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The HDR Vision is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general RIF, angiography and pediativ examinations.

The HDR Vision is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastroninal examinations, cramil, skeletal, procecc and hing exposures as well as examination of the units may also be used in lymphography, endocony, myelography, venggraphy, pediatrics, arthrography, interventional radiology, digital angiocraphy and digital subtaction angiography (DSA).

HDR Vision may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations.

The HDR Vision is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.

The HDR Vision is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract. The units may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, interventional radiology, digital angiography and digital subtraction angiography (DSA).

HDR Vision is a universal fluoroscopic x-ray diagnostic system (RIF system), with an overtable X-ray tube assembly. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations.

HDR Vision can be configured as a single tube system, with only an overtable tube or it can be combined with an additional 3D overhead tube crane, that can be moved longitudinally and laterally as well as vertically and a bucky wall stand.

This device employs similar materials and processes as found in the predicate device. The device produces ionizing radiation that is employed to generate radiographic and fluoroscopic images of the anatomy. HDR Vision is not a stand-alone device, but functions as the platform for specific X-ray components, X-ray tube and housing, flat detector, digital imaging system, Bucky wall stand, collimator, generator etc. Many of the components used in HDR Vision are either commercially available with current Pausch systems or include minor modifications to existing components.

This 510(k) premarket notification for the HDR Vision device does not include a detailed study with acceptance criteria and reported device performance in the way typically expected for AI/ML-based medical devices.

Instead, this submission claims substantial equivalence to a predicate device (Siemens Medical Systems AXIOM Luminos dRF, K062623), meaning it asserts that the new device is as safe and effective as a legally marketed device. The focus is on demonstrating similar technological characteristics and intended use, rather than presenting a de-novo study with quantitative acceptance criteria for diagnostic performance.

Therefore, many of the requested sections (1, 2, 3, 4, 5, 6, 7, 8, 9) cannot be fully answered with the provided text because these elements are typically associated with studies proving the performance of an AI algorithm, which is not the primary subject of this 2008 submission for a general fluoroscopic X-ray system.

However, I can extract the relevant information regarding the device itself and the basis of its clearance.

Description of Device and Substantial Equivalence Claim

The HDR Vision is a universal diagnostic imaging system for radiographic and fluoroscopic studies. It is intended to visualize anatomical structures by converting X-rays into a visible image. It can perform a range of applications including general R/F, angiography, and pediatric examinations.

The device claims substantial equivalence to the Siemens Medical Systems AXIOM Luminos dRF (K062623). The Flat Panel Detector Pixium RF 4343 in the HDR Vision is also claimed to be substantially equivalent to the Pixium 5100 in the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable (N/A) in the context of this 510(k) submission.

This 510(k) submission primarily focuses on demonstrating substantial equivalence in terms of intended use and technological characteristics to a predicate device, rather than presenting specific quantitative acceptance criteria for diagnostic performance of an AI algorithm or a de novo clinical study with reported performance metrics. The submission states: "The HDR Vision complies with the same or equivalent standards and has the same intended use as the predicate device and does not raise new questions of safety or effectiveness and is substantially equivalent to the Siemens AXIOM Luminos dRF; K062623 (August 22, 2007)."

Therefore, there are no specific quantitative acceptance criteria or reported device performance metrics for diagnostic accuracy presented in this document. The "acceptance criteria" here are implicitly satisfied by demonstrating equivalence to the predicate device's established safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable (N/A).

As this is a substantial equivalence claim for a conventional imaging system, there is no "test set" in the context of an algorithmic performance evaluation described in the provided text. No patient data or images were used to test the diagnostic accuracy of the device as an AI/ML product.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not Applicable (N/A).

No test set for diagnostic accuracy is described, therefore no experts were used to establish ground truth for such a set within this submission.

4. Adjudication Method for the Test Set

Not Applicable (N/A).

No test set for diagnostic accuracy or algorithmic performance is described, so no adjudication method is mentioned.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done.

This type of study is typically conducted for AI/ML-enabled devices to compare human reader performance with and without AI assistance. The HDR Vision is a conventional fluoroscopic X-ray system, and its premarket notification does not include such a study.

6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study was not done.

The HDR Vision is an imaging system designed for human operators; it is not an algorithm-only device. Its premarket notification does not describe a standalone performance study in the context of AI/ML.

7. The Type of Ground Truth Used

Not Applicable (N/A).

No ground truth for an AI/ML algorithm or diagnostic performance study is mentioned in this submission. For a conventional imaging device like the HDR Vision, the "ground truth" is inherently the clinical diagnosis made by medical professionals using the images produced by the device, in conjunction with other clinical information.

8. The Sample Size for the Training Set

Not Applicable (N/A).

This document describes a conventional X-ray system, not an AI/ML-based device that would require a training set.

9. How the Ground Truth for the Training Set Was Established

Not Applicable (N/A).

As no training set is relevant for this conventional imaging device, no ground truth establishment method is described.

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