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510(k) Data Aggregation
(183 days)
Fujifilm's Tomosynthesis option is intended to acquire tomographic images of human anatomy and to be used with Fujifilm's DR X-ray systems. Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. It is not intended for mammographic applications.
Tomosynthesis is an advanced radiographic application that produces individual coronal "slice" images through an anatomical region of interest (ROI). To produce these slices, multiple projection radiographic images are acquired in rapid succession as the X-ray tube sweeps and rotates across the ROI. Once acquired, these projection images are subject to image processing that registers and reconstructs them into individual tomographic slices.
Here's a summary of the acceptance criteria and study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Regulatory Compliance | Conformance to applicable voluntary standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-4, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, IEC 60825-1, UL 60601-1, DICOM. | The proposed device conforms to the listed voluntary standards. |
| Device Performance | Satisfactory results from bench testing. | Bench testing to evaluate Tomosynthesis performance was completed, and the results were satisfactory. |
| Software Functionality | Satisfactory results from software verification and validation testing. | Software verification and validation testing demonstrated satisfactory results. |
| Image Quality | Diagnostic image quality substantially equivalent to legally marketed devices, including the existing linear tomography capability of the AcSelerate system. | Image quality evaluation demonstrated the proposed Tomosynthesis' diagnostic image quality is substantially equivalent to legally marketed devices, including the existing linear tomography capability of the AcSelerate system. |
| Substantial Equivalence | Similar Indications for Use, functional, and technical requirements as the predicate device (K051967), and similar X-ray system and generator specifications as the previously-cleared FDR AcSelerate System (K093427). | The proposed device has very similar Indications for Use, functional and technical requirements as the predicate device, K051967. Most X-ray system and X-ray generator specifications remain the same as the previously-cleared FDR AcSelerate System in K093427. |
2. Sample size used for the test set and the data provenance:
The document mentions "Various bench testing" and "software verification and validation testing" but does not specify the sample size of cases or tests used in these evaluations. It also does not provide details on the data provenance (e.g., country of origin, retrospective or prospective nature) for the images or data used in the image quality evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not specify the number of experts used or their qualifications for establishing ground truth in any of the evaluations. The comparison is made against "legally marketed devices" and the "existing linear tomography capability," implying a comparative assessment rather than an independent expert ground truth establishment for a specific test set.
4. Adjudication method for the test set:
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating the test results.
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:
No information indicates that a multi-reader multi-case (MRMC) comparative effectiveness study was conducted, nor is there any mention of AI assistance or its effect size on human readers. The Tomosynthesis option itself is a new imaging modality, not an AI-assisted interpretation tool mentioned in this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device described is an X-ray system component that produces images, not an algorithm that interprets images. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study as typically applied to AI interpretation algorithms is not directly applicable here. The "image quality evaluation" assesses the quality of the output images themselves, which would then be interpreted by humans.
7. The type of ground truth used:
For the image quality evaluation, the implicit ground truth appears to be established by comparison to the image quality of "legally marketed devices" and the "existing linear tomography capability" of the predicate system. This suggests a comparative evaluation against established diagnostic quality standards rather than an independent gold standard like pathology or long-term outcomes data for each case. The "satisfactory" outcomes for bench testing and software verification likely rely on meeting predefined engineering and performance specifications.
8. The sample size for the training set:
The document is a 510(k) summary for a hardware/software upgrade to an X-ray system, not a machine learning algorithm that requires a training set in the typical sense. Therefore, information about a "training set" is not relevant and not provided.
9. How the ground truth for the training set was established:
As this is not a machine learning device with a training set, this question is not applicable to the provided document.
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