(148 days)
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:
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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.
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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)
| Feature/Test | Acceptance Criteria (Implied by Regulatory Standards & Predicate Comparison) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate | The Tixel® System is intended for dermatological procedures requiring ablation and resurfacing of the skin, which is the same intended use as the predicate device (Venus Viva SR Device). |
| Technological Characteristics | Safe and effective operation; no new safety/effectiveness issues compared to predicate or reference. | Both Tixel and predicate transfer energy via a handpiece to a console. Tips are comparable in physical design (array of pins/pyramids). Patient-contacting materials are biocompatible. Both deliver localized, fractional thermal effects. While Tixel uses heat conduction and predicate uses fractional radiofrequency, this difference "does not result in different types of safety or effectiveness questions." Uses metallic elements for thermal energy, similar to CONMED Altrus. |
| Biocompatibility | Pass cytotoxicity, sensitization, irritation for surface contact (≤ 24 hours). | All tests showed passing results. Surface chemical analysis showed no diffusion of underlying materials. |
| Cleaning/Disinfection | Effective cleaning; high-level disinfection for tip. | Cleaning validation passed. Tip undergoes high-level disinfection via dry heat (ISO 20857), achieving complete kill of 10^6 Bacillus atrophaeus spores. |
| Shelf Life/Tip Durability | Functionality maintained over specified operating cycles. | Tixel designed for 100,000 pulses per tip. Shelf-life testing showed no deterioration of handpieces after 250,000 cycles. |
| Electrical Safety & EMC | Compliance with IEC 60601-1 and IEC 60601-1-2. | Conducted by an independent test laboratory; results implicitly acceptable for clearance. |
| Software Verification | Acceptable for software release. | Testing results were found acceptable for software release. |
| Bench Testing | Performs according to specifications and functions as intended. | Bench testing demonstrated that Tixel performs according to specifications and functions as intended. |
| Animal Study (Performance Comparison) | Similar treatment effect (lesion depth, width, inflammation, healing) to predicate device. | In a porcine model, Tixel-treated and predicate (Venus Viva)-treated animals showed similar immediate skin changes. Histopathology demonstrated similar lesion depths for Tixel and Venus Viva at medium and high settings, creating a focus of ablation over a wedge-shaped dermal area of collagen coagulation. Increased energy levels led to proportionately greater thermal lesions. "Tixel displays a similar treatment effect compared to the predicate." |
Regarding the specific questions you asked for AI/diagnostic devices:
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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."
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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.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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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).
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The sample size for the training set: Not applicable, as this is a physical device, not an AI model requiring a training set.
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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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.