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Therapeutic Ultrasound

1. Pain relief
2. Reduction of muscle spasm
3. Joint contractures

Transcutaneous Electrical Nerve Stimulation

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

The CT2011 SonicStimu Pain Relief Device is comprised of following main components:

• A system console including software and control electronics;
• A control and display panel;
• Device accessories including AC-DC Adaptor, Electrode 40*90mm, Lead for adapter, Lead for electrical.

The CT2011 is a single channel combination unit for therapeutic ultrasonic and transcutaneous electrical nerve stimulation. The microprocessor in CT2011 provides pro-modulated low frequency and monophasic electrical pulse waveforms with enhanced reliability and ease of using of the device. In the same time it offers I MHz ultrasound treatment also.

The user interface friendly comprises keys, LCD and audio feedback. The LCD provides operator information about operation mode and signal intensities. The user through control buttons to make adjusting power for ultrasound and stimulation. The CT2011 can be used as electrical stimulation or ultrasound therapeutic equipment separately or combination for both.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CT2011 SonicStimu Pain Relief Device:

This submission is a 510(k) Pre-Market Notification, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than proving independent efficacy or performance against specific clinical acceptance criteria. Therefore, the information typically found in efficacy studies (like clinical acceptance criteria or detailed performance metrics against a ground truth) is not present for the proposed device itself in this document.

The "acceptance criteria" discussed implicitly refer to regulatory compliance and the characteristics used to establish substantial equivalence with the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for substantial equivalence based on non-clinical testing, there isn't a table of specific clinical acceptance criteria and corresponding performance metrics for the CT2011 SonicStimu Pain Relief Device. Instead, a comparison to the predicate device (Sonicator Plus 940) is provided, and the "acceptance criteria" are implied to be that the proposed device performs at least as well as, or is technologically similar enough to, the predicate device such that it raises no new questions of safety or effectiveness.

Below is a table summarizing the technological characteristics compared from the provided text, which served as the basis for determining substantial equivalence rather than fulfilling specific performance acceptance criteria:

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "The CT2011 SonicStimu Pain Relief Device did not conduct, nor rely upon, clinical tests to determine substantial equivalence." (Section 7 and 8).

Therefore, there was no "test set" of clinical data, no sample size for such a set, and no data provenance (e.g., country of origin, retrospective/prospective). The evaluation was entirely non-clinical, based on engineering design validation and compliance with voluntary standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

As no clinical test set was used, no experts were involved in establishing ground truth for a clinical test set. The validation was based on compliance with standards and internal design requirements.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC study was done. The submission explicitly states "Discussion of Clinical Tests Performed: Not applicable."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the device itself is a "standalone" pain relief device (not an algorithm), the context of this question usually applies to AI/software. Since this device is a physical medical device (ultrasound and TENS stimulator), the concept of "standalone algorithm performance" doesn't directly apply. However, its performance claims are based on its physical characteristics and electrical/ultrasonic output, validated through non-clinical bench testing.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is effectively compliance with recognized electrical, mechanical, and safety standards (e.g., IEC 60601 series, ISO 14971) and successful completion of bench testing to validate design requirements. Biocompatibility was also assessed through testing of materials. There is no clinical ground truth (like pathology, expert consensus, or outcomes data) because no clinical studies were performed.

8. The Sample Size for the Training Set

Not applicable, as there was no "training set" in the context of collecting clinical or diagnostic data. The device's design and functionality are based on engineering principles and established medical device standards, not machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no "training set." The device's design and manufacturing are based on established engineering practices, safety standards, and the predicate device's characteristics.

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