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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 in management of patient data, clinical information, reports from ophthalmic diagnostic instruments through either a direct connection with the instruments or through computerized networks.

Harmony is a modification to the existing Harmony cleared in K182376. The differences between the new version and the currently cleared version are modifications to the graphical user interface consisting of PixelSmart Technology, Internationalization support, Analytical thickness grids, Hanging protocols, and Automatic image smoothing while zooming in.

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 is used together with a number of computerized digital imaging devices, including:

• Optical Coherence Tomography devices .
• Mydriatic retinal cameras .
• Non-mydriatic retinal cameras .
• Biomicroscopes (slit lamps)

In addition, Harmony collects and manages patient demographics, image data, and clinical reports from a range of medical devices, including:

• Scanning Laser Ophthalmoscope images and videos .
• Non Radiometric Ultrasound devices ●
• Video image sources ●
• TWAIN compliant imaging sources ●
• Compliant data sources placed in network accessible folders and directories
• . Images of known format from digital cameras and scanners
• . Printer files of known format form computerized diagnostic devices
• Electronic information complying to accepted DICOM formats
• Other devices connected in proprietary formats ●

There are 5 notable device modifications subject of this submission: PixelSmart Technology, International support, Analytical thickness grids, Hanging protocols, and Automatic image smoothing while zooming in, along with some minor modifications.

PixelSmart is an optional post-processing image enhancement algorithm performing a moving average across OCT B-scans, reducing speckle noise and improving contrast by applying smoothing.

International support adds the possibility to use the Harmony user interface and online user manual in Spanish, in addition to the standard English software.

Analytical thickness grids offer the same functionality as the existing, cleared thickness grids in Topcon's IMAGEnet 6, now also in Harmony. The grids show sectorial average thickness values as derived from OCT segmentation data.

Hanging protocols allows a customizable image display arrangement in the Harmony user interface, resembling the arrangement of physical images on a light box.

Automatic image smoothing while zooming in is an optional display feature that will cause OCT B-scan images on higher zoom levels to look less pixelated.

The provided text describes a 510(k) premarket notification for a device called "Harmony" by Topcon Healthcare Solutions. This submission is for modifications to an existing cleared device (K182376). As such, the focus is on demonstrating that the modifications do not introduce new safety or effectiveness concerns and that the device remains substantially equivalent to its predicate.

Therefore, the document does not contain the kind of detailed clinical study and performance data (e.g., acceptance criteria tables, sample sizes for test/training sets, expert ground truth establishment, MRMC studies) that would typically be required for the initial clearance of a novel AI/ML-driven device with diagnostic claims. Instead, it relies on demonstrating that the "modified Harmony" functions equivalently to the predicate Harmony, primarily through software validation and verification.

Based on the provided text, here's what can and cannot be answered:

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

• Cannot be provided. The document states: "Software validation and verification demonstrate that Harmony performs as intended and meets its specifications, using methods equivalent to the predicate device." However, it does not specify quantitative acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy, F1-score) or report specific performance values for the modified features. This is expected given that the modifications are primarily related to UI, image enhancement (PixelSmart), and display features, not fundamental diagnostic algorithms requiring extensive performance studies against clinical ground truth.

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

• Cannot be provided in detail. The document mentions "software validation and verification activities" and "non-clinical performance testing." These are typically done with internal test cases or simulated data rather than large, independent clinical test sets for a device of this nature (an image management and processing system with UI/display modifications). There is no mention of specific sample sizes of patient images or their provenance.

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/Cannot be provided. Since no formal clinical test set with a "ground truth" adjudicated by multiple experts is described for the modifications in this 510(k) summary, details about expert involvement are not present. The changes (PixelSmart, Internationalization, Analytical thickness grids, Hanging protocols, Automatic image smoothing) relate to image display, processing, and user interface, rather than directly generating a diagnostic output that would require expert-adjudicated ground truth.

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

• Not applicable/Cannot be provided. As no multi-expert ground truth establishment for a test set is described, there's no mention of an adjudication method.

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 document describes modifications to an image management and processing system. The "PixelSmart" technology is an optional post-processing image enhancement algorithm (moving average to reduce speckle noise and improve contrast). While this could hypothetically improve reader performance, the submission does not present an MRMC study to quantify such an effect. This type of study is more common for AI algorithms directly assisting in interpretation or detection, which is not the primary claim for these modifications.

