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510(k) Data Aggregation
(30 days)
WBR XPRESS3.CARDIAC
The Xpress3.Cardiac is indicated for the acquisition, formatting and storage of scintigraphy camera output data. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, ind in various forms of animated sequences, showing kinetic attributes of the image organs.
The Xpress3.cardiac is an image processing system, which is interfaced to gamma cameras. Gamma camera cardiac, fast acquired, data are reconstructed by the Xpress3.cardiac. The Xpress3.cardiac utilizes parallel and non - parallel beams and produce high resolution images. The images can be transferred to any other PACS device, which is DICOM or Interfile compatible.
The provided text does not contain specific acceptance criteria, study details, or performance metrics for the Xpress3.cardiac device. It primarily presents a 510(k) summary and the FDA's clearance letter, which focus on regulatory aspects like substantial equivalence to a predicate device and intended use, rather than a detailed technical evaluation or clinical study results.
Therefore, I cannot populate the table or answer most of the questions based on the provided input.
Here's what I can extract and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria (if stated) | Reported Device Performance (if stated) |
|---|---|---|
| Device Performance: Resolution | Not explicitly stated | "reconstructed images are equivalent or of better resolution comparing to images that are reconstructed by Filtered Back - Projection." |
| Regulatory Compliance | 21CFR 820.30 regulations | "The device has been designed, verified and validated complying to 21CFR 820.30 regulations." |
| Substantial Equivalency | Substantially equivalent to K050815 and K080784 | "UltraSPECT opinion that the Xact.cardiac & Xpress.cardiac are substantially equivalent..." (FDA concurred) |
2. Sample size used for the test set and the data provenance
- Sample size: Not mentioned.
- Data provenance: Not mentioned (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not mentioned.
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
- A MRMC study is not mentioned. The device is described as an image processing system, which, in 2008, might have been evaluated differently than modern AI-powered diagnostic tools. There is no mention of "human readers improve with AI vs without AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies a standalone evaluation in terms of image quality ("equivalent or of better resolution"), but a formal "standalone" study in the context of clinical decision-making performance (e.g., sensitivity, specificity) is not described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not mentioned. The statement "Bench and clinical data demonstrate that reconstructed images are equivalent or of better resolution" suggests a comparison metric, but the ground truth for this comparison is not specified.
8. The sample size for the training set
- Not mentioned.
9. How the ground truth for the training set was established
- Not mentioned.
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