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The Activator II® is indicated for chiropractic adjustment of the spine and extremities.

The Activator II ® is a chiropractic adjusting instrument for use in spinal manipulative therapy. The instrument is approximately seven (7) inches in length and approximately 2.5 inches wide at the handles. The major components of the device include handles for holding the device and applying thrust, a thrust element for delivering an input force to the patient, a body contact member, a spring for propelling the thrust element, and an adjustment knob. The body contact member is manufactured from silicone rubber. The adjustment knob is used for manually adjusting the amount of potential energy imposed on the spring and for controlling the magnitude of the resulting input force. When the handle is depressed, the body contact member applies the force in a specific line of drive at a rapid speed. This action is similar to a practitioner manually applying thumb thrust at specific contact points to achieve chiropractic adjustment.

This document describes the Activator II®, a chiropractic adjusting instrument, and the basis for its substantial equivalence to predicate devices, thus demonstrating it meets acceptance criteria for market clearance.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the comparison to the predicate device, the Activator I, and the demonstration of similar performance characteristics. The reported device performance is based on the Activator II®'s ability to cause vertebral movement at very low energy, as detailed in the study mentioned.

2. Sample size used for the test set and the data provenance

The study referenced, "Accuracy of Piezoelectric Accelerometers Measuring Displacement of a Spinal Adjusting Instrument," involved testing the Activator II® on:

• One human subject
• One animal subject

The data provenance is from a published study in the Journal of Manipulative and Physiological Therapeutics, Volume 9, Number 1, March 1986. The country of origin of the data is not explicitly stated, but given the journal and the company's location (Phoenix, Arizona), it is likely to be prospective data collected in the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not explicitly state the number of experts or their qualifications used to establish ground truth for this particular study. The study focuses on the accuracy of piezoelectric accelerometers measuring displacement, suggesting a technical assessment rather than a subjective expert assessment of chiropractic effect. The "ground truth" in this context would likely be the objective displacement measurements themselves.

4. Adjudication method for the test set

Not applicable. The study appears to be a technical measurement of instrument displacement, not a clinical assessment requiring adjudication of observer interpretations.

5. 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

Not applicable. This is not a study involving human readers or AI assistance. It describes a medical device for chiropractic adjustments.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device. The study describes the performance of a physical chiropractic adjusting instrument.

7. The type of ground truth used

The ground truth used in the referenced study appears to be objective displacement measurements obtained through an "electronic system to measure the displacement of the Activator II® instrument." This is a form of measurement/instrumentation data.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. It is a mechanical device.

9. How the ground truth for the training set was established

Not applicable. As above, there is no training set for this mechanical device.

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