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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

2. Sample Size Used for the Test Set and Data Provenance

• Test Set (Clinical Study): A total of 109 subjects were enrolled and randomized (54 to Tixel, 55 to LipiFlow). 106 subjects underwent the assigned procedure.
• Data Provenance: The study was a prospective, multi-center, randomized, controlled, pivotal trial conducted at 5 centers in the United States between September 2022 and June 2023.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable to this device submission as it is not an AI/ML-driven diagnostic or image analysis device that relies on human expert ground truth for its performance evaluation in the typical sense. The "ground truth" for the clinical study was established by objective clinical measurements and patient-reported outcomes (TBUT, OSDI, MGS, adverse events) as performed by masked assessors (clinical personnel) to reduce bias. The qualifications of these clinicians involved in the assessments are not explicitly stated beyond being "masked assessment" and "physician assistant" for follow-up calls.

4. Adjudication Method for the Test Set

Not applicable in the context of typical AI/ML device evaluations. The clinical study established "ground truth" through direct clinical measurements and standardized questionnaires. Bias was mitigated by having assessments performed by masked personnel (i.e., not the person who conducted the treatment procedure).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study design is typically used for AI/ML diagnostic imaging devices evaluating reader performance. This study was a randomized, controlled clinical trial comparing the therapeutic device (Tixel i) directly against a predicate device (LipiFlow) in terms of patient outcomes (effectiveness) and adverse events (safety).

• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as this is not an AI-assisted device for human readers. The study focuses on the therapeutic outcome of the device itself.

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

Not applicable. This is a medical device, not an AI algorithm. The performance evaluated was that of the device and its treatment effect on patients.

7. The Type of Ground Truth Used

The "ground truth" for the clinical effectiveness endpoints was based on:

• Objective clinical measurements: Tear Break-Up Time (TBUT), Meibomian Gland Score (MGS), ocular surface staining, intraocular pressure, and best corrected distance visual acuity.
• Patient-reported outcomes: Ocular Surface Disease Index (OSDI) questionnaire, pain and discomfort visual analog scale.
• Observed events: Ocular adverse events.

8. The Sample Size for the Training Set

Not applicable. This is a hardware medical device and not an AI/ML algorithm that requires a "training set" in the computational sense. The device's design was likely informed by engineering principles, physiological understanding of MGD, and existing predicate devices.

9. How the Ground Truth for the Training Set was Established

Not applicable. See point 8.

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