(17 days)
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
The Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2, is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.
The provided text describes a 510(k) premarket notification for a modified medical device, the Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2. It focuses on demonstrating substantial equivalence to a predicate device (Alphenix, INFX-8000C/B, V8.0 K181804). The submission primarily discusses changes to software and hardware and verification and validation testing, rather than an acceptance criteria study with clinical performance metrics that would typically be seen for AI-based devices.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test sets, expert involvement, and ground truth establishment, which are common for AI/ML device studies, are not explicitly provided in this document. This submission is for a modification of an X-ray system, not a new AI algorithm.
However, I can extract the information that is present and indicate what is not available based on the provided text.
Acceptance Criteria and Device Performance
The document does not specify quantitative acceptance criteria for image quality or clinical performance that would typically be reported for an AI device. Instead, it refers to:
- Conformance to standards: "This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard]." and "This device is in conformance with the applicable parts of the IEC60601-1 standards, its collateral standards and particular standards; IEC 60601-2-43 and IEC60601-2-28."
- Verification/validation testing: "Risk analysis and verification/validation testing conducted through bench testing demonstrate that the established specifications for the device have been met."
- Phantom testing: "Phantom testing was conducted to verify image metrics related to improvements and changes to the predicate device."
- Substantial equivalence: The overall goal is to demonstrate that "the system modifications result in performance that is equal to or better than the predicate system."
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category (Derived from text) | Specific Criteria (from text) | Reported Device Performance/Conclusion |
|---|---|---|
| Conformance to Regulations/Standards | - Applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard]. |
- IEC 60601-1, IEC 60601-2-43, IEC 60601-2-28.
- ANSI AAMI ES 60601-1:2005/(R)2012+A1:2012
- IEC 60601-1-2:2014
- IEC 60601-1-3:2008 +A1:2013
- IEC 60601-1-6:2010 +A1:2013
- IEC 60601-2-28:2017
- IEC 60601-2-43:2010 +A1:2017
- IEC 62304:2006 +A1:2015
- IEC 62366:2007 +A1:2014 | "All requirements of the Federal Diagnostic Equipment Standard... will be met and reported via product report."
"Testing of the modified system was conducted in accordance with the applicable standards..." |
| System Specifications | - Established specifications for the device. - Performance equal to or better than the predicate system. | "Risk analysis and verification/validation testing conducted through bench testing demonstrate that the established specifications for the device have been met."
"This submission contains test data that demonstrates that the system modifications result in performance that is equal to or better than the predicate system." |
| Image Quality | - Verified image metrics related to improvements and changes to the predicate device. | "Phantom testing was conducted to verify image metrics related to improvements and changes to the predicate device."
No specific quantitative metrics (e.g., SNR, contrast) are provided in this summary. |
| Software Validation | - Software Documentation for a Moderate Level of Concern, per FDA guidance. - Application of risk management and design controls that mitigated all known risks to an acceptable level. | "Successful completion of software validation, application of risk management and design controls..."
"Software Documentation... is also included as part of this submission."
"all known risks were mitigated to an acceptable level." |
| Substantial Equivalence | - Modifications do not change the indications for use or the intended use of the device. | "The Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2, is substantially equivalent to the Alphenix, INFX-8000C/B, V8.0... The modifications incorporated do not change the indications for use or the intended use of the device."
"It is concluded that the subject device is substantially equivalent in safety and effectiveness to the predicate device." |
Additional Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "bench testing" and "phantom testing" but does not give the number of cases or phantoms used.
- Data Provenance: Not specified, but given it's phantom testing, it's synthetic/controlled data rather than patient data. The context (Canon Medical Systems Corporation, Japan) suggests testing likely occurred in a controlled environment by the manufacturer. It's not retrospective or prospective in the clinical sense, as it refers to engineering and phantom tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. For phantom testing of an X-ray system, ground truth is typically established by the known physical properties of the phantom and the expected image output based on system specifications, rather than expert interpretation of images. Clinical images and expert review were "deemed not necessary."
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/None specified. The testing described is technical verification and validation, not a reader study requiring adjudication of diagnostic interpretations.
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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. This was not an AI device or an MRMC study. The device is an "Image-Intensified Fluoroscopic X-ray System." The software changes primarily relate to "improved usability," "operating system update," "AlphaCT IQ improvement," "2D IQ Improvement," "Dose optimization," and "ABC control optimization," rather than AI-driven diagnostic assistance. The document explicitly states "Clinical images were deemed not necessary for the aforementioned improvements via design control and risk management activities."
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a complete X-ray system, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the technical validation described, the "ground truth" would be the known physical parameters of the phantoms and the objective measurements of the system's output (e.g., image metrics like resolution, contrast, dose, specified by engineering requirements). "Clinical images were deemed not necessary," so no pathology or outcomes data was used for this validation.
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The sample size for the training set:
- Not applicable. This is not an AI/ML algorithm that requires a training set in the typical sense. The software updates are improvements to system control, image processing, and usability, based on design and engineering principles rather than machine learning from large datasets.
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How the ground truth for the training set was established:
- Not applicable, as there is no mention of an AI training set.
§ 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.