(125 days)
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.
§ 882.1460 Nystagmograph.
(a)
Identification. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.(b)
Classification. Class II (performance standards).