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The InMode RF Multi-System with the Non-invasive Applicators employs RF energy for various applications:

•Forma (Plus). Plus (Plus Plus) and Plus90 for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.

•WMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids.

•BodyFX™ (WMBody)/MimiFX™ for Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite.

The InMode RF Multi-System with the Fractional Applicators employs RF energy for various applications:

•Fractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacing of the skin.

•Fractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV

•Morpheus8™ for dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV

The InMode RF Multi-System supports multiple radiofrequency (RF) applications and accessories. The InMode RF Multi-System is compatible with the Fractional RF Applicators and the Non-Invasive RF Applicators, and employs RF energy for various applications.

The InMode RF Multi-System consists of platform console with an AC/DC power supply unit, two applicator connectors, RF generator, RF measuring circuit, controller, footswitch and user interface including a touch screen. The RF Applicator is connected to the console via a cable and a footswitch activates the energy delivery to the applicator. The applicators are comprised of a handle and electrodes, and some of them are used with a single-use tip.

This 510(k)-file submission includes all the FDA-Cleared applicators under one submission with the RF-supporting console, as cleared in K182325, compatible with all applicators.

The below list comprises the set of applicators to be registered under the subject device:

• . Non-Invasive RF Applicators:
  • Forma (Plus) O
  • Plus (Plus Plus) O
  • Plus90 O
  • WMface O
  • BodyFXTM (WMBody) O
  • MiniFX™ O
• Fractora O
  • 24 pins tip (FRF) -
  • -60 pins tip
• Morpheus8™M O
  • 12 pins tip (Prime Tip) ।
  • 24 pins tip (Fractora 3D) -
  • 40 pins tip (Body Tip) -
  • -T tip

This document describes a 510(k) premarket notification for the InMode RF Multi-System. It aims to demonstrate substantial equivalence to previously cleared predicate devices. The information provided heavily focuses on bench performance data (electrical safety, EMC, software V&V) and comparison to predicate devices, rather than clinical performance data with specific acceptance criteria directly tied to efficacy on patients.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set information is not detailed in this document in the typical format one would expect for a clinical performance study demonstrating direct efficacy on patients for specific indications.

The document states "Clinical Performance Data: Non-Applicable" and "Animal Performance Data / Histology Data: Non-Applicable". This indicates that the substantial equivalence determination for this device largely relies on similarities in design, materials, and compliance with general electrical and safety standards, rather than new clinical trials demonstrating performance against specific clinical efficacy metrics.

However, based on the provided text, I can infer the acceptance criteria and how the device proves it meets those criteria in the context of a 510(k) submission, which focuses on substantial equivalence to existing devices.

Here's an interpretation based on the provided document:

Acceptance Criteria and Device Performance (in the context of Substantial Equivalence)

The primary acceptance criterion for a 510(k) submission, especially when clinical data is "Non-Applicable," is demonstrating substantial equivalence to existing legally marketed predicate devices. This means that the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not applicable in the context of a clinical test set for efficacy. The "testing" here refers to bench testing for electrical safety, EMC, software V&V, and comparison of technical specifications. There are no explicit "test set" patient sample sizes mentioned for clinical performance, as the document states "Clinical Performance Data: Non-Applicable."
• Data Provenance: The data provenance is primarily from bench testing conducted by the manufacturer (InMode Ltd.) and external labs for standard compliance. The country of origin for the applicant is Israel. This is a premarket notification, indicating retrospective evaluation against regulatory standards and existing predicate devices, rather than prospective clinical data collection for this submission.

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

• Not applicable. Since the study is primarily focused on demonstrating substantial equivalence through bench testing, rather than establishing clinical ground truth for diagnostic or therapeutic accuracy, there is no mention of external experts or their qualifications for establishing ground truth in this context. The "ground truth" here is compliance with recognized safety and performance standards (e.g., IEC standards), which is assessed through defined test procedures.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations of clinical data or images. This is not a human-reader study or a clinical trial requiring such adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers Improvement:

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states "Clinical Performance Data: Non-Applicable." This type of study is specifically designed to assess human reader performance, usually in diagnostics, often with AI assistance.

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

• Not applicable. This device is a physical RF energy system used by a human operator, not an AI algorithm. Its "performance" is its ability to deliver RF energy safely and effectively as designed, and to perform its indicated functions.

7. The Type of Ground Truth Used:

• The "ground truth" for this 510(k) submission is based on:
  • Regulatory Standards: Compliance with recognized international standards for medical electrical equipment (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-2).
  • Bench Test Results: Data from electrical safety, EMC, and software verification and validation testing, which confirmed the device's technical specifications and adherence to design requirements.
  • Comparison to Predicate Devices: The established safety and effectiveness of the legally marketed predicate devices serve as the "ground truth" for substantial equivalence. The new device is compared against the known characteristics and performance of these predicates.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that requires a "training set" of data in the sense of machine learning. The device's functionality is based on established RF technology and engineering principles.

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

• Not applicable, as there is no "training set" in the machine learning sense. The device's design and operational parameters are based on scientific and engineering knowledge, informed by the specifications of previously cleared predicate devices.

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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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