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The EXILIS device is indicated for the primary treatment of dermatologic and general surgical procedures for non-invasive treatment of wrinkles and rhytids. EXILIS is a state-of-the-art device to apply therapy by a non-invasive method of high-frequency field.

The EXILIS device is indicated for the primary treatment of dermatologic and general surgical procedures for non-invasive treatment of wrinkles and rhytids. EXILIS is a state-of-the-art device to apply therapy by a non-invasive method of high-frequency field.

The control unit of the device is fitted with a color touch screen, which significantly facilitates the use of the device is equipped with a stylus (touch pen) for comfortable control of the touch screen. The vertically oriented design of the device enables to see the on-screen information from various positions of the operator. In addition, the brightness of the screen can be set to match the lighting in the surgery. The on-screen information will guide you through the entire therapy by means of easy setting of parameters using touch-screen buttons and knobs/keys on the device. For easier control, the applicator is equipped with buttons, enabling to operate the device during therapy, and a display, which shows the set and indicated parameters.

Any therapeutic parameter can be set easily by simple use of the touch-screen buttons. During the entire therapy time the device informs you about the therapeutic method, the type of the therapy applied, the set power, and other necessary data.

The EXILIS device enables to insert the patient's name and additional corresponding information in its internal memory and link these data with the pre-defined or customer protocols. At the patient's next visit simply call his/her name on the device and apply the preset therapy. The EXILIS device is placed in a specially designed cart, the shape of which provides the maximum comfort of the handling and use of the device. Four stable castors ensure easy moving of the device in the office or surgery.

The acceptance criteria and study information for the EXILIS device (K092191) are detailed below based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate devices." (Section 10, Clinical Testing). Therefore, there is no separately identified "test set" in the context of clinical data. The performance evaluation was based on non-clinical testing, verification, and validation of the device's hardware and software.

• Sample Size: Not applicable in the context of a clinical test set. The validation was against software design specifications and applicable voluntary standards.
• Data Provenance: The data provenance is internal, based on the manufacturer's (BTL Industries, Inc.) hardware and software development, verification, and validation processes, as well as third-party testing for safety and EMC standards. There is no mention of country of origin for a clinical dataset, nor whether it was retrospective or prospective, as no clinical study was conducted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As no clinical testing was performed, there was no clinical "test set" requiring expert consensus for ground truth establishment. The ground truth for the non-clinical testing was based on engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used. The performance was assessed against engineering specifications and regulatory standards.

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. No MRMC study was conducted. The EXILIS device is an electrosurgical cutting and coagulation device, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. The EXILIS is a medical device for dermatologic and general surgical procedures, not an algorithm. Its performance is inherent in its operation by a human user.

7. The Type of Ground Truth Used

For the non-clinical testing:

• Hardware and Software Performance: The ground truth was established by the Software Design Specifications and other internal engineering specifications.
• Safety and EMC: The ground truth was established by national and international safety and electromagnetic compatibility (EMC) standards.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. Its development involves traditional engineering design and testing, not machine learning.

9. How the Ground Truth for the Training Set was Established

Not applicable. No training set was used.

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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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