(200 days)
The T~PLUS is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation. The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.
The Wintecare T~PLUS is a device for diathermy / Tecar therapy. It consists of a control unit which generates a radiofrequency current which is delivered to the patient, through two different types of electrodes: stainless steel conductive resistive electrodes, and thin-layer insulated capacitive electrodes are inserted into a smart handle/handpiece, one handpiece for each kind of electrode, and the handpiece is connected to the control unit by means of a 2-metre cable.
In resistive mode the system delivers a high-frequency current of 447 kHz directly to the patient's skin surface. In capacitive mode, the electrode coating creates a layer between the electrode and the human tissue, forming a capacitor that allows a high-frequency current to pass. The high frequency current is automatically tuned by the equipment according to the patient's impedance. Current returns through the indifferent return electrode. The RF energy generates a heating profile that produces a moderate temperature rise in the subcutaneous tissue.
The use of Wintecare Conductive A+ Cream is recommended on the patients' skin prior to each treatment session with the TPLUS. The cream is offered with the TPLUS and is part of this 510(k) submission.
The provided text describes a 510(k) premarket notification for a medical device called T~PLUS, which is a diathermy/Tecar therapy device. The document focuses on demonstrating substantial equivalence to a predicate device and includes information about non-clinical and clinical testing.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria in the sense of predefined thresholds for performance metrics. Instead, it details that the device underwent testing to demonstrate certain aspects. For the clinical testing, the "performance" can be inferred from the stated outcome.
| Performance Aspect | Acceptance Criteria (inferred/demonstrated) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-2-2 | Demonstrated compliance through testing. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | Demonstrated compliance through testing. |
| Biocompatibility (electrodes/cream) | Compliance with ISO 10993-5 and ISO 10993-10 | Demonstrated compliance through testing. Additionally, correspondence of conductive cream ingredients between INCI UE and INCI US classification, and IUPAC nomenclature, was demonstrated. |
| Therapeutic Temperature Maintenance | Ability to maintain therapeutic temperature between 40° and 45°C for at least 10 minutes, never exceeding 45°C. | Clinical testing demonstrated the ability of the T~PLUS to maintain therapeutic temperature for at least 10 minutes on patients, between 40° and 45°C, never exceeding 45°C. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that clinical testing was performed but does not specify the sample size (number of patients) involved in this testing.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that it's "clinical testing" for a device seeking market clearance, it is generally assumed to be prospective clinical data, but this is not explicitly confirmed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide details on the number of experts or their qualifications used to establish ground truth for the clinical testing. The objective of the clinical testing was to demonstrate the device's ability to maintain a specific temperature range, which likely relies on direct measurement rather than expert interpretation of an outcome.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method. Given the nature of the clinical test (temperature maintenance), it's unlikely a formal adjudication process (like 2+1 review) for primary endpoints would be necessary, as the measurement of temperature is typically objective.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed. The study focuses on the device's ability to perform its intended function (temperature maintenance) rather than comparing performance with and without AI assistance (as this is not an AI device based on the description).
6. Standalone Performance Study
The clinical testing described is effectively a standalone performance study for the device. It demonstrates the T~PLUS's ability to maintain a therapeutic temperature without human intervention in the temperature delivery mechanism itself, although a human operator would apply the device. The reported performance details the device's outputs (temperature range and duration) when used on patients.
7. Type of Ground Truth Used
For the clinical testing of therapeutic temperature maintenance, the "ground truth" was established by direct measurement of the tissue temperature on patients, ensuring it remained within the specified range (40° to 45°C for at least 10 minutes and never exceeding 45°C). This is an objective, quantitative ground truth.
8. Sample Size for the Training Set
The document does not mention a training set as this device does not appear to involve machine learning or artificial intelligence that would typically require a training data set. The device operates based on radiofrequency physics and controls, not learned algorithms.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set or AI/ML components, this question is not applicable based on the provided text.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.