(7 days)
MAX is indicated for chiropractic adjustment of the spine and/or extremities. MAX should be used by a licensed health care professional only. Intended for external use only.
MAX is a hand-held chiropractic adjusting instrument that features automatic battery-powered operation instead of manual thrust. The electromechanical instrument uses a plunger-like mechanism to deliver thrust for chiropractic adjustment. The instrument is intended for use by a health care professional licensed by the law of the state in which he or she practices.
The provided text describes a chiropractic adjusting instrument (MAX Adjusting Instrument) and its 510(k) summary for FDA clearance. It does not contain information about acceptance criteria for an AI/ML device, nor does it detail a study proving such a device meets acceptance criteria.
The document is a regulatory submission for a physical medical device, not a software or AI device. Therefore, the questions regarding acceptance criteria, study design for AI, sample sizes (test/training sets), expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for AI are not applicable and cannot be answered from the provided text.
The "Performance Data" section of the document only states:
| | Performance Data | MAX has four force settings that have been mechanically tested to deliver 75N, 125N, 175N, or 250N per thrust. The lithium-ion rechargeable battery has been tested for safety and performance. |
This indicates mechanical testing of force settings and battery safety/performance, which are standard for physical medical devices and not related to AI model evaluation.
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