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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, diagnostic 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 Synergy ODM cleared in K151952. The differences between the new version and the currently cleared version are modifications to the GUI using a responsive design and a change to the front end platform from Microsoft Silverlight to HTML5.

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)

This document (K182376) is a 510(k) premarket notification for a software platform called Harmony. It primarily focuses on demonstrating substantial equivalence to a predicate device (Topcon Corporation Synergy ODM, K151952) rather than presenting new performance study data with acceptance criteria.

The key takeaway is that no performance data was required or provided to prove the device meets acceptance criteria as this submission is for a modification to an already cleared device. The manufacturer states that "Software validation and verification demonstrate that Harmony performs as intended and meets its' specifications." This implies that the acceptance criteria are related to the software's functional specifications, which were validated internally, but no detailed performance study meeting specific clinical or diagnostic metrics is presented here.

Therefore, many of the requested sections regarding a study that proves the device meets acceptance criteria cannot be extracted from this document because such a study was not deemed necessary for this particular submission.

Here's a breakdown of what can be inferred and what cannot:

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

• Acceptance Criteria: Not explicitly stated with specific numerical targets. Based on the "Performance Data" section, the acceptance criteria are implicitly tied to the software's functional specifications and its ability to perform as intended. These would likely include criteria such as:
  • Successful import, processing, measurement, analysis, and storage of clinical images and videos of the eye.
  • Proper management of patient data, clinical information, and reports from ophthalmic diagnostic instruments.
  • Successful connection (direct or network) with ophthalmic diagnostic instruments.
  • Correct execution of viewing operations (zoom, pan, contrast/brightness adjustment, drawing tools).
  • Accurate line and area measurement capabilities.
  • Accurate Cup to Disc ratio and MPS (Macular Photocoagulation Study) measurements.
  • Proper functioning of network and security features (web-based access, DICOM communication).
  • Correct printing, archiving, and backup functionality.
• Reported Device Performance: The document states, "Software validation and verification demonstrate that Harmony performs as intended and meets its' specifications." No specific performance metrics (e.g., accuracy, sensitivity, specificity, resolution, speed) are provided.

Table (based on inference):

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

• Sample Size: Not specified. As no performance study with a test set was required, this information is not provided. The "validation and verification" likely refer to internal software testing rather than a clinical study with a patient data test set.
• Data Provenance: Not specified.

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

• Not applicable/Not specified, as no clinical test set requiring expert ground truth establishment was described.

4. Adjudication method for the test set:

• Not applicable/Not specified, as no clinical test set requiring adjudication was described.

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 MRMC comparative effectiveness study was done or reported. The device is described as a "comprehensive software platform" and "image management system," not an AI diagnostic tool designed to assist human readers in a diagnostic capacity that would typically warrant such a study.

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

• Not applicable/Not specified. The device is a "software platform intended for use in importing, processing, measurement, and storage...as well as in management of patient data, clinical information, reports." This describes an infrastructure and management tool, not an algorithm with standalone diagnostic performance.

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

• Not applicable/Not specified. The "ground truth" in this context would likely be the expected functional behavior and output of the software, verified through software testing, rather than clinical ground truth from patient data.

8. The sample size for the training set:

• Not applicable/Not specified. This device is not described as an AI or machine learning model that would require a training set in the typical sense. It is a software platform for managing images and data.

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

• Not applicable/Not specified, as there is no mention of a training set.

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Synergy ODM 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 comection with the instruments or through computerized networks.

Synergy ODM is a modification to Synergy ODM cleared in K132667. The key differences between the cleared product and the one that is the subject of this 510(k) are minor modifications to the GUI. addition of a mobile GUI. minor workflow enhancements, additional measurements based on existing line and area measurement tools, minor enhancements to the data acquisition and export functionality, addition of two new reports, minor enhancements to external access to Synergy ODM, performance enhancements to decrease start up time, enhancement to external interfaces, changes to configuration options and tools which are not accessible to the end user, modifications required to maintain compatibility with external products, modification to tools which are not accessible to the user, and bug fixes.

