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The Nydiag 200 rotary chair is an optional accessory for the Interacoustics eye movement recording systems. The rotary chair is used to elicit Vestibulo-Ocular Reflexes in patients aged 2 years or older who weigh less than 135 kg / 300 lbs who are being tested for bilateral or unilateral lesions in the peripheral vestibular organs.

The Nydiag 200 is a rotation chair, including a chair unit and a motor pedestal unit. The Nydiag 200 is controlled by software. The rotating chair is an optional accessory and is used for stimulation of the patients balance organs. The chair is supplied from the mains and controlled from a computer through an USB connection. The chair unit includes the chair itself attached to a frame assembly, seat belts and other restraints, patient discomfort signal device and goggle connections (Firewire and USB). The pedestal includes a power unit and motor and gearing units.

The Nydiag 200 Rotary Chair is a medical device, and the provided document is a 510(k) premarket notification summary. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy or performance against specific, quantifiable acceptance criteria in the same way a new drug or novel high-risk device might.

Therefore, many of the typical performance study details (like sample size, ground truth establishment, expert qualifications, and MRMC studies) are not present in this type of submission for this particular device. The "acceptance criteria" here are primarily about meeting safety standards and demonstrating equivalence to the predicate device in terms of technological characteristics and intended use.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable/not provided. The submission focuses on bench testing and comparison of characteristics, not on a clinical test set with patient data.
• Data Provenance: Not applicable, as no human data is mentioned for testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable/not provided. Ground truth in a clinical sense is not established for this type of technical equivalence submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set or adjudication process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No. This type of study is not mentioned as it's not typically required for a Class I/Unclassified device demonstrating substantial equivalence through bench testing and comparison of technical specifications. The comparison is between devices, not human readers.
• Effect Size of Human Readers Improvement: Not applicable.

6. If a Standalone Performance Study Was Done (Algorithm Only Without Human-in-the-Loop Performance)

• Standalone Performance Study: A "bench test" was performed on the device. However, this refers to engineering and functional testing of the hardware and software components (e.g., motor rotation accuracy, safety features, software control) against relevant standards, not a clinical performance study measuring diagnostic accuracy.
  • "During bench test the device was tested according to appropriate standards and found safe and efficient according to the purpose of the device." This confirms some form of performance assessment but not a diagnostic accuracy study.

7. The Type of Ground Truth Used

• Ground Truth Type: For the bench testing, the "ground truth" would be established by engineering specifications, relevant industry standards, and the intended functional performance of the device (e.g., if it's supposed to rotate at X speed, does it?). For the equivalence claim, the ground truth is the predicate device's established characteristics and indications for use.

8. The Sample Size for the Training Set

• Sample Size: Not applicable/not provided. As this is not an AI/ML device that learns from data, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Ground Truth Establishment: Not applicable. No training set is involved.

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