(153 days)
The VisualEyes 515/ VisualEyes 525 system provides information to assist in the nystagmographic evaluation, diagnosis and documentation of vestibular disorders. Nystagmus of the eye is recorded by use of a goggle mounted with cameras. These images are measured, recorded, displayed and stored in the software. This information then can be used by a tained medical professional to assist in diagnosing vestibular disorders. The target population for VisualEyes 515/525 system is 5 years of age+
VisualEyes 515/ 525 is a software program that analyzes eye movements recorded from a camera mounted to a video goggle. A standard Video Nystagmography (VNG) protocol is used for the testing. VisualEyes 515/ 525 is replacing the existing Micromedical Technologies Spectrum vestibular testing software system and Interacoustics VN415 and VO425 vestibular testing software (510(k) cleared under K964646 and K072254). The software system will work with the existing Micromedical VisualEyes Goggle and Interacoustics VN415/VO425 Goggle. The goggle hardware is not part of this submission and is still assumed covered by K964646 and K072254. The software is intended to run on a Microsoft Windows PC platform. The "525″ system is a full featured system (all vestibular tests as listed below) while the "515" system has a limited number of tests (indicated with a * below).
VNG in general is used to record nystagmus during oculomotor tests such as saccades, pursuit and gaze testing, optokinetics and also calorics.The VisualEyes 515/ 525 software performs the following standard vestibular tests: *Spontaneous Nystagmus, Gaze, Smooth Pursuit, Saccade, Optokinetic, *Positionals, *Dix-Hallpikes and *Caloric tests. These are exactly the same standard tests that are performed in the predicate devices and are described in the ANSI standard (ANSI S3.45-1999, "American National Standard Procedures for Testing Basic Vestibular Function"). There are no difference in any settings or parameters in these default tests in any of the devices. The clinical validation tests showed that each test was performed in exactly the same manner and resulted in similar findings when comparing VE525 to the predicate devices.
The provided text describes the Interacoustics VisualEyes 515/525 system, a video nystagmography (VNG) device, and its substantial equivalence determination to predicate devices. However, it does not contain the specific details required to fully address all aspects of your request, particularly regarding quantitative acceptance criteria, statistical study design, and sample sizes for training and test sets.
Here's an analysis based on the information provided, highlighting what is present and what is missing:
Acceptance Criteria and Study Details for VisualEyes 515/525
The provided document describes a substantial equivalence (SE) determination based on a comparison to predicate devices, rather than a clinical trial with predefined quantitative acceptance criteria and a detailed statistical analysis of performance metrics. Therefore, a table of acceptance criteria with reported device performance, a sample size for the test set, detailed ground truth establishment, and MRMC study details cannot be fully constructed from the given text.
The core of the "study" described is a side-by-side comparison to demonstrate the algorithms for detecting and analyzing nystagmus were similar to the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, no numerical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) are explicitly stated, nor are specific quantitative performance metrics reported for the VisualEyes 515/525. The "acceptance criteria" appear to be based on demonstrating "equivalence" in functionality and results compared to predicate devices.
| Acceptance Criterion (Inferred from SE determination) | Reported Device Performance (Inferred) |
|---|---|
| Similar algorithms for detecting and analyzing nystagmus to predicate devices | "All results showed equivalence between the predicates and the subject, this means that results processed in predicates are showing equivalence to results from the subject device." |
| Performance as specified | "All these activities, testing and validation show that VisualEyes 515/ 525 perform as specified and is safe and effective." |
| No essential or major differences affecting safety and effectiveness compared to predicate devices | "We did not find any essential or major differences between the devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "The demonstration was carried out as a side by side comparison where the same patient was analysed by the subject device and the predicate device simultaneously."
- Sample Size for Test Set: Not explicitly stated. The text refers to "the same patient" in a singular sense, but then mentions "test subjects" in plural. It is unclear how many patients/subjects were included in this comparison.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved simultaneous analysis of "the same patient" with conjugate eye movements. It is a prospective comparison in the sense that data was collected specifically for this validation, but not necessarily a "clinical trial" as commonly understood.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study described is a comparison between devices, not primarily against an independent expert-established ground truth. The implication is that the predicate devices' outputs serve as a reference for equivalence.
4. Adjudication Method for the Test Set
This information is not provided. Given the side-by-side comparison, it's possible the "adjudication" was a direct functional comparison of the outputs, but no formal adjudication method is outlined.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not explicitly described. The document focuses on device-to-device equivalence rather than human-reader performance with or without AI assistance. The device assists trained medical professionals, but its impact on human reader improvement or an effect size is not discussed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The described "performance tests" involving the side-by-side comparison with predicate devices can be considered a form of standalone algorithm evaluation when comparing the output signals and processed data directly. However, the device is explicitly intended to "provide information to assist in the nystagmographic evaluation, diagnosis and documentation of vestibular disorders," implying a human-in-the-loop for diagnosis. The study focused on the equivalence of the raw measurements and processed data between the new and predicate devices.
7. The Type of Ground Truth Used
The "ground truth" for the performance comparison in this context appears to be the output of the legally marketed predicate devices (Micromedical Technologies Spectrum and Interacoustics VN415/VO425 systems). The goal was to show that the VisualEyes system produced "similar findings" and "equivalence" to these established devices.
"One camera recorded the left eye and was processed in the predicate device and the other recorded the right eye and was processed in subject device. All results showed equivalence between the predicates and the subject..."
8. The Sample Size for the Training Set
This information is not provided. The document makes no mention of a "training set" for the algorithms, which is typical for machine learning-based devices. The algorithms likely rely on established biomechanical models for eye movement rather than a distinct training phase.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned (see point 8), this information is not provided.
Summary of Missing Information:
The provided 510(k) summary is focused on establishing substantial equivalence to previously cleared predicate devices, emphasizing functional and technological similarity. It does not contain the detailed statistical analysis, quantitative performance metrics, and specific study design elements (like explicit sample sizes for testing/training, ground truth establishment by experts, or MRMC studies) that would typically be found in direct performance studies or clinical trials for novel devices or AI/ML-driven diagnostics. The "study" described is a technical comparison rather than a full-fledged clinical validation with predefined endpoints.
§ 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).