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The BIOXEL CO2 Surgical Laser System is indicated for use, in the non-fractionated mode, for Incision, Excision, Ablation, Vaporization, and Coagulation of Human Body Soft Tissues. The system is intended for use in Dermatology, Plastic and General Surgery, Neurosurgery, and Podiatry.

The BIOXEL CO2 Surgical Laser System is indicated for use, in the fractionated mode, for Ablative Skin Resurfacing, Wrinkle, Fine line, Rhylides, and Furrows in Dermatology.

The BIOXEL CO2 Surgical Laser System is used in Dermatology, Plastic and General Surgery, Neurosurgery and Podiatry.

This equipment consists of main body, Articulated Arm, hand-piece, protective goggles, foot switch and power cable. In a main body, there are a monitor displaying all information needed by an operator at a glance and a touch LCD screen, which facilitates operation of this equipment at user's convenience. The laser output is initiated with the foot switch.

The provided text is a 510(k) premarket notification for a medical device, the BIOXEL Fractional CO2 Surgical Laser System. This document outlines the device's characteristics, indications for use, and a comparison to predicate devices, but it does not contain the detailed information typically found in a scientific study that proves the device meets specific acceptance criteria.

Instead, the document focuses on regulatory compliance and demonstrating substantial equivalence to previously marketed devices. Therefore, I cannot construct the requested table and answer the study-specific questions as the necessary information is not present in the provided text.

Here's what I can extract and what is missing:

Information Present:

• Device Name: BIOXEL Fractional CO2 Surgical Laser System
• Indications for Use:
  • Non-fractionated mode: Incision, Excision, Ablation, Vaporization, and Coagulation of Human Body Soft Tissues in Dermatology, Plastic and General Surgery, Neurosurgery, and Podiatry.
  • Fractionated mode: Ablative Skin Resurfacing, Wrinkle, Fine line, Rhylides, and Furrows in Dermatology.
• Predicate Devices: K111831 MX-7000 MICROXEL and K180036 SMAXEL.
• Summary of Performance Testing (General):
  • Software: Verification and validation testing confirm appropriateness for release.
  • Electrical Safety and Electromagnetic Compatibility: Tested per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1.
  • Biocompatibility: Established per ISO 10993-5.
• Conclusion: The device was found substantially equivalent to predicate devices.

Information NOT Present (which would be required to answer your questions):

• Specific Acceptance Criