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The Non-Mydriatic Auto Fundus Camera AFC-330 with Image Filing Software NAVIS-EX is intended to capture, display, store and manipulate images of the retina and the anterior segment of the eye, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.

The Non-Mydriatic Auto Fundus Camera AFC-330 with Image Filing Software NA VIS-EX ("AFC-330 with NA VIS-EX") is a conventional non-mydriatic auto fundus camera. The AFC-330 with NAVIS-EX captures fundus images using a built-in colour CCD camera without the use of mydriatic agents. With this single device, registration of patient information, image capture, and viewing of captured images are possible. By connecting a personal computer (PC) to the device via a LAN and installing the NA VIS-EX image filing system software, images captured by this device can be transferred to the PC and viewed and managed on the PC.

The provided text is a 510(k) summary for the Nidek Non-Mydriatic Auto Fundus Camera AFC-330 with Image Filing Software NAVIS-EX. It describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria, as typically found in clinical performance studies of AI/CADe devices.

The document states:

• Testing in support of substantial equivalence determination: "All necessary bench testing was conducted on the AFC-330 with NA VIS-EX to support a determination of substantial equivalence to the predicate devices. The performance testing included the following tests:
  • Electrical and mechanical safety testing
  • Electromagnetic compatibility testing
  • Light burden testing
  • Verification and validation testing"
• Summary: "The collective performance testing results demonstrate that AFC-330 with NA VIS-EX is substantially equivalent to the predicate devices."

This indicates that the submission relied on bench testing to demonstrate performance characteristics related to safety and fundamental functionality, rather than a clinical study evaluating diagnostic accuracy against specific performance metrics and acceptance criteria for an AI or CADe component. The device appears to be a traditional fundus camera with image filing software, not a product that performs automated diagnostic interpretations requiring acceptance criteria like sensitivity, specificity, or AUC based on expert reads.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies proving the device meets them because such information is not present in the provided text. The submission focuses on demonstrating substantial equivalence through standard device testing (safety, EMC, light burden, verification/validation) for a medical imaging acquisition and management system.

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ORION is an ophthalmic camera that is indicated for use in capturing images of the retina.

The Nidek Technologies Srl ORION is an instrument for the diagnosis of retinal diseases. It is able to capture color images of the patient retina through CCD cameras. The fundus camera ORION is supplied with Xenon light and IR LEDs sources suitable for performing the above described examinations. The system includes also the dedicated NAVIS software (running with Windows XP e 2000 operative system).

The provided text describes the ORION fundus camera, but it does not contain information about specific acceptance criteria or a study that evaluates the device against such criteria. The document is a 510(k) premarket notification for the ORION device, focusing on demonstrating substantial equivalence to predicate devices, rather than detailed performance evaluations against predefined clinical endpoints.

Here's a breakdown of what the document does state and what it lacks in relation to your request:

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

• Lacking. The document states: "The performance data indicate that the fundus camera ORION device meets all specified requirements, and is substantially equivalent to the predicate device." However, it does not elaborate on what those "specified requirements" are, nor does it present any specific performance metrics or data in a table format. The assessment is qualitative and focuses on equivalence rather than meeting numerical criteria.

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

• Lacking. The document makes no mention of a test set, sample sizes, or data provenance for any performance study.

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)

• Lacking. No information is provided regarding experts or ground truth establishment.

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

• Lacking. No adjudication method 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

• Lacking. The device is a fundus camera, not an AI-powered diagnostic tool for interpretation. Therefore, an MRMC study related to AI assistance for human readers is not applicable to this device as described. The document focuses on the camera's ability to capture images.

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

• Lacking/Not Applicable. This is a hardware device (ophthalmic camera) with accompanying software for image management (NAVIS). It is not an algorithm that operates in a "standalone" diagnostic capacity or replaces human interpretation. Its performance is related to image acquisition quality, not automated diagnosis.

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

• Lacking. No ground truth information is provided as no detailed performance study results are presented.

8. The sample size for the training set

• Lacking. No training set is mentioned for any algorithm as the device itself is an image acquisition system, not explicitly an AI/ML diagnostic algorithm.

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

• Lacking. Not applicable, as no training set is mentioned.

