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The Glaucoma Module is a software application intended for the management, display and analysis of visual field and optical coherence tomography data. It is intended as an aid to the detection and management of visual field defects and progression of visual field loss.

The Glaucoma Module works as an optional module, integrated into the Harmony user interface, and interfacing to Harmony to access the relevant data and information. Harmony is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye, as well as for management of patient data, diagnostic data, clinical information, reports from ophthalmic diagnostic instruments through either a direct connection with the instruments or through computerized networks. Harmony was most recently cleared by FDA in K182376.

The Glaucoma Module is a fully interactive multi-modality software for clinicians to assess, diagnose and manage patients who are glaucoma suspects or have been diagnosed with glaucoma. The Glaucoma Module is an aid to detection and management of visual field and OCT data.

The Glaucoma Module displays key information for diagnosis and management using a wellorganized interface.

Glaucoma Module is integrated into the Harmony user interface that utilizes both OCT exam and Visual Field data in an interactive manner. It employs two main sections, the Hood Dashboard screen used to determine glaucoma suspects and the Glaucoma Trend screen which can be used to observe patient data over a larger period of time.

The Glaucoma Module does not include predictive interpretations of the correlation of structural and functional measures, two measures that are understood to be independent of each other.

The Glaucoma Module will work with the following medical devices:

• Topcon's Maestro. Maestro 2, and Triton Optical Coherence Tomography devices .
• Zeiss' Visual Field instruments HFA3 and HFA Iii
• Visual Field data from other manufacturers. (e.g. Oculus EasyField) through DICOM ● OPV data format.

Here's a breakdown of the requested information based on the provided text:

Key Takeaway: The provided 510(k) summary for the Topcon Healthcare Solutions Glaucoma Module states that no performance data was required or provided for its clearance. This means there is no study described in this document that proves the device meets specific acceptance criteria related to its clinical performance. Instead, the clearance primarily relies on demonstrating substantial equivalence to a predicate device through similar intended use and technological characteristics, as well as software validation and verification.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states, "No performance data was required or provided. Software validation and verification demonstrate that the Glaucoma Module performs as intended and meets its' specifications." Therefore, the "acceptance criteria" here are primarily functional and technical requirements met through software testing and comparison to a predicate, not clinical performance metrics like sensitivity, specificity, or accuracy.

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

• Sample Size: Not applicable. No clinical performance testing against a specific test set is mentioned.
• Data Provenance: Not applicable. No clinical performance testing data is provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Not applicable. No clinical performance testing against a ground truth is mentioned.

4. Adjudication Method for the Test Set

• Not applicable. No clinical performance testing with adjudication is 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

• No. An MRMC comparative effectiveness study was not done or reported.

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

• No. A standalone performance study was not done or reported. The device is described as a software application for clinicians to aid in assessment, diagnosis, and management, implying a human-in-the-loop context. However, no performance data (standalone or otherwise) is presented.

7. The Type of Ground Truth Used

• Not applicable. No ground truth for clinical performance evaluation is mentioned.

8. The Sample Size for the Training Set

• Not applicable. The document does not describe any machine learning or AI algorithm development that would involve a training set. The device is a "software application intended for the management, display and analysis..." and not an AI/ML diagnostic tool requiring such a set.

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

• Not applicable. As no training set is mentioned, no ground truth for it was established.

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