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Therapeutic Ultrasound

• Application of therapeutic deep heat for the treatment of selected sub-chronic medical conditions such as:
• 1. Pain relief, muscle spasms and joint contractures.
• 2. Relief of pain, muscle spasms and joint contractures that may be associated with:
• · Adhesive capsulitis
• Bursitis with slight calcification
• · Myositis
• · Soft tissue injuries
• · Shortened tendons due to past injuries and scar tissues
• 3. Relief of sub-chronic, chronic pain and joint contractures resulting from:
• · Capsular tightness
• · Capsular scarring

For TENS, Interferential, premodulated(IFC), NMS and Microcurrent:

• 1. Symptomatic relief of chronic intractable pain
• 2. Post-traumatic acute pain
• 3. Post-surgical acute pain

Additionally for NMS. NMS Burst, Hi-Volt and Russian:

• 1. Relaxation of Muscle spasms
• 2. Prevention or retardation of disuse atrophy
• 3. Increasing local blood circulation
• 4. Muscle re-education
• 5. Maintaining or increasing range of motion
• 6. Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

For EMG

• To determine the activation timing of muscles for:
• 1. Retaining of muscle activation
• 2. Coordination of muscle activation

An indication of the force produced by muscle for control and maintenance of muscle contractions

• 1. Relaxation muscle training
• 2. Muscle re-education

For EMG triggered Stim

• 1. Stroke rehab by muscle re-education
• 2. Relaxation of muscle spasms
• 3. Prevention or retardation of disuse atrophy
• 4. Increase local blood circulation
• 5. Muscle re-education
• 6. Maintaining or increasing range of motion

For DC Continuous Mode

• Relaxation of muscle spasm 1)

ComboRehab is four channels combination unit, can provide muscle stimulation, ultrasound, biofeedback and combination therapy. This product is designed to offer a multiple choices for clinician in one compact and integrated package.

A large control knobs located on the panel, allows clinician very easy to select different therapy mode and set therapeutic parameters. The award winning design offers a 5 inch Touch TFT LCD color display screen that can helps clinician to monitor the treatment information promptly.

In the electrotherapy mode, it's freedom for clinician to select one, two, three or four channels into therapy. A comprehensive set of current waveforms is available, targeting both pain management and muscle stimulation applications; interferential (4-pole), premodulated (2-pole interferential), Russian, NMS (Pulsed mode, burst mode), high volt, TENS, Microcurrent and Direct current.

The Ultrasound mode can be equipped with two applicators, 1cm² and 5cm². The applicators can operate in continuous or pulsed mode at an ultrasound frequency of 1 MHz or 3 MHz.

The EMG mode can provide us detail information about the organ-specific properties of a muscle through surface EMG electrodes. EMG biofeedback activity can couple with triggered electrical muscle stimulation using selected electrotherapy waveforms for the maximum benefit in muscle re-education.

The combination electrotherapy is used for the management of pain and muscle spasm. All functions of 1 or 3 MHz Ultrasound can be combined with Interferrential, Premodulated, Asymmetrical Biphasic. NMS, NMS burst mode, and High Voltage pulsed Current.

I am sorry, but without specific test data or performance metrics for the ComboRehab device, I cannot fill in the table for acceptance criteria and reported device performance. The provided text outlines the device's indications for use and lists the non-clinical tests performed, along with the standards it conforms to, but it does not contain quantifiable performance data or specific acceptance criteria for those performances.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance studies that would typically include acceptance criteria and their fulfillment.

However, I can provide the other requested information based on the text:

1. A table of acceptance criteria and the reported device performance
Not available in the provided text. The document states that "Nonclinical testing was performed in order to validate the design according with the company's specified design requirements, and to assure conformance with the following voluntary design standards." However, the specific reported device performance against numerical acceptance criteria is not detailed. The non-clinical tests focused on safety and electromagnetic compatibility per international standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not provided. The document explicitly states "ComboRehab did not conduct, nor rely upon, clinical tests to determine substantial equivalence." Therefore, there was no "test set" in the context of clinical data for performance evaluation as typically understood for AI/medical device assessment. The non-clinical tests performed were likely on device prototypes or production units, not on human subjects or clinical data sets.

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)
Not applicable. As no clinical tests were performed, there was no ground truth to be established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As no clinical tests were performed, there was no need for an adjudication method.

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. No multi-reader, multi-case clinical studies were conducted, as explicitly stated in the document. The device is a physical therapy device, not an AI-assisted diagnostic tool for 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 therapy unit that provides various modalities (ultrasound, muscle stimulation, biofeedback). It is not an algorithm-only device or an AI system that would have "standalone" performance in the sense of a diagnostic or interpretive algorithm. Its performance is inherent to its physical operation and energy delivery.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical tests performed, "ground truth" would refer to the adherence of the device's output to engineering specifications and international safety standards (e.g., electrical safety, electromagnetic compatibility, output intensity measurements). This is established through laboratory measurements and calibration against known standards, not clinical "ground truth" like pathology or expert consensus.

8. The sample size for the training set
Not applicable. No training set was used, as the device is not an AI/machine learning system that requires data training.

9. How the ground truth for the training set was established
Not applicable. No training set was used.

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