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Hang Ups InvertAlign is intended to be used for inversion, a method of gravity-assisted traction that utilizes the user's own body weight. Inversion is indicated of gray intervertebral dimentions, decrease pressure on the intervetebral discs, stretch and relax muscles, and temporarily relieve back pain associated with the listed contitions.

The InvertAlign is a non-invasive traction device that utilizes gravity to apply traction. The user straddles the main shaft of the InvertAlign and while resting his seat on the base of the table frame, the user places each foot on the foot platform. The user's ankles slide between the foam padded ankle clamps. In the InvertAlign's full upright position, the user will be reclined in the supine position at approximately 10 degrees off vertical. By pulling the locking pin and locking the clamps securely to the ankles, the user or supervisor is able to manually adjust the foam clamps to form a secure but comfortable fit. The user or supervisor may then use the tilt control button to increase / decrease the angle of inversion. The InvertAlign can be stopped at any angle and is able to tilt beyond ninety degrees from horizontal to allow the user to hang and move freely at full inversion.

The provided text is a 510(k) summary for a medical device called "Hang Ups InvertAlign." This document primarily focuses on demonstrating substantial equivalence to predicate devices and describes the device's technological characteristics and intended use. It does not contain information on acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for such a study.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document because it does not exist within the provided text. Similarly, I cannot answer the other questions about study specifics (sample size, data provenance, ground truth experts, adjudication methods, MRMC studies, standalone performance, training set details) as this information is not present.

The document's "Summary of Safety and Effectiveness" section focuses on the historical use of inversion and the features of the device that contribute to safety and effectiveness, rather than a formal study with acceptance criteria and measured performance.

In summary, the requested information about acceptance criteria and a study proving their fulfillment is not available in the provided 510(k) summary.

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