(243 days)
SmartCT assists physicians during vascular and non-vascular procedures, with diagnosis, treatment planning, interventional procedures and treatment follow-up by creating 3D views from sets of 2D images created during rotational acquisitions.
SmartCT provides high-speed and high-resolution 3D visualizations of vasculature, hemorrhages, soft tissue and bone structures.
SmartCT provides live image guidance for navigating endovascular structures anywhere in the body.
SmartCT helps to assess anatomical intra-procedurally, such as the estimate of a vessel or lesion size, diameter or volume, and anatomical distances between relevant structures.
SmartCT is intended to be used for human patients that have been elected for the procedures as described in the Indications for Use.
SmartCT is a 3D image visualization and analysis software product (Interventional Tool) intended to provide fast and high-resolution 3D visualization of vasculature, hemorrhages, soft tissue and bone structures, thereby helping the physician to identify pathologies and supporting the physician to define and plan the intervention strategy.
SmartCT runs on a software platform called the Interventional Workspot, and is intended to be used with a Philips Interventional X-Ray System.
SmartCT supports 3D Rotational Angiography (3DRA), Cone Beam CT (CBCT) and VasoCT acquisition protocols, and it includes 3D roadmap functionality. The CBCT and VasoCT protocols are only available for the 20" detector of the Interventional X-Ray system. The 3DRA protocols are available for all detectors.
The 3DRA protocols are available with SmartCT Angio, the CBCT protocols with SmartCT Soft Tissue and the VasoCT protocols with SmartCT Vaso. The 3D roadmap functionality (SmartCT Roadmap) comes in combination with SmartCT Angio, SmartCT Soft Tissue or SmartCT Vaso.
SmartCT includes filters to improve the image quality of the reconstruction by reducing the noise caused by metal objects or other objects that absorb high levels of X-ray radiation.
SmartCT provides overlays of live 2D fluoroscopic images with a 3D reconstruction of the vessel tree.
SmartCT offers tools to manually measure sizes and volumes of anatomical structures such as lesions, aneurysms or vessels. It also offers a vessel analysis tool that provides semi-automatic measurements of the diameter of a segmented vessel.
SmartCT can be controlled from both the control room and the examination room.
SmartCT provides workflow guidance to support the physician in the workflow of acquiring and processing 3D images.
The Philips Medical Systems SmartCT device did not require a clinical study to demonstrate substantial equivalence. Instead, equivalence was established through non-clinical performance testing and comparison to predicate devices. Therefore, the information provided below is derived from the non-clinical performance testing and usability validation described in the 510(k) summary.
Acceptance Criteria and Device Performance for SmartCT (K201583)
The provided documentation does not include a specific table of acceptance criteria with corresponding device performance metrics in quantitative terms for the SmartCT device. Instead, it describes general compliance with recognized standards and successful completion of various tests.
However, based on the non-clinical performance testing and validation activities, the acceptance criteria implicitly relate to:
- Compliance with recognized standards: The device must comply with a list of FDA-recognized consensus standards (e.g., IEC 62304 for software life cycle, IEC 62366-1 for usability, ISO 14971 for risk management, NEMA PS 3.1 - 3.20 DICOM).
- Functional and non-functional requirements: All requirements specified in the System Requirements Specification must be met.
- Safety risk control measures: All safety risk control measures from the Detailed Risk Management Matrix must be implemented.
- Privacy and Security requirements: All privacy and security requirements and mitigations must be implemented.
- Usability: The device must be safe and effective for the intended use, users (physicians and nurse/technicians), and use environment.
- Intended use and claims: The device must conform to its intended use, claims, and user needs, as demonstrated through simulated use and expert opinion.
Reported Device Performance (Implicit):
The documentation states that:
- "Results demonstrated that all executed verification tests were passed."
- "SmartCT was found to be safe and effective for the intended use, users and use environment." (From Usability validation)
- "Results demonstrated that all executed validation protocols were passed." (From Simulated use design validation)
- "Results demonstrated that these commercial claims and user needs were successfully validated." (From Clinical experience/expert opinion evaluation)
- "All these tests were used to support substantial equivalence of the subject device and demonstrate that SmartCT: complies with the afore mentioned international and FDA-recognized consensus standards, and meets the acceptance criteria and is adequate for its intended use."
