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The InMode FRF Applicator is intended for use in Dermatologic and General Surgical procedures for Electrocoagulation and Hemostasis.

At higher energy levels greater than 62 mJ/pin, use of the FRF applicator is limited to Skin Types I-IV.

The InMode FRF Applicator is a treatment hand piece attached the FDA cleared InMode WMFace treatment system (K140926).

The InMode WMFace device with the FRF Applicator employs fractional RF multielectrode technology for procedures requiring electrocoagulation and hemostasis. The FRF Applicator is designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multi-electrode pins. The Device provides enhanced safety while minimizing possible side effects by monitoring RF parameters.

The InMode WMFace device with the FRF Applicator consists of an AC/DC power supply unit, RF generator, controller and user interface including a LCD screen and functional buttons. The FRF Applicator is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises a disposable, single use, 24 electrode pin array tip.

Following are the InMode WMFace device with the FRF Applicator specifications: FRF Applicator RF Max Output Power: 65 Watt FRF Applicator RF Output Frequency: 1[MHz] ± 2% Dimension: 46cm W x 46cm D x 100cm H (14.2'' W x 14.2'' D x 40'' H) Weight: 30 Kg (66 lbs) Main Line Frequency (nominal): 50-60 Hz Input Voltage (nominal): 100-240 VAC

The provided text describes a 510(k) premarket notification for the InMode FRF Applicator, a medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or clinical superiority. Therefore, the information provided does not detail a study proving the device meets specific performance acceptance criteria in the way a clinical trial for a new drug or a novel AI diagnostic device would.

Instead, the "study" proving the device meets acceptance criteria for 510(k) clearance is primarily a demonstration of its substantial equivalence to a predicate device through:

• Bench testing: Verifying its output parameters are similar to the predicate and meet design requirements.
• Animal study: Assessing its safety and ability to achieve specified indications in an animal model.
• Compliance with recognized standards: Adhering to electrical safety and electromagnetic compatibility standards.

Given this context, I will address the questions as they relate to the information available in the document, acknowledging where the requested information (e.g., about AI performance metrics, MRMC studies, or multi-expert ground truth establishment for a test set) is not applicable to a 510(k) for an electrosurgical device.

Here's a breakdown of the acceptance criteria and the "study" evidence:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set (for performance validation):
  • Bench Test: No specific "sample size" of devices or measurements is given, but it implies multiple tests were conducted to measure accuracy and consistency of RF output. "Performance bench tests were conducted to measure the accuracy and consistency of the RF output parameters..." (Page 5).
  • Animal Study: The study was conducted on a "swine model." The specific number of animals is not provided.
• Data Provenance: Not specified, but standard for pre-market notification submissions implies industry-sponsored testing typically conducted in the country of origin of the manufacturer (Israel, in this case, for InMode MD Ltd.). The animal study was "pre-clinical." Both bench testing and animal studies are typically prospective tests designed for regulatory submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This question is N/A as it pertains to AI/diagnostic device ground truth establishment, which is not relevant for this electrosurgical device's 510(k) submission. The "ground truth" for this device's performance is objective measurements (RF output), observation of tissue effects in an animal model, and compliance with engineering and safety standards.

4. Adjudication Method for the Test Set

• N/A. This concept applies to human reader studies for diagnostic performance, not the bench and animal testing described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC study was not done. This type of study is relevant for AI-assisted diagnostic tools measuring human reader performance. The document explicitly states "Clinical Performance Data: Not Applicable" (Page 5).

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

• N/A. This device is not an algorithm; it is an electrosurgical tool. Its "standalone" performance is assessed through its physical outputs (RF energy) and effects on tissue, as demonstrated in bench and animal studies.

7. The Type of Ground Truth Used

• For Bench Testing: The "ground truth" was the predefined design requirements and the RF output parameters of the predicate device. The device's measured RF output was compared to these established values.
• For Animal Performance Data: The "ground truth" for safety and effectiveness was established by histology analysis of tissue post-treatment in the swine model, performed immediately, 7, 14, and 21 days post-treatment. This is a form of pathology/histological outcomes data. The observation of electrocoagulation and hemostasis in vivo also serves as direct evidence.

8. The Sample Size for the Training Set

• N/A. This device is not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

• N/A. This device is not an AI algorithm.

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