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· 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)

The Topcon 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic conditions.

It is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures.

It also includes a reference database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the human retina to a database of known normal subjects.

It is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.

All the above functionalities and indications are available in combination with IMAGEnet 6.

· Indications for Use of the combination of the Maestro2 in conjunction with IMAGEnet6

Maestro2 in combination with IMAGEnet 6 is indicated as an aid in the visualization of vascular structures of the posterior segment of the eye including the retina, optic disc and choroid.

• · IMAGEnet6 Ophthalmic Data System
  The IMAGEnetto Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices.

It is intended for processing and displaying ophthalmic images and optical coherence tomography data.

The IMAGEnet6 Ophthalmic Data System uses the same algorithms and reference databases from the original data capture device as a quantitative tool for the comparison of posterior ocular measurements to a database of known normal subjects.

· Indications for Use of the combination of the Maestro2 in conjunction with IMAGEnet6

Maestro2 in combination with IMAGEnet 6 is indicated as an aid in the visualization of vascular structures of the posterior segment of the eye including the retina, optic disc and choroid.

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2) with system linkage software (herein referred to as "Maestro2") is a non-contact ophthalmic device combining spectral-domain optical coherence tomography (SD-OCT) with digital color fundus photography. Maestro2 includes an optical system of OCT, fundus camera (color, IR and Red-free image), and anterior observation camera. Maestro2 is used together with IMAGEnet6 by connecting via System linkage software which is a PC software installed to off the shelf PC connected to Maestro2 is capable of OCT imaging and color fundus photography. For this 510(k) notification, Maestro2 has been modified to allow for OCT "angiographic" imaging (only in conjunction with IMAGEnet6).

IMAGEnet6 is a software program installed on a server computer and operated via web browser on a client computer. It is used in acquiring, storing, managing, processing, measuring, displaying of patient information, examination information and image information delivered from TOPCON devices.

When combined with Maestro2, IMAGEnet6 plays an essential role as the user interface of the external PC by working together with the linkage software of Maestro2. In this configuration, IMAGEnet6 performs general GUI functions such as providing of the log-in screen, display of the menu icons, display function, measurement, analysis function, image editing functions, storing and management of data of the captured OCT scans and provides the reference database for quantitative comparison. For this 510(k) notification, IMAGEnet6 has been modified to allow for OCT "angiographic" imaging on the Maestro2.

Here's a summary of the acceptance criteria and study details for the Topcon Corporation's 3D OCT-1 (Maestro2) and IMAGEnet6 Ophthalmic Data System, primarily focusing on the new OCT Angiography functionality:

Acceptance Criteria and Device Performance

The study primarily focused on comparing the performance of the Maestro2 (with IMAGEnet6) against the predicate CIRRUS HD-OCT, particularly for its new OCT Angiography (OCTA) imaging capabilities. The acceptance criteria were implicitly defined through the evaluation of "response rates" and agreement metrics.

