(186 days)
The DEKA TIAC II RF device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The DEKA TIAC II massage device is intended to provide a temporary reduction in the appearance of cellulite.
The DEKA TIAC II is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcutaneous tissue, for temporary relief of pain and muscle spasm and increase local circulation. The device has integrated massaging handpieces intended to provide a temporary reduction in the appearance of cellulite.
The DEKA TIAC II consists of the following main components:
- microprocessor-driven control unit
- high-frequency electromagnetic energy generator
- user interface with 10.4" color touch screen
- 2 RF handpieces for application of radiofrequency
- 2 integrated massaging balls handpieces
Contact quality monitoring system is present for monitoring of the contact quality under the RF handpiece electrodes.
The electrical specifications are 100-240Vac, 50/60Hz, 1500VA.
This document describes the DEKA TIAC II device, a medical radio frequency and massage device intended for temporary relief of pain, muscle spasms, increased local circulation, and temporary reduction in the appearance of cellulite. The study proving the device meets acceptance criteria is detailed in the Non-Clinical Performance Data section on pages 6 and 7 of the provided document.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Non-clinical - Tissue heating performance | - The sample temperature in the range 40-43°C for at least for 10 minutes in the active zone of the handpieces (hot spots); |
- Skin surface increase in temperature not greater than 3°C;
- Temperature outside the hot spot never exceeding 40°C;
- Dissipation phase not increasing the temperature at the end of the treatment. | - Number of planned tests: 2
- Number of tests executed: 2
- Number of positive outcome: 2 (100%)
- Device able to heat the target tissue maintaining the tissue temperature in the range 40°C - 43°C for at least 10 minutes in the active zone, with no significant temperature increase out of depth. |
| Non-clinical – Human skin temperature maintaining performance | - Skin temperature is maintained in the range 40-45°C for at least 10 minutes; - Skin temperature doesn't exceed 45°C over the entire test period. | - Number of planned tests: 36
- Number of tests executed: 36
- Number of positive outcome: 36 (100%)
- Device able to keep the skin surface temperature in the range 40º-45ºC for at least 10 minutes. |
2. Sample Size Used for the Test Set and the Data Provenance:
-
Non-clinical Tissue heating performance:
- Sample Size: Ex-vivo pig muscle sample (20x20x5 cm). Two tests were executed (2 for Deep handpiece and 2 for Shallow handpiece).
- Data Provenance: Not explicitly stated, but "ex-vivo pig muscle sample" implies a laboratory setting, likely in Italy where the submitter is located. This is retrospective as the tests were performed before submission.
-
Non-clinical Human skin temperature maintaining performance:
- Sample Size: 3 people of different skin types (Fitzpatrick I, III, IV). 36 tests were executed (e.g., each handpiece on each person, across three body areas at different power settings).
- Data Provenance: Not explicitly stated, but likely conducted in Italy. This is retrospective as the tests were performed before submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document. The tests performed are objective measurements of temperature, not subjective evaluations requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable as the tests performed are objective measurements with pre-defined acceptance criteria, not subjective assessments requiring adjudication.
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 applicable. The DEKA TIAC II is a medical device for heating tissue and massage, not an AI-powered diagnostic or interpretive tool that would involve human readers. The document states "Clinical Performance Data: None."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The DEKA TIAC II is a physical medical device. The "tests performed" are evaluations of the device's physical output and effect on tissue/skin, not autonomous algorithmic performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- Non-clinical Tissue heating performance: The ground truth was direct temperature measurement within the tissue and on the skin surface.
- Non-clinical Human skin temperature maintaining performance: The ground truth was direct skin surface temperature measurement.
8. The Sample Size for the Training Set:
This information is not applicable/not provided. This device is not an AI/machine learning device that requires a training set in the conventional sense. The "training" for the device's design and engineering would be based on general biophysics, engineering principles, and potentially prior device development, rather than a specific labeled dataset.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable/not provided for the reasons stated above.
§ 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.