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The GyroStim is intended to assist in the treatment of balance disorders and vestibular dysfunction in adult patients, age 18 and older, up to 400lb. It is intended to be used by a trained medical professional as prescribed by physician in a clinical environment.

GyroStim is an AC powered computer-controlled multi-axial positional and rotational chair. The device consists of a patient chair mounted within a rotational frame assembly that is capable of rotating in the pitch and yaw axes. The rotational frames are automated with computer-controlled drive systems capable of executing preprogrammed positional and rotational motion profiles. The system provides clinicians with a safe and efficient means for administering a wide range of specific positional and rotational motions for inducing stimulation of the vestibular system.

GyroStim operational software runs on a pc-based desktop computer. The software can capture, monitor, and display the patient's subjective response to each run. The response data may be used by the clinician for clinical decision support (CDS) to assist with progress evaluation, for profile selection and rate of therapy advancement, for individualizing therapy sessions, and for monitoring and preventing overstimulation.

Patient data is collected and stored and may be accessed for graphing, analysis, and reports.

The software includes libraries of prewritten profiles. A library of pre-written positional profiles located on the RUN BPPV page contains a collection of profiles for executing commonly used canalith repositioning maneuvers. A library of pre-written motion profiles located on the RUN GyroStim page contains a collection of profiles for executing motion induced vestibular stimulation.

Specifically, the library of motion profiles contains 30 levels of motion induced vestibular stimulation intensity, ranging from Level 1 to Level 30. The lowest level of motion induced vestibular stimulation intensity is Level 1, which rotates at a rate of 1 revolution per minute (RPM) or 0.016667 Hz. The highest level of motion induced vestibular stimulation intensity is Level 30. which rotates at 30 RPM or 0.5Hz. The intensity of the 30 levels differs and increments linearly at a rate of 1 RPM or 0.01667Hz per level; i.e.. Level 1 rotates at 1 RPM or 0.01667 Hz, Level 2 rotates at 2 RPM or 0.03334 Hz, Level 3 rotates at 3 RPM or 0.05 Hz, and so on up to Level 30 which rotates at 30 RPM or 0.5 Hz. Additionally, each of the 30 Levels offer a selection of run durations at 15 seconds (s), 30s, 60s, and 180s.

When configured with the integrated patient transfer system, GyroStim provides accessibility to the large population of patients with moderate to severe mobility challenges, many of whom are limited or unable to engage in the existing standard of care for balance disorders and vestibular dysfunction.

The GyroStim assembly, operational software, and libraries of profiles provide clinicians with a safe, effective, and efficient medical device for assisting in the treatment of balance disorders and vestibular dvsfunction.

Here's a breakdown of the acceptance criteria and the study details for the GyroStim device, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

The provided document describes a preliminary clinical study and various non-clinical bench (performance) tests.

1. Clinical Study:

• Sample size used for the test set and the data provenance:
  • The document states that the study "utilized retrospective data from the two treatment groups: GyroStim group, and SOC Group." However, it does not specify the exact sample size (number of patients) used in either group.
  • The data provenance is retrospective. The country of origin of the data is not specified.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
  • The assessments and treatments were performed by a "vestibular and balance medical specialist (DPT)."
  • The document does not mention a number of experts for establishing ground truth or their specific qualifications beyond "DPT." It implies one such specialist conducted the assessments and treatments.
• Adjudication method: Not described or applicable, as it was a retrospective comparison of treatment outcomes, not a diagnostic study requiring expert consensus on individual cases.
• 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:
  • No, this was not an MRMC study. The GyroStim is a physical device for therapy, not an AI for image interpretation or diagnosis by human readers.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
  • The document describes the performance of the device itself in both non-clinical and clinical contexts. The "algorithm" (software) of GyroStim is part of the device's control system, and its verification was done as a standalone test (software verification). However, the overall clinical study evaluated the device in use by a trained medical professional, so it's not a purely "algorithm-only" performance in the clinical sense.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
  • Outcomes data obtained from "pre and post intervention assessments" using "quantitative equipment and methods, including SOT, DHI, ABC, DVA, and mDGI." The "ground truth" for effectiveness was based on the improvement in these objective and subjective balance scores.
• The sample size for the training set: Not applicable. The clinical study was a comparison of treatment outcomes using an existing device (GyroStim) against standard of care. There is no mention of a machine learning model being trained on a separate dataset for clinical decision-making within the scope of this FDA summary. The "RUN GyroStim profiles" are pre-written profiles within the software, not learned models from a training set in the typical AI sense.
• How the ground truth for the training set was established: Not applicable, as there was no explicit training set described for an AI/ML model for clinical decision-making.

2. Non-Clinical Bench (Performance) Testing:

• Sample size used for the test set and the data provenance: This refers to physical units of the device (V4-GYROSTIM III-04A, V4-GYROSTIM III-04, GyroStim software). The sample size implicitly refers to the device units tested to ensure compliance with the specified standards. The data provenance is from internal engineering analysis and testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: These tests rely on established engineering standards and test methods (e.g., IEC, ANSI/AAMI). The "ground truth" is compliance with these standards, verified by qualified engineers or test facilities. The specific number or qualifications are not detailed beyond adherence to the standards.
• Adjudication method: Not applicable for bench testing. Pass/fail criteria are defined by the standards.
• MRMC study: Not applicable.
• Standalone performance: Yes, these are standalone performance tests of the device and its software components against engineering and safety standards.
• Type of ground truth: Defined engineering and safety standards (e.g., ANSI/AAMI/ES 60601-1, IEC 60601-1-2, IEC 62304, IBC 2018).
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

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