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The Modified Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is intended for use in dermatological 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 hand pieces.

The massage component of the Alma Lasers Accent Uniform Hand piece 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 Unipolar and Bipolar hand pieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids.

The Pixel RF Tips (stationary and rolling), when used with the unipolar hand piece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.

Ultrasound Module provides ultrasonic diathermy intended for:

• Relief of pain
• Muscle spasms
• · Joint contractures
• · NOT for the treatment of malignancies

The hand pieces above are intended to be used with the console cleared in K101147 Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite].

The Alma Lasers Accent XL is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.

The provided document describes the Accent XL with the Alma Ultra hand piece and its substantial equivalence to predicate devices, primarily for its ultrasonic diathermy function. The document does not contain information on clinical studies involving human patients, human readers, or a multi-reader multi-case (MRMC) comparative effectiveness study with or without AI assistance. The focus is on technical performance bench testing and regulatory equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the performance bench testing conducted and comparison to predicate devices, ensuring it meets similar specifications and safety standards.

2. Sample size used for the test set and data provenance

The document describes bench testing, not a clinical study on a patient test set. The sample size for the bench tests is not specified, but it refers to physical testing of the device's electrical, thermal, and mechanical properties. The data provenance is from bench laboratory testing conducted by the manufacturer, not from human subjects or retrospective/prospective clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was regulatory submission based on technical compliance and substantial equivalence, not a study requiring expert-established ground truth for a clinical dataset.

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

Not applicable. This was bench testing against predefined technical standards and predicate device specifications, not a study requiring adjudication of clinical findings.

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

No, an MRMC comparative effectiveness study was not done. This document does not describe a study involving human readers or AI assistance.

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

No, a standalone algorithm performance study was not done. This device is a physical medical device (ultrasonic diathermy) and does not involve AI algorithms.

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

For the technical performance bench testing, the "ground truth" was established by engineering and safety standards (e.g., IEC standards for electrical safety, EMC, and ultrasonic physiotherapy equipment) and comparison to the specifications of legally marketed predicate devices. For the temperature performance, the criteria (e.g., raising skin temperature to 40-45°C in less than 15 minutes) served as the ground truth.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/ML device.

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

Not applicable. There is no mention of a "training set" as this is not an AI/ML device.

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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):

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:

1. 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.
2. 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.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. 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.
7. The sample size for the training set: Not applicable. This device does not use a training set as an AI algorithm would.
8. 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.

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