(66 days)
The Philips Integris Allura 9 system with FD Option is intended for use in cardiac x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placing, atherectomies) pacemaker implantations, and electrophysiology.
The Philips Integris Allura 9 system with FD Option is an angiographic x-ray system with a solid state x-ray imaging device for cardiovascular diagnostic and interventional procedures. The monoplane system can be configured as either a floor or ceiling suspended G-arm frontal stand. The x-ray detector is comprised of amorphous silicon with a cesium iodide scintillator. The system supports generating and recording x-ray diagnostic images using fluoroscopic and fluorographic techniques. X-ray images are detected with a flat dynamic x-ray detector (FD) and are recorded on digital storage medium. The system offers the functionality to review and analyze the images. Digital images with corresponding patient and examination data may be archived on film (video or laser hardcopy) or on digital storage media.
This Philips Medical Systems 510(k) summary (K020055) describes the PHILIPS Integris Allura 9 system with FD Option, an angiographic x-ray system. The document focuses on regulatory submission and substantial equivalence to predicate devices rather than detailed performance studies with acceptance criteria. As such, information on specific acceptance criteria and detailed study results is not provided in the given text.
However, based on the provided text, we can infer some general information about safety and effectiveness, which would typically be supported by testing and data:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of quantitative acceptance criteria or specific reported device performance metrics (e.g., spatial resolution, contrast-to-noise ratio, dose reduction, or clinical accuracy). Instead, it states that the device:
- "will comply with the applicable requirements of 21 CFR, Subchapter J - Radiological Health, parts 1020.30, .31, and .32."
- "will comply with applicable requirements of the Underwriters Laboratories Standard for Safety, X-ray Equipment (UL 187 and UL 2601) and be classified by Underwriters Laboratories."
- "will also comply with the ACR/NEMA DICOM digital imaging communication standard."
These are regulatory and interoperability compliance statements rather than performance metrics with specific acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a clinical study with a "test set" and therefore does not provide information on sample size or data provenance (e.g., country of origin, retrospective/prospective). The submission relies on demonstrating substantial equivalence to predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since no specific clinical performance study with a test set is described, there is no information about expert involvement in establishing ground truth.
4. Adjudication Method:
No adjudication method is mentioned as there is no specific clinical performance study described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not described in this document. The device itself is an angiographic x-ray system, not an AI-powered diagnostic tool in the sense of computer-aided detection (CADx) or diagnosis (CADx) that would typically involve a human-AI comparison study.
6. Standalone (Algorithm Only) Performance Study:
A standalone performance study for an algorithm is not applicable or described, as this device is a complete x-ray imaging system, not a software algorithm for diagnostic interpretation in isolation.
7. Type of Ground Truth Used:
As no specific clinical performance study is described, no information on the type of ground truth (e.g., expert consensus, pathology, outcomes data) is provided.
8. Sample Size for the Training Set:
The device is a hardware imaging system, not a machine learning algorithm that requires a "training set." Therefore, this information is not applicable and not provided.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated above.
Summary of what the document does provide:
- Predicate Devices: Philips Integris H5000 system (K984545) and GE Medical Systems' solid state digital detector (K993037).
- Substantial Equivalence Argument: The Philips Integris Allura 9 system with FD Option does not introduce any new indications for use or new potential hazards compared to the predicate devices.
- Compliance with Standards: The device is stated to comply with relevant sections of 21 CFR Subchapter J (Radiological Health), UL Standards (UL 187 and UL 2601), and ACR/NEMA DICOM standard.
- Indications for Use: Cardiac x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP).
§ 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.