Synergy ODM is a software platform that collects, processes, measures, analyzes, stores, and manages patient data and clinical information. Synergy ODM is used together with a number of computerized digital imaging devices. In addition. Synergy ODM software collects and manages patient demographics, image data, and clinical reports from a range of medical devices. Synergy ODM enables a real-time review of diagnostic patient information at a PC workstation. Synergy ODM also includes an internetbrowser-based user interface to allow authorized users to access, view, create reports, and analyze patient and examination data saved in a centralized database. The system utilizes dual level authentication and 128-bit encryption to ensure secure networking environment.

The provided text describes a 510(k) premarket notification for the "Synergy ODM" device. It is a software platform for managing ophthalmic images and patient data. However, the document explicitly states that "No performance data was required or provided." Therefore, I cannot provide the detailed information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.

Here's why I cannot fulfill your request based on the provided text:

• No performance data: The critical sentence "No performance data was required or provided. Software validation and verification demonstrate that the Synergy ODM performs as intended and meets its' specifications" indicates that the regulatory submission did not include a study with performance metrics against acceptance criteria.
• Substantial Equivalence: The submission focuses on demonstrating "Substantial Equivalence" to a predicate device (Topcon Corporation Synergy ODM, K132667) rather than proving performance against novel acceptance criteria. This means the device is considered safe and effective because it is very similar to an already approved device, not because a new clinical performance study was conducted.

Since the document explicitly states no performance data was provided, I cannot generate the requested table or answer the other questions about acceptance criteria and study details. The device's approval was based on demonstrating substantial equivalence to a predicate device, not on a new performance study.

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The IMAGEnet 5 PC Software 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 imaging devices through a direct connection with Topcon instruments or through computerized networks.

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letter for the IMAGEnet 5 PC Software System does not contain the detailed information necessary to answer your request about acceptance criteria, study details, and data provenance.

The document is a clearance letter, which confirms that the device is substantially equivalent to a predicate device and can be marketed. It states the indications for use but does not delve into the specifics of performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert qualifications that would be found in a study report or a more detailed submission.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance: This information is not present in the document.
2. Sample sizes, data provenance, number of experts, adjudication methods for the test set: These study design details are not included.
3. MRMC comparative effectiveness study results or effect size: This type of study detail is not in the provided text.
4. Standalone performance details: The document does not describe standalone algorithm performance.
5. Type of ground truth used: This is not mentioned.
6. Sample size for the training set: This is not mentioned.
7. How the ground truth for the training set was established: This is not mentioned.

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Synergy ODM 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, diagnostic data, clinical information, reports from ophthalmic diagnostic instruments through either a direct connection with the instruments or through computerized networks.

Synergy ODM is a software platform that collects, processes, measures, analyzes, stores, and manages patient data and clinical information. Synergy ODM is used together with a number of computerized digital imaging devices. In addition, Synergy ODM software collects and manages patient demographics, image data, and clinical reports from a range of medical devices. Synergy ODM enables a real-time review of diagnostic patient information at a PC workstation. Synergy ODM also includes an internetbrowser-based user interface to allow authorized users to access, view, create reports, and analyze patient and examination data saved in a centralized database. The system utilizes dual level authentication and 128-bit encryption to ensure secure networking environment.

The provided text for K132667 states: "No performance data was required or provided. Software validation and verification demonstrate that the Synergy ODM performs as intended and meets its' specifications."

Therefore, it is not possible to describe acceptance criteria or a study proving device performance based on the provided document. The device, Synergy ODM, is a software platform for image management in ophthalmology, and its 510(k) clearance was based on substantial equivalence to predicate devices, without requiring clinical performance data.

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The TRC-50DX Retinal Camera is intended for use in capturing images of the retina and the anterior segment of the eye and presenting the data to the eye care professional, with the use of a mydriatic.

