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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.

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

• Test Set (Human Being Testing for RF temperature elevation): "The study was conducted on three body parts..." The sample size is not explicitly stated but implies a very small number, possibly just one subject given the phrasing "on the human skin" not "on human subjects." This is likely a preliminary engineering verification test, not a clinical trial.
• Data Provenance: Not specified, but generally, for such a non-clinical test, it would be internal lab data (e.g., from the manufacturer or a contract lab). It is retrospective in the context of the 510(k) submission, as the data was collected prior to the submission.

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

• Not applicable as this is a non-diagnostic device. The "ground truth" for the human being testing was the measured tissue temperature.

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

• Not applicable for this type of non-clinical, non-diagnostic device testing.

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 an AI-assisted diagnostic imaging device.

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

• Not applicable. This device provides RF and EMS therapy; it's not an algorithm that standalone performs a diagnostic task. The device's "standalone" performance is its ability to deliver the specified energy within safety limits.

7. The type of ground truth used:

• For the "human being testing," the ground truth was measured tissue temperature.
• For other performance tests (electrical safety, EMC, etc.), the ground truth was defined by compliance with recognized standards (e.g., IEC 60601-1).

8. The sample size for the training set:

• Not applicable. This is not a machine learning device that requires a "training set" in the typical ML sense. Its design and validation are based on engineering principles and compliance with established standards, building upon prior predicate devices.

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

• Not applicable, as there is no "training set."

Summary of the "Study" (Non-Clinical Performance Testing):

The document describes various non-clinical performance tests rather than a single "study" proving diagnostic accuracy. These tests include:

• Usability and Risk Management Assessments: Verified user interface, safety, and performance.
• Biocompatibility Testing: On tissue-contacting probes for cytotoxicity, sensitization, and intracutaneous reactivity.
• Software Assessment: Validated against FDA guidelines, including requirements, hazard analysis, and testing.
• Electromagnetic Compatibility (EMC) Testing: Evaluated emissions and immunity.
• Electrical Safety Testing: Compliance with IEC 60601-1.
• Human Being Testing (Temperature Elevation): Conducted to demonstrate the device's ability to maintain a therapeutic temperature (38-42°C) on human skin across "three body parts" using all modes and power settings. This is the closest to a "study" involving humans, but it's a performance verification rather than a clinical trial for efficacy or diagnostic performance.

The overarching "acceptance criteria" for this 510(k) submission are that the device meets the safety, performance, and design standards of its legally marketed predicate devices and established consensus standards (e.g., IEC 60601-1), and that any differences do not raise new questions of safety or effectiveness.

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