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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 System with the Fractora3D/3D-90 Applicators is intended for use in Dermatological and General Surgical procedures for Electrocoagulation and Homeostasis.

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

The InMode System with the Fractora3D/3D-90 Applicators is a computerized, programmed, RF technology based device intended for dermatological applications which requires skin electrocoagulation and hemostasis. The device platform is basically constituted on the same system platform as FDA cleared for InMode FRF Applicator (K151273). The InMode System with the Fractora3D/3D-90 Applicators employs fractional RF multi-electrode technology for procedures requiring electrocoagulation and hemostasis. The Fractora3D/3D-90 Applicators are designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multielectrode pins. The Device provides enhanced safety while minimizing possible side effects by monitoring RF parameters. The InMode System with the Fractora3D/3D-90 Applicators consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Fractora3D/3D-90 Applicators are 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 pins tip.

Based on the provided text, the device in question is the "InMode System with Fractora3D/3D-90 Applicators," which is an electrosurgical cutting and coagulation device. The document is a 510(k) summary, which aims to demonstrate substantial equivalence to a predicate device rather than proving efficacy through clinical trials with specific acceptance criteria as one might see for novel AI/software devices. Therefore, much of the requested information regarding "acceptance criteria" for performance, "ground truth establishment," "expert adjudication," and "multi-reader multi-case studies" is not applicable or explicitly stated in the context of this traditional medical device submission.

Here's a breakdown of the information that is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

• AAMI/ANSI 60601-1:2005/(R) 2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
• IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
• IEC 60601-2-2 Edition 5.0 2009-02, Medical Electrical Equipment Part 2-2: Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories. |
  | Accuracy and Consistency of RF Output Parameters (Bench Test) | Performance bench tests were performed to measure the accuracy and consistency of the RF output parameters. Results demonstrated that the InMode System complies with design requirements and consists of similar RF output specifications as the predicate device. |
  | Safety and Efficacy for Indicated Use (Animal Study) | A preclinical study on a porcine model evaluated thermal effects and tissue healing. "The animal study results show that the InMode System with the Fractora3D/3D-90 Applicators are safe for use and effective in achieving the specified indications of dermatological and general electrocoagulation and hemostasis." |
  | Biocompatibility of Patient Contact Materials | All device materials which come in direct contact with the patient skin are biocompatible. Reference made to predicate devices: K102461, K082451, K142438, K151019 and K081365 for biocompatibility determination. |
  | Substantial Equivalence to Predicate Device (Performance Specs)| The performance specifications (including RF frequency, pulse duration, and RF energy per pin) of the InMode System were shown to be similar and yielded similar RF energy per pin values to those of the predicate EndyMed Intensif Applicator (K130501). |

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

• Test Set Sample Size:
  • Bench Test: Not explicitly stated how many tests were run, but it refers to "performance bench tests."
  • Animal Study: The study was conducted on a "porcine model." The exact number of animals is not specified, but it refers to a "single RF treatment" per animal at various follow-up times (immediately, 7, 14, and 21 days post-treatment).
  • Clinical Data: "Not Applicable" for this 510(k) submission.
• Data Provenance: The device manufacturer (InMode MD Ltd.) is located in Israel. The studies are described as pre-clinical (animal model) and bench tests. The location where these specific tests were performed is not detailed. The data is retrospective in the sense that it's reported for a 510(k) submission, but the tests themselves would have been performed prospectively as part of validation.

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

• This concept of "ground truth established by experts" is not explicitly applicable or discussed in the context of this traditional device submission for electrocoagulation and hemostasis. The "ground truth" for the animal study would be the histological findings and clinical observations of tissue effect and healing. The expert interpreting these would likely be a veterinary pathologist, but their number and qualifications are not specified in this summary.

4. Adjudication method for the test set

• Not applicable/mentioned. This is typically relevant for diagnostic AI studies where multiple readers might review cases.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, an MRMC comparative effectiveness study was not done. The document states "Clinical Performance Data: Not Applicable."

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

• This is not an AI/algorithm-driven device. It is a physical electrosurgical device. Therefore, the concept of "standalone performance" of an algorithm is not applicable. The device's performance stands alone in its ability to deliver RF energy as specified.

7. The type of ground truth used

• For the non-clinical studies:
  • Bench Tests: The ground truth is the designed specifications and physical measurements of RF output parameters.
  • Animal Study: The ground truth is histological analysis (tissue changes and healing process) and observation of the gross thermal effects in the porcine model.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a "training set."

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

• Not applicable. As this is not an AI/machine learning device, there is no "training set" or ground truth establishment method for one.

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