(110 days)
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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.