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The Tixel® 2 System is intended for dermatological procedures requiring ablation and resurfacing of the skin, and for treatment of periorbital wrinkles.

The Tixel® 2 System is a thermo-mechanical fractional skin treatment device that is designed to perform ablative fractional skin treatment is achieved by transfer of energy in the form of heat to the skin to create coagulation sites. The treatment is applied through an operating Tip that consists of 81 (standard Tip) or 24 (small Tip) biocompatible titanium, square pyramidal shapes assembled over a gold-plated copper base that are heated by an underlying flat ceramic heating element. The desired skin treatment is achieved by defining the speed and distance at which the Tip contacts and pushes the skin, and the number of pulses performed. Based on the treatment parameters selected, the pyramids contact the skin surface in 81 (or 24 for the small Tip) discrete, non-overlapping areas and by the transfer of heat, a matrix of coagulation sites and thermal necrosis is generated.

Tixel 2 transfers heat to the tissue by direct conduction to target tissue in a localized manner via the discrete non-overlapping pyramids. The complete Tixel 2 System contains two Handpieces, which are attached to the Tixel 2 Console by an umbilical tube. The Console's touch screen is used to control the system parameters.

The provided text describes the Tixel® 2 System, a thermo-mechanical fractional skin treatment device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-based diagnostic or prognostic device. The document is an FDA 510(k) summary for a medical device that performs ablation and resurfacing of the skin, and treats periorbital wrinkles.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer questions regarding sample size for test/training sets, expert involvement, adjudication methods, MRMC studies, or standalone performance, as this information is not present in the given text.

The information provided pertains to the Tixel® 2 System as a physical medical device, not an AI/ML algorithm requiring such validation.

Here's what the document does provide regarding its performance and safety validation:

The "Performance Data" section lists various engineering and biological tests performed to establish equivalence with its predicate device (Novoxel Tixel® System K202988):

• Disinfection validation: per ISO 20857
• Use-life validation testing
• Software and cybersecurity validation: per FDA guidance
• Electrical safety: per IEC 60601-1 and 60601-1-6
• EMC: per IEC 60601-1-2
• Comparative animal tissue histology studies: (In-Vivo and Ex-Vivo)

The "Clinical Data" section describes a prospective, blinded (pre- and post-treatment), single-arm clinical study evaluating the safety and efficacy of the Tixel® 2 in the treatment of periorbital wrinkles:

• Sample size: 51 patients (48 completed the study).
• Data provenance: Two clinics (US, Israel).
• Ground Truth: Clinical assessment metrics:
  • FWCS score: Performed by blinded raters for baseline and 3-month follow-up visits, demonstrating improvement > 1 grade.
  • GAIS assessment: Performed at follow-up compared to baseline. Mean score at Visit 5 was 3.54±0.68, and 3.52±0.58 at Visit 6 (3-month FU). Most subjects achieved the highest improvement grade (grade 4, 75-100%).
  • Raters: At least 2 out of 3 raters were in agreement for grading 83.3% of subjects as responders. (Specificity of "raters'" qualifications is not provided beyond "blinded raters").
  • Safety Outcomes: No SAEs or significant related AEs. Two AEs (Erythema, back pain) were reported in two subjects (3.92%). Mean procedure-associated VAS pain scores were low.

This information is relevant to the device's clinical performance, but not in the context of an AI/ML model's performance on a specific decision threshold or diagnostic accuracy.

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