Table of Acceptance Criteria and Reported Device Performance

• 3x3-mm macular scan: 75.0%
• 6x6-mm macular scan: 71.0%
• 4.5x4.5-mm disc scan: 71.0%
  Pathology Group:
• 3x3-mm macular scan: 75.6%
• 6x6-mm macular scan: 77.9%
• 4.5x4.5-mm disc scan: 74.4% |
  | Visibility of Key Anatomical Vascular Features Response Rate (FAZ, large, medium, small vessels/capillaries - Maestro2 scans same or better grade than CIRRUS HD-OCT) | High percentage indicating comparable or superior visibility of features. | Entire Cohort:
• 3x3-mm Macular Scan: FAZ visibility 87.1%, medium vessels 87.9%, small vessels/capillaries 82.3%
• 6x6-mm Macular Scan: FAZ visibility 81.5%, large vessels 87.1%, medium vessels 77.4%, small vessels/capillaries 79.8%
• 4.5x4.5-mm Disc Scan: large vessels 83.9%, medium vessels 80.6%, small vessels/capillaries 80.6% |
  | Positive Percent Agreement (PPA) for Pathological Vascular Features (Maestro2 vs. FA/ICGA) | High PPA indicating good sensitivity in identifying pathologies. | Microaneurysms (MAs):
• 3x3-mm macular scans: 96.6%
• 6x6-mm macular scans: 96.6%
• 4.5x4.5-mm disc scans: 73.9%
  Retinal Ischemia/Capillary Dropout (RI/CD):
• 3x3-mm scans: 93.1%
• 6x6-mm scans: 100%
• 4.5x4.5-mm disc scans: 75.0%
  Choroidal Neovascularization (CNV):
• 3x3-mm macular scans: 88.9%
• 6x6-mm macular scans: 84.2%
• 4.5x4.5-mm disc scans: 66.7% |
  | Negative Percent Agreement (NPA) for Pathological Vascular Features (Maestro2 vs. FA/ICGA) | High NPA indicating good specificity in ruling out pathologies. | Microaneurysms (MAs):
• 3x3-mm macular scans: 92.7%
• 6x6-mm macular scans: 92.7%
• 4.5x4.5-mm disc scans: 100%
  Retinal Ischemia/Capillary Dropout (RI/CD):
• 3x3-mm scans: 85.4%
• 6x6-mm scans: 87.8%
• 4.5x4.5-mm disc scans: 85.7%
  Choroidal Neovascularization (CNV):
• 3x3-mm macular scans: 82.7%
• 6x6-mm macular scans: 84.3%
• 4.5x4.5-mm disc scans: 98.4% |
  | Response Rate for Identification of Pathologies (Maestro2 scans same or better outcome than CIRRUS HD-OCT) | High percentage indicating comparable or superior ability to identify specific pathologies. | Microaneurysms (MAs) response rates:
• 3x3-mm macular scans: 81.0%
• 6x6-mm macular scans: 82.1%
• 4.5x4.5-mm disc scan: 75.6%
  RI/CD response rates:
• 3x3-mm macular scans: 76.2%
• 6x6-mm macular scans: 79.8%
• 4.5x4.5-mm disc scans: 71.8%
  CNV response rates:
• 3x3-mm macular scans: 79.8%
• 6x6-mm macular scans: 81.0%
• 4.5x4.5-mm disc scan: 75.3% |

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: 124 eligible eyes from 122 subjects. This included 38 "normal" eyes and 86 "pathology" eyes.
   • Data Provenance: Prospective, multi-center, observational study. The country of origin of the data is not explicitly stated in the provided text, but "multi-center" suggests data from various clinical sites.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not explicitly stated. The text mentions that images were sent to an "independent reading center (RC) for image grading," implying multiple experts, but the exact number is not provided.
   • Qualifications of Experts: Not explicitly stated. The nature of the study (comparing OCTA images and identifying vascular pathologies) suggests that the graders at the independent reading center would be ophthalmologists or trained image graders with expertise in retinal imaging and pathology.

3. Adjudication method for the test set:

   • The document implies that an "independent reading center (RC)" performed "image grading." The specific adjudication method (e.g., 2+1, 3+1, none) is not explicitly stated.

4. 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:

   • This was a comparative effectiveness study, but it primarily compared device performance (Maestro2 vs. CIRRUS HD-OCT) and visualization capabilities against a reference standard (dye-based angiography), rather than assessing improvement in human readers with AI assistance versus without. The OCTA function itself is part of the imaging device, providing images for human interpretation, not an AI assisting human reads. Therefore, an effect size of human readers improving with/without AI assistance is not applicable to this study design as described. The study aims to demonstrate that the new device's OCTA images are comparable or superior to the predicate device and aid in visualizing vascular structures.

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

   • The document describes the device as providing visualization capabilities ("indicated as an aid in the visualization"). The PPA/NPA results compare the device's diagnostic capability for certain pathologies against dye-based angiography, suggesting a standalone assessment of the image data's ability to reveal these pathologies. However, the exact methodology for pathology identification (e.g., whether it relied purely on automated detection within the device or expert interpretation of the OCTA images generated by the device) is not fully detailed. Given the context of "image grading" by a reading center, it strongly suggests expert interpretation of the images produced by the Maestro2 (device-only output).

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

   • The ground truth for identifying key pathological vascular features (Microaneurysms, Retinal Ischemia/Capillary Dropout, and Choroidal Neovascularization) was established by dye-based angiography (e.g., fluorescein angiography [FA] and indocyanine green angiography [ICGA]). This is referred to as the reference standard against which the OCTA images from Maestro2 and CIRRUS HD-OCT were compared. Additionally, "clinically significant pathology" as determined by clinical assessment was used to categorize the "Pathology Population."

