(27 days)
The WBR - thr, wBR - wb are indicated for the acquisition, formatting and storage of scintigraphy camera output data. They are capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the image organs.
The WBR -- fHR and the WBR -- fWB are image processing systems, which are interfaced to gamma cameras. Camera- fast acquired data is reconstructed by the WBR - FHR or processed by the WBR - fWB, which utilize parallel and non parallel beams and produce high resolution images. The images can be transferred to any other PAC'S device, which is DICOM or Interfile compatible.
The provided text is a 510(k) Summary and FDA clearance letter for the WBR-fHR and WBR-fWB devices. It asserts that the devices are substantially equivalent to a predicate device (K031874 WBR-WB) and mentions "Bench and clinical data demonstrate that reconstructed images are equivalent or of better resolution comparing to the images that are back projection reconstructed." However, it does not provide detailed acceptance criteria or a comprehensive study plan with the specific information requested in your prompt.
Therefore, much of the requested information cannot be extracted directly from this document.
Here's an attempt to answer based only on the provided text, with clear indications of what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document generally states "equivalent or of better resolution comparing to the images that are back projection reconstructed." | Reconstructed images are equivalent or of better resolution compared to images that are back projection reconstructed. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document only mentions "Bench and clinical data."
- Data Provenance: Not specified (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
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: Not explicitly mentioned as an MRMC study. The document mentions "clinical data" but does not detail a comparative effectiveness study involving human readers with and without AI assistance, nor does it quantify an effect size for human reader improvement. The device is described as an image processing system, not an AI assistance tool for human readers in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The study description is too brief to confirm if a standalone algorithm-only performance assessment was done. It states "reconstructed images are equivalent or of better resolution," suggesting an evaluation of image quality produced by the algorithm itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not specified. The comparison is made against "images that are back projection reconstructed," implying a comparison of image quality or resolution, but not against a definitive ground truth of patient pathology or outcomes.
8. The sample size for the training set
- Sample Size (Training Set): Not specified.
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not specified. It is unclear if a "training set" in the modern AI sense was used, as this document is from 2004 and the device is described as an "image processing system" rather than a machine learning algorithm.
Summary of Limitations:
This 510(k) summary provides a high-level overview of the device and its intended use, focusing on demonstrating substantial equivalence to a predicate device. It indicates that "Bench and clinical data" were reviewed but does not elaborate on the specific methodology, sample sizes, expert involvement, or statistical outcomes that would typically be found in a detailed study report for AI/ML-driven devices following current regulatory guidance. The information provided is insufficient to answer most of your detailed questions regarding acceptance criteria and study particulars.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.