Search Results

The XERF is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

XERF is an electrosurgical unit which uses high frequency electrical currents for treatment. When high frequency is irradiated on the skin, the treated skin tissue is heated, resulting in coagulation. This equipment generates high frequency of 2 MHz and 6.78 MHz and is delivered non-invasively into skin through the tip of the handpiece. There are a total of 12 types of active electrode tips compatible with the handpiece; the different tips are intended for various applications and treatment zones. The system also includes a return pad corresponding to the neutral electrode which is intended to be attached to the patient's back to disperse the generated energy. For adjustment of treatment parameter, data can be used by adjusting the operator interface through LCD touch screen. Treatment is conducted using foot switch or finger switch after ready when applied treatment parameter is output to the tissue.

The provided FDA 510(k) Clearance Letter for the XERF device does not contain the kind of detailed information about acceptance criteria and a study proving the device meets them that your request outlines. This document is a clearance letter, which means the FDA has already assessed the sufficiency of the submitted information, including performance data, and found the device substantially equivalent to a predicate.

Specifically, the document states:

• "No clinical tests were included as part of this submission." This immediately tells us there was no study involving human subjects to demonstrate the device meets acceptance criteria in a clinical setting.
• The "Performance" section describes ex-vivo thermal studies. While these are performance tests, they are not clinical studies with acceptance criteria based on human outcomes or expert assessment of clinical images, as typically implied by your request.

Therefore, for aspects like "Table of acceptance criteria and reported device performance," "Sample size used for the test set," "Number of experts," "Adjudication method," "MRMC comparative effectiveness study," "Standalone performance," "Type of ground truth," "Sample size for training set," and "How ground truth for training set was established," the provided text does not contain this information. These details would typically be found in the more comprehensive 510(k) submission itself, rather than in the final clearance letter summary.

However, I can extract the available information from the "Performance" section regarding the ex-vivo studies.

Summary of Device Performance and Related Information from the Provided Text:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria (Implicit from study goal): Achieving coagulation, uniform coagulation, and thermal performance equivalent to predicate device.
• Reported Device Performance:
  • Study 1 (Ex-vivo thermal study - tissue effects): "Coagulation was observed when treatment was performed with five stacked pulses with the interval of 200ms (within the same treatment spot without moving the tip). Coagulation surface correlated to the perimeter of the RF tip treatment surface. Uniform coagulation at entire perimeter and depth was observed in tested tissues."
  • Study 2 (Ex-vivo thermal study - temperature-time curves): "The ex-vivo dermal temperature testing confirmed that the XERF device's thermal performance is equivalent to that of the Thermage FLX device in terms of time-dependent heating and cooling behavior."

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated for the ex-vivo studies.
• Data Provenance: Ex-vivo (not human/clinical) tissues: kidney, liver, and skin. No country of origin mentioned for the tissues.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as no clinical ground truth was established. The tissue analysis involved standard H&E histology performed on biopsy samples. The expertise of those analyzing the histology (e.g., pathologist) is not specified.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable as no clinical ground truth was established by experts.

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:

• No MRMC study was done. This device is an electrosurgical unit, not an AI diagnostic/imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a medical device, not an algorithm, and its performance was assessed ex-vivo.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the ex-vivo tissue study: Histology (H&E staining and analysis under light microscope) was used to assess coagulation.
• For the ex-vivo thermal curve study: Direct temperature measurements using fiber optic sensors.

8. The sample size for the training set:

• Not applicable. The device is not an AI/ML algorithm that requires a training set in the conventional sense. The studies described are performance validation tests for the device itself.

9. How the ground truth for the training set was established:

• Not applicable.

Ask a specific question about this device