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510(k) Data Aggregation
(362 days)
El..En. Electroic Engineering SpA
The DEKA TIAC1 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 1 massage device is intended to provide a temporary reduction in the appearance of cellulite.
The DEKA TIAC 1 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 1 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.
Here is a summary of the acceptance criteria and the study that proves the DEKA TIAC 1 device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The sample temperature in the range 40-43°C for at least 10 minutes in the active zone of the handpieces (hot spots). | • Number of planned tests: 2 |
| • Number of tests executed: 2 | |
| • Number of positive outcomes: 2 (100%) | |
| Device successfully heated target tissue to 40°C - 43°C for at least 10 minutes in the active zone of handpieces. | |
| Skin surface increase in temperature not greater than 3°C. | • Number of planned tests: 2 |
| • Number of tests executed: 2 | |
| • Number of positive outcomes: 2 (100%) | |
| Device did not show any significant increase in temperature out of the depth of action of the handpieces, implying skin surface temperature stayed within limits (no specific value for skin surface provided, but "not showing any significant increase" suggests meeting the 3°C criterion). | |
| Temperature outside the hot spot never exceeding 40°C. | • Number of planned tests: 2 |
| • Number of tests executed: 2 | |
| • Number of positive outcomes: 2 (100%) | |
| Device did not show any significant increase in temperature out of the depth of action of the handpieces, implying temperatures outside the hot spot remained below 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 outcomes: 2 (100%) | |
| The text states that the device successfully met this criterion. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The tests were performed on "20x20x5 cm ex-vivo pig muscle sample" for both the Deep handpiece and the Shallow handpiece. The "Number of planned tests" was 2, and "Number of tests executed" was 2. This suggests a total of two distinct tests (one for each handpiece type or two independent runs with the same type of sample) on the ex-vivo pig muscle.
- Data Provenance: The data is from non-clinical performance tests conducted on ex-vivo pig muscle samples. This indicates the data is from laboratory testing and not from human subjects. The country of origin of the data is not specified, but the applicant (El.En. S.p.A.) is based in Italy. The tests are prospective as they were specifically performed to evaluate the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The "ground truth" for these non-clinical tests was likely established by the measurement instruments and methodology used to record tissue temperature, rather than expert human assessment.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation involved objective physical measurements (temperature readings) rather than 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 provided document describes non-clinical performance testing of a physical medical device (RF and massage device) and does not involve AI or human readers for diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is an electrosurgical device, not an algorithm, and its performance was evaluated in a standalone physical test setting.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests was established by direct measurement of tissue temperature using appropriate instrumentation within the ex-vivo pig muscle samples.
8. The Sample Size for the Training Set
This information is not applicable. The DEKA TIAC 1 is a physical electrosurgical and massage device, not an AI/machine learning algorithm, and therefore does not have a "training set" in that context. The document describes non-clinical performance and a comparison to a predicate device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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