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ICOONE h is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

The Icoone-h device is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body.
lcoone-h Laser is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths:
LED @ 650nm (50Mw) Laser @ 915nm (1W)
The light sources can be activated through the display, either combined or independently (only one of the two or both).
The sources are neither adjustable in intensity (always output at nominal value, as per specifications) nor in frequency (always continuous - CW).
Once selected, by turning on the Robosolo hand piece, both suctioning and light emission are activated at the same time.
The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.

This FDA 510(k) summary for the ICOONE h device does not include acceptance criteria or a study proving that the device meets those criteria. Instead, it argues for substantial equivalence to predicate devices based on indications for use, technological characteristics, and conformance to safety standards.

Therefore, I cannot provide the requested table or describe a study that proves the device meets acceptance criteria based on the provided text.

However, I can extract information related to the device's characteristics and the basis for its substantial equivalence claim, which may be relevant to regulatory acceptance:

Information available from the provided text:

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

As stated previously, explicit acceptance criteria and corresponding performance metrics are not provided in the document. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria. The table below summarizes the comparison to predicate devices, which serves as the basis for regulatory acceptance in this context.

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

The document explicitly states "Clinical tests- brief discussion: Not applicable." This indicates that no clinical studies were performed to establish the device's safety or effectiveness as part of this 510(k) submission. Therefore, there is no test set, sample size, or data provenance to report from this document in this context. The acceptance is based on substantial equivalence to predicate devices, which were assessed through non-clinical technical characteristics and compliance with recognized standards.

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):

Not applicable, as no clinical tests were performed, and therefore, no "ground truth" for a test set was established using experts in this submission.

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

Not applicable, as no clinical tests were performed.

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:

Not applicable. This device is not an AI-assisted diagnostic tool, and no MRMC study was conducted.

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

Not applicable. This is a physical therapeutic device, not an algorithm, and no standalone performance study was conducted in the context of an algorithm.

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

Not applicable, as no clinical data or ground truth related to patient outcomes or diagnoses were generated for this 510(k) submission. The "ground truth" for regulatory clearance is based on the substantial equivalence argument, particularly alignment with the established safety and efficacy profiles of predicate devices and compliance with relevant safety standards.

8. The sample size for the training set:

Not applicable, as no algorithm or machine learning model was developed or trained for this device.

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

Not applicable, as no algorithm or machine learning model was developed or trained for this device.

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