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The device is intended to measure, record and display the movements of the eyeballs during their involuntary movements (nystagmus) and while testing the patient's vestibular function.

The device is for prescription use only and it is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.

The device is a PC-based system for measuring, recording and displaying the eve movements. Its components include video goggles or surface electrodes to record the eve movements, a PC interface to acquire the data, a series of software modules to display and analyze the data and various stimulation devices.

This 510(k) summary does not contain information related to specific acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement as requested.

The document primarily focuses on establishing substantial equivalence to previously cleared devices based on intended use and technological characteristics (like safety compliance, type of system, construction, power source, and computer interface).

Therefore, I cannot populate the requested table or answer the specific questions about the study from the provided text. The document doesn't include a performance study with detailed acceptance criteria and reported results.

Here's an overview of what is available in the document:

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

• Not Available. The document does not specify performance acceptance criteria (e.g., accuracy, precision, sensitivity, specificity) for measuring eye movements, nor does it present results from a study demonstrating the device meets such criteria. The table in the document compares technological specifications (safety compliance, type, construction, power source, computer interface) of the device against predicate devices, not performance against acceptance criteria.

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

• Not Available. No performance study is described, so no sample size for a test set or data provenance is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Available. No ground truth establishment is described as part of a performance study.

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

• Not Available. No adjudication method is 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:

• Not Applicable. The device is a Nystagmographer (EyeTracker, IDEAS), which measures and displays eye movements. It is not an AI-assisted diagnostic device, and thus, a MRMC study on human reader improvement with AI assistance is not relevant to this type of device.

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

• Not Available. While the device works as a standalone measurement system, the document does not describe a formal "standalone performance study" in the context of typical AI/diagnostic device evaluations, with specific metrics and acceptance criteria. It mainly focuses on functional equivalence to predicates.

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

• Not Available. No performance study or ground truth definition is provided.

8. The sample size for the training set:

• Not Applicable/Not Available. The device is a measurement system, not a machine learning model that requires a training set.

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

• Not Applicable/Not Available. As above, no training set is relevant to this device's description.

In summary, the provided 510(k) documentation focuses on substantial equivalence based on design and intended use, rather than presenting a detailed performance study with specific acceptance criteria and clinical results. For devices like nystagmographs, regulatory clearance often relies more on demonstrating that the device reliably performs its intended measurement function and is safe, similar to existing predicate devices, rather than a clinical efficacy trial with diagnostic accuracy metrics.

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The DDAT OMT is intended to be used to observe, record and measure eye movements in patients during ocular motor testing. The DDAT OMT is intended for use by qualified medical personnel trained in the use of nystagmographs.

The DDAT OMT is a computer based medical device comprising of a Computer, a Display Monitor for viewing eye movements, a Lightbar which provides the stimulus for the eye movement and a client amplifier that tracks the patient's eye movement.

The provided document is a 510(k) summary for the DDAT OMT device, a nystagmograph. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics typically found in a PMA submission or a comprehensive independent study report.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and MRMC studies is not available in this 510(k) summary.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the 510(k) summary. 510(k) submissions typically rely on demonstrating substantial equivalence to a predicate device through technical comparisons, rather than presenting a performance study against predefined quantitative acceptance criteria for parameters like sensitivity, specificity, accuracy, etc.

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

This information is not provided in the 510(k) summary. There is no mention of a clinical "test set" in the context of a performance study. The submission focuses on comparison to a predicate device (CHARTR® ENG/VNG Diagnostic System, K991497).

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

This information is not provided in the 510(k) summary. As no specific clinical test set or performance study is detailed, there's no mention of experts establishing ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not provided in the 510(k) summary. The DDAT OMT is described as a "computer based medical device comprising of a Computer, a Display Monitor for viewing eye movements, a Lightbar which provides the stimulus for the eye movement and a client amplifier that tracks the patient's eye movement." There is no indication of AI assistance or an MRMC study comparing human readers with and without such assistance. This device is an nystagmograph, which records and measures eye movements, not an AI-powered diagnostic aid for interpretation.

