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The Veradius Unity device is intended to be used and operated by: adequately trained, qualified, and authorized health care professionals such as physicians, surgeons, cardiologists, and radiographers, who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional, and surgical procedures on all patients except neonates (birth to one month), within the limits of the device is to be used in health care facilities both inside and outside the operating room, in sterile environments, in a variety of procedures.

The proposed Veradius Unity is a counterbalanced C-arm with a thin flat detector x-ray system. The system consists of two main component parts: the C-arm stand (comprising X-ray generator and X-ray tube, Flat Detector and the X-ray control user interface) and the mobile viewing station (comprising the image processor, monitors, user interface for image/patient handling and optionally an integrated workstation)

Here's the breakdown of acceptance criteria and the study that proves the device meets them, based on the provided text:

Device Name: Veradius Unity

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a sample size for a test set in the context of imaging data or patient studies. The "testing" referred to is primarily non-clinical performance and verification/validation testing of the device's components and new features. The provenance of any underlying data used for these tests is also not mentioned (e.g., country of origin, retrospective/prospective). It explicitly states: "The subject of this premarket submission Veradius Unity did not require clinical studies to support substantial equivalence because the Veradius Unity utilizes identical components throughout the imaging chain and the system's equivalent performance in light of the modifications could be supported through verification and validation testing alone."

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

Not applicable. As no clinical studies were performed, there was no separate "ground truth" for a test set established by medical experts in the typical sense of evaluating diagnostic accuracy. The testing focused on device functionality and engineering performance.

4. Adjudication method for the test set

Not applicable, as no clinical studies with a test set requiring adjudication were conducted.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states that "clinical studies to support substantial equivalence" were not required.

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

Not applicable, as this device is an imaging system (hardware and software), not an AI algorithm designed to operate entirely without human input for image interpretation or diagnosis. The "Outline tool" and "ClearGuide" are features embedded within the system to assist human users, not standalone diagnostic algorithms.

7. The type of ground truth used

For the non-clinical performance tests, the "ground truth" was established by engineering specifications, international standards (IEC, ISO), and FDA guidance documents. The device's performance was validated against these predefined technical requirements and functional standards. There was no "pathology" or "outcomes data" ground truth collection mentioned.

8. The sample size for the training set

Not applicable. This document describes a medical imaging device (C-arm X-ray system), not an AI algorithm that would typically require a "training set" of data for machine learning. The "improvements" are hardware and software features, not AI model updates.

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

Not applicable, as there was no training set for an AI algorithm.

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The Veradius device is intended to be used and operated by: adequately trained, qualified, and authorized health care professionals such as physicians, surgeons, cardiologists, and radiographers. who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional, and surgical procedures on all patients except neonates (birth to 1 month), within the limits of the device is to be used in health care facilities both inside and outside the operating room. in sterile as well as nonsterile environments, in a variety of procedures.

The proposed Veradius R1.2 is a counterbalanced C-arm with a thin flat detector x-ray system. The system consists of two main component parts: the C-arm stand (comprising X-ray generator and X-ray tube. Flat Detector and the X-ray control user interface) and the mobile viewing station (comprising the image processor, monitors, user interface for image/patient handling and optionally an integrated workstation).

The provided text describes the Philips Veradius R1.2, an interventional fluoroscopic X-ray system, and its submission for 510(k) clearance. The focus of the submission is to demonstrate substantial equivalence to its predicate device, the Veradius R1.1 (K090590).

Here's an analysis based on the provided input:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The submission focuses on establishing substantial equivalence to a predicate device, rather than defining novel acceptance criteria for new clinical performance. The acceptance criteria and supporting study are framed by demonstrating that the changes in Veradius R1.2 do not negatively impact safety and effectiveness compared to the predicate, and that the device complies with relevant standards and guidelines.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) summary, the "acceptance criteria" are primarily framed around compliance with regulatory standards and demonstrating that the device maintains the safety and effectiveness of its predicate. The reported device performance is stated as meeting these criteria.

2. Sample size used for the test set and the data provenance

The document does not provide information on the sample size or data provenance (e.g., country of origin, retrospective/prospective) for any specific test sets related to clinical images or patient data. The non-clinical performance data section refers to "verification and validation tests" and "test results" but does not detail the datasets used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The submission focuses on non-clinical performance data and asserts equivalence in image quality, but it does not describe any specific human expert review for establishing ground truth on image interpretation.

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

No information on an adjudication method is provided. This is consistent with the lack of explicit clinical study data involving human interpretation described in the summary.

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 mentioned. The device is an X-ray system, not an AI-assisted diagnostic tool. There is no AI component described, therefore, no such comparative study involving human readers with/without AI assistance was conducted.

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

No standalone algorithm-only performance study was conducted or mentioned. The device is a medical imaging system, not a standalone diagnostic algorithm.

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

The document does not explicitly describe the type of ground truth used. For image quality, it states that "Image Quality is equal to the predicate," implying a comparison against established standards or perhaps internal benchmarks of the predicate device's image quality. However, the exact methodology for determining this "ground truth" for image quality, or any other performance aspect, is not detailed in terms of expert consensus, pathology, or outcomes data.

8. The sample size for the training set

No training set is mentioned or implied. The product is a hardware X-ray system with some software components consistent with its function as an imaging device. There is no indication of a machine learning or AI component that would require a "training set."

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

As no training set is mentioned, this question is not applicable.

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The Veradius device is intended to be used and operated by: adequately trained, qualified and authorized health care professionals such as physicians, surgeons, cardiologists and radiographers who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device.

The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except babies, within the limits of the device. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.

Applications:

• Orthopedic Neuro Abdominal Vascular Thoracic Cardiac

The Veradius device is a Mobile C-arm X-ray System designed for medical applications during diagnostic, interventional and surgical procedures.

