:

• Dual video monitors .
• Input isolation transformer .
• Digital image processing and x-ray control .
• Monoblock X-ray tube and high-voltage power supply .
• lmage intensifier ●

The provided text does not contain information about specific acceptance criteria, device performance metrics, or study details such as sample sizes, data provenance, expert qualifications, or adjudication methods for the MINI 6800 Digital Mobile C-arm.

The document is a 510(k) Summary and a Substantial Equivalence Letter for the device. It focuses on:

• Device Description and Intended Use: General fluoroscopic visualization, surgical orthopedic, and extremity imaging, not for whole-body pediatric imaging.
• Substantial Equivalence: Comparing the MINI 6800 to other marketed mobile C-arms, stating they share similar functions and components (x-ray generator, image intensifier, video display, digital image processing).
• User Characteristics: Healthcare professionals trained in medical x-ray equipment.
• Technical Specifications: kVp, µA ranges, automatic exposure rate control, major system components (monitors, image intensifier, etc.), and physical characteristics.
• Standards Compliance: A list of product safety and electrical standards the device is designed in accordance with (e.g., 21 CFR 1020.30-32, ANSI/NFPA 70 & 99, UL 2601, various IEC standards).

Therefore, I cannot fill out the requested table or answer the specific questions about acceptance criteria, study design, or performance metrics as this information is not present in the provided text. The document asserts conformity to various safety and performance standards ("designed in accordance with product safety requirements"), but it does not detail specific acceptance criteria for image quality, diagnostic accuracy, or any other functional performance and then report study results against those criteria. It is a regulatory submission for substantial equivalence, not a scientific publication detailing a performance study.

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The IMDIS is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

The IMDIS is comprised of two mobile units: a C-arm stand and a workstation. The C-arm stand supports the high-voltage generator, x-ray controls, and a "C" shaped apparatus which supports an x-ray tube on one end and an image intensifier on the other. The Carm is designed to perform linear and rotational motions which allow the user to position the x-ray imaging components at various angles and distances with respect to the patient. The mobile workstation, supports image display monitors, image processing and recording devices.

Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCRs. Video outputs are compatible with RS-170 format for domestic markets, CCIR format for international markets, and DICOM 3.0. An auxiliary connection is provided for a Medrad angiographic injector system to facilitate synchronized acquisition of angiographic images during contrast media iniection.

I'm sorry, but the provided text does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets them.

The document is a 510(k) summary for the OEC Medical Systems, Inc. Interventional Mobile Digital Imaging System (IMDIS). It includes:

• Device Description: What the IMDIS is and its components.
• Indications For Use: The intended applications of the device.
• Substantial Equivalence: Comparison to already marketed devices (OEC Medical Systems SERIES 9600® and Philips Medical Systems BV 300 Series Mobile C-arm System).
• Standards: A list of product safety requirements and electrical/radiation standards the device is designed in accordance with.

However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about a specific study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication method, MRMC studies, standalone performance).
3. Information on training set size or how its ground truth was established.

This document mainly focuses on demonstrating that the IMDIS is substantially equivalent to existing devices and complies with relevant safety standards, rather than detailing a performance study with specific acceptance criteria and results for the device itself.

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The Series 7600 Mobile Digital C-arm is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

The Series 7600 system is comprised of two mobile units: the C-arm unit supports the high-voltage generator, x-ray components and x-ray controls; and the other unit, a mobile workstation, supports image display monitors, image processing and recording devices. The C-arm includes a "C" shaped arm that supports an x-ray tube on one end and an image intensifier on the other. The Carm is designed to perform linear and rotational motions which allow the user to position the x-ray imaging components at various angles and distances with respect to the patient.

This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets those criteria. The document describes the device, its intended use, and substantial equivalence to other marketed devices. It also lists the standards the device complies with. There is no performance data, clinical study information, or details about ground truth establishment.

Therefore, I cannot provide the requested information based on the provided text.

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The Series 9600 Mobile Digital Imaging System is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

The Series 9600 system is comprised of two mobile units: the C-arm unit supports the high-voltage generator, x-ray components and x-ray controls; and the other unit, a mobile workstation, supports image display monitors, image processing and recording devices. The C-arm includes a "C" shaped arm that supports an x-ray tube on one end and an image intensifier on the other. The Carm is designed to perform linear and rotational motions which allow the user to position the x-ray imaging components at various angles and distances with respect to the patient.

Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCRs. Video outputs are compatible with RS-170 format for domestic markets, CCIR format for international markets, and DICOM 3.0.

This document is a 510(k) summary for the OEC Medical Systems Series 9600 Mobile Digital Imaging System (modified - Phase III). It focuses on establishing substantial equivalence with existing devices rather than presenting a study of the device's performance against specific acceptance criteria.

Therefore, the provided text does not contain the information required to populate the table and answer the questions about acceptance criteria and a study proving the device meets those criteria.

The document details:

• The device's proprietary and classification names.
• Indications for use and user characteristics.
• A general description of the system.
• The standards the device complies with (e.g., FDA Federal Performance Standard for Diagnostic X-ray Systems, ANSI/NFPA, UL, CSA, IEC standards related to electrical safety and radiation protection).

However, it does not include:

• A set of quantitative acceptance criteria for image quality, diagnostic accuracy, or any other performance metric.
• A study design, methodology, or results demonstrating the device's performance against such criteria.
• Information about training/test set sample sizes, data provenance, ground truth establishment, expert qualifications, or MRMC studies.

The purpose of this 510(k) summary is to demonstrate that the modified Series 9600 is substantially equivalent to legally marketed predicate devices, not to prove its performance against novel acceptance criteria through a specific clinical or technical study.

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