Search Results
Found 1 results
510(k) Data Aggregation
(102 days)
TR-100
The TR-100 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 TR-100 massage device is intended to provide a temporary reduction in the appearance of cellulite.
The TR-100 is a state-of-the-art radiofrequency device with integrated massager, that enables the application of therapy by a non-invasive, high-frequency field. The control unit of the system is fitted with a color touch screen, to facilitate use of the device. The on-screen information guides the operator through the entire therapy. For easier control, the handpiece is equipped with buttons, enabling operation of the device during therapy. The energy flow is indicated by the illuminated treatment tip. The TR-100 consists of the following main components: microprocessor-driven control unit, high-frequency electromagnetic energy generator, massage generator, user interface with 8.4" color touch screen, handpiece.
The provided text describes the TR-100 device and its substantial equivalence to a predicate device (Exilis XP) for market clearance. The key study mentioned is a clinical performance testing to prove the device's ability to reach and maintain an effective treatment temperature.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document defines the "Effective Treatment Temperature" as 40 - 45 °C (104 - 113 °F) for both the TR-100 and the predicate device, Exilis XP. The clinical testing aims to prove that the TR-100 reaches this temperature and maintains it for the required time.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Effective Treatment Temperature is reached and maintained for the required time | The clinical performance testing was conducted "to prove that the device reaches the effective treatment temperature and maintain it for required time." The effective treatment temperature is specified as 40 - 45 °C (104 - 113 °F). While the document states the aim of the test was to prove this, it does not explicitly provide the specific quantitative results (e.g., average temperature achieved, duration maintained) from this testing within the provided text. It merely states that the study was performed to demonstrate this capability. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the sample size used for the clinical performance testing.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications to establish ground truth for the clinical performance test. Given the nature of a thermal device where the "ground truth" is likely direct temperature measurement, it may not have relied on expert interpretation in the same way an image-based diagnostic device would.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The clinical testing described is focused on the device's ability to achieve and maintain temperature, not on the improvement of human readers with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable in the context of this device. The TR-100 is a physical device that delivers radiofrequency energy and massage, not an algorithm for image analysis or diagnosis. The "performance" being evaluated is its physical delivery of heat, not an algorithmic output.
7. The Type of Ground Truth Used
The ground truth implicitly used for the clinical performance testing would be direct temperature measurements of the tissue being treated. The acceptance criteria themselves define the target temperature range (40-45 °C).
8. The Sample Size for the Training Set
The document does not mention a training set. This is a physical therapy device with heating capabilities, not an AI/ML device that requires a training set in the typical sense. The "training" would be the engineering and developmental phases to tune the device's output to achieve the desired therapeutic temperature.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set (in the AI/ML sense) is mentioned or relevant for this type of device.
Ask a specific question about this device
Page 1 of 1