7. The sample size for the training set:

   • The document only describes a clinical performance test study. Information regarding a specific training set size is not provided within this document. The device uses algorithms and reference databases, suggesting prior training, but details on that process or data size are absent.

8. How the ground truth for the training set was established:

   • As no information on a specific training set is provided, how its ground truth was established is also not detailed in this document. The document mentions "reference databases for posterior ocular measurements" (e.g., for normal subjects), implying ground truth for these databases would have been established through prior clinical studies or expert consensus on normal ocular anatomy.

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The IMAGEnet6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices.

It is intended for processing and displaying ophthalmic images and optical coherence tomography data.

The IMAGEnet6 Ophthalmic Data System uses the same algorithms and reference databases from the original data capture device as a quantitative tool for the comparison of posterior ocular measurements to a database of known normal subjects.

IMAGEnet6 Ophthalmic Data System is a Web application that allows management of patient information, exam information and image information. It is installed on a server PC and operated via a web browser of a client PC.

When combined with 3D OCT-1 (type: Maestro2), IMAGEnet6 provides GUI for remote operation function. This function is an optional function which enables users to use some of the image capture function by operating the PC or tablet PC connected to the external PC of 3D OCT-1 (Type:Maestro2) device via ethernet cable. The remote operation function is not intended to be used from any further distance (e.g., operation from different rooms or different buildings) other than social distancing recommendations.

The provided document is a 510(k) Premarket Notification from the FDA for the IMAGEnet6 Ophthalmic Data System. This device is a Medical Image Management and Processing System, classified as Class II, with product code NFJ.

Based on the document, the IMAGEnet6 Ophthalmic Data System, subject device (version 2.52.1), is considered substantially equivalent to the predicate device (IMAGEnet6, version 1.52, K171370). The submission is primarily for a software update with changes including a modified remote operation function and expanded compatibility with additional Topcon devices.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria in a typical clinical study format (e.g., target sensitivity, specificity). Instead, the acceptance criterion for the software modification (remote operation function) appears to be that its performance (image quality and diagnosability) is equivalent to or the same as the device without the remote operation function.

2. Sample size used for the test set and data provenance:

• Sample Size for Test Set: Not explicitly stated. The document mentions "comparison testing" was performed for the modified remote operation function, but the size of the test set (number of images or cases) is not provided.
• Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

This information is not provided in the document. As "clinical performance data was not required for this 510(k) submission," there is no mention of expert-established ground truth for a clinical test set. The assessment of "image quality and diagnosability" was likely an internal validation, possibly by qualified personnel, but the specifics are not disclosed.

4. Adjudication method for the test set:

This information is not provided. Given that clinical performance data was not required, a formal adjudication process akin to clinical trials is unlikely to have been detailed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is an image management and processing system, not an AI-powered diagnostic tool intended to assist human readers in interpretation.
• Effect Size: Not applicable, as no such study was performed or required.

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

• The document implies that "comparison testing" was conducted to confirm image quality and diagnosability with and without the remote operation function. This would be a form of standalone performance assessment of the system's ability to maintain image integrity and diagnostic utility, but it does not involve the standalone diagnostic performance of an algorithm without human input for disease detection.

7. The type of ground truth used:

• The document states that "clinical performance data was not required." Therefore, there is no mention of a ground truth established by expert consensus, pathology, or outcomes data for diagnostic accuracy. The ground truth for the "comparison testing" of the remote operation function would likely be the inherent quality and diagnostic features of the images generated by the original (non-remote) system. The testing aimed to confirm that the remote function did not degrade this baseline.

8. The sample size for the training set:

IMAGEnet6 is described as a "software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices." It uses "the same algorithms and reference databases from the original data capture device as a quantitative tool for the comparison of posterior ocular measurements to a database of known normal subjects."

This suggests the device itself is not a deep learning AI model that requires a "training set" in the conventional sense of machine learning for diagnostic tasks. Rather, it integrates existing algorithms and reference databases. Therefore, the concept of a "training set" for the IMAGEnet6 software as a whole is not applicable in the context of this 510(k) submission.

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

As the concept of a training set for a machine learning model is not applicable to the functionality described for IMAGEnet6 in this submission, the method for establishing ground truth for a training set is not relevant or discussed. The reference databases it utilizes would have had their own data collection and establishment methods, but those pertain to the underlying instruments, not the IMAGEnet6 system itself regarding this submission.

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