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The DY Instrument, Inc. AIS100 Automatic Intramuscular Stimulator Device is intended, as part of a treatment regimen, for

1. Intramuscular stimulation
2. Symptomatic relief of tension-type headache of myofascial origin

The AIS 100 is an intramuscular stimulator device that aids administering of intramuscular stimulation (or dry needling) for treatment. The device produces an automated forward and backward motion of a needle at a constant speed, which replaces the manual stroking of a needle when rendering the intramuscular stimulation (or dry needling) treatment. This enables the practitioner to administer the intramuscular stimulation treatment effectively with less physical effort when compared to the manual method. The device consists of a main control unit, a hand-held motor unit, and an AC power supply adapter.

1. Acceptance Criteria and Reported Performance:

The document doesn't explicitly state quantitative acceptance criteria in terms of specific metrics for the device's performance (e.g., a required percentage of pain relief). Instead, the study's goal was to demonstrate the safety and efficacy of the device and the intramuscular stimulation procedure.

The reported performance from the clinical study is:

2. Sample Size and Data Provenance:

• Test Set Sample Size: 28 individuals.
• Data Provenance: The study was a prospective clinical study conducted with individuals receiving treatment. The country of origin is not explicitly stated, but the submission is to the US FDA, implying the study likely took place in the US or under US regulatory standards.

3. Number and Qualifications of Experts for Ground Truth: No information is provided regarding experts used to establish ground truth for the test set. The study directly measured patient-reported outcomes (pain scale, pain disability index) and objective physical measurements (range of motion).

4. Adjudication Method:

The document does not mention any adjudication method. The outcome measurements appear to be direct patient responses and physical measurements without a need for independent expert review for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. This study focuses on the device's performance in direct treatment, not on how it assists human readers in interpreting data.

6. Standalone Performance:

Yes, a standalone clinical study was performed. The study evaluates the AIS100 Automatic Intramuscular Stimulator device in combination with a detailed treatment regimen to assess its safety and efficacy in treating tension-type headaches. This is a study of the device's clinical performance, not an algorithm's performance.

7. Type of Ground Truth Used:

The ground truth was established through a combination of:

• Patient-reported outcomes: Using a pain scale and the pain disability index.
• Objective physical measurements: Range of motion of the cervical spine (flexion, extension, and lateral flexion).
• Safety monitoring: Observation for any adverse effects.

8. Sample Size for Training Set:

This device is a physical stimulator, not an AI/ML algorithm that requires a training set in the conventional sense. Therefore, there is no "training set" as understood in machine learning. The clinical study described serves as the clinical validation dataset for demonstrating safety and efficacy.

9. How Ground Truth for Training Set was Established:

Not applicable, as there is no training set for an AI/ML model for this device. The clinical study directly measured treatment outcomes in human subjects.

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