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The BACK3 COLOR device 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 BACK3 COLOR massage device is intended to provide a temporary reduction in the appearance of cellulite.

The BACK3 COLOR generates high frequency sinusoidal current with a monopolar mode of application using two electrodes. A fixed electrode is placed in contact with the patient and a handheld 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 capacitor resistive monopolar mode and a multipolar mode.

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

The provided text describes the BACK3 COLOR device, which is an electrosurgical cutting and coagulation device. The 510(k) summary focuses on establishing substantial equivalence to a predicate device (Winback Back 3SE, K162828) rather than presenting specific performance criteria and a study to prove meeting those criteria in the traditional sense of a clinical trial for diagnostic devices.

Instead, the acceptance criteria and study detailed here are focused on demonstrating that the new device (BACK3 COLOR) functions safely and effectively, and is technologically equivalent to the previously cleared predicate device, without introducing new questions of safety or effectiveness.

Here's a breakdown of the information requested, based on the provided text:

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

Since this is a substantial equivalence submission, the "acceptance criteria" are generally that the new device performs equivalently to the predicate device in terms of safety and technical specifications. The "reported device performance" is essentially the confirmation that these specifications are met for the new device.

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

• Sample Size: The "Human being testing" for tissue temperature elevation involved three different people.
• Data Provenance: The document does not specify the country of origin or whether the study was retrospective or prospective. Given it's a testing requirement for the device's performance, it is highly likely to be a prospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not typically applicable or detailed in a substantial equivalence filing for an electrosurgical device like this. The specific "Human being testing" described focused on physical measurements (temperature) directly from the device's application, rather than subjective interpretation by experts to establish a "ground truth" for a diagnostic outcome. Therefore, no experts for "ground truth" establishment in this sense are mentioned.

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

Not applicable. The human being testing involved direct measurement of physical parameters (skin and room temperature) rather than subjective assessments that would require adjudication.

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 device is an electrosurgical and radiofrequency therapy device, not a diagnostic imaging device with AI assistance for human readers. No MRMC study was mentioned or required.

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

Not applicable. This device delivers energy therapy; it is not an algorithm-based diagnostic tool. The "Software Assessment" done was for the device's operational software, not for a standalone diagnostic algorithm.

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

For the "Human being testing," the "ground truth" was the direct measurement of skin and room temperatures to demonstrate the device's ability to maintain a therapeutic temperature. This is a direct physical measurement, not a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This document describes a medical device for physical therapy, not a machine learning model that requires a training set in that context. The "Software Assessment" refers to validation testing of the device's operational software.

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

Not applicable, as there is no mention of a training set for a machine learning model.

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