(205 days)
A hand held cutaneous electrode to be used with Dynatronics Solaris devices to apply electrical stimulation and/or apply heat and cooling to the skin.
The Dynatron Peltier ThermoStim probe is used to provide therapeutic electrical stimulation and thermal therapy treatments. The probe consists of a handle with a treatment head and connections to a Dynatron Solaris series controlling console for power and communications with a port for connection to electrical stimulation outputs. The probe acts as an electrode for therapeutic electrical current provided by a Dynatron Solaris device in the delivery of electrical stimulation therapy. The treatment head transfers thermal energy (hot or cold) supplied from a thermo-electric chip. The probe is a passive, manual therapy accessory. Treatment cycles are controlled through previously cleared Dynatron Solaris series electrical stimulation devices. The probe has a rectangular wedge treatment face of approximately 1¼³ x 2¼" with rounded edges. The maximum surface area that could come in contact with a patient is approximately 38 cm-.
The provided text serves as a 510(k) summary for the Dynatron Peltier ThermoStim device, which is a combination electrical stimulation and thermal therapy probe. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data in the manner typically found in a clinical trial.
Therefore, the requested information, particularly regarding detailed acceptance criteria, specific study designs, sample sizes for test and training sets, expert qualifications, and comparative effectiveness data with human readers, is not present in the provided document. The document primarily describes the device's technical specifications and compares them to a predicate device to establish substantial equivalence for regulatory approval.
However, I can extract the general performance characteristics and the basis for the declaration of substantial equivalence, which can be interpreted as implicitly meeting regulatory acceptance.
Here's what can be inferred from the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative, pass/fail manner. Instead, "acceptance" is implicitly based on demonstrating that the Dynatron Peltier ThermoStim probe performs "equivalently" to the predicate device, Dynatron ThermoStim probe (K120835). The performance characteristics are compared in relation to the predicate's known performance.
| Characteristic | Implied Acceptance Criteria (Based on Predicate Equivalence) | Reported Device Performance (Dynatron Peltier ThermoStim Probe) |
|---|---|---|
| Indications for Use | Must match the predicate device's Indications for Use. | "A hand held cutaneous electrode to be used with Dynatronics Solaris devices to apply electrical stimulation and/or apply heat and cooling to the skin." (Matches predicate) |
| Target Populations | Patients with acute or sub-acute pain (Matches predicate). | Patients with acute or sub-acute pain |
| Thermal Range (Hot) | Within a therapeutic range, comparable to predicate. Predicate: 104-112°F | 90-112°F (Falls within and slightly extends the lower end of the predicate's range, still considered therapeutic) |
| Thermal Range (Cold) | Within a therapeutic range, comparable to predicate. Predicate: 36-50°F | 39-60°F (Falls within and slightly extends the upper end of the predicate's range, still considered therapeutic) |
| Range of Skin Temperatures (Hot) | Within therapeutic range, comparable to predicate. Predicate: 105.5-108.3°F | 90-110.5°F (Falls within and slightly extends range of predicate, still considered therapeutic) |
| Range of Skin Temperatures (Cold) | Within therapeutic range, comparable to predicate. Predicate: 53.5-56.5°F | 44-60.5°F (Falls within and slightly extends range of predicate, still considered therapeutic) |
| Electrical Stimulation Waveforms | Must show "no differences" from the predicate device output. | "Analysis of the wave forms for delivery of electrical stimulation treatments show no differences with the output from the predicate device compared to the subject device." |
| Current Density (Gravity Pressure) | Must provide a safe current density; generally comparable to predicate. Predicate: Flat - 0.11 W/cm², Round - 0.20 W/cm² | 0.08 W/cm² (Lower than predicate, indicating potentially safer or equivalent performance regarding current density) |
| Power Density (Gravity Pressure) | Must provide a safe power density; generally comparable to predicate. Predicate: Flat - 4.4mA/cm², Round - 8.3mA/cm² | 3.3mA/cm² (Lower than predicate, indicating potentially safer or equivalent performance regarding power density) |
| Safety Standards Compliance | Compliance with EN60601-1 (dielectric strength) and EN60601-1-2 (electromagnetic compatibility) required prior to marketing. | "will be tested for dielectric strength per EN60601-1 and for electromagnetic compatibility per EN60601-1-2. Per the March 2000 F.DA Office of Device Evaluation guidance document 'Use of Standards in Substantial Equivalence Determinations' these tests will be completed prior to marketing the device." (Commitment to meet these standards) |
| Mechanical Design Considerations | Treatment area large enough for safe current density; patient contact materials identical to predicate. | "Both probes have treatment areas large enough for a safe current density to mitigate risks of patient injury. Patient contact surfaces for both the predicate and subject probe are identical aluminum composition." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Non-clinical Bench Testing" and "Thermal data was collected." However, it does not specify the sample size of devices tested or the number of measurements taken for either the electrical stimulation waveform analysis or the thermal data collection. The data provenance is implied to be from Dynatronics' internal testing ("Non-clinical Bench Testing"), likely in the USA where the company is located. The nature of the testing (bench testing) is prospective for these measurements.
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)
This information is not provided. The device is purely a physical therapy accessory and likely does not involve diagnostic interpretation by experts for its core function. The "ground truth" for the performance tests (waveform analysis, temperature measurements) would be established by calibrated measurement equipment, not expert opinion.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret medical images or data and their disagreements need resolution. Since this document describes bench testing of a physical device, such adjudication methods are not relevant.
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
This information is not provided and not applicable. The Dynatron Peltier ThermoStim is a physical therapy device, not an AI-powered diagnostic tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are outside the scope of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical therapy probe that inherently requires human-in-the-loop operation by a practitioner. There is no "algorithm only" performance to evaluate in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For electrical stimulation waveform analysis: Comparison against expected, known waveforms from the predicate device and the controlling Solaris console. The "ground truth" is the established electrical signal parameters.
For thermal data: Calibrated temperature measurements. The "ground truth" is the actual measured temperature by sensors.
For safety standards: Compliance with international safety standards (EN60601-1, EN60601-1-2). The "ground truth" is adherence to these normative standards.
8. The sample size for the training set
This information is not provided and not applicable. The Dynatron Peltier ThermoStim probe does not utilize machine learning or AI models that require a "training set" of data.
9. How the ground truth for the training set was established
This information is not provided and not applicable as there is no training set for this type of medical device.
§ 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).