(165 days)
The ICS Impulse System Model 1085 is used in the assessment of the vestibular-ocular reflex (VOR) and nystagmus by measuring, recording, displaying, and analyzing eye and head movements.
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, USB 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 eye. 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 software also records and displays the information obtained during Positional and Oculomotor tests. A Positional test is performed by moving that patient from one position to another position. In the example of Dix-Hallpike, the patient is sitting and the patient's head is turned 45 degrees to one side and then the patient is moved from the sitting position to the supine position. An Oculomotor test is performed by having the patient stare in various directions or under various environments. In the example of Gaze, the patient is sitting and the patient is asked to stare left, right, up, down or center. The Gaze test can be performed with vision or with vision denied. For both Positional and Oculomotor the goggles collect head and eye data. The accelerometer in the small sensor measures where the head is in space. That information is taken and the patient's head position or any movement during testing is displayed in the software. The high speed camera captures the image of the eye. The OTOsuite Vestibular software processes the eye velocity data (the response). The eye movement is analyzed to determine the slow phase velocities (SPV). The head data is only used during collection to display if the patient's head is moving and to guide the tester to position the patient's head appropriately for the test. This is what we refer to as "Head Position Feedback". Tests where slow phase velocity is measured display the eve position trace and slow phase velocity beats in a graph. In Oculomotor there are 2 tests VOR and Skew Deviation that are not SPV tests. VOR (vestibular ocular reflex) which allows for both visual VOR (VVOR) and VOR suppression (VORS). This test is very similar to the head impulse test but the head movement is slow (0.5 Hz) and small (10 degrees). In VVOR the patient is sitting and the examiner moves the head from side to side (like a sinusoid) while the patient stares at a fixed target. In VORS the patient is sitting and the examiner moves the head from side to side (like a sinusoid) while the patient stares at a moving dot projected from the goggle using one of the lasers. The analysis is similar to head impulse, 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. In Skew Deviation (also known as cover test or alternate cover test) the patient is sitting and the tester covers and uncovers. The OTOsuite Vestibular software measures the eye position trace during the cover and uncover environments and displays an average eye position shift.
The provided text describes a 510(k) premarket notification for the ICS Impulse System Model 1085, which is a nystagmograph used to assess vestibular-ocular reflex (VOR) and nystagmus by measuring, recording, displaying, and analyzing eye and head movements.
However, the document is a Summary of Substantial Equivalence, not a full study report of the device's performance against specific acceptance criteria. It primarily focuses on comparing the new device (ICS Impulse Model 1085) to previously cleared predicate devices (K061791 ICS Chartr 200 VNG and K122550 ICS Impulse Type 1085) to demonstrate substantial equivalence, rather than providing detailed performance metrics from a specific study against pre-defined acceptance criteria.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and specific performance metrics are not available in the provided text.
Here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document declares that "The ICS Impulse adequately meets the design requirements and acceptance criteria" but does not provide a specific table of acceptance criteria with corresponding performance results. The "Description of Testing" section mentions:
- UL Electrical Safety testing (passed)
- EMC testing (passed)
- Software validation (performed)
- Risk analysis (performed)
- Biocompatibility testing (successfully performed)
- Clinical analysis based on published literature (performed)
These are general types of testing, but no quantitative acceptance criteria or performance metrics are detailed.
2. Sample Size Used for the Test Set and Data Provenance:
- Not explicitly stated for a performance test set. The document mentions "A clinical analysis based on published literature." This suggests that the clinical validation was not based on a new, direct clinical study with a specific test set but rather a review of existing literature, likely supporting the underlying principles of the device's measurements (VOR, nystagmus). Therefore, there is no specific "test set" with a defined sample size or provenance in the context of a prospective study of the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable based on the provided text. Since a direct clinical performance study with a defined test set and ground truth established by experts is not described, this information is not available. The "clinical analysis based on published literature" does not involve fresh ground truth establishment for a specific device test set.
4. Adjudication Method for the Test Set:
- Not applicable based on the provided text. No adjudication method is described as there is no specific test set undergoing human expert review for performance evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No indication of an MRMC study. The document focuses on demonstrating substantial equivalence to predicate devices, not on showing how much human readers improve with AI vs. without AI assistance. This suggests that no MRMC study was performed or reported in this 510(k) summary. The device, a nystagmograph, primarily measures and displays physiological data; it's not described as an AI-powered diagnostic aid that assists human readers in interpreting images or data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document implies that the device "measures, records, displaying, and analyzing eye and head movements." The software processes data: "The OTOsuite Vestibular software processes the head velocity data and velocity data for eye movement (the response)." and "The OTOsuite Vestibular software processes the eye velocity data (the response)." This indicates the algorithm performs analysis alone to generate data. However, specific performance metrics of this standalone algorithmic analysis (e.g., sensitivity, specificity, accuracy against a true measurement) are not reported in this 510(k) summary document. It states the system allows the clinician to "determine if the response is within normal limits or not," implying human interpretation of the algorithm's output.
7. The Type of Ground Truth Used:
- Not explicitly detailed for device performance evaluation. Given that the clinical analysis was based on published literature, the "ground truth" would refer to the accepted understanding and measurement of VOR and nystagmus as established in the scientific and medical community. There's no mention of a specific, newly established ground truth (e.g., pathology, outcomes data) for validating the device's measurements in a direct study.
8. The Sample Size for the Training Set:
- Not applicable/Not provided. The document describes software validation and risk analysis, but it does not mention a "training set" in the context of a machine learning or AI algorithm that would require one. The device measures physical parameters, and its "analysis" seems to be based on known physiological principles rather than statistical learning from a large dataset.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not provided. As there's no mention of a training set, this information is not relevant to the provided text.
In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence, not a detailed report of a clinical performance study with specific acceptance criteria and results. Therefore, most of the detailed information requested regarding study design, sample sizes, ground truth, and expert involvement is not present.
§ 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).