(164 days)
The ICS Impulse System is used in the assessment of the vestibular-ocular reflex (VOR) by measuring, recording, displaying, and analyzing eye and head movements. (Prescription use).
The device is a combination of hardware and software. The patient wears a pair of lightweight, tightly-fitting goggles on which is mounted a very small, very light, very fast, fire-wire video camera and a half silvered mirror. This transparent mirror reflects the image of the patient's eye into the camera. The eye is illuminated by a low-level infra-red light emitting diode which is not visible to the patients. A small sensor on the goggles measures the head movement. The whole goggle system is lightweight but it must be secured tightly to the head to minimize goggle slippage. The software records and displays the information obtained during what is known as a "head impulse test" The basic head impulse test starts with the tester standing behind the patient who is wearing the goggles. While the patient is asked to stare at the fixation dot placed on a projection surface in front of them, the tester rotates the patient's head horizontally through a small angle (about 10-20 degrees) in a brief, abrupt and unpredictable manner, varying the direction and the velocity. The goggles collect both head and eye data. The gyroscope measures the velocity of the head movement (the stimulus). The high-speed camera captures the image of the eve. The OTOsuite Vestibular software processes the head velocity data and velocity data for eye movement (the response). Simultaneous displays of the data for head movement and for eye movement allow the clinician to determine if the response is within normal limits or not.
The provided text describes the ICS Impulse device, its intended use, and a comparison to predicate devices, but it does not include detailed information regarding specific acceptance criteria for performance, nor does it present the results of a study designed to explicitly "prove the device meets the acceptance criteria" in a quantitative manner as typically expected for medical device approvals of this nature (e.g., sensitivity, specificity, accuracy against a gold standard in a clinical trial).
The document states that "Clinical testing compared test results to Scleral Search Coils test results. ICS Impulse adequately meets the design requirements and acceptance criteria." However, it does not elaborate on what these "design requirements and acceptance criteria" were in terms of specific performance metrics or thresholds, nor does it provide the detailed results of this clinical testing.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Safety: | |
| Electrical Safety per UL2601 - IEC-60601 (Predicate) | Complies with UL 60601-1, IEC 62471, 1st ed., IEC 60825-1, 2nd ed. UL Listed |
| EMC (Electromagnetic Compatibility) | IEC 60601-1-2: 2007 |
| Software Validation | Performed |
| Risk Analysis | Performed |
| Effectiveness/Performance: | |
| Adequately meets design requirements and acceptance criteria (general statement) | "Clinical testing compared test results to Scleral Search Coils test results. ICS Impulse adequately meets the design requirements and acceptance criteria." |
| Substantial Equivalence to Predicate Devices (Vorteq, VisualEyes) | Concluded to be "as safe and effective as the predicate device, and has essentially the same indications for use." |
| Accuracy/Agreement with Scleral Search Coils (Implicit from clinical testing) | Not specifically quantified or detailed in terms of metrics (e.g., correlation coefficient, mean difference, % agreement). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country, retrospective/prospective).
The text only says "Clinical testing compared test results to Scleral Search Coils test results."
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)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
The "Scleral Search Coils" are referred to as the reference standard, which is an objective measurement technique rather than an expert interpretation. If expert interpretation was involved in the "Scleral Search Coils test results," it's not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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 specified. The document does not describe the device as an "AI" or "CAD" system in the context of human reader improvement. It's a measurement and display device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device performs measurements and displays data for a clinician to interpret. The "clinical testing" implicitly refers to the device's measurements being compared to a reference standard, which is a form of standalone performance evaluation of the measurement capability, even if the final interpretation is by a human. However, explicit "standalone" performance metrics (e.g., sensitivity, specificity, accuracy) are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth (reference standard) used for the clinical testing was "Scleral Search Coils test results." Scleral Search Coils are considered a gold standard for precise eye movement measurement.
8. The sample size for the training set
- Not specified. The document does not explicitly mention a "training set" in the context of machine learning. The clinical testing described seems to be a validation/comparison study.
9. How the ground truth for the training set was established
- Not applicable/Not specified, as a training set is not explicitly mentioned.
§ 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).