(24 days)
Routine Radiographic/Fluoroscopic examinations of the entire human anatomy, gastrointestinal tract, interventional capabilities, and organ examination.
The FV-RF is a Stationary X-ray System, a device intended for radiographic/fluoroscopic examinations of various anatomical regions. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
The provided text describes a 510(k) notice for the "FV-RF," a Stationary X-ray System. However, it does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria in the way typically expected for an AI/CAD device. This document is a regulatory submission for a conventional X-ray system, focusing on substantial equivalence to legally marketed devices and compliance with safety standards, rather than performance metrics of an AI algorithm.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's an attempt to extract what is available and indicate what is missing:
Acceptance Criteria and Device Performance Study for FV-RF (Stationary X-ray System)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No explicit quantitative acceptance criteria are provided in the document for the device's diagnostic performance. The document focuses on regulatory compliance and substantial equivalence to existing devices. | "The product will perform in accordance with the development specifications." |
| "The FV-RF represents the current state-of-the-art technology, therefore, is equivalent to legally marketed devices." | |
| "Effectiveness is established by Shimadzu's evaluation throughout all phases of the FV-RF development." |
Study Details:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document refers to "Shimadzu's evaluation throughout all phases of the FV-RF development" but does not detail specific test sets, sample sizes, or data provenance.
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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):
- Not applicable/Not provided. This is a conventional X-ray system, not an AI or CAD system requiring expert-established ground truth for its performance assessment in the context of this 510(k). The "ground truth" for a conventional X-ray system's performance would typically relate to image quality parameters, radiation dose, and functional accuracy, which are assessed against technical specifications and regulatory standards rather than clinical expert consensus on specific diagnoses from a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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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 is a conventional X-ray system, and such a study is not relevant to its regulatory submission as described.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a conventional X-ray system, not an algorithm. Its performance is inherent in its physical operation and image acquisition capabilities.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable. The "effectiveness" mentioned in the document for the FV-RF is based on meeting development specifications and adherence to safety and performance standards (e.g., UL 187, IEC 601-1, FDA 21 CFR 820, 1020.30 through 32), not on diagnostic outcomes or expert consensus on a disease state from a dataset.
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The sample size for the training set:
- Not applicable. This is a physical X-ray system, not an AI model requiring a training set.
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How the ground truth for the training set was established:
- Not applicable.
Summary of what the document does state regarding effectiveness and testing:
- Effectiveness is established by Shimadzu's evaluation throughout all phases of the FV-RF development. This implies internal testing and validation against design specifications.
- The product will perform in accordance with the development specifications. This is a general statement of intent regarding performance.
- The FV-RF represents the current state-of-the-art technology, therefore, is equivalent to legally marketed devices. Substantial equivalence is a key aspect of this 510(k).
- Compliance with Federal Diagnostic X-Ray Performance Standards and other safety standards (UL 187, IEC 601-1, FDA 21 CFR 820, 1020.30 through 32) are explicitly mentioned as part of the safety and effectiveness considerations. These standards often dictate specific tests and performance limits for components (e.g., radiation output, image quality parameters like resolution, contrast, noise). However, the specific acceptance criteria and numerical results from such tests are not provided in this summary document.
This document is a high-level summary for a conventional medical device's 510(k) submission, confirming its regulatory compliance and functional intent, rather than a detailed performance study for an AI component.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.