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

• Not explicitly described as a formal validation study. The "PixelSmart" feature is an algorithm (moving average). Its performance would be evaluated internally for its intended effect (reducing speckle noise, improving contrast). However, the document does not present a standalone performance study with metrics like sensitivity/specificity for a specific clinical task. The assessment is that it "performs as intended" and "meets its specifications" as an image enhancement tool.

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

• Not applicable/Cannot be provided. The modifications are not addressing a diagnostic claim that would require ground truth from expert consensus, pathology, or outcomes data. The "ground truth" for verifying these changes would relate to software functionality (e.g., does PixelSmart correctly apply a moving average? Does the Spanish UI display correctly?).

8. The sample size for the training set

• Not applicable/Cannot be provided. The "Harmony" system itself is a software platform. While the PixelSmart feature is an algorithm, the document does not describe it as a machine learning model that undergoes a "training" phase with a large dataset. It's described as a "moving average across OCT B-scans," suggesting a rule-based or conventional image processing algorithm rather than a deep learning model. Therefore, there's no mention of a training set size.

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

• Not applicable/Cannot be provided. As there's no description of a training set, the method for establishing its ground truth is not provided.

Summary of what is described regarding the study/validation:

• Type of Study: Software validation and verification, and non-clinical performance testing.
• Purpose: To demonstrate that the modified Harmony functions equivalently to the predicate Harmony and that the modifications do not introduce new safety or effectiveness concerns.
• Assessment: Risk assessment was conducted, and "newly identified risks or modified existing risks are mitigated, and no unacceptable risk was identified."
• Standards Followed: IEC 62304 (Medical Device Software Life Cycle Processes), NEMA PS 3.1-3.20 (DICOM), ISO IEC 10918-1 (JPEG), ISO 14971 (Risk Management).

In essence, this 510(k) relies on demonstrating the equivalence of a modified, already cleared, non-diagnostic software platform through robust engineering and software validation principles, rather than extensive clinical performance studies common for novel AI diagnostic devices.

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Harmony Referral System (Harmony RS) is a comprehensive software platform intended for use in importing, processing, viewing, measurement and storage of clinical images and videos as well as in management and communication of patient data, diagnostic and clinical information and reports from ophthalmic diagnostic instruments through either direct connection with the instruments or through computerized networks. The system neither performs any interpretations nor provides treatment recommendations.

Harmony Referral System is an internet-browser-based software platform that allows users to access examination data of a patient from different sources. Harmony Referral System may be used together with a number of computerized digital imaging devices and third party software. In addition. Harmony Referral System software collects and manages patient demographics, image data, and clinical reports from a range of approved medical devices. Harmony Referral System enables a real-time review of diagnostic patient information at a PC workstation. The software uses SSL encryption in network communication and secure network infrastructure with firewalls and additionally also VPN and IP-based access restrictions to ensure secure networking environment. The Harmony Referral System does not perform automated image analysis but provides measurements based on pixels of an image, which were marked by the user manually on the screen including cup-disk ratio and line and area measurements.

The provided document, a 510(k) summary for the Topcon Harmony Referral System (Harmony RS), states that no performance data was required or provided for this device. Therefore, it is not possible to describe acceptance criteria or a study proving the device meets those criteria from this document.

The document explicitly states:

Performance Data

"No performance data was required or provided. Software validation and verification demonstrate that Harmony RS performs as intended and meets its' specifications."

And under the "Substantial Equivalence" section:
"The different technological characteristics of the devices do not raise new questions of safety and effectiveness. The differences in hardware requirements and system access are all system features that can be evaluated during software validation and verification and were primarily revised to allow the system to operate with newer hardware, browsers and operating systems."

This indicates that the FDA's clearance was based on demonstrating substantial equivalence to a predicate device (Topcon Harmony, K182376) and on software validation and verification, rather than a clinical performance study with defined acceptance criteria.

While the document details the device's intended use and technical specifications, it does not contain the information requested in the prompt regarding acceptance criteria, study design, sample sizes, expert ground truth, or adjudication methods for performance evaluation.

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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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