(315 days)
The Doctor Tecar Plus and Doctor Tecar Smart devices are 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.
Doctor Tecar Plus and Doctor Tecar Smart are devices for diathermy. This therapy develops an increase in temperature in the area of the body which is treated through the passage of a particular electrical current. Through twin delivering modes, capacitive and resistive, the operator can set a specific treatment. The purpose of the treatment is to raise the temperature inside the tissue at a value maximum to 45 °C. The device is composed by a touch screen and a Multi-Function knob (only Plus model) for managing all the device's functions, a plate, an handpiece for the delivery of radiofrequency energy, software and an on/off button to activate and deactivate the energy emission.
The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance criteria in the typical sense of an AI/ML medical device submission. Instead, it describes a 510(k) submission for a non-AI medical device (radiofrequency device) and its general safety and performance testing.
The document primarily focuses on establishing substantial equivalence for the "Doctor Tecar Plus" and "Doctor Tecar Smart" devices to a predicate device (NuEra Tight RF Family, K200359). The "study" mentioned is a "Bench Test" to demonstrate the device's capability to maintain skin temperature.
Given the information, I will interpret the request within the context of the provided document, even though it doesn't involve AI/ML or comparative effectiveness studies with human readers.
Here's an attempt to extract and present the information based on the provided text:
Acceptance Criteria and Device Performance (Based on provided "Bench Test")
1. Table of Acceptance Criteria & Reported Device Performance
| Acceptance Criteria (from "Bench Test" description) | Reported Device Performance (from "Bench Test" description) |
|---|---|
| Capability to maintain a skin surface temperature of 40℃ - 45℃ for 10-20 minutes after the temperature of the skin has reached 40℃. | "The test report demonstrates that Doctor Tecar Plus is capable of maintaining a skin surface temperature of 40℃ - 45℃ for 10-20 minutes after the temperature of the skin has reached 40℃." |
| "No discrepancies were found." | |
| Safety demonstration when using the device as intended. | "The test recorded actual skin temperature data to demonstrate safety when using the device as intended." |
| "No discrepancies were found." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 3 different people.
- Data Provenance: The document does not specify the country of origin of the data. The test was conducted for each person in three different places on the body. It included participants with light and dark skin, and different somatotypes. The test was performed in automatic mode (using electrodes) and in manual mode (with nine different applicators) for each person and each body place. The nature of the study appears to be a prospective bench test, as it describes actively performing measurements.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable (N/A): This type of information is not relevant to the described "Bench Test." The test focuses on physical measurements (temperature) directly from the device and human skin, not on subjective expert interpretation of output (like image diagnosis with AI). There's no mention of experts establishing a "ground truth" in the diagnostic sense.
4. Adjudication Method for the Test Set
- Not Applicable (N/A): No adjudication method is mentioned or required for this type of quantitative bench test. The temperature measurements are objective.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No: A MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for a radiofrequency medical device, not an AI/ML diagnostic aid. Therefore, there is no discussion of human readers improving with or without AI assistance.
6. Standalone (Algorithm Only) Performance
- Not Applicable (N/A): This is a physical medical device, not an algorithm. The "Bench Test" describes the device's direct physical performance; thus, the concept of "standalone algorithm performance" is not relevant.
7. Type of Ground Truth Used
- Physical Measurements/Observed Performance: The "ground truth" in this context is the actual temperature measured on the skin and the device's ability to maintain that temperature within a specified range, as observed directly during the bench test. It's not a diagnostic "ground truth" derived from expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
- Not Applicable (N/A): This document describes testing of a physical medical device, not the development or training of an AI algorithm. Therefore, there is no concept of a "training set" in this submission.
9. How Ground Truth for Training Set Was Established
- Not Applicable (N/A): As there is no training set, this question is not applicable to the provided document.
§ 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.