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INDIBA COMPACT devices are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain. muscle spasms and increase in local circulation.

The massage electrodes are intended to provide a temporary reduction in the appearance of cellulite.

The INDIBA COMPACT devices are therapeutic devices for deep, non-invasive diathermy. The device consists of a console which generates a radiofrequency current which is delivered to the patient, in monopolar form, through two different types of electrodes: steel conductive resistive electrodes, and thin-layer insulated capacitive electrodes are inserted into a handle/handpiece, one handle for each kind of electrode, and the handle is connected to the console by means of a cable.

In resistive mode the system delivers a high- frequency current of 448 kHz directly to the patient's skin surface. In capacitive mode, the electrode coating creates a layer between the electrode and the human tissue, forming a capacitor that allows a high-frequency current at 448 kHz to pass. Current returns through the neutral return electrode.

INDIBA Compact devices are provided with an electroconductive media which is applied to the patients' skin prior to each treatment session. The RF energy generates a heating profile that produces a moderate temperature rise in the subcutaneous tissue. In Compact Lite, the temperature on the skin is measured using a separate IR (Infra-red) thermometer and in Compact Plus and Compact Pro temperature is measured through the smart electrodes and smart handle, which inform of the surface skin temperature trough a color scale. There are also other accessories available as massage electrodes with different shapes that can be used to massage the skin during cellulite treatment.

The provided text is a 510(k) summary for the INDIBA COMPACT devices. It asserts that the device is substantially equivalent to a predicate device (INDIBA Diathermia Radiofrequency Device, K161458) based on non-clinical data.

Key Findings:

• No Clinical Studies Submitted: The document explicitly states, "No clinical studies are submitted."
• Basis of Substantial Equivalence: Substantial equivalence is supported by non-clinical performance tests, including electrical safety, electromagnetic compatibility, and software verification to IEC 62304. Biocompatibility of patient-contacting materials was also evaluated per ISO 10993-1.

Given these findings, it is not possible to describe acceptance criteria or a study that proves the device meets those criteria, as no clinical studies with acceptance criteria or performance metrics were provided for the INDIBA COMPACT devices in this document.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. Multi reader multi case (MRMC) comparative effectiveness study results or effect size
6. Standalone (algorithm only) performance
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

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