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The Philips Integris Allura Flat Detector release 1.2 system is intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology.

The Philips Integris Allura Flat Detector release 1.2 system is an angjographic x-ray system with a solid state x-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures. The monoplane system can be configured either a floor or ceiling suspended G-arm frontal stand. The x-ray detector is comprised of amorphous silicon with a cesium iodide scintilator. 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 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 digital storage media, video or laser hardcopy.

This document (K031333) is a 510(k) summary for the Philips Integris Allura Flat Detector release 1.2 system. It states the device's intended use and declares substantial equivalence to predicate devices. However, this document does not contain details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader comparative effectiveness studies.

The information provided focuses on regulatory aspects, such as:

• Company Information: Philips Medical Systems North America Company
• Device Name: Philips Integris Allura Flat Detector release 1.2 system
• Classification Name: Angiographic x-ray system, Solid x-ray Imager
• Predicate Devices: Philips Integris Allura Flat Detector release 1.0 system (K022899) and GE Innova 4100 system.
• Device Description: Angiographic x-ray system with a solid-state flat dynamic x-ray detector (amorphous silicon with a cesium iodide scintillator) for cardiovascular and vascular diagnostic and interventional procedures.
• Indications for Use: Cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology.
• General Safety and Effectiveness: Compliance with 21CFR, Subchapter J - Radiological Health, parts 1020.30, 32 and 1040.10, UL 2601-1, and ACR/NEMA DICOM standard.
• Conclusion: Substantially equivalent in safety and effectiveness to predicate devices.

Therefore, based solely on the provided text, I cannot complete the requested table or answer the specific questions about acceptance criteria and study details. The document is a regulatory submission for substantial equivalence, not a detailed performance study report.

To answer your questions, I would need a different type of document, such as a clinical study report, a detailed design validation report, or the relevant sections of the predicate device's 510(k) submission if the performance claims are based on that.

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The Philips Integris Allura Flat Detector release 1.0 system is intended for use in cardiovascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology.

The Philips Integris Allura Flat Detector release 1.0 system 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 a either a floor or ceiling suspended G-arm frontal stand. The x-ray detector is comprised of amorphous silicon with a cessium 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 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 digital storage media, video or laser hardcopy.

The Philips Integris Allura Flat Detector release 1.0 is an angiographic x-ray system with a solid state x-ray imaging device. The provided text is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a detailed study is not available in the provided document.

Here's a breakdown of what can be extracted and what is missing:

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

This information is not provided in the document. The 510(k) summary focuses on general safety and effectiveness and substantial equivalence to a predicate device. It does not list specific quantitative performance acceptance criteria or report on device performance against such criteria.

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

This information is not provided in the document. The 510(k) summary does not describe any specific test set, its sample size, or data provenance for performance evaluation.

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):

This information is not provided in the document. As no specific test set or ground truth establishment process is described, details about experts are absent.

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

This information is not provided in the document. No adjudication method is mentioned as there's no description of a test set and ground truth establishment.

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:

This information is not provided in the document. The device is an x-ray system, not an AI-powered diagnostic tool, and there is no mention of an MRMC study or AI assistance.

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

This information is not provided in the document. The device itself is an imaging system, and the document focuses on its substantial equivalence and general safety, not on standalone algorithm performance.

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

This information is not provided in the document. There is no description of any ground truth being established for performance evaluation.

8. The sample size for the training set:

This information is not provided in the document. There is no mention of a "training set" as the device is an imaging system, not an AI model that undergoes training in this context.

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

This information is not provided in the document. No training set or its ground truth establishment is discussed.

Summary of available information:

The provided documents confirm the device's indications for use and its substantial equivalence to a predicate device (Philips Integris Allura 9 system with FD Option, K020055). The basis for clearance is that the device "does not introduce any new indications for use, nor does the use of the device result in any new potential hazard." The product is an angiographic x-ray system intended for cardiovascular x-ray imaging applications.

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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).

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