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The Tixel i is indicated for the application of localized heat and pressure therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD).

The Tixel i is intended to deliver heat and pressure to the eyelids of patients with evaporative dry eye disease (DED) due to meibomian gland dysfunction (MGD). The Tixel i is comprised of a Console, which is connected via an umbilical tube to an applicator, referred to as "Handpiece."

The Handpiece includes a therapeutic element, the "Tip," fixated on its distal end. A clear polycarbonate illuminated Distance Gauge, mounted on the distal end of the Handpiece, covers the Tip and allows proper and safe positioning of the Handpiece on the skin prior to performing a treatment pulse. The Distance Gauge is removed only when the Tip is being cleaned.

The Tip is comprised of a gold-plated copper base and a thin-walled titanium alloy cover. The active surface of the Tip consists of an array of 24 (6×4) square-based pyramids, evenly spaced. The pyramids have a blunt apex to allow effective heat transfer and prevent any risk of mechanical puncturing of the skin. The backplane of the Tip attaches to a ceramic heater that maintains a constant temperature during operation.

During a Tixel i procedure, an Aestek plastic ocular shield (Oculo-Plastik, Inc.) is to be inserted under the eyelids on the ocular surface to protect the eye during the procedure.

The FDA 510(k) summary for the Novoxel Tixel i device does not describe an AI/ML-driven device, but rather a medical device for treating dry eye disease. Therefore, many of the typical acceptance criteria and study details relevant to AI/ML devices (e.g., number of experts, adjudication methods, MRMC studies, training/test set ground truth establishment, standalone performance) are not applicable here.

However, based on the provided text, I can infer the "acceptance criteria" through the study's primary and secondary endpoints for clinical performance and the non-clinical testing performed to ensure safety and functionality.

Here's an attempt to structure the information based on your request, adapting it to the nature of the device described:

Acceptance Criteria and Device Performance for Novoxel Tixel i (TXLI0001)

The Tixel i device is an eyelid thermal pulsation system indicated for the application of localized heat and pressure therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD). Its acceptance criteria are primarily defined by its non-inferiority to a legally marketed predicate device (LipiFlow) in terms of clinical effectiveness and an acceptable safety profile.

1. Table of Acceptance Criteria and Reported Device Performance

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