In summary: The provided 510(k) document for the ORION fundus camera primarily demonstrates substantial equivalence to existing predicate devices based on technological characteristics and intended use. It does not provide detailed performance data, acceptance criteria, or information on specific clinical studies that would fulfill the requested categories. The statement "The performance data indicate that the fundus camera ORION device meets all specified requirements" is a high-level declaration without supporting evidence in this document.

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The MP-1 MICRO PERIMETER is indicated for use as :

• Color retinography .
• Fixation examiner ●
• Fundus-related microperimetry .
• Visual rehabilitation. .

The Nidek Technologies Srl MP-1 MICRO PERIMETER is an instrument for the diagnosis of retinal diseases. It is able to capture infrared live sequences and color images of the patient retina through CCD cameras and at the same time to project light stimuli on the retina in those retinal positions chosen by the operator.
The MP-1 MICRO PERIMETER is supplied with Xenon light and Halogen light sources suitable for performing the above described examinations.
The system includes also a suitable Insulation transformer, a LCD S-VGA Monitor and an IBM Personal Computer, which incorporates the dedicated NAVIS software (with Windows 2000 operative system).

The provided text describes the MP-1 Micro Perimeter and its substantial equivalence to a predicate device, but it does not contain information about specific acceptance criteria or a study proving that the device meets those criteria with performance metrics. The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies against pre-defined acceptance criteria.

However, based on the provided text, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the provided text. The document asserts that the device "meets all specified requirements" without detailing what those requirements are or providing specific numerical targets for performance.
• Reported Device Performance: Not numerically reported in the provided text. The document broadly states that "The performance data indicate that the modified MP-1 MICRO PERIMETER device meets all specified requirements, and is substantially equivalent to the predicate device." No specific metrics (e.g., sensitivity, specificity, accuracy, precision for different examinations) are given.

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

• Test Set Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective).

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

• Not specified in the provided text.

4. Adjudication method for the test set:

• Not specified in the provided text.

5. Multi Reader Multi Case (MRMC) comparative effectiveness study:

• No, an MRMC comparative effectiveness study is not mentioned. The document focuses on demonstrating substantial equivalence of the device itself (MP-1 MICRO PERIMETER) to predicate devices, not on comparing human reader performance with and without AI assistance.

6. Standalone (algorithm only without human-in-the-loop performance) study:

• Yes, implicitly. The claim of "performance data indicate that the modified MP-1 MICRO PERIMETER device meets all specified requirements" implies that the device's technical specifications and functions (e.g., ability to capture images, project stimuli, record answers, compensate for eye movements, generate sensitivity maps) were tested and found to perform as intended. However, details of these tests (like specific metrics, methodologies, or data used) are not provided. The device itself is an instrument, not an AI algorithm that produces a diagnostic output for human review in the same way modern AI systems do. Its 'standalone' performance refers to its ability to accurately execute its functions (image capture, stimulus projection, etc.).

7. Type of ground truth used:

• Not specified in the provided text. For a device like this, ground truth would likely be based on:
  • Clinical observation/diagnosis: For evaluating the relevance and accuracy of the generated sensitivity maps or fixation information against a patient's actual condition.
  • Known physical properties/measurements: For validating the accuracy of stimulus projection or image capture.

8. Sample size for the training set:

• Not applicable/Not specified. This device pre-dates the widespread use of deep learning AI, so a "training set" in the modern sense (for an AI algorithm) is not relevant to this submission. If there were calibration or development data, it is not mentioned.

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

• Not applicable/Not specified (as per point 8).

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The MP-1 MICRO PERIMETER is indicated for use as :

• Color retinography
• Fixation examiner
• Fundus-related microperimetry

The Nidek Technologies Srl MP-1 MICRO PERIMETER is an instrument for the diagnosis of retinal diseases. It is able to capture infrared live sequences and color images of the patient retina through CCD cameras and at the same time to project light stimuli on the retinal positions chosen by the operator.

The MP-1 MICRO PERIMETER is supplied with Xenon light and Halogen light sources suitable for performing the above described examinations.

The system includes also a suitable Insulation transformer, a 15-inch LCD S-VGA Monitor and an IBM Personal Computer, which incorporates the dedicated NAVIS software (with Windows 2000 operative system).

I am sorry, but the provided text does not contain the detailed information necessary to complete the table and answer all the questions regarding the acceptance criteria, specific study design, and performance data for the Nidek Technologies Srl MP-1 MICRO PERIMETER.

