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The Thermi Injectable RF® Electrodes used with the Thermi RF Generator System are indicated:

• *for use in dermatological and general surgical procedures for electrocoagulation and hemostasis
• • to create lesions in nervous tissue when used in combination with Thermi RF Generator.

The Thermi Injectable RF® Electrodes are designed to provide finely-controlled radiofrequency (RF) energy in combination with the Thermi RF Generator. They are not intended to function with other RF generators or other non-Thermi branded products.
The Injectable RF® Electrodes are a combination of a RF electrode and a RF cannula to allow percutaneous application of RF energy. The RF electrode delivers the RF signal from the generator to the active tip of the cannula. The device utilizes an insulated shaft along the outside of the cannula to avoid transition of the RF signal outside of the tip area. From the active tip, the RF signal causes the tissue molecules to vibrate resulting in the formation of heat. The heated area is a function of the active tip size (length, gauge). The device is offered in different sizes to accommodate multiple anatomies and desired heating areas. The device connects to a Thermi RF Generator and requires the use of a grounding pad to complete the circuit.
The Injectable RF® Electrodes are available in different lengths, different tip exposures and different thicknesses. The lengths that are available for the Thermi Injectable RF® Electrodes range from 5 cm to 20 cm. The cannula portion is coated with an insulation layer such that only the tip will transmit the RF signal and ablate the tissue. The tip exposures available for the Thermi Injectable RF® Electrodes range from 5 mm to 10 mm. The diameters available for the Thermi Injectable RF® Electrodes range from 16 GA to 20 GA. The cannula electrodes have a blunt tip. All the RF electrodes have a 264 cm long silicone cable. The disposable cannula electrode is provided sterile in a sealed tray for single use only.

The provided text describes the Thermi Injectable RF® Electrodes, a medical device for electrosurgical cutting and coagulation, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving device meets acceptance criteria.

Specifically, the document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed study report with specific acceptance criteria, sample sizes, expert qualifications, or comparative effectiveness study results.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information: The document states that the device "met all performance and functional testing and performed as intended," but it does not provide specific quantitative acceptance criteria for each test (e.g., "tensile strength must be >X Newtons"). It also doesn't provide specific quantitative results for each test.

Regarding the Study: The document describes "performance data" which includes electrical safety testing and bench testing. These are more akin to verification and validation activities rather than a "study" in the sense of a clinical trial or comparative effectiveness study.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified. The document generically mentions "testing" or "a series of bench testing" but does not give the number of devices or components tested for any specific test.
• Data Provenance: Not specified. The tests are bench tests, so they are likely conducted in a controlled lab environment. No information on country of origin or whether it's retrospective/prospective in the clinical sense is provided, as these are not clinical studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable. The "ground truth" for these engineering and electrical safety tests would be the established international standards (e.g., IEC 60601 series) and internal design specifications. There's no mention of human experts establishing ground truth for individual test outcomes in the way one would for image interpretation or diagnosis.

4. Adjudication Method for the Test Set:

• Not applicable. This concept typically applies to clinical studies where multiple reviewers assess a case and their interpretations need to be reconciled. For bench testing, results are typically objective measurements or pass/fail against predetermined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No. An MRMC study was not done. The document does not describe any clinical study involving human readers or comparative effectiveness for this device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable. This device is hardware (electrodes) used with a generator. It's not an algorithm or AI system. Its performance is inherent to its physical and functional characteristics when operated by a human user.

7. The Type of Ground Truth Used:

• For electrical safety: International standards (IEC 60601 series).
• For bench testing (dimensional, functional, tensile strength, etc.): Internal design specifications and validated test protocols.

8. The Sample Size for the Training Set:

• Not applicable. This is a hardware device; there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As above, no training set.

In summary: The provided document is a 510(k) summary, which is a regulatory document focused on demonstrating substantial equivalence to a predicate device through engineering and electrical safety testing. It is not a detailed clinical study report and therefore lacks the specific details requested regarding clinical acceptance criteria, expert involvement, and comparative effectiveness studies.

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