Search Results

The InMode RF System is indicated for use in dermatological and general surgical procedures where coagulation/contraction of soft tissue or hemostasis is needed.

The InMode RF System is a computerized system generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring electrocoagulation/contraction of soft tissue and hemostasis. The InMode RF System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating.

The InMode RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF handpiece is connected to the console via a cable and a foot switch activates the energy delivery to the handpiece. Multiple handpieces are available, all comprised of a disposable, single use plastic handle with active internal electrodes. A subset of handpieces have both internal (active) and external (return) electrodes.

The provided FDA 510(k) summary (K240780) is for an InMode RF System and describes its substantial equivalence to a predicate device (K233642).

Here's an analysis of the acceptance criteria and study information based on the provided text:

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

The document does not explicitly state a table of quantifiable acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device by comparing indications for use, technological characteristics, and safety and efficacy data. The acceptance criteria appear to be met by showing that the new handpieces (HP1022B6A and HP2539B6A) perform similarly to the cleared handpieces and predicate device.

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

• Sample size for test set: Not explicitly stated. The document mentions "Comparative ex vivo tissue study results demonstrate the safety and efficacy of thermal effects of the new handpieces on three different tissue types, muscle, liver, and fat." The type of tissue (muscle, liver, fat) is mentioned, but not the number of samples or specimens used for each.
• Data provenance: "ex vivo tissue study." This suggests the data was obtained from tissues outside of a living organism, likely from animal or cadaveric sources in a laboratory setting. The country of origin is not specified. It is a retrospective study in the sense that the data was collected for the purpose of demonstrating equivalence for this submission.

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

The document does not provide any information about the number or qualifications of experts involved in establishing ground truth for the ex vivo tissue study.

4. Adjudication method for the test set

The document does not mention any adjudication method for the test set.

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 electrosurgical cutting and coagulation device, not an AI-assisted diagnostic or interpretative system that would typically involve human readers.

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

This is not applicable, as the device is a medical instrument (RF System) and not an algorithm or software-only device. Its performance is inherent to its physical operation.

7. The type of ground truth used

The ground truth for the "ex vivo tissue study" would likely be based on:

• Direct observation/measurement: Of the thermal effects (e.g., coagulation depth, tissue contraction, hemostasis) on the tissue samples after RF energy application.
• Histopathological analysis: Microscopic examination of the treated tissues to assess cellular changes and thermal damage.

The "ground truth" for electrical and mechanical safety and electromagnetic compatibility would be adherence to the specified IEC standards.

8. The sample size for the training set

This is not applicable. This is a medical device (hardware) submission, not a machine learning or AI model that requires a training set. The "training" of its performance is through its design and engineering, and then validated through testing.

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

This is not applicable as there is no training set for this type of device.

Ask a specific question about this device