(11 days)
The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is intended for use in dermatologic and general surgical procedures.
The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is indicated for the non-The Alma Baser Painty of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar handpieces.
The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is comprised of the following main components:
- Console .
- A Bipolar RF handpieces (normal and small-tip)
- A Unipolar RF handpieces (normal and unilarge)
- Control panel .
- Footswitch. .
This document is a 510(k) summary for the Alma Lasers Family of Accent™ RF Systems and primarily focuses on establishing substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria, a detailed study proving device performance against those criteria, or the methodology of an AI-powered system.
However, based on the provided text, I can infer the acceptance criteria and the study done from the perspective of a 510(k) submission, not from a clinical performance study.
Acceptance Criteria and Reported Device Performance (from a 510(k) perspective):
| Acceptance Criteria (for 510(k) Equivalence) | Reported Device Performance (as stated in the 510(k)) |
|---|---|
| Same Indications for Use | "The Alma Lasers Accent XL™ RF device shares the same indications for use..." |
| Similar Device Operation | "...device operation..." |
| Similar Technical Capabilities | "...technical and functional capabilities..." |
| Substantially Equivalent to Predicate | "...therefore is substantially equivalent to the predicate Accent™ system." |
Based on the provided document, the following information regarding acceptance criteria and a study to prove device performance is either not applicable (for an AI diagnostic device) or not present:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a traditional medical device (RF system) rather than an AI-powered diagnostic device. The submission focuses on device equivalence, not clinical performance data in this manner.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth as typically defined for AI diagnostic performance studies is not relevant here.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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. This device is not an AI diagnostic tool and does not involve human readers interpreting AI output.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a 510(k) submission of this nature is primarily the established performance and safety of the predicate device.
- The sample size for the training set: Not applicable. This device does not use a training set as an AI algorithm would.
- How the ground truth for the training set was established: Not applicable.
Summary of the "Study" (from a 510(k) perspective):
The "study" presented here is a 510(k) premarket notification to demonstrate substantial equivalence of the Alma Lasers Family of Accent™ RF Systems (specifically Accent XL) to its predicate device, the Alma Lasers, Ltd. Accent™ (K070004).
- Type of Study: Regulatory submission (510(k) to establish substantial equivalence).
- Methodology: Comparison of the new device (Accent XL) against a legally marketed predicate device (Accent™) based on:
- Indications for Use
- Device Operation
- Technical and Functional Capabilities
- Conclusion: The Accent XL™ RF device was found to be substantially equivalent to the predicate Accent™ system because it shares "the same or similar indications for use, similar design features, and functional features."
In essence, this document is a regulatory filing for a non-AI medical device; therefore, many of the requested details pertaining to AI performance studies are not relevant nor included.
§ 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.