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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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The Tixel® 2 System is intended for dermatological procedures requiring ablation and resurfacing of the skin, and for treatment of periorbital wrinkles.

The Tixel® 2 System is a thermo-mechanical fractional skin treatment device that is designed to perform ablative fractional skin treatment is achieved by transfer of energy in the form of heat to the skin to create coagulation sites. The treatment is applied through an operating Tip that consists of 81 (standard Tip) or 24 (small Tip) biocompatible titanium, square pyramidal shapes assembled over a gold-plated copper base that are heated by an underlying flat ceramic heating element. The desired skin treatment is achieved by defining the speed and distance at which the Tip contacts and pushes the skin, and the number of pulses performed. Based on the treatment parameters selected, the pyramids contact the skin surface in 81 (or 24 for the small Tip) discrete, non-overlapping areas and by the transfer of heat, a matrix of coagulation sites and thermal necrosis is generated.

Tixel 2 transfers heat to the tissue by direct conduction to target tissue in a localized manner via the discrete non-overlapping pyramids. The complete Tixel 2 System contains two Handpieces, which are attached to the Tixel 2 Console by an umbilical tube. The Console's touch screen is used to control the system parameters.

The provided text describes the Tixel® 2 System, a thermo-mechanical fractional skin treatment device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-based diagnostic or prognostic device. The document is an FDA 510(k) summary for a medical device that performs ablation and resurfacing of the skin, and treats periorbital wrinkles.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer questions regarding sample size for test/training sets, expert involvement, adjudication methods, MRMC studies, or standalone performance, as this information is not present in the given text.

The information provided pertains to the Tixel® 2 System as a physical medical device, not an AI/ML algorithm requiring such validation.

Here's what the document does provide regarding its performance and safety validation:

The "Performance Data" section lists various engineering and biological tests performed to establish equivalence with its predicate device (Novoxel Tixel® System K202988):

• Disinfection validation: per ISO 20857
• Use-life validation testing
• Software and cybersecurity validation: per FDA guidance
• Electrical safety: per IEC 60601-1 and 60601-1-6
• EMC: per IEC 60601-1-2
• Comparative animal tissue histology studies: (In-Vivo and Ex-Vivo)

The "Clinical Data" section describes a prospective, blinded (pre- and post-treatment), single-arm clinical study evaluating the safety and efficacy of the Tixel® 2 in the treatment of periorbital wrinkles:

• Sample size: 51 patients (48 completed the study).
• Data provenance: Two clinics (US, Israel).
• Ground Truth: Clinical assessment metrics:
  • FWCS score: Performed by blinded raters for baseline and 3-month follow-up visits, demonstrating improvement > 1 grade.
  • GAIS assessment: Performed at follow-up compared to baseline. Mean score at Visit 5 was 3.54±0.68, and 3.52±0.58 at Visit 6 (3-month FU). Most subjects achieved the highest improvement grade (grade 4, 75-100%).
  • Raters: At least 2 out of 3 raters were in agreement for grading 83.3% of subjects as responders. (Specificity of "raters'" qualifications is not provided beyond "blinded raters").
  • Safety Outcomes: No SAEs or significant related AEs. Two AEs (Erythema, back pain) were reported in two subjects (3.92%). Mean procedure-associated VAS pain scores were low.

This information is relevant to the device's clinical performance, but not in the context of an AI/ML model's performance on a specific decision threshold or diagnostic accuracy.

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The Tixel® System is intended for dermatological procedures requiring ablation and resurfacing of the skin.

The Tixel is a thermo-mechanical fractional skin treatment device that is designed to perform ablative fractional skin treatment is achieved by transfer of energy in the form of heat to the skin to create coagulation sites.

The treatment is applied through an operating Tip that consists of 81 (standard tip) or 24 (small tip) biocompatible titanium square pyramidal shape assembled over gold plated copper base that are heated by an underlying flat ceramic heating element. The desired skin treatment is achieved by defining the speed and distance at which the Tip contacts and pushes the skin and the amount of pulses performed. Based on the treatment parameters selected the pyramids contact the skin surface in 81 (or 24 for small tip) discrete, non-overlapping areas and by the transfer of heat, a matrix of coagulation sites and thermal necrosis is generated.

Tixel transfers heat to the tissue by direct conduction to target tissue in a localized manner via the discrete non-overlapping pyramids. The Tixel Tip contacts the skin for a very short period. defined by pulse duration that varies between 5 and 16ms.

The Tip is mounted directly above the heating element in the Handpiece. The Tip and the heating element are mounted on a titanium alloy assembly. The Tip assembly structure is rigidly connected to the motor shaft (also known as forcer) by a polymer component. The polymeric components provide both thermal and electrical insulation between the heating element and the motor shaft. The Handpiece is attached to the Tixel Console by an umbilical tube. The console touch screen is used to control the system parameters.

The provided text is a 510(k) summary for the Novoxel Tixel® System, which is a medical device. This document describes the device, its intended use, and its comparison to a predicate device to establish substantial equivalence for FDA clearance.

However, the information provided does not contain acceptance criteria and a study that proves the device meets those criteria in the way you've outlined for AI-driven diagnostic or assistive technologies.

Here's why and what information is available:

• Type of Device: The Tixel System is a thermo-mechanical fractional skin treatment device, which is an electrosurgical cutting and coagulation device and accessories. This is a physical treatment device, not an AI or diagnostic software. Therefore, the "acceptance criteria" and "study" format you've requested (e.g., performance metrics like sensitivity/specificity, human reader improvement with AI, ground truth establishment by experts, sample size for test/training sets) are not directly applicable to this type of device.

• Focus of the Document: The 510(k) summary aims to demonstrate substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device, not necessarily proving performance against specific, quantifiable diagnostic metrics for AI.

Therefore, I cannot populate the table and sections as requested for an AI/diagnostic device.

However, I can extract the relevant "performance data" that the 510(k) uses to demonstrate safety and effectiveness for this physical medical device:

1. Acceptance Criteria and Reported Device Performance (Non-AI/Diagnostic)

Regarding the specific questions you asked for AI/diagnostic devices:

2. Sample size used for the test set and data provenance:

   • Animal Study: Five female domestic pigs were used. This is an animal model study, not human clinical data. The provenance is not specified beyond "porcine model."
   • Other tests (Biocompatibility, Cleaning, Electrical Safety, Software, Bench): These typically involve laboratory samples, components, or software code, not patient-derived "test sets."

3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable in the context of this device. The histopathology from the animal study would have been evaluated by veterinary pathologists, but the number and specific qualifications are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used:

   • For the animal study: Histopathology (depth and width of lesions, inflammatory reaction, healing process) from harvested tissue samples.
   • For other tests: Engineering specifications, regulatory standards, and objective measurements (e.g., electrical parameters, bacterial count for disinfection).

8. The sample size for the training set: Not applicable, as this is a physical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, the document addresses regulatory requirements for a physical medical device (Tixel® System) by demonstrating substantial equivalence to a predicate device, focusing on safety and effectiveness through engineering tests, biocompatibility, cleaning validation, and an animal study. It does not contain the type of performance evaluation metrics or study designs typically associated with AI or diagnostic software.

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