Search Results

The WBR- WB 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 - WB is an image processing system, which is interfaced to gamma cameras. The camera-acquired data is processed by the WBR - WB, which produces high resolution images. The images can be transferred to any other PACS device, which is DICOM or Interfile compatible.

The provided text describes a 510(k) submission for the WBR-WB image processing system. However, the information regarding specific acceptance criteria and the detailed study proving the device meets these criteria is very limited. The submission primarily focuses on substantial equivalence to a predicate device (K030870 WBR-HR).

Here's an analysis of the available information according to your requested points:

Device: WBR-WB Image Processing System

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document does not explicitly state specific quantitative acceptance criteria. Instead, it generally claims "Bench and clinical data demonstrate that processed images are equivalent or of better resolution comparing to the un - processed images."

Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance

The document states "Bench and clinical data demonstrate..." but does not provide details about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not specify the number of experts or their qualifications used to establish ground truth for any test set.

4. Adjudication Method

The document does not mention any adjudication method like 2+1 or 3+1.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor does it describe any effect size of human readers improving with AI vs. without AI assistance. The system described is an image processing system, not explicitly an AI-assisted diagnostic tool in the sense of providing specific interpretations.

6. Standalone (Algorithm Only) Performance Study

The document states "Bench and clinical data demonstrate that processed images are equivalent or of better resolution comparing to the un - processed images." This implies a standalone performance evaluation of the algorithm's output (processed images) against unprocessed images. However, the specific metrics and methodology of this evaluation are not detailed.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. Given the nature of an image processing system for resolution improvement, it's likely that objective image quality metrics or visual assessments by experts (though not explicitly stated) would have been used. It's not pathology or outcomes data.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. The submission is a 510(k) for an image processing system, which may or may not involve machine learning in the modern sense. Given the 2003 date, it's less likely to be a deep learning system with a distinct training set as understood today.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned, this information is not provided.

Summary of Limitations in the Provided Document:

The 510(k) summary is very high-level and lacks specific details regarding the clinical study, acceptance criteria, sample sizes, expert involvement, and ground truth methodologies that would typically be expected for a comprehensive description of device validation. This is characteristic of some older 510(k) submissions, particularly for devices seeking substantial equivalence where detailed clinical trial data might not have been a primary requirement if bench testing and comparison to general performance of the predicate were deemed sufficient. The submission focuses more on the technical function of processing gamma camera data and displaying it, rather than a diagnostic aid with specific performance metrics.

Ask a specific question about this device

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.

Ask a specific question about this device