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The BRC 2200 is intended for temporary symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain.

The BRC 2200 is a non-invasive, therapeutic device that delivers bipolar electrical current. In order to maintain a neutral charge for each cycle, the device delivers a current of one polarity for the first half of the cycle and then the opposite polarity for the second half of the cycle. The BRC 2200 is a hand-held device with a touch screen designed for ease of the user. The licensed healthcare professional uses a pass code to access screens regarding the treatment options and patient information. The main treatment screen shows the progression of the treatment, date, time, battery level, and gives options to pause the treatment or reduce the power if the patient feels discomfort. The BRC 2200 contains 24 pre-programmed treatments accessible only to the licensed healthcare professional. Using the designated pass code, the licensed healthcare professional selects the treatment and updates the correct patient information to the device before starting the treatment. Once the treatment has started, the patient will be able to pause the treatment or reduce power if he/she feels mild discomfort. Components included with the BRC 2200 contain a pair of single-use electrodes, a pair of electrode cables, a battery charger, and an optional USB cable. The electrodes come in a variety of sizes ranging from extra-small to large and either two inch or three inch widths. The electrodes attach by being circumferentially wrapped around a limb or the trunk of the body and the overlapping ends secured with hook and loop fasteners to maintain circumferential tension during treatment. The electrodes consist of a conductive layer sandwiched between a layer of polyurethane foam and a layer of synthetic neoprene. The foam is in contact with normal, intact skin for up to 3 hours and complies with ISO 10993. The electrode cables attach to the electrodes via a silver metal hook and loop fastener which then attaches to the BRC 2200 using push-pull connectors. The electrode cables used with the electrodes can be multi-use and are available in 40, 50, and 60 inches in length. These three different sizes in electrode cables allow for differences in the placement of electrodes and the different sizes of patients. In order to conduct the current through the body, the electrodes require water as the conducting medium. This is achieved by soaking the electrodes in water or normal saline solution and applying to the location in which current flow should be directed. The BRC 2200 is powered by a Tenergy 3.7V Li-polymer rechargeable battery. The battery is charged by the Tenergy 3.7V Li-ion battery charger model OH-1048A0451500U. The optional USB cable allows the licensed healthcare professional to obtain treatment information and transfer it to a computer. The BRC 2200 is a prescription device and can be used in a healthcare facility or at home.

This 510(k) submission (K121578) is for the BRC 2200, a transcutaneous electrical nerve stimulator (TENS) device. The primary claim for substantial equivalence is based on comparing the BRC 2200 to a legally marketed predicate device, the BodiHealth System (K052836). The focus of this submission is on demonstrating similar technical, functional, and performance characteristics, and adherence to relevant safety standards, rather than a clinical study evaluating the device's efficacy against specific acceptance criteria related to patient outcomes or pain relief.

Therefore, the requested information categories related to clinical studies, ground truth establishment, expert adjudication, multi-reader multi-case studies, and human-in-the-loop performance are not directly applicable or available in this 510(k) summary, as the submission relies on demonstrating substantial equivalence through non-clinical testing and comparison of technical specifications.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria in this 510(k) summary are implicitly defined by demonstrating that the BRC 2200 device shares "similar technical, functional, and performance characteristics" with the predicate device, BodiHealth System (K052836), and that it complies with relevant non-clinical standards. The predicate device serves as the benchmark for these "acceptance criteria."

Note on "Acceptance Criteria": For a 510(k) submission based on substantial equivalence to a predicate device, the "acceptance criteria" are generally met by demonstrating that the new device is as safe and effective as the predicate device. This is often achieved by showing similar technological characteristics and performance, and compliance with recognized safety standards. Direct quantitative "acceptance criteria" for clinical efficacy (e.g., "reduce pain by X%") are typically not part of a 510(k) where substantial equivalence is demonstrated through non-clinical means, as is the case here.

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

Not applicable/provided. This submission relies on non-clinical testing and comparison to a predicate device's technical specifications, not a clinical test set with patient data for assessing performance like accuracy, sensitivity, or specificity. The "test set" here refers to the device itself undergoing various engineering and safety tests.

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

Not applicable/provided. No clinical "ground truth" for patient outcomes was established or utilized in this 510(k) for the BRC 2200. The "ground truth" for the non-clinical tests would be the established safety and performance specifications defined by the relevant IEC and ISO standards.

4. Adjudication method for the test set

Not applicable/provided. As there was no clinical test set requiring expert interpretation or consensus, no adjudication method was used. Non-clinical tests were likely evaluated against pre-defined engineering and safety specifications.

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/provided. The BRC 2200 is a TENS device, not an AI-assisted diagnostic or interpretive device. Therefore, MRMC studies and AI assistance are irrelevant to this submission.

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

Not applicable/provided. The BRC 2200 is a TENS device that delivers electrical current; it does not involve an algorithm with standalone performance in the context of interpretation or diagnosis. It is inherently a human-in-the-loop device in its application (a healthcare professional operates it), but this is not an "algorithm only" scenario.

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

Non-clinical/Engineering Standards. The "ground truth" for this 510(k) is the adherence to established international and national standards for medical device safety and performance criteria for TENS devices. This includes:

• Electrical Safety: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-10.
• Biocompatibility: ISO 10993-1, ISO 10993-5, ISO 10993-10.
• General Performance Characteristics: Comparison against the technical specifications of the predicate device (BodiHealth System K052836) to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable/provided. This device does not use machine learning or AI that would require a "training set" in the conventional sense.

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

Not applicable/provided. As there is no training set, there is no method for establishing its ground truth.

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