(153 days)
A hand held cutaneous electrode to be used with Dynatronics Solaris devices to apply electrical stimulation and apply heat and cooling to the skin
The Dynatron ThermoStim probes are used to provide therapeutic electrical stimulation and thermal therapy treatments. The probes consist of a handle with a treatment head and connections for a lead wire and/or circulating water. The probes act as an electrode for therapeutic electrical current provided by a Dynatron Solaris device, or other similar Dynatronics electrical stimulation devices in the delivery of electrical stimulation therapy. The treatment head transfers thermal energy (hot or cold) from circulating water when connected to a Dynatron QUAD7™.
The probes are a passive, manual therapy accessory. Treatment cycles are controlled through previously cleared Dynatronics electrical stimulation and OUAD7 devices.
There are two versions of the probe face - a flat head with a surface area of 11.4 cm2 (1.5," diameter) and a domed head with a surface area of 12.3cm-(1.1" diameter).
This document describes the Dynatron ThermoStim Combination Electrical Stimulation and Thermal Therapy probe and its substantial equivalence to predicate devices, rather than a clinical study establishing its performance against acceptance criteria in the manner requested.
However, based on the provided text, I can extract and infer information relevant to your request regarding acceptance criteria and performance, primarily from the "Performance Characteristics" and "Non-clinical Bench Testing" sections.
The device is intended to provide therapeutic electrical stimulation and thermal therapy (hot and cold). The "acceptance criteria" here are implied by the desired therapeutic ranges and the device's ability to deliver these. The study described is a non-clinical bench test comparison.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Non-Clinical Bench Testing) |
|---|---|
| Electrical Stimulation: | |
| Delivery of various waveforms | Wave forms captured show no differences between ThermoSTIM probe and predicate Ultrasound probe in combo mode. |
| Compliance with safety standards for electrical stimulation (dielectric strength, EMC) | Probes pass applicable test limits per EN60601-1 (dielectric strength) and EN60601-1-2 (EMC). |
| Thermal Therapy (Hot): | |
| Target temperature: 110°F | Results showed temperatures consistently between 104°F and 112°F when delivering hot mode with electrical stimulation. |
| Thermal Therapy (Cold): | |
| Selectable target temperature: 37 - 50°F | (Performance for cold therapy not explicitly detailed in summary, but indicated as a selectable target.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "two body parts per patient" for the thermal data collection. There is no explicit number of patients or total "test set" samples (e.g., number of probes tested, number of measurements taken for waveforms, or number of patients if clinical). The electrical waveform analysis compares the ThermoSTIM probe to a predicate, implying at least one of each was tested.
- Data Provenance: Non-clinical bench testing. No country of origin is specified, but the submission is to the U.S. FDA by a U.S. company. The testing is retrospective in the sense that it evaluates the manufactured device; it is not a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This document describes non-clinical bench testing. Therefore, "ground truth" is established by measurement instruments (e.g., oscilloscopes, thermometers) and engineering standards (EN60601-1, EN60601-1-2). No human experts are explicitly mentioned for establishing a ground truth for the test set beyond the engineering team conducting the tests and interpreting the instrument readings against specified criteria.
4. Adjudication Method for the Test Set
- Not applicable as it's non-clinical bench testing involving objective measurements against defined engineering standards and electrical/thermal targets. There is no human subjective assessment or adjudication process described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC comparative effectiveness study was not done. This document primarily focuses on demonstrating substantial equivalence through non-clinical bench testing, comparing the new device's technical performance characteristics to existing predicate devices and safety standards. There is no mention of human readers or AI assistance in this context.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is a manual therapy accessory that requires a human practitioner to apply it. It is not an algorithm-only device or an AI system. The "standalone" performance here refers to the device's ability to deliver electrical and thermal energy as designed, which was evaluated in the bench tests.
7. The Type of Ground Truth Used
- The ground truth for the non-clinical bench testing was primarily objective physical measurements (electrical waveforms, temperature readings) compared against engineering specifications and regulatory standards (e.g., EN60601-1, EN60601-1-2).
8. The Sample Size for the Training Set
- This device is a physical medical device, not an AI/ML algorithm. Therefore, the concept of a "training set" in the context of machine learning does not apply. The device's design and manufacturing processes are refined through engineering development and testing.
9. How the Ground Truth for the Training Set Was Established
- As above, this is not an AI/ML algorithm, so there is no "training set" or establishment of ground truth for a training set in that context. The device's "training" or development involves iterative design, prototyping, and engineering validation to meet design specifications and regulatory requirements.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).