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The BACK 3 device employs RF technology or EMS technology for the treatment of selected medical conditions.

The BACK 3 device in RF mode is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The BACK 3 massage device is intended to provide a temporary reduction in the appearance of cellulite.

The BACK 3 device in EMS mode is intended for:

*Prevention or retardation of disuse atrophy
*Increasing local blood circulation
*Muscle re-education
*Maintaining or increasing range of motion.

The RF treatment mode and EMS mode should not be used in combination or sequentially.

The BACK 3 device generates high frequency sinusoidal current with a monopolar mode of application using two electrodes. A neutral electrode is placed in contact with the patient and a handheld active electrode is manipulated by a therapist. When both electrodes are in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in a capacitive or resistive monopolar modes and a multipolar mode.

The product consists of a power console, LCD monitor, and accessories including capacitive, resistive and multipolar electrodes. The unit can be adjusted to provide various levels of treatment frequency ranging from 300kHz to 1MHz.

The product can also employ EMS technology. It generates a 4kHz or 1.5kHz electrostimulation signal (modulated at a frequency set between 2Hz and 200Hz).

The two RF and EMS technologies should not be used in combination or sequentially.

An Emergency stop button feature allows the patient to shut down the unit in the event of any discomfort.

The provided text describes a 510(k) premarket notification for the "BACK 3" medical device. It focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and various types of performance testing.

However, the document does not contain the level of detail typically found in a clinical study report that would establish specific acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity, AUC) and then prove the device meets those criteria through a test set. This document is a regulatory submission for a physical therapy device that uses RF and EMS technology, not an AI/algorithm-based diagnostic device. Therefore, a study demonstrating performance against a fixed set of accuracy metrics on a test set (like for an imaging AI) is not applicable in the way queried.

The "studies" mentioned are primarily non-clinical performance tests proving the device functions as intended and meets safety standards, rather than clinical efficacy studies or diagnostic accuracy studies.

Here's a breakdown of what can be extracted, and what cannot be derived from the provided text based on your request:

What can be extracted:

1. A table of acceptance criteria and the reported device performance:

The acceptance criteria here are based on meeting safety and performance standards equivalent to the predicate devices, rather than specific accuracy metrics like sensitivity or specificity. No numerical performance metrics for diagnostic accuracy are provided, as this is not a diagnostic device.

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