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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 TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is a noncontact, 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 and non-Mydriatic conditions.

The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retina, 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 macula in the human retina to a database of known normal subjects.

The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2)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.

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. The color fundus camera acquires color images of the posterior segment of the eye under mydriatic or non-mydriatic conditions. 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. 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.

This document is a 510(k) summary for the Topcon 3D Optical Coherence Tomography 3D OCT-1 (type: Maestro2) with System linkage software. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a performance study with detailed acceptance criteria for an AI/algorithm-driven diagnostic device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them, especially in the context of AI/algorithm performance. It primarily addresses the device's technical specifications, intended use, and conformance to general medical device standards.

Specifically, it states:

• "This section is not applicable because clinical data was not required for this 510(k) submission." (Page 6)
• The substantial equivalence discussion highlights that the main difference in the subject device is the "system linkage software" and an "optional remote operation function." For the remote operation function, it states that "comparison testing confirmed that image quality and diagnosability is the same with or without the remote operation function." This is a functional comparison, not a clinical performance study with defined acceptance criteria for diagnostic output.

In summary, the provided text does not offer the details required to answer your prompt.

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The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is a noncontact, 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 and non-Mydriatic conditions.

The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retina, 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 macula in the human retina to a database of known normal subjects.

The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2)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.

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: 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. The color fundus camera acquires color images of the posterior segment of the eye under mydriatic or non-mydriatic conditions.

This document is a 510(k) premarket notification for the TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type: Maestro2). It aims to demonstrate substantial equivalence to a legally marketed predicate device (TOPCON 3D OCT-1, K170164). The document indicates that clinical performance data was NOT required for this 510(k). Therefore, the device's acceptance criteria and the study proving it meets them do not involve clinical trials or human-in-the-loop performance studies as typically seen with AI-powered diagnostics.

Instead, the performance data provided focuses on verifying the device functions as intended through engineering tests against a set of FDA-recognized, voluntary consensus standards and in-house specifications. The substantial equivalence argument relies on the similarity of intended use, indications for use, operating principle, and technological characteristics to the predicate device.

Therefore, based on the provided document, the following points regarding acceptance criteria and studies are applicable primarily to the technical performance and substantial equivalence to a predicate device, rather than a clinical performance study of a novel AI algorithm.

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

The document doesn't present a specific "acceptance criteria" table with precise numerical values for clinical performance metrics. Instead, it demonstrates compliance with recognized technical standards for ophthalmic devices and general medical electrical equipment. The "reported device performance" is implicitly that the device meets these standards and performs equivalently to the predicate.

Here's an interpretation based on the provided information, focusing on functional specifications, as no clinical performance data was provided or required:

• IEC 60601-1-2:2014+AMD1:2020 (Medical electrical equipment - Electromagnetic disturbances)
• ANSI AAMI ES60601-1:2005/(R)2012 (Medical electrical equipment - Basic safety and essential performance)
• ISO 15004-1:2020 (Ophthalmic instruments - General requirements) | Device performs as intended and complies with these standards, demonstrating substantial equivalence. |
  | Ophthalmic Instrument Specifics | Compliance with:
• ISO 10940:2009 (Ophthalmic instruments - Fundus cameras)
• ANSI Z80.36-2021 (Light Hazard Protection for Ophthalmic Instruments) | Device performs as intended and complies with these standards, demonstrating substantial equivalence. Specifically "Device testing confirmed Maestro2 fulfills the standard for fundus camera." |
  | Usability | Compliance with:
• IEC 60601-1-6:2013 (Usability)
• IEC 62366-1:2015+AMD1:2020 (Application of usability engineering) | Device performs as intended and complies with these standards. |
  | Laser Safety | Compliance with:
• IEC 60825-1:2007 (Safety of laser products) | Device performs as intended and complies with these standards. |
  | Biocompatibility (if applicable) | Compliance with:
• ISO 10993-1:2018 (Biological evaluation - General)
• ISO 10993-5:2009 (Biological evaluation - Cytotoxicity)
• ISO 10993-10:2010 (Biological evaluation - Irritation and skin sensitization) | Device performs as intended and complies with these standards. |
  | Software Performance | Compliance with:
• IEC 62304:2015 (Medical device software - Software life cycle processes) | Software verification and validation testing were performed and documentation provided. "Software for Maestro2 was concluded to be a Moderate level of concern." "software testing confirmed Maestro2 functions as intended with the updated windows OS version." |
  | Interoperability | Compliance with:
• NEMA PS 3.1 - 3.20 2021e (Digital Imaging and Communications in Medicine (DICOM) Set) | Device performs as intended and complies with this standard. |
  | Functional Equivalence | Match or demonstrate equivalent performance for:
• Type of photography (Color, Red-free, IR)
• Picture angle
• Operating distance
• Observable/photographable pupil diameter
• Scan range and pattern
• Scan speed
• Lateral and In-depth resolution
• Fixation target
• Absence/presence of movable IR filter (with justification for difference)
• Focal length of relay lens (with justification for difference)
• Camera specifications (Resolution, Sensor type, IF, Pixel size) | "The results of the testing support substantial equivalence by demonstrating that the device performs as intended and complies with the same standards as the predicate device." Differences in camera, IR filter, focal length, and OS are addressed with verification testing deeming them equivalent or not affecting SE. |

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

Since no clinical data was required or submitted, there is no "test set" of patient data in the clinical sense. The testing performed was primarily engineering and validation testing of the device's technical specifications and compliance with standards. The document does not specify sample sizes for these technical tests (e.g., how many units were tested for electrical safety or image resolution), nor does it describe data provenance in terms of patient demographics or study design (retrospective/prospective, country of origin).

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

This information is not applicable as the submission did not rely on a clinical test set with ground truth established by medical experts. The ground truth for technical tests would be established by engineering specifications and reference standards.

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

Not applicable, as no clinical test set requiring medical expert adjudication was used.

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:

Not applicable. The device is an imaging device (OCT) and does not appear to incorporate AI for diagnostic assistance according to the provided summary, nor was a comparative effectiveness study involving human readers required or conducted.

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

Not applicable. This device is an imaging system, not presented as an "algorithm only" diagnostic tool. Its performance characterization is based on technical specifications and adherence to engineering standards.

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

The "ground truth" for this submission refers to the technical and performance specifications outlined in the relevant FDA-recognized consensus standards (e.g., IEC, ISO, ANSI) and the manufacturer's in-house specifications. For example, for image resolution, the ground truth is a specific lines/mm measurement that the device must achieve.

8. The sample size for the training set:

Not applicable. This document is for an imaging device, not an AI model that requires a "training set" of data for learning.

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

Not applicable, as there is no "training set" for this device.

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