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• The DEKA LOTUS 570mm pulsed light handpiece is indicated for photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.
· The DEKA LOTUS 500G pulsed light handpiece is intended for treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.
· The DEKA LOTUS RF handpiece is indicated for use in dermatologic and general surgical procedures for the noninvasive treatment of mild to moderate facial wrinkles and rhytides.

The DEKA LOTUS is a device provided with two pulsed light handpieces and a RF handpiece.
The two pulsed light handpieces have a built-in cooled waveguide which differ in emission spectrum, connected to the main unit through a flexible multifunctional cable.
The handpiece uses a linear Xenon flashlamp, emitting a broad spectrum of electromagnetic radiation (light) when energized.
The RF handpiece produces a particular electric current at 1MHz that induces a molecular oscillation on the cells, raising their temperature locally. The RF current flows through the special electrodes, forming a homogeneous heat area.
The modifications to the device respect to DEKA LOTUS (K233473) consist of replacement of the filter of 590nm Intensed Pulsed Light Handpiece with a 570nm filter. The intended use of modified device, as described in the labelling, has changed as a result of the modifications. Labelling itself has been updated accordingly.

The provided text is a 510(k) summary for the DEKA LOTUS device, which is an intense pulsed light (IPL) and radiofrequency (RF) system. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with detailed acceptance criteria and validation results for an AI algorithm.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found within the provided text.

The document states:

• Clinical Performance Data: None. This explicitly indicates that no clinical studies were performed to prove the device meets acceptance criteria in a clinical setting.
• Non-Clinical Performance Data: "Test according to IEC 60601-2-57:2011 for the modified IPL Handpiece." This refers to electrical safety and electromagnetic compatibility standards, not performance criteria for a specific medical outcome or AI algorithm.

The core of this 510(k) submission is a comparison of the device's technical specifications and intended use against a predicate device (Quanta Chrome K202503 and existing DEKA LOTUS K233473) to establish substantial equivalence. The "Acceptance Criteria" here are implicitly linked to demonstrating that the new device variant (specifically, a 570nm filter change for an IPL handpiece) is as safe and effective as the predicate, based on technical similarity, without requiring new clinical performance studies.

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