Search Results

The Welch Allyn RetinaVue Network is a web-based software system application intended for use in storing, managing, and displaying patient data, diagnostic data, and images from computerized diagnostic instruments. Original and enhanced images can be viewed by trained healthcare professionals.

The RetinaVue Network software enables providers to transfer eye images.

1. Transfer images via the Client or Customer portal to the database for storage and/or to the Over-read (Physician) Portal for interpretation.
2. Allow for the enhancement and interpretation of images and report generation at the Over-read (Physician) Portal.
3. Transfer reports from the Over-read (Physician) Portal to the Customer Portal for download.

The provided document is a 510(k) summary for the Welch Allyn RetinaVue Network. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device's performance against detailed acceptance criteria through a clinical study for a new intended use.

Specifically, the document states:

• "PERFORMANCE DATA: RetinaVue Network is a software-only device and was designed and tested within the framework as defined by ISO 14971:2007 Medical devices - application of risk management to medical devices, FDA Guidance dated October 2, 2014 Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, FDA Guidance dated January 11, 2002 General Principles of Software Validation and IEC 62304:2006 Medical device software - software life cycle processes. Usability engineering/human factors testing and was performed in accordance with FDA Guidance dated February 3, 2016 Applying Human Factors and Usability Engineering to Medical Devices and IEC 62366-1:2015-02 incl. Corr. (2016) Application of Usability Engineering to Medical Devices. RetinaVue Network is DICOM compliant as stipulated in its DICOM Conformance Statement. Performance testing confirmed that RetinaVue Network performs as intended, supports the indications for use statement, demonstrates that the device is substantially equivalent to the predicate, and does not raise new questions regarding safety and effectiveness."
• "CLINICAL PERFORMANCE DATA: None required nor submitted."

This explicitly states that no clinical performance data was required or submitted, and the performance testing conducted was focused on demonstrating substantial equivalence and compliance with relevant standards and guidance documents for a PACS medical image system, not on proving a specific clinical acceptance criteria (like diagnostic accuracy, sensitivity, specificity, etc.) with a test set involving human experts.

Therefore, most of the information requested in your prompt regarding clinical acceptance criteria and related study details (e.g., sample size for test set, expert ground truth, MRMC study, standalone performance, training set details) is not applicable to this 510(k) submission for the Welch Allyn RetinaVue Network.

Here's a breakdown of what can be answered based on the provided document:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The document primarily focuses on demonstrating substantial equivalence to the predicate device (Zeiss FORUM® FORUM Archive, FORUM Viewer (K122938)) in terms of intended use, technological characteristics, and performance for a PACS medical image system. Specific quantitative clinical performance acceptance criteria (e.g., specific accuracy, sensitivity, or specificity thresholds for disease detection) are not stated or required for this type of device.
• Reported Device Performance: The document states that "Performance testing confirmed that RetinaVue Network performs as intended, supports the indications for use statement, demonstrates that the device is substantially equivalent to the predicate, and does not raise new questions regarding safety and effectiveness." This implies the system functions correctly as a PACS for storing, managing, and displaying medical images, including image enhancement features. Specific metrics beyond functional conformity and compliance with standards are not provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable as no clinical test set for performance evaluation (e.g., diagnostic accuracy) was required or submitted. The testing referenced is software verification and validation, usability testing, and compliance with standards like DICOM, ISO, and IEC.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable; no clinical ground truth establishment was conducted for a clinical performance study. The "trained healthcare professionals" mentioned in the indications for use are expected to interpret the images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable.

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, an MRMC study was not done. The device is described as a PACS system, not an AI-assisted diagnostic tool for humans, and explicitly states "CLINICAL PERFORMANCE DATA: None required nor submitted."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• No, a standalone diagnostic performance analysis was not done. The device is a PACS, displaying images for human review. It is not an algorithm that outputs a diagnostic result on its own.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable for a clinical performance study. For software validation, the "ground truth" would be the expected functional behavior based on specifications and regulatory requirements.

8. The sample size for the training set

• Not applicable; this is a PACS system, not a machine learning model that requires a training set for clinical diagnostic performance.

9. How the ground truth for the training set was established

• Not applicable.

Ask a specific question about this device