The Topcon TRC-50DX Retinal Camera is designed to observe, photograph and record the fundus oculi of a patient without coming into contact with the patient's eye and provide an electronic image of the fundus oculi information for subsequent diagnosis. The TRC-50DX is provided in several configurations based on the photography needs of the user.

Here's a breakdown of the acceptance criteria and study information for the Topcon TRC-50DX Retinal Camera, based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly state numerical acceptance criteria (e.g., "device must achieve a score of X or higher"). Instead, it describes a comparative study where the TRC-50DX's image quality was evaluated against predicate devices. The acceptance criterion is implicitly that the TRC-50DX's image quality is "similar to or better than" the predicate devices.

• Focus
• Illumination
• Field Definition
• Artifact
• Small Pupil Artifact
• Media Opacity | "The study found the scores from the TRC-50DX images were similar to or better than the scores of the images from the predicate devices." (Predicate devices: Topcon TRC-NW7SF Mark II Retinal Camera and Canon CX-1) |
  | Safety | Compliance with relevant safety standards (e.g., optical radiation, electrical safety) | "Software verification and validation, system performance testing, optical radiation safety hazard analysis (ISO 15004-1 and ISO 15004-2) and electrical safety and EMC testing (IEC 60601-1 and IEC 60601-1-2) have been performed to support the substantial equivalence of the TRC-50DX." |
  | Substantial Equivalence | Same intended use, similar indications for use, technological characteristics, and principles of operation as predicate devices. | "The Topcon TRC-50DX Retinal Camera has the same intended use and similar indications for use, technological characteristics, and principles of operation as the previously cleared predicates. The Topcon TRC-50DX Retinal Camera is as safe and effective as its predicate devices, and thus, substantially equivalent." |

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not explicitly stated in the provided text.
   • Data Provenance: Not specified. The document does not mention the country of origin or if the data was retrospective or prospective.

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

   • Number of Experts: Not explicitly stated. The document mentions "a masked examiner."
   • Qualifications of Experts: Not explicitly stated beyond "a masked examiner."

3. Adjudication Method:

   • Not specified. The document only mentions that images were "evaluated and graded by a masked examiner." This implies a single grader, not an adjudication process involving multiple experts for discrepant cases.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Was it done? No, an MRMC comparative effectiveness study, in the sense of comparing human readers' performance with and without AI assistance, was not performed. The study involved a human examiner grading images from different cameras, not evaluating the impact of an AI algorithm on human reading.
   • Effect Size: Not applicable, as no such study was conducted.

5. Standalone Performance (Algorithm Only):

   • Was it done? No. The TRC-50DX is a retinal camera (hardware device) for capturing images, not an AI algorithm for interpreting them. The performance testing focused on the image quality of the camera itself, as evaluated by a human.

6. Type of Ground Truth Used:

   • Expert Consensus/Grading: The "ground truth" for image quality in this context was established through subjective grading by "a masked examiner" based on specific image quality factors (focus, illumination, field definition, artifact, small pupil artifact, and media opacity).

7. Sample Size for the Training Set:

   • Not applicable. This device is a retinal camera (hardware), not an AI algorithm that requires a training set. The performance testing assessed the camera's ability to produce images, not the performance of a learned model.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as no AI model training was involved.

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The TRC-NW300 intended for use in capturing images of the retina and the anterior segment of the eye and presenting the data to the eye care professional, without the use of a mydriatic.

The Topcon TRC-NW300 is a fundus camera designed to observe, photograph and record the fundus oculi of a patient's eye with or without the use of a mydriatic. The TRC-NW300 does not come into contact with the patient's eye and provides the fundus oculi image information as an electronic image for later analysis. The TRC-NW300 houses a color LCD monitor used for observation and display of a photographed image and a digital photography unit used for recording images. A photographed image may be recorded on a commercially available memory card inserted in the memory card slot of the TRC-NW300, to a commercially available image filing system, or on a commercially available storage device (such as a flash memory, a hard disk or a card reader/writer) connected to the TRC-NW300. A photographed image may also be printed on a commercially available digital printer connected to the TRC-NW300.

