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CO2 LASER Part: Fractional mode is indicated only for ablative skin resurfacing. Non-fractional mode is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery). otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.

The Ilooda Fraxis CO2 Laser is comprised of the following major components:

• The main console unit 1.
• 2. Delivery handpieces (2)
• 3. Footswitch.
• 4. Accessories
     The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.

The provided text details a 510(k) premarket notification for the Ilooda Fraxis CO2 Laser, showing its substantial equivalence to a predicate device (Fraxis Duo). However, the document does not contain any information about acceptance criteria, device performance testing against specific clinical endpoints, or related studies (such as MRMC, standalone, or ground truth establishment) typically associated with AI/ML-driven medical devices.

The performance testing section (VIII) only lists general safety and electrical standards (e.g., IEC 60601-1, IEC 60601-2-22) and mentions software verification/validation and biocompatibility. Crucially, Section IX explicitly states:

"Based on the similarities in the safety and effectiveness profiles of the subject, primary predicate and reference devices, no clinical studies were deemed needed to support this submission."

This indicates that the device's approval was based on demonstrating substantial equivalence to a legally marketed predicate device, rather than on demonstrating performance against specific clinical acceptance criteria in a dedicated study. The information required in your request, such as acceptance criteria, sample sizes, expert adjudication, MRMC studies, standalone performance, and detailed ground truth establishment, is typically associated with a more rigorous clinical validation process for novel devices or AI/ML components, which was not performed or submitted for this particular 510(k).

Therefore, I cannot fulfill your request for the specific details within the given document because the document does not contain that information.

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