The device consists mainly of two parts: the C-arm stand (comprising X-ray generator and X-ray tube, Flat Detector and the X-ray control user interface) and the mobile viewing station (comprising the image processor, monitors, mains control unit, an user interface for image/patient handling and optionally an integrated workstation).

All movements of the C-arm stand are manual except the height movement. The Mobile viewing station can be used standalone for reviewing and archiving purposes,

Here's an analysis of the provided text regarding the Veradius device, focusing on acceptance criteria and supporting studies:

It's important to note that the provided 510(k) summary is for a new version of a mobile C-arm X-ray system, where the primary change is the Image Detection Subsystem (IDS), specifically replacing an Image Intensifier with a Flat Detector. The summary emphasizes substantial equivalence to a predicate device (Pulsera K061685). Therefore, the "acceptance criteria" and "device performance" are primarily focused on demonstrating that the new component (IDS) does not compromise image quality or safety and maintains the same intended use as the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) summary (substantial equivalence for a component change), the acceptance criteria are not explicitly stated in quantitative metrics like sensitivity/specificity for a diagnostic AI. Instead, they relate to overall image quality and functional equivalence to the predicate device.

The new IDS detects X-rays and converts them to digital images, applying calibration to obtain required data, functionally similar to the predicate's IDS. (Page 2, Section 5) |
| No new indications for use. | "The Veradius does not introduce any new indications for use..." (Page 2, Section 7)
"Indications for Use are equal to Pulsera." (Page 3, Table 1, Row 9)
The Indications for Use statement on Page 5 is identical to the general description of the predicate's use. |
| No new potential hazards or effects on safety. | "Nor does the use of the device result in any new potential hazard." (Page 2, Section 7)
"The new technologic characteristic does not affect safety or introduce any new type of hazards." (Page 2, Section 7)
"A product risk management is executed and all risks are reduced to an acceptable level by implementation and verification of appropriate measures." (Page 3, Section 9)
The Level of Software concern is MODERATE (Page 3, Section 9). |
| Maintain substantial equivalence to predicate device. | "Philips Medical Systems Nederland BV considers the Veradius to be substantially equivalent with the predicate device." (Page 2, Section 7)
"Results of the conducted tests conclude that the Veradius is substantial equivalent to its predicate device." (Page 3, Section 8) |
| Function as intended for specified applications. | The device is intended for "radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except babies," across various applications (Orthopedic, Neuro, Abdominal, Vascular, Thoracic, Cardiac). (Page 2, Section 6 and Page 5, Indications for Use)
Non-clinical and clinical tests were performed to "verify and validate the system functionality for the intended use." (Page 3, Section 8) |

Study Details from the Provided Text:

This document is a premarket notification (510(k)), not a detailed study report. As such, it provides summary statements rather than in-depth methodological details of the studies.

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

• Sample Size for Test Set: Not explicitly stated. The text mentions "comparison between images pairs taken during non-clinical performance tests." This implies a set of images was used, but the quantity is not provided.
• Data Provenance: The study is described as "non-clinical performance tests." This suggests the data was likely generated in a controlled, engineering-focused environment within Philips Medical Systems Nederland B.V. (The Netherlands, where the manufacturer is located). Given it's a "non-clinical" test, it likely involved phantoms or standardized test objects, not patient data in the clinical sense of "retrospective or prospective."

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not mentioned. This type of detail is usually found in a full study report, which is not this document. Since the evaluation was likely "non-clinical performance tests" focused on image quality comparison, it may not have required formal adjudication of clinical diagnoses.

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

• MRMC Study: No, an MRMC study was not explicitly mentioned or described. The performance evaluation focuses on "Image Quality is equal or even better" based on the "comparison between images pairs taken during non-clinical performance tests." This typically implies objective measurements or subjective comparison by engineers/specialists, not a formal MRMC study involving human readers diagnosing clinical cases with and without AI assistance (as this is an X-ray system, not an AI diagnostic tool in the modern sense).

6. If a Standalone Performance (Algorithm Only) Was Done

• Standalone Performance: The description of "non-clinical performance tests" to evaluate "Image Quality" of the new "Image Detection Subsystem (IDS)" is essentially a standalone performance evaluation of the system's image acquisition and processing capabilities. The IDS itself is an algorithm-driven component (converting X-rays to digital images and applying calibration). However, it's not "algorithm only" in the sense of a pure AI diagnostic software; it's a core hardware/software component of the imaging chain.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Type of Ground Truth: Not explicitly stated. For "non-clinical performance tests" assessing "Image Quality," the ground truth likely involved:
  • Objective image quality metrics: Such as spatial resolution, contrast-to-noise ratio, modulation transfer function (MTF), dose efficiency, etc., measured using phantoms.
  • Reference images: Comparison against images produced by the predicate device under identical conditions, or against established standards for image quality.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable in the context of advanced AI models that require large training datasets. The "Veradius" is a C-arm X-ray system with a new detector, not an AI diagnostic algorithm that learns from vast image datasets to identify pathologies. The "IDS" performs image conversion and calibration, which are rule-based or empirically derived processes, not deep learning-based training.

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

• Ground Truth for Training Set: Not applicable for the same reasons as #8. The "training" of such a system would involve engineering and calibration procedures during design and manufacturing, not data-driven machine learning.

Summary Takeaway:

This 510(k) emphasizes substantial equivalence for a physical device (mobile C-arm X-ray system) with a component change (detector type). The "studies" mentioned are "non-clinical performance tests" designed to show that the new detector either maintains or improves image quality and that the overall system remains as safe and effective as its predicate. It is not an AI diagnostic device, so many of the requested details concerning AI-specific study methodologies (MRMC, large training sets, expert consensus for ground truth) are not present in this type of submission.

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