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The Spinalight Atlas Percussion Instrument is to be used by a licensed Chiropractor to assist in making a Chiropractic adjustment to the atlas vertebrae. This adjustment is indicated when the doctor believes this bone to be out of alignment.

The Percussion Adjusting Instrument is comprised of a Chiropractic Adjusting Table and a support system with a percussion device, which a Chiropractor positions over his patient to deliver an adjustment to the Atlas Vertebra (C-1). After the doctor positions the patient on the table, he aligns the instrument head so that the stationary stylus is positioned to the Atlas on predetermined vectors. Once this is completed the Chiropractor activates a solenoid contained within the adjusting head which strikes the proximal end of the stationary stylus generating a percussion wave through the stylus into the transverse process of the Atlas Vertebra. The objective is to produce a movement of the Atlas toward its proper alignment under the skull. Any time the patient is being positioned on the table or headpiece the percussion head is placed in the "Safe to Move" position.

Here's a breakdown of the acceptance criteria and study information based on the provided document, addressing each of your points.

Important Note: The document describes a physical medical device (Atlas Percussion Adjusting Instrument), not an AI/software device. Therefore, many of your requested points regarding AI-specific assessments (e.g., ground truth for AI training sets, MRMC studies, AI effect size) are not applicable to this submission. The "acceptance criteria" here refer to the device's functional performance and safety, primarily in comparison to its predicate device.

Device Description

The Atlas Percussion Adjusting Instrument, Model C-1000, is a chiropractic device used by licensed chiropractors to adjust the atlas vertebrae. It consists of a chiropractic adjusting table and a support system with a percussion device. The device is designed to deliver a percussion wave through a stylus to the atlas vertebra to facilitate its movement towards proper alignment.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are framed in terms of demonstrating substantial equivalence to a predicate device (Atlas Adjusting Instrument, Model 8000, K946258) by ensuring the safety and effectiveness are not adversely impacted by the device modifications.

Given the nature of the device, the performance data focuses on demonstrating that modifications made to the new device (C-1000) do not compromise safety or effectiveness compared to the predicate.

Study Details (as applicable to a physical device)

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • The document does not specify a "test set" in terms of patient data or a specific number of trials for the performance tests beyond stating "Testing was completed." The tests mentioned are engineering and functional tests on the device itself (e.g., measuring force, acoustic pressure, electrical safety) rather than clinical trials with human subjects for performance evaluation because the modifications were deemed not to impact safety or effectiveness.
   • No information on data provenance (country of origin, retrospective/prospective) is provided, as it's not a clinical study involving aggregated patient data.

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

   • Not applicable. This is not an AI/image analysis device that requires expert-established ground truth for a test set. The validation revolves around engineering and functional tests of the physical device.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. This is not an AI/image analysis device requiring adjudication for "ground truth."

4. 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 a physical medical device, not an AI device. No MRMC study was performed.

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

   • Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable in the context of AI. For this device, the "ground truth" for safety and performance is based on direct physical measurements, engineering standards (e.g., EMC, electrical safety), and functional assessments demonstrating equivalence to the predicate device. The comparison is made against the known safe and effective performance of the predicate.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an AI model requiring a training set.

8. How the ground truth for the training set was established:

   • Not applicable. This is a physical medical device, not an AI model.

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