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Therapeutic Ultrasound:

1. Pain relief
2. Reduction of muscle spasm
3. Localized increase of blood flow
4. Increase range of motion of contracted joints using heat and stretch techniques.

Neuromuscular Stimulation:

1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain
2. Temporary relaxation of muscle spasm
3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
4. Increase of blood flow in the treatment area.
5. Prevention or retardation of disuse atrophy in post-injury type conditions
6. Muscle re-education
7. Maintaining or increasing range of motion

The BRH-A2 CUSEFS is comprised of the following main components:

• A system console including software and control electrodes; ●
• A control and display panel
• Specially designed cart
• User-friendly touch screen
  . The BRH-A2 CUSEFS is powered by standard one phase 120 or 230 V power supply.

The BRH-A2 CUSEFS is a two-channel combination unit for therapeutic ultrasound and 4-Pole Interferential Current therapy folded into a specially designed cart. The microprocessor controlled BRH-A2 CUSEFS provides 4-Pole Interferential Current therapy alternating current with enhanced reliability and user friendly interface. The BRH-A2 CUSEFS offer 1 and 3 MHz ultrasound treatment modes.

There is a user-friendly touch screen interface. The screen provides operator information about operation mode and signal intersities. Large control knobs on the touch screen make adjusting power for ultrasound and muscle stimulation.

The BRH-A2 CUSEFS can provide 4-Pole Interferential Current therapy only and ultrasound treatment only.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) system. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone clinical study involving an AI algorithm and human readers.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, how ground truth was established, training set size) are not applicable as this document does not describe such a study.

The acceptance criteria here are implicitly defined by the FDA-recognized standards for the safety and effectiveness of ultrasonic physiotherapy equipment and nerve and muscle stimulators, and the device's performance is demonstrated through bench testing and non-clinical testing to meet these standards.

Here's a breakdown of the information that can be extracted from the document, tailored to the context of a 510(k) submission for substantial equivalence:

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

The acceptance criteria for this 510(k) submission are the requirements outlined in the referenced FDA-recognized standards for medical electrical equipment and the device's ability to demonstrate similar performance and safety characteristics to the predicate devices. The reported device performance is that it "Passed all testing requirements" for these standards.

2. Sample Size Used for the Test Set and the Data Provenance:
The document does not describe a clinical study with a test set of human subjects or patient data. The testing mentioned refers to bench testing and non-clinical testing of the device itself against established engineering and safety standards. Therefore, "sample size for the test set" and "data provenance" in the context of patient data are not applicable.

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 not a study assessing an AI algorithm's performance against human readers or a clinical ground truth. The "ground truth" here is compliance with engineering and safety standards, which is assessed through instrument calibration, performance measurements, and risk analyses according to the specified international standards.

4. Adjudication Method for the Test Set:
Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No. The document explicitly states that bench testing and non-clinical testing were conducted to demonstrate safety, effectiveness, and substantial equivalence. It does not mention any MRMC study or AI assistance to human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. The device is a physical therapeutic ultrasound and electrical stimulation unit, not a standalone algorithm.

7. The Type of Ground Truth Used:
The "ground truth" in this context is the compliance with recognized international standards for medical device safety and performance, such as IEC 60601 series, ISO 14971, IEC 62304, and ISO 13485. This is established through documented testing procedures and results, as well as comparison to predicate devices' known characteristics.

8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that would require training data.

9. How the Ground Truth for the Training Set Was Established:
Not applicable.

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