The provided 510(k) summary for the Topcon TRC-NW300 Non-Mydriatic Retinal Camera primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria and performance metrics for the device itself.

Therefore, many of the requested details, particularly regarding specific numerical performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods for a diagnostic effectiveness study, are not explicitly present in the provided document. The document mainly highlights compliance with safety and electrical standards and modifications from previous models.

However, based on the information provided, here's what can be gathered:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific, quantifiable acceptance criteria (e.g., sensitivity, specificity, image quality scores) and corresponding reported device performance metrics in the way a diagnostic study would.

Instead, the performance data section states:

• "The TRC-NW300 has been tested and found in compliance with the following recognized consensus standards: IEC 60601-1, IEC 60601-1-2, ISO 15004-1, ISO 15004-2."
• "Additionally, design verification tests were performed as a result of the risk analysis assessment. These test results demonstrated that the TRC-NW300 met predetermined acceptance criteria."

The "acceptance criteria" here refer to meeting the requirements of these standards and the predetermined criteria of internal design verification tests, which are not detailed in this summary.

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

Not applicable/Not provided. The document does not describe a clinical performance study with a test set of images or patients for diagnostic accuracy. The "test results" refer to engineering design verification.

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

Not applicable/Not provided. There is no mention of a test set with ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable/Not provided.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Not applicable/Not provided. The document does not describe an MRMC study comparing human readers with and without AI assistance. The device is a retinal camera, not an AI diagnostic tool.

6. Standalone Performance Study (Algorithm Only)

Not applicable/Not provided. The device is a retinal camera for image capture, not an AI algorithm for standalone diagnosis. The "performance data" refers to the camera's technical performance and safety compliance.

7. Type of Ground Truth Used

Not applicable/Not provided in the context of a diagnostic performance study. The ground truth for the device's functional integrity was established through compliance with recognized safety and performance standards (e.g., electrical safety, light hazard protection) and internal design verification against "predetermined acceptance criteria."

8. Sample Size for the Training Set

Not applicable/Not provided. The device is a camera, and there is no mention of a training set as would be used for a machine learning algorithm.

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

Not applicable/Not provided.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" or rather, the evidence provided to demonstrate that the TRC-NW300 meets its acceptance criteria, is based on:

• Compliance with Recognized Consensus Standards: The device was tested and found compliant with:
  • IEC 60601-1: General Requirements for Safety of Medical Electrical Equipment.
  • IEC 60601-1-2: Electromagnetic Compatibility.
  • ISO 15004-1: General requirements applicable to all ophthalmic instruments.
  • ISO 15004-2: Light hazard protection for ophthalmic instruments.
• Design Verification Tests: These tests were performed as a result of a risk analysis assessment. The document states that "These test results demonstrated that the TRC-NW300 met predetermined acceptance criteria." These are internal engineering and functional tests to ensure the device performs as designed and safely, especially considering the modifications from its predicate.
• Substantial Equivalence Argument: The core of the 510(k) submission is to argue that the TRC-NW300 is substantially equivalent to its predicate devices (TRC-NW200 and TRC-NW8F). This argument is based on the device having the "same intended use and similar indications, principles of operation, and technological characteristics." The modifications (e.g., higher megapixel camera, smaller pupil photography, auto-focus, automatic flash, USB memory card capability) were evaluated, and Topcon determined "they do not affect the safety or effectiveness of the device." Many of the new features were already cleared in the TRC-NW8F.

In essence, the "acceptance criteria" here are primarily functional, safety, and performance standards as an ophthalmologic imaging device, and the "proof" is through conformity to these standards and a comparison to previously cleared, substantially equivalent devices. The document does not describe a clinical study focused on diagnostic accuracy or reader performance.

