Search Results

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

• i-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)/MiniFX™ 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 Pro 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 62m.J/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 Pro System supports multiple radiofrequency (RF) applications and accessories. The InMode RF Pro System is compatible with the Fractional RF Applicators and the Non-Invasive RF Applicators, and employs RF energy for various applications.

The InMode RF Pro 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.

The provided text describes the FDA 510(k) clearance for the InMode RF Pro System, demonstrating substantial equivalence to a predicate device (InMode RF Multi System, K201150). The study focuses on safety and performance rather than diagnostic accuracy or human reader improvement with AI. Therefore, many standard acceptance criteria for AI-powered diagnostic devices (e.g., sensitivity, specificity, F1 score, MRMC studies) are not applicable here.

Below is an adaptation of your requested table and information based on the available data, focusing on the device's substantial equivalence through performance and safety testing.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The document describes several non-clinical studies and tests performed to demonstrate the device's safety and effectiveness, primarily through comparison to a predicate device for the purpose of 510(k) clearance.

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

• Electrical Safety & EMC Testing: Sample size not specified, but typically involves testing a representative number of units or a single unit for regulatory compliance. Data provenance is internal testing performed by the manufacturer or accredited labs based on international standards.
• Software Verification & Validation: Sample size for testing not specified, but covers the entire software system. Data provenance is internal software development and testing.
• Bench Testing (i-Forma Applicator):
  • Ex-vivo tissue study: Sample size not specified for the ex-vivo model (e.g., number of tissue samples). Data provenance is internal lab testing.
  • Comparative test on human volunteers: The document states "human volunteers," but does not specify the number of volunteers. Data provenance would be a clinical study, likely conducted by the manufacturer. This would be considered prospective data collection.

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

• This is not applicable as the studies were focused on device performance and safety (e.g., electrical, thermal, software verification) against established engineering and medical device standards, rather than diagnostic accuracy requiring expert consensus on "ground truth." The "ground truth" for these tests would be the measured physical parameters, the functionality of the software, and the physiological response (temperature elevation) in tissue/volunteers, compared against predetermined specifications and the predicate device.

4. Adjudication Method for the Test Set

• Not applicable in the context of device safety and performance testing against objective standards or direct comparison to a predicate. Results are typically quantitative measurements and observations, not subjective interpretations requiring adjudication.

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. This device is not an AI-powered diagnostic system aimed at improving human reader performance. It is an RF energy delivery system for aesthetic and medical treatments.

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

• No. This is an RF energy delivery system, not a standalone AI algorithm. The performance studies evaluate the physical device's operation, safety, and functionality.

7. The Type of Ground Truth Used

• For Electrical Safety, EMC, Usability, High-Frequency Surgical Equipment Safety: Compliance with specific international consensus standards (IEC 60601-1, -1-2, -1-6, -2-2). The "ground truth" is adherence to the technical requirements and limits defined by these standards.
• For Software Verification and Validation: Adherence to FDA guidance for software in medical devices and the software's specified functional requirements.
• For Bench Testing (i-Forma Applicator):
  • Accuracy of RF output parameters & temperature sensor accuracy: Measured values against calibration standards and design specifications.
  • Temperature build-up in ex-vivo model & ex-vivo tissue study: Measured temperature and tissue penetration against expected physiological effects and comparison to the predicate device.
  • Comparative test on human volunteers: Measured thermal effect (e.g., temperature elevation) against the thermal effect of the predicate device and safety thresholds.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML-driven diagnostic or analytical tool that requires a "training set" in the conventional sense. The software is likely deterministic control software, validated against specifications rather than trained on data.

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

• Not applicable, as there is no "training set."

Ask a specific question about this device