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The Profound Matrix System is intended for dermatological procedures, as follows:

The Matrix Pro applicator is indicated for general dermatological procedures for electrocoagulation and hemostasis. The Matrix Pro applicator is indicated for the percutaneous treatment of facial wrinkles in patients with Fitzpatrick Skin Types I-IV.

The Sublative RF applicator is indicated for dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. At higher energy levels greater than 62mJ/pin, the Sublative RF applicator is limited to Fitzpatrick Skin Types I-IV.

The Sublime applicator is indicated for non-invasive wrinkle treatment. At higher energy levels, greater than 100 J/cm³, the Sublime applicator is limited to Fitzpatrick Skin Types I-IV.

Profound Matrix is a system that combines three existing technologies and applications for dermatological procedures. Each respective technology is used in one of the three applicators designed for the Profound Matrix System. These three applicators are named: Matrix Pro, Sublative RF and Sublime.

The system console consists of a CPU, power supply, RF pulse generator, I/O board, splitter/distribution board and footswitch board. When the system is powered up, the user can select between user mode and service/maintenance mode. After selecting user mode and entering the required password, the user is requested to choose between the Matrix Pro, the Sublative RF or the Sublime applicators. Only one applicator can be used to treat a patient at any given time.

The user interfaces with the Profound Matrix System and applicators' settings through the 15″ touch screen. Each of the applicators have a finger trigger that can be used to activate the applicator or alternatively the end user can use the footswitch to activate the applicator.

Matrix Pro: The Matrix Pro applicator is designed to deliver bipolar, non-ablative radiofrequency energy through a 7x7 matrix/grid of sterile microneedles to the skin in a fractional manner. The microneedles can be set up to pulse up to a maximum of three depths during each insertion of the matrix/grid of microneedles with a maximum depth of up to 3.5mm. The Matrix Pro applicator delivers the right amount of energy at the precise depth, every time. The technology of the Matrix Pro applicator combines adjustable depth, energy, and real time impedance monitoring for customizable and consistent results. The Profound Matrix system monitors tissue impedance across the 3 modalities, in real-time, while simultaneously adjusting RF energy pulse duration and power output. The result is an accurate dose of RF energy delivery with every treatment application for consistent treatment outcomes, independent of patient-to-patient, body location, skin hydration, and procedural-related impedance variations.

Sublative RF: The Sublative RF applicator delivers bipolar radiofrequency (RF) to the skin surface in a fractional manner via an array of multi-electrode pin tips, which results in heating of both the demarcated spots to temperatures that ablate and resurface at contact points of the multi-electrode pins while also delivering heat in a wide diffuse manner to the dermis.

Sublime: The Sublime applicator uses a combination of an infrared (IR) light source and bipolar radiofrequency (RF) to bulk heat the dermis and affect dermal collagen in order to treat wrinkles. The bulk heating of the dermal layers refers to the gradual and gentle accumulation of heat with each additional pass performed.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Profound Matrix System with the Matrix Pro Applicator.

Context: The Candela Corporation sought clearance for a new indication for their Profound Matrix System (specifically the Matrix Pro applicator) – the percutaneous treatment of facial wrinkles in patients with Fitzpatrick Skin Types I-IV. This new indication builds upon existing clearances for general dermatological procedures and electrocoagulation/hemostasis for the Matrix Pro, and similar wrinkle treatment indications for other applicators within the Profound Matrix system (Sublative RF and Sublime) and a predicate device (Lutronic Infini).

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the new wrinkle treatment indication was the successful identification of post-treatment photographs by a majority of blinded evaluators, indicating an improvement in wrinkle appearance.

Additional Efficacy & Safety Metrics (Supporting Data, not explicit acceptance criteria but demonstrating effectiveness and favorable risk-benefit profile):

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