Search Results

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.

Ask a specific question about this device

The InMode System with the Morpheus8 Applicators is intended for use in dermatological procedures for electrocoagulation and hemostasis.

At higher energy levels greater than 62 mJ/pin, use of the Morpheus8 (Fractora) Applicator is limited to Skin Types I-IV.

The InMode System with the Morpheus8 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 InMode System with the Morpheus8 Applicators (K192695). The InMode System with the Morpheus8 Applicators employs fractional RF multi-electrode technology for procedures requiring electrocoagulation and hemostasis. The Morpheus8 Applicators are 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 System with the Morpheus8 Applicators consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Morpheus8 Applicators are connected to the console via a cable and a foot switch activates the energy delivery to the applicator. The Morpheus8 Applicator comprises handle and detachable, sterilized, disposable, single use 12, 24, 40 pin and T tip head accessory.

This document describes a 510(k) premarket notification for the InMode System with the Morpheus8 Applicators. The primary purpose of this submission is to demonstrate substantial equivalence to a previously cleared device (K192695). As such, the "acceptance criteria" and "study" described are primarily focused on demonstrating this equivalence rather than a de-novo clinical trial for a new performance claim.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly defined by the substantial equivalence comparison to the predicate device (K192695). The reported device performance is largely a direct comparison of technological characteristics and safety standards adherence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The primary test set mentioned is an ex-vivo tissue study on a porcine animal model. The sample size is not explicitly stated as a number of animals or tissue samples, but it indicates "a single treatment of two different harvested porcine tissues: muscle and fat."

• Sample size: Not explicitly quantified. Refers to "a single treatment of two different harvested porcine tissues."
• Provenance: Ex-vivo tissue study on a porcine animal model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The ex-vivo study describes TTC staining to visualize coagulation necrosis, which is typically evaluated by pathologists or scientists with expertise in tissue histology, but no specific number or qualifications are given for ground truth establishment.

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

This information is not provided. The ex-vivo study focused on an objective measurement of coagulation necrosis visualized by TTC staining, rather than a subjective interpretation that would typically require an adjudication method.

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 comparative effectiveness study was done. This device is an electrocoagulation and hemostasis device, not an AI diagnostic or assistance tool. Therefore, the concept of "human readers improve with AI assistance" is not applicable.

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

Not applicable. This device is a medical instrument (hardware-based) for dermatological procedures, not an algorithm, and it requires human operation.

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

For the ex-vivo tissue study, the type of "ground truth" used was visualization of tissue coagulation necrosis pattern immediately stained by TTC staining. This is a direct pathological/histological assessment marker for the intended effect of electrocoagulation.

8. The sample size for the training set

Not applicable. This device is hardware-based and does not involve AI or machine learning models that require a "training set."

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

Not applicable. As stated above, there is no AI/ML training set.

Ask a specific question about this device