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The Glow by EndyMed is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The TC applicator is indicated for mild to moderate facial wrinkles and rhytides. The FSR applicator is indicated for Dermatological procedures requiring ablation and resurfacing of the skin.

The EndyMed Glow is a non-invasive unit consists of a user interface, programmable logic controller (PLC), an RF power module, internal electronics, and treatment handpieces. The user interface allows the selection of treatment parameters by pressing on the treatment buttons; A LCD screen displays the current treatment settings. The PLC is a specially configured computer that provides the operational and safety functions of the system. The system is connected to one or two out of 2 TC handpieces with different size electrode areas for different treatment sites, or to a FSR handpiece. The RF power module provides RF energy to the handpiece, producing a sinusoidal signal at 1MHz frequency.

The provided text is a 510(k) Summary for the "Glow by EndyMed" device. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It does not contain information about a clinical study designed to prove the device meets specific acceptance criteria.

The document primarily focuses on:

• Device Description and Intended Use: Describing what the device is and what it's used for.
• Predicate Devices: Identifying previously cleared devices to which "Glow by EndyMed" claims substantial equivalence.
• Performance Standards: Stating compliance with general safety and EMC standards for medical electrical equipment.
• Technological Characteristics Comparison with Predicates: Asserting that the device has the same technological characteristics as the predicate devices.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies cannot be extracted from this document as such studies are not described.

The document states:

• "The Glow by EndyMed has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate devices."
• "The TC applicator has exactly the same RF technology characteristics as the EndyMed Imagine TC Skin Treatment System (K0834610) and the FSR applicator has the same fractional RF technology as the EndyMed Fractional Skin Resurfacing (FSR) Applicator (K101510)."

This indicates that the primary "proof" of meeting acceptance criteria for a 510(k) submission like this is typically through demonstrating substantial equivalence to already cleared devices, rather than through new clinical performance studies with defined acceptance criteria for a novel device. The implicit acceptance criteria are that the device performs as safely and effectively as the predicate devices.

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