(90 days)
The ICS Medical Model VG-30 Video Goggles are intended to provide video signals of patient's eyes thus making it possible to observe, record, and measure eye movements during testing of vestibular function.
The ICS Medical Model VG-30 Video Goggle consists of two small video cameras mounted in a custom housing to be worn on the face of the patient to view the patients eyes. The goggles use infrared (IR) Illumination to allow the eyes to be viewed in total darkness, a feature produced by a cover that can be installed on the front of the goggle housing.
The provided document is a 510(k) summary for the ICS Medical Model VG-30 Video Goggle, which seeks to establish substantial equivalence to a predicate device (ICS Video Goggle, K991497). This type of submission focuses on comparing the new device's characteristics and performance to a legally marketed predicate, rather than presenting a detailed new performance study with acceptance criteria in the typical sense of a clinical trial.
Therefore, the requested information elements related to specific acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable or not explicitly detailed in this 510(k) summary because the submission relies on demonstrating substantial equivalence.
Here's an analysis based on the provided text, addressing the points where information is available or noting its absence:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria for performance in the typical sense (e.g., a specific sensitivity or specificity target). Instead, the "acceptance criteria" for a 510(k) submission are implicitly met by demonstrating substantial equivalence to the predicate device. This means showing that the new device is as safe and effective as the predicate.
- Reported Device Performance: The "performance" assessment is primarily a comparison of design and material specifications to the predicate device. The key performance claim is its ability to "provide video signals of patient's eyes thus making it possible to observe, record, and measure eye movements during testing of vestibular function," which is identical to the predicate's intended use.
| Characteristic | Predicate Device (ICS Video Goggle - K991497) | New Device (ICS Medical Model VG-30 Goggle) | Comparison / "Acceptance Criteria Met" |
|---|---|---|---|
| Housing Material | ABS Plastic | ABS Plastic | Identical / Met |
| Face Cushion Material | Neoprene Rubber | Polyvinyl Chloride | Different, but not deemed critical |
| Number of Light Emitting Diodes (LED's) | 7 per eye (Total: 14) | Identical | Identical / Met |
| Mirror Adjustment Capability to Center the Image | Yes | Yes | Identical / Met |
| Horizontal Image Adjustment by Mirror Adjustment | Yes | Yes | Identical / Met |
| Vertical Image Adjustment by Adjusting Cameras | Yes | Yes | Identical / Met |
| Mirror Material | Polycarbonate plastic | Identical | Identical / Met |
| Strap Material | Neoprene Rubber | Identical | Identical / Met |
| Video Camera Adjustment Capability | Yes | Yes | Identical / Met |
| Friction Fit Light Occluding Cover | Yes | Identical | Identical / Met |
| Weight | Approximately 21 oz. | Approximately 18.5 oz. | Different (lighter), not deemed critical |
| Safety Standards Compliance | Met for predicate | Designed to meet same safety standards | Equivalent safety claim |
| Intended Use | Observe, record, measure eye movements during vestibular testing | Observe, record, measure eye movements during vestibular testing | Identical / Met |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable / Not Provided: As this is a 510(k) submission for substantial equivalence based on design comparison, a "test set" in the context of clinical performance evaluation with a specific sample size is not described. The assessment is primarily based on engineering and material comparisons to the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable / Not Provided: No "ground truth" establishment by experts for a specific test set is described, as the submission focuses on device characteristics relative to a predicate, not a de novo clinical performance study.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided: No adjudication method is mentioned as there is no specific test set requiring such a process.
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 (Video Goggle) is an accessory for observing and recording eye movements; it is not an AI-powered diagnostic tool that assists human readers in interpretation. Therefore, an MRMC comparative effectiveness study regarding "human readers improving with AI" is not relevant to this device and was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This device is a video goggle, an accessory that provides video signals for human observation or subsequent analysis by other systems (e.g., a nystagmograph). It does not perform an "algorithm only" standalone diagnostic function, so no such performance study would be applicable or provided.
7. The Type of Ground Truth Used
- Not Applicable / Implicit via Predicate: The "ground truth" in this context is implicitly the established safety and effectiveness of the predicate device. The new device demonstrates substantial equivalence by showing it shares the same technological characteristics, intended use, and performs similarly to the predicate. There is no independent "ground truth" (like pathology or outcomes data) established for a new clinical performance study.
8. The Sample Size for the Training Set
- Not Applicable / Not Provided: This device is not an AI/ML-based algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not Applicable / Not Provided: As there is no training set mentioned, the method for establishing its ground truth is also not applicable.
In summary, this 510(k) submission successfully demonstrated substantial equivalence by comparing the design, materials, and intended use of the new VG-30 Video Goggle to a previously cleared predicate device, rather than through a new clinical performance study with acceptance criteria and ground truth as might be seen for novel diagnostic devices.
§ 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).