The document is a 510(k) premarket notification summary and an FDA clearance letter. It states:

• "The performance data indicate that the MP-1 MICRO PERIMETER device meets all specified requirements, and is substantially equivalent to the predicate device." This general statement confirms that performance data was submitted and found acceptable, but it does not provide the specific acceptance criteria or the reported device performance values.
• It primarily focuses on establishing substantial equivalence to predicate devices (NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000; HUMPHREY FIELD ANALYZER; CONFOSCAN 2 CONFOCAL MICROSCOPE). This typically means showing that the new device is as safe and effective as the legally marketed predicate devices, often through comparison of technological characteristics and intended use, rather than extensive new clinical efficacy studies.

Therefore, I cannot extract the specific details for the following requested information:

• A table of acceptance criteria and the reported device performance: This information is not present.
• Sample sized used for the test set and the data provenance: Not described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not described.
• Adjudication method for the test set: Not described.
• 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 described. The device is not an "AI" device as we understand it today; it's an ophthalmic imaging and perimetry device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not described.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not described.
• The sample size for the training set: Not described (and likely not applicable in the context of an "AI training set" for a device from 2002).
• How the ground truth for the training set was established: Not described.

The document indicates that the device's performance was deemed sufficient for substantial equivalence based on a comparison to predicate devices, but the specifics of how that performance was measured and what the exact criteria and results were are not included in this summary. Such details would typically be found in the full 510(k) submission, not the publicly available summary.

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The ConfoScan 2 Confocal Microscope is intended for use in the precise display and digital storage of images of the corneal layers (endothelium, descemet's membrane, stroma, bowman's membrane, and epithelium) and corneal components (endothelial cells, stromal keratocytes, nerve fibers, basalar and superficial cells). The microscope is also used for optical pachymetry, post-surgery interface evaluation, endothelial cell analysis, haze detection, foreign bodies, corneal dystrophies, keratoconus, keratitis, and trauma.

The ConfoScan 2 Confocal Microscope is indicated for use as a diagnostic tool for observation of the cell layers of the anterior parts of the eye.

The Nidek Technologies Srl ConfoScan 2 Confocal Microscope is a fully digital, corneal confocal microscope that allows a user to view and image human corneal layers in vivo. The confocal arrangement consists of one slit that illuminates the tissue and a second slit that filters the reflected light from unfocused layers. The user can view, magnify, measure, and photograph scparate layers of the transparent structures and tissues of the cornea. One examination records 350 different images.

The ConfoScan 2 microscope is supplied with a Quartz Halogen light source and a scauning slit, suitable for performing ophthalmic examination. The system includes a 15-inch LCD S-VGA Monitor and a Personal Computer, which incorporates the dedicated NAVIS software.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ConfoScan 2 Confocal Microscope:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria or detailed device performance metrics in the way one might see for a diagnostic accuracy study. Instead, the performance evaluation focuses on compliance with established standards and equivalence to a predicate device.

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

• Test Set Sample Size: For the "Endothelial Cell Analysis Software Validation," 134 samples (extracted from corneal images) were used.
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective.

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

The document does not explicitly state the number of experts used to establish ground truth for the "Endothelial Cell Analysis Software Validation," nor their qualifications. The validation involved "comparison to the results of two other commercially available specular microscopes," implying these microscopes (and their inherent cell analysis methods) served as a reference or "ground truth surrogate," rather than a distinct panel of human experts.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. The validation was a comparison against other commercially available devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described. The performance evaluation focuses on device-to-standard compliance and device-to-device comparison for the endothelial cell analysis software. There is no mention of human readers improving with or without AI assistance.

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

Yes, a standalone evaluation of the algorithm's performance was done for the "Endothelial Cell Analysis Software Validation." The ConfoScan 2 Confocal Microscope's software analyzed 134 samples and produced automatic cell density values, which were then compared to other commercial devices. This is a standalone assessment of the algorithm's output.

7. The Type of Ground Truth Used

For the "Endothelial Cell Analysis Software Validation," the ground truth was based on the results obtained from two other commercially available specular microscopes. This suggests a comparative reference standard, rather than a definitive "true" value derived from pathology or long-term outcomes. For the other tests (electrical safety, etc.), the "ground truth" was compliance with harmonized standards.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size used for training the ConfoScan 2 Confocal Microscope's software or any algorithms.

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

The document does not provide information regarding how the ground truth for any potential training set was established.

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