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The Aluma Skin Renewal System is intended for use in Dermatologic and The Anama UKIN Keneral Systems of the non-invasive treatment of wrinkles and rhytids.

The Aluma Skin Renewal System is a non-invasive, non-ablative unit consisting of a user interface, a programmable logic controller (PLC), an RF power module, internal electronics, a vacuum pump, and a treatment handpiece with interchangeable tips (small and large). The interface allows the selection of treatment parameters by pressing on the treatment buttons; an LCD screen displays the current treatment settings. The PLC is a specially configured computer that provides the operational and safety function of the system. The RF power module provides RF energy to the handpiece, producing a sinusoidal signal at a 468 kHz frequency

The provided text is a 510(k) summary for the Aluma™ Skin Renewal System. It focuses on establishing substantial equivalence to predicate devices for regulatory clearance, primarily for the non-invasive treatment of wrinkles and rhytids.

Unfortunately, the provided document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Details about sample size, data provenance, or ground truth establishment for any test set.
• Information about expert involvement, adjudication methods, or MRMC studies.
• Discussion of standalone algorithm performance.
• Details on the training set or its ground truth establishment.

The document is a regulatory submission demonstrating substantial equivalence to predicate devices (Thermage, Inc ThermaCool™ TC System and Syneron Medical Ltd., Polaris™) based on similar indications for use and technological characteristics. It does not describe a performance study with specific acceptance criteria as you've outlined.

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