Search Results

The Clinicon SureLase CO2 Laser System is intended for use in laser surgery procedures for incision, excision, vaporization, ablation, coagulation, or cauterization in specialties such as: general surgery, cosmetic surgery, dermatology, gynecology, head & neck surgery, neurosurgery, oral surgery, otorhinolaryngology, pediatric surgery, plastic & reconstructive surgery, podiatry, and urology.

The Clinicon SureLase laser system is a mobile platform that utilizes a radio frequency (RF) excited carbon dioxide (CO2) laser tube to produce an infrared beam at a nominal 10.6 µm wavelength at powers adjustable from 2 to 20 Watts Continuous Wave (CVV). Laser energy is conducted to the point of application by a flexible fiber waveguide and handpiece / tip assembly. Laser system operation is controlled by operator input on a touch-screen display panel. The RF laser drive is modulated to provide additional pulsed and superpulse emission modes selected from the laser system control panel.

The provided document describes the Clinicon SureLase CO2 Laser System, a medical device for various surgical procedures. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy.

Instead, the document focuses on:

• Regulatory information: 510(k) summary, classification, product codes, predicate devices.
• Device description: Operating principles, technical specifications (power, pulse characteristics, physical dimensions).
• Intended use: The broad range of surgical specialties and procedures for which the laser is designed.
• Performance Testing (Regulatory Compliance): It states that performance was evaluated through "verification and validation tests per product requirements and specifications" and "inspections and tests derived from applicable regulations and safety standards" (e.g., 21 CFR 1040, IEC 60601 series, IEC 60825-1).

Crucially, Section 9 explicitly states: "Animal and Clinical Testing Device performance evaluation did not involve Animal of Clinical Testing." This means there was no clinical study conducted with human patients or animal models to assess the device's performance in terms of clinical outcomes, diagnostic accuracy, or comparison with human readers.

Therefore, I cannot provide the requested information in the format you specified because the document does not contain data related to:

1. Acceptance criteria and reported device performance (clinical/diagnostic): The document lists technical specifications (e.g., CW power 2-20 watts), which are internal performance requirements, but not external clinical acceptance criteria for effectiveness or safety in patient care.
2. Sample size, data provenance, number of experts, adjudication, MRMC studies, standalone performance, or type of ground truth for a test set. These are all concepts related to clinical or diagnostic performance studies, which were not performed.
3. Sample size or ground truth for a training set: Since no clinical studies were performed, there's no mention of training sets for an AI/algorithm-based device.

Based on the provided text, the Clinicon SureLase CO2 Laser System's approval was based on demonstrating substantial equivalence to predicate devices and compliance with relevant safety and performance standards for laser equipment, rather than a clinical effectiveness study with human subject data or an AI/algorithm performance study.

Ask a specific question about this device