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The Slit Lamp SL-2G is an AC-powered slitlamp biomicroscope intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

The Slit Lamp SL-2G is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light. The Slit Lamp SL-2G is composed of the following components: microscope unit, illumination unit, chinrest, table and power unit. The slitlamp biomicroscope is used for the observation of the eye. It has an illumination unit to illuminate the eye, and a binocular stereoscopic microscope to zoom and observe patient's eyes, and also can observe the three-dimensional image.

This submission describes a slit lamp biomicroscope, a medical device used for eye examinations. The acceptance criteria and supporting studies for this type of device are primarily focused on compliance with recognized performance standards related to safety, electromagnetic compatibility, and specific ophthalmic instrument requirements, rather than clinical performance metrics typically associated with AI/software devices. Therefore, many of the requested elements (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training sets) are not applicable in the context of this traditional medical device submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable for this type of device. The "test set" here refers to the device itself undergoing engineering and performance testing against established standards, not a clinical data set.

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

Not applicable. Ground truth for a physical medical device's compliance with safety and performance standards is established through engineering tests, measurements, and adherence to manufacturing specifications, not typically through expert consensus on a clinical test set.

4. Adjudication Method for the Test Set

Not applicable. The "adjudication method" is not relevant for testing against engineering and performance standards.

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. This is a traditional medical device (slit lamp), not an AI/Software as a Medical Device (SaMD). Therefore, no MRMC comparative effectiveness study was performed or is relevant.

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

No. This is a manual medical device operated by a human, not an algorithm.

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

The "ground truth" for this device's acceptance is its compliance with internationally recognized consensus standards (IEC, ISO) and its demonstration of similar technological characteristics and performance parameters to previously cleared predicate devices. This involves direct measurement, engineering verification, and comparison of specifications.

8. The Sample Size for the Training Set

Not applicable. This is a hardware medical device, not a machine learning algorithm.

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

Not applicable. There is no training set for this device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The "study" demonstrating the device meets the acceptance criteria is a substantial equivalence comparison to predicate devices, supported by compliance with recognized international consensus standards.

• Substantial Equivalence: The Topcon Slit Lamp SL-2G was compared to the HAAG-STREIT Slit Lamps BM 900/BQ 900/BP 900 (K100202) and BC 900 (K982057).

  • Identical Intended Use/Indications for Use: Both the proposed device and predicates are intended for eye examination of the anterior eye segment to aid in diagnosing diseases or trauma.
  • Similar Technological Characteristics: Both are AC-powered slit lamp biomicroscopes that project a light beam into the patient's eye.
  • Equivalent Performance Parameters: "Exposure parameters including slit image width, slit image length, illumination field diameter and slit direction are all within the specifications of the previously cleared predicate devices."
  • Light Source: While the SL-2G uses an LED (max 160,000 Lux), this is noted as one of the available light sources for the predicate BM 900/BQ 900/BP 900 series (which has a maximum brightness up to 450,000 Lux). The SL-2G's brightness is within an acceptable range for a slit lamp.
  • Magnification: The SL-2G has the same magnification steps and eyepiece lens magnification as the predicate BP 900.

• Compliance with Standards: The device conforms to the following standards, which define electrical safety, electromagnetic compatibility, and specific requirements for ophthalmic instruments and slit lamp microscopes:

  • IEC 60601-1 (General Safety)
  • IEC 60601-1-2 (Electromagnetic Compatibility)
  • ISO 15004-1 (Ophthalmic Instruments - General Requirements)
  • ISO 15004-2 (Light Hazard Protection)
  • ISO 10939 (Slit Lamp Microscopes Specific)

The conclusion is that the Topcon Slit Lamp SL-2G is "substantially equivalent" to its predicate devices because it shares the same intended use, similar technological characteristics, and conforms to the same recognized performance standards. This demonstrates that the device meets safety and effectiveness requirements without raising new questions of safety or effectiveness.

