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510(k) Data Aggregation
(339 days)
VESTICON
The Epley Omniax is intended to assist in the diagnosis and treatment of balance disorders and vertigo, including benign paroxysmal positional vertigo.
The Epley Omniax is a multi-axial positional chair that includes the chair unit and an operator's pedestal. The chair unit includes the chair itself attached to a frame assembly. seat belts and other restraints, and videonystagmography goggles attached to a computer. The operator's pedestal includes the power distribution system, isolation transformer, and computer with monitor, keyboard, and mouse. The two computers communicate wirelessly to transmit and record the chair movements and the eye movements. The device has a number of safety features, such as emergency stop buttons, override buttons, pinch guards, and manual crank in case of power failure. The patient is strapped into the Omniax, dons goggles with a camera attached, and the operator selects a series of moves utilizing one or both of the axes. The position of the patient in relation to gravity and any eye movements are shown on the operator's computer and recorded for future viewing. Review of these recordings allows the operator to assess conditions and select appropriate treatment.
The Epley Omniax is a multi-axial positional chair intended to assist in the diagnosis and treatment of balance disorders and vertigo, including benign paroxysmal positional vertigo. The provided text describes performance testing that supports the device's substantial equivalence to existing standard of care methods.
Here's an analysis of the provided information:
1. Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical acceptance criteria (e.g., specific sensitivity, specificity, or agreement thresholds). Instead, the performance testing aimed to demonstrate "substantial equivalence" to the standard of care. The reported performance is an affirmation of this equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to Standard of Care (SOC) for diagnostic capabilities | "Studies performed provide a comparative analysis of the diagnostic... capabilities of the Omniax versus a common standard of care (SOC) method... Both studies reported findings of equivalence to that of the standard of care." |
| Substantial equivalence to Standard of Care (SOC) for treatment capabilities | "Studies performed provide a comparative analysis of the... treatment capabilities of the Omniax versus a common standard of care (SOC) method... Both studies reported findings of equivalence to that of the standard of care." |
| Safety Profile | "In addition, no complications or adverse events were reported in either study." |
2. Sample Size and Data Provenance for Test Set
- Sample Size (Diagnostic Study): 27 subjects
- Sample Size (Treatment Study): 37 subjects
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective, as subjects "completed" and "were analyzed."
3. Number and Qualifications of Experts for Ground Truth
The text states the "Standard of Care (SOC) method" involved "a common standard of care (SOC) method" consisting of "videonystagmograph (VNG) goggles and an examination table used by a physician performing manual maneuvers of the patient." This implies that the ground truth for diagnosis and treatment effectiveness was established by these physicians performing the manual maneuvers.
- Number of Experts: Not specified. It refers to "a physician" (singular) performing the maneuvers, but it's unclear if this was one physician for all cases or multiple physicians.
- Qualifications of Experts: "Physician." Specific specialties (e.g., Otolaryngologist, Neurologist) or years of experience are not mentioned.
4. Adjudication Method for Test Set
Not applicable/Not mentioned. The studies compared the Epley Omniax to a standard of care method. It doesn't describe a process of expert adjudication to establish ground truth for the test set cases, but rather implies the physicians' assessment using the SOC method served as the reference.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not described. The study compared the device (Epley Omniax) with a manual standard of care method. The Epley Omniax itself is a mechanical device operated by a human, not an AI algorithm assisting human readers.
6. Standalone (Algorithm Only) Performance
No, a standalone (algorithm only) performance study was not done. The Epley Omniax is a mechanical chair with software control. Its performance is intrinsically linked to the human operator interacting with the machine and the patient. It is not an AI algorithm making diagnoses or performing treatments autonomously.
7. Type of Ground Truth Used
The ground truth used was based on the assessment and observations of physicians utilizing the "common standard of care (SOC) method," which involved manual manipulation of the patient while using videonystagmography (VNG) goggles. This represents a form of expert consensus/clinical diagnosis based on established medical practice.
8. Sample Size for Training Set
Not applicable. The Epley Omniax is a mechanical device with software, not a machine learning or AI algorithm that requires a training set in the conventional sense. The device's design and functionality are based on medical principles and engineering, not data-driven training.
9. How Ground Truth for Training Set was Established
Not applicable, as there is no mention of a training set for a machine learning algorithm. The "training" in this context would refer to the engineering and medical expertise used in the device's development to ensure its movements and data capture are accurate and medically relevant, presumably based on existing medical knowledge of balance disorders and vertigo.
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