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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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