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Synergy is a comprehensive software platform intended for use in acquisition or importing, processing, measurement, analysis and storage of clinical images and videos of the eye as well as in 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.

Synergy is a software platform that collects, processes, measures, analyzes, stores, and manages patient data and clinical information. Synergy is used together with a number of computerized digital imaging devices. In addition, Synergy software collects and manages patient demographics, image data, and clinical reports from a range of approved medical devices. Synergy enables a real-time review of diagnostic patient information at a PC workstation. In addition to the desktop application, Synergy also includes an internet-browser-based user interface to allow authorized users to access, view, create reports, and analyze patient and examination data saved in a centralized database. The system utilizes dual level authentication and 128-bit encryption to ensure secure networking environment.

This 510(k) summary provides information for the Topcon Medical Systems, Inc. Synergy, an ophthalmic image management system.

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

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

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

The document explicitly states: "No performance data was required or provided." Therefore, there is no test set sample size and no data provenance mentioned for a clinical performance study. The evaluation focused on software validation and verification.

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

As no performance data was provided, there was no test set and therefore no experts used to establish ground truth for a clinical performance evaluation.

4. Adjudication method for the test set

Not applicable, as no performance study with a test set was conducted.

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 MRMC comparative effectiveness study was done. The device description indicates it is a software platform for image management and analysis, not an AI-assisted diagnostic tool that would typically involve human readers.

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

No standalone performance study was done in the context of clinical accuracy or diagnostic capability, as explicitly stated: "No performance data was required or provided." The "standalone" aspect described is the software itself performing its intended functions (acquisition, processing, measurement, analysis, storage, management) rather than a diagnostic algorithm.

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

Since no performance data or clinical study was conducted, no ground truth was established or used in the context of diagnostic accuracy. The "ground truth" for the device's functionality would have been its own specifications, verified through software validation and verification.

8. The sample size for the training set

Not applicable, as this device is an image management system and not an AI/ML diagnostic algorithm that typically requires a training set for model development.

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

Not applicable, as no training set was used for an AI/ML model.

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The Topcon 3D OCT-1000 MARK II is a non-contact ophthalmic imaging system for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging of the retina, retinal nerve fiber layer and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including but not limited to macular edema and central serous retinopathy.

The Topcon 3D OCT-1000 is a non-contact ophthalmic imaging system for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging of the retinal nerve fiber layer and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including but not limited to macular edema and central serous retinopathy. The 3D OCT-1000 Mark II has the same intended uses and indications for use as the 3D OCT-1000. The technological characteristics are the identical for the two devices, with the exception that during OCT imaging, the scan pattern for the 3D OCT-1000 is delivered as continuous wave (CW) light source; whereas, it is delivered as pulsed lighting in the 3D OCT-1000 Mark II.

The provided 510(k) summary for the Topcon 3D OCT-1000 MARK II indicates that its acceptance criteria and the study proving it meets these criteria are based on demonstrating substantial equivalence to a legally marketed predicate device, the 3D OCT-1000. This is not a study proving clinical diagnostic performance against specific acceptance criteria for a new clinical claim, but rather a technical comparison.

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

Acceptance Criteria and Device Performance

• Intended Use
• Indications for Use
• Technological Characteristics
• Engineering Design and Specifications
• Software Design and Specifications
• Laser Classification | The 3D OCT-1000 MARK II has the same intended uses and indications for use as the 3D OCT-1000. The technological characteristics are identical, with the exception of the scan pattern light source (continuous wave for predicate, pulsed lighting for 3D OCT-1000 MARK II).
  Software validation testing and image capture testing were performed on the 3D OCT-1000 MARK II.
  Test results demonstrated sufficient agreement with captured images from the 3D OCT-1000.
  The results of performance testing and software validation testing did not raise any issues on the safety or effectiveness of the device. |

Study Details

The "study" in this context is a comparison to a predicate device, not a typical clinical trial assessing diagnostic accuracy against an established ground truth.

