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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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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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