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The Modified Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL, Accent Elite] is intended for use in dermatologic and general surgical procedures.

The Alma Lasers Family of Accent™ RF Systems [Accent XL, Accent Elite] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with unipolar and bipolar handpieces.

The massager component of the Alma Lasers Accent UniForm Handpiece is intended for use with the Modified Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite] to provide:
Temporary reduction in the appearance of cellulite. .
Simultaneous application of the RF energy and mechanical manipulation of the skin is intended for use with the Modified Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite] to provide:
Temporary reduction in the appearance of cellulite. .

The Alma Lasers Accent Elite system similar to Accent™ RF Systems [Accent, Accent XL } is comprised of the following main components:
. Console
a Bipolar RF module
A Unipolar RF module (UniLarge)
A UniForm (RF and Massage) module
. Control panel
Footswitch. .
Modules are used to deliver radiofrequency energy to the treatment site. Each RF module consists of the following components:
. Handle - used for holding the module
. Trigger - activates the radiofrequency energy emission when pressed in Ready mode
Applicator tip establishes contact with the patient's skin .
. Thermoelectric cooler - integrated within the module, provides internal module cooling
. RF emission indicator - blue LED illuminates prior to- and during RF emission
Umbilical cable contains coolant tubes. RF-power cable and the communication . cable that controls the operation of the module
. Module connector - connects the module to its port. It incorporates an integrated impedance matching network (IMN) and a memory chip which stores information about the module and the parameter settings.
The UniForm module additionally employs a massaging mechanism that works in conjunction with the RF energy application.
The Accent Elite is a computerized system with embedded software that controls its operation. The software also runs the graphical user interface, which enables user-friendly control of the system operation.

The provided document is a 510(k) summary for a medical device (Modified Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL, Accent Elite]), seeking substantial equivalence to predicate devices. It does not describe or conduct a study involving acceptance criteria and reported device performance in the way typically associated with clinical trials or AI/algorithm evaluation.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared devices based on technical characteristics and safety performance testing rather than clinical efficacy studies with specific performance metrics against a defined ground truth.

Therefore, many of the requested elements for describing an acceptance criteria study and the methodology behind it (like sample size, data provenance, expert ground-truthing, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission.

However, I can extract the information that is present concerning the rationale for substantial equivalence and the listed safety performance testing.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance Study Information

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical outcome. Instead, the "acceptance criteria" for this submission are compliance with recognized safety standards and demonstration of substantial equivalence in technical characteristics.

The results of the performance testing showed compliance with these standards. |
| Clinical Equivalence (Implicit) | Based on the above, the device is considered "safe and effective, and performs at least as safely and effectively as the predicate Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL] for the intended use and indications." (This is a conclusion drawn from the technical and safety equivalence, not from a comparative clinical efficacy study provided in this summary). |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided. This document does not describe a clinical performance study with a test set of patient data. The "performance testing" refers to engineering and electrical safety standards compliance.

3. 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 / Not Provided. No clinical ground truth was established for a test set in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable / Not Provided. No clinical test set or adjudication method is described.

5. 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 / Not Provided. This device is an RF system for dermatologic/surgical procedures, not an AI or imaging diagnostic tool. Therefore, an MRMC study is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not Applicable / Not Provided. This device does not feature an algorithm for standalone performance evaluation in the context of AI or diagnostic systems.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable / Not Provided. The "ground truth" for this submission relates to compliance with engineering safety standards and established technical specifications, not clinical outcomes or expert consensus on a diagnostic task.

8. The sample size for the training set

• Not Applicable / Not Provided. This device is not an AI/machine learning system, so there is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

• Not Applicable / Not Provided. No training set exists.

Summary of the Study (as described in the 510(k) Summary):

The "study" described in this document is a regulatory submission demonstrating substantial equivalence rather than a clinical performance study measuring specific outcomes. The primary "studies" conducted were non-clinical performance testing to ensure safety and compliance:

• Type of Study: Non-clinical performance testing for electrical safety and electromagnetic compatibility.
• Purpose: To demonstrate that the Modified Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite] is as safe and effective as its predicate devices, primarily through compliance with international standards (IEC 60601 series).
• Methodology: The system was tested against the requirements of IEC 60601-1-2: 2004 (electromagnetic compatibility), IEC 60601-1:1988 with amendments (general safety), and IEC 60601-2-2:2006 (particular requirements for high-frequency surgical equipment).
• Conclusion: The tests demonstrated compliance with these standards, supporting the conclusion of substantial equivalence to the predicate devices. This equivalence is based on the device sharing the same intended use, indications for use, operation principle, and similar technical and functional capabilities, alongside meeting safety criteria.

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