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

   • No specific sample size for a "test set" (in the sense of patient data for diagnostic accuracy) is mentioned.
   • The document implies a technical comparison and validation of the device's imaging capabilities against the predicate. Data provenance is not specified other than it being from performance and software validation testing.

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

   • Not applicable as a traditional "test set" with expert-established ground truth for diagnostic accuracy was not performed in this 510(k) submission. The "ground truth" for the device's performance was its agreement with the predicate device's output.

3. Adjudication method for the test set:

   • Not applicable for the reasons stated above.

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:

   • No MRMC study was conducted or reported. This device is an imaging system, not an AI-powered diagnostic tool requiring human reader assistance assessment.

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

   • No "standalone" algorithm performance study (in the context of automated diagnosis) was performed. The device itself is an imaging system, and its performance was assessed in terms of its ability to acquire images and its agreement with the predicate device's image acquisition.

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

   • The "ground truth" for this submission was the performance and output of the legally marketed predicate device, the Topcon 3D OCT-1000. The new device's images and performance were compared for "sufficient agreement" with the predicate.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set of data.

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

   • Not applicable as there was no training set.

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The Topcon 3D OCT-1000 is a non-contact ophthalmic imaging system for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging of the retina, retinal nerve fiber laver and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including but not limited to macular edema and central serous retinopathy. The device is indicated for assessing the area, location, and measurement of retinal thickness, including in patients with retinal pathologies. In addition, the device is indicated to detect separation between identified retinal layers and surfaces, i.e., retinal tissue layers.

The Topcon 3D OCT-1000 is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in vivo viewing, axial, cross-sectional and three-dimensional imaging and measurements of posterior ocular structures, including retina, retinal nerve fiber layer, macula, and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases affecting the posterior segment of the eye.

The Topcon 3D OCT-1000 for Measurement of Retinal Thickness uses optical coherence tomography, which relies upon interferometry of superluminescent diode light reflected from the fundus of the eye to obtain cross-sectional images of the retina. The Topcon 3D OCT-1000 for Measurement of Retinal Thickness is identical to the FDA-cleared Topcon 3D OCT-1000 (K063388), with the exception of the addition of a new software module allowing for the measurement of retinal thickness.

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Acceptance Criteria": "The device provides accurate measurements that correlate with manually identified retinal boundaries in both healthy and diseased retinas.",
    "Reported Device Performance": "Topcon conducted performance testing demonstrating that from an analytical perspective, the device provides accurate measurements. Additional performance testing demonstrated that the accuracy of the measurements reported from the device correlate with measurements calculated using manually identified retinal boundaries in a population with healthy retinas and a population with diseased retinas."
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The sample size for the test set is not specified. The study included 'a population with healthy retinas and a population with diseased retinas'. Data provenance (country of origin, retrospective/prospective) is not specified.",
  "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)": "The document states that measurements were correlated with 'manually identified retinal boundaries'. The number and qualifications of experts involved in this manual identification are not specified.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Adjudication method is not specified.",
  "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": "A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study focused on the correlation between device measurements and manually identified boundaries, not on human reader performance with or without AI assistance.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Yes, a standalone performance study was conducted. The document states, 'Topcon conducted performance testing demonstrating that from an analytical perspective, the device provides accurate measurements.' and 'the accuracy of the measurements reported from the device correlate with measurements calculated using manually identified retinal boundaries'. This indicates an evaluation of the algorithm's direct measurement capabilities.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The ground truth used was based on 'manually identified retinal boundaries'. This implicitly suggests expert human assessment as the basis for comparison.",
  "8. The sample size for the training set": "The sample size for the training set is not specified.",
  "9. How the ground truth for the training set was established": "How the ground truth for the training set was established is not specified in the provided document."
}

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