(206 days)
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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with International and FDA-recognized consensus standards and FDA guidance documents. List includes: IEC 60601-2-43 (2010), IEC 60601-2-28 (2010), ISO 14971 (2007), ISO 62304 (2006), FDA Guidance "Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005), FDA Guidance "510(k)'s for Solid State X-ray Imaging Devices" (August 6, 1999), FDA Guidance "Radio Frequency Wireless Technology in Medical Devices" (August 14, 2013). | The test results demonstrate that the proposed Veradius R1.2 complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance. |
| Meets acceptance criteria and is adequate for its intended use. | The test results demonstrate that the proposed Veradius R1.2 meets the acceptance criteria and is adequate for its intended use. |
| Image quality is equal to the predicate. | The test results demonstrate that Image Quality is equal to the predicate. |
| Verification and validation tests performed to address intended use, technical claims, requirement specifications, and risk management results. | Verification and validation tests have been performed to address intended use, the technical claims, requirement specifications, image quality, and the risk management results. |
| Substantial equivalence to predicate device (K090590) in terms of Indications for Use, Basic Design Features, Fundamental Scientific Technology, and Operating Principle and Control Mechanism. | The proposed Veradius R1.2 is substantially equivalent to the currently marketed and predicate Veradius Mobile X-Ray system with regards to: Indications for use; Basic Design Features; Fundamental scientific technology; Operating Principle and control mechanism. The document also states, "The proposed Philips Veradius R1.2 has identical indications to the currently marketed and predicate Veradius Mobile C-arm X-ray system (Veradius R1.1)." |
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.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.