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The Accent™ device is intended for use in dermatologic and general surgical procedures.

The Accent™ device is indicated for use in dermatologic and general surgical procedures for the non-invasive treatment of wrinkles and rhytids using combined treatment with UniPolar and BiPolar.

The Alma Lasers Accent™ device is comprised of the following main components:

• Main console containing the major electrical components, including the: .
  • Control Panel; A
  • Radiofrequency (RF) Module; A
  • a Power Supply Module;
  • Service Panel; A
  • A Cooling Module;
  • A Handpiece holders;
  • A Emergency stop push button;
  • A Key switch;
  • A RF energy emission visual and audio indicators;
  • A Connector ports for the handpieces and power cord:
  • A Main circuit breaker; and
• UniPolar (i.e., monopolar) and Bipolar Handpieces incorporating:
  • Treatment tip with thermoelectric cooling (TEC) for cooling the treatment ア site during use for patient comfort;
  • A Handpiece trigger;

  • Umbilical connection to the main console; and

• Accessories:
  • A Cart:
  • Water Filling Kit;
  • 0 Non-contact thermometer.

The Alma Lasers Accent™ is a portable system used to deliver radiofrequency energy to the patient treatment site via a delivery handpiece.

This document is a 510(k) premarket notification for the Alma Lasers Accent™ device. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria or the details of a study demonstrating the device meets such criteria in terms of quantitative performance metrics.

The provided text states:

• "Clinical information was provided to demonstrate safety and effectiveness."
• "Clinical information demonstrating the safety and effectiveness of the Alma Lasers Accent™ device for the non-invasive treatment of wrinkles and rhytids was provided."

This suggests a clinical study was performed, but the details of that study, including acceptance criteria and reported performance, are not present in this 510(k) summary. FDA 510(k) summaries often only provide a high-level overview.

Therefore, I cannot populate the table or answer the specific questions below with the provided information.

Based on the provided text, the following information is NOT available:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc).
• The sample size for the training set.
• How the ground truth for the training set was established.

The document primarily focuses on establishing "substantial equivalence" to existing predicate devices for regulatory clearance, rather than presenting a detailed performance study with quantitative acceptance criteria.

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