(21 days)
The WBR- HR 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, and in various forms of animated sequences, showing kinetic attributes of the image organs.
The WBR - HR is an image processing system, which is interfaced to gamma cameras. The camera-acquired data is reconstructed by the WBR - HR, which utilizes parallel and non - parallel beams and produces high resolution images. The images can be transferred to any other PACS device, which is DICOM or Interfile compatible.
The provided text is a 510(k) summary for the WBR-HR device. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain the specific details required to complete your request for acceptance criteria and a detailed study description.
The document states: "Bench and clinical data demonstrate that reconstructed images are equivalent or of better resolution comparing to the images of the predicate device. No adverse affects have been detected." This is a summary statement of the study's conclusion, not a detailed description of the study itself.
Therefore, I cannot provide the requested information in the format you specified. Here's why and what's missing:
Missing Information:
- Acceptance Criteria: The document does not define specific performance metrics (e.g., resolution, signal-to-noise ratio, diagnostic accuracy) that the device needed to meet to be deemed "equivalent or of better resolution."
- Reported Device Performance: While it states "equivalent or of better resolution," it doesn't provide quantitative results or specific measurements for the WBR-HR or the predicate device.
- Sample Size for Test Set: No information is given about the number of images or patients used in the clinical or bench evaluations.
- Data Provenance: The country of origin and whether the data was retrospective or prospective are not mentioned.
- Number of Experts and Qualifications: No details on radiologists or other experts involved in evaluating the images or establishing ground truth.
- Adjudication Method: Not specified.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No mention of such a study or any effect size related to AI assistance. The WBR-HR is an image processing system, not explicitly an "AI" device as understood today.
- Standalone Performance: While it processes images, the context implies comparison to a predicate, not a standalone evaluation against a clinical gold standard in terms of diagnostic utility.
- Type of Ground Truth: Not specified (e.g., pathology, clinical follow-up, expert consensus).
- Sample Size for Training Set: The document is about a 510(k) submission, and the WBR-HR is described as an image processing system, not an AI/machine learning device that would typically have a "training set" in the modern sense.
- Ground Truth for Training Set: Not applicable given the above.
Conclusion:
Based on the provided text, it is not possible to fill out the table and detailed study information as requested because the document is a high-level summary of a 510(k) submission, not the detailed study report itself. It simply states that data demonstrating equivalence or better resolution was provided to the FDA.
§ 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.