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

This information is not provided in the 510(k) summary. There's no mention of an algorithm-only performance study. The device is a measurement tool intended for use by "qualified medical personnel trained in the use of nystagmographs," implying human-in-the-loop operation.

7. The Type of Ground Truth Used

This information is not provided in the 510(k) summary. There is no mention of a performance study requiring a distinct "ground truth." The submission focuses on equivalence to a predicate device.

8. The Sample Size for the Training Set

This information is not provided in the 510(k) summary. As it's not an AI/ML device that requires a training set in the typical sense, this information is not relevant to the content of this 510(k) submission.

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

This information is not provided in the 510(k) summary.

Summary of what the document DOES provide:

• Device Name: DDAT OMT
• Intended Use: Used to observe, record and measure eye movements in patients during ocular motor testing. Intended for use by qualified medical personnel.
• Predicate Device: CHARTR® ENG/VNG Diagnostic System (K991497) marketed by ICS Medical Corporation.
• Basis for Equivalence: "No significant differences between the DDAT OMT and the predicate device that would adversely affect the use of the device. The DDAT OMT is substantially equivalent to the predicate device in design, function, materials, and indications for use/intended use."

The 510(k) summary format does not generally require the detailed clinical study data and performance metrics you've requested. Its purpose is to demonstrate that a new device is "substantially equivalent" to an already legally marketed device, meaning it's as safe and effective.

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This device is used to observe, record and measure eye movements in patients during testing of vestibular function.

The CHARTR® ENG/VNG Diagnostic System is a computer based medical device consisting of a Computer utilizing the Pentium III processor, Windows 98 Operating System. Computer Monitor, two Display Monitors for viewing eve movements and utilizes the following accessories: Light Bar, Video Goggles, External Isolation Transformer. Video Distribution Amplifier. Caloric Stimulator. Color Printer, Patient Electrodes, and Interconnection Cables.

The provided text is a 510(k) summary for the ICS Medical CHARTR® ENG/VNG Diagnostic System, and a letter from the FDA determining substantial equivalence to predicate devices. This type of document is generally focused on regulatory approval based on equivalence to existing devices, rather than detailed studies proving performance against acceptance criteria for a novel device. Therefore, much of the requested information regarding specific study details (like sample sizes, expert qualifications, adjudication methods, or MRMC studies) is not present in the provided text.

Based on the information available:

Acceptance Criteria and Device Performance

The document does not explicitly state acceptance criteria in terms of quantitative performance metrics for the CHARTR® ENG/VNG Diagnostic System itself. Instead, the basis for approval is "substantial equivalence" to predicate devices. The "performance" reported implicitly is that the device "observes, records, and measures eye movements in patients during testing of vestibular function," which aligns with the intended use statement.

Study Details (Based on available information)

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

• Not provided. The document describes a regulatory submission based on substantial equivalence to predicate devices, not a de novo study with a specific test set.

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

• Not provided. Ground truth establishment, if any, is not detailed.

3. Adjudication method for the test set:

• Not provided.

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, an MRMC study was not described. The device is for recording and measuring eye movements, not an AI-assisted diagnostic tool for human readers in the context typically associated with MRMC studies in imaging.

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

• Not explicitly described as a standalone performance study. The device is a "computer based medical device" that utilizes accessories to "observe, record, and measure eye movements." Its performance is inherent in its function as a diagnostic system for vestibular function, rather than an "algorithm only" in the sense of an AI model being evaluated. The approval is based on its functional equivalence to existing devices.

6. The type of ground truth used:

• Not explicitly stated as a separate ground truth study. The basis for approval is substantial equivalence to established devices, implying that the "ground truth" is effectively the established performance and clinical utility of those predicate devices for their intended use.

7. The sample size for the training set:

• Not applicable/Not provided. This document does not describe the development or training of an AI model with a training set. It refers to a computer-based system, but not an AI/ML system in the modern sense.

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

• Not applicable/Not provided. As there is no mention of a training set, the establishment of its ground truth is not discussed.

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