Detailed Study Information (Based on Non-Clinical & Usability Validation):
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Category Reported Device Performance Regulatory Compliance Complies with IEC 62304, IEC 62366-1, IEC 82304-1, ISO 14971, ISO 15223-1, UL 2900-1, NEMA PS 3.1-3.20, IEC 80001-1. Functional & Non-Functional Requirements All executed verification tests were passed to verify functional and non-functional requirements, performance, reliability, and safety. Safety Risk Control All safety risk control measures from the Detailed Risk Management Matrix were implemented; verification tests passed. Privacy & Security All privacy and security requirements and mitigations were implemented; verification tests passed. Usability Found to be safe and effective for the intended use, users (physicians, nurse/technicians), and use environment. Validation protocols in the form of a clinical workflow were passed by participants who fulfill the intended user profile. Intended Use & Claims Conforms to intended use, claims, and user needs. Commercial claims and user needs regarding clinical functionality were successfully validated by assessing clinical images. -
Sample sizes used for the test set and data provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for "test sets" in the traditional sense of a clinical trial. Instead, it refers to:
- "Representative clinical users (both physicians and nurse/technicians)" for usability validation. The exact number is not provided.
- "Participants who fulfill the intended user profile" for simulated use validation. The exact number is not provided.
- "Clinical images" for expert opinion evaluation. The number of images is not provided.
- Data Provenance: The document does not specify country of origin for the data used in these non-clinical tests. It refers to a "simulated use environment" and "clinical images," implying retrospective or simulated data rather than prospective patient data.
- Test Set Sample Size: The document does not specify a numerical sample size for "test sets" in the traditional sense of a clinical trial. Instead, it refers to:
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Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Number of Experts: The document refers to "representative clinical users (both physicians and nurse/technicians)" for usability validation and suggests "expert opinion" for clinical experience evaluation. The exact number of experts is not quantified in the provided text.
- Qualifications of Experts: The experts were identified as "physicians and nurse/technicians." Specific experience levels (e.g., "radiologist with 10 years of experience") are not detailed.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth or evaluating performance in the context of the described non-clinical tests. The tests focused on compliance with requirements, usability, and claims validation, often through successful completion of tasks or expert feedback, rather than a diagnostic accuracy assessment requiring multi-reader adjudication.
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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 Study: A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The 510(k) summary explicitly states that the proposed SmartCT "did not require clinical study since substantial equivalence... was demonstrated with the following attributes: Indication for use; Technological characteristics; Non-clinical performance testing; and Safety and effectiveness." The SmartCT device is described as "3D image visualization and analysis software" and an "Interventional Tool," suggesting it enhances existing capabilities rather than being a standalone diagnostic AI. Therefore, no effect size of human reader improvement with/without AI assistance is provided.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The SmartCT device is designed as an "Interventional Tool" that "assists physicians" and "provides live image guidance for navigating endovascular structures." Its description emphasizes visualization, analysis, and guidance for physicians during procedures. While it includes "implementing algorithm on Vessel Analysis tool," the testing described (usability, simulated workflow) inherently involves human interaction. Therefore, a standalone (algorithm only) performance study in the absence of a human operator was not conducted or reported as such. The focus appears to be on human-in-the-loop performance and interaction.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical validation activities, the "ground truth" was established through:
- Expert Opinion/Feedback: For Usability validation and Clinical experience evaluation, "representative clinical users (physicians and nurse/technicians)" and "experts" assessed the device's safety, effectiveness, and ability to meet claims/user needs with "clinical images."
- System Requirements Specification: For software verification testing, performance was measured against predefined functional and non-functional requirements.
- Industry Standards: Compliance with recognized international and FDA consensus standards served as a form of ground truth for regulatory and technical performance.
- For the non-clinical validation activities, the "ground truth" was established through:
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The sample size for the training set:
- The document does not provide information regarding a specific "training set" sample size. Given that the SmartCT is described as "3D image visualization and analysis software" that utilizes existing acquisition protocols (3DRA, CBCT, VasoCT) and includes "filters to improve the image quality of the reconstruction" and an "implementing algorithm on Vessel Analysis tool," it's possible that internal development and optimization (which might involve training data) occurred. However, the FDA submission focuses on validation and verification against established standards and predicate devices rather than the specifics of machine learning model training.
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How the ground truth for the training set was established:
- As no information on a specific "training set" is provided, the method for establishing its ground truth is also not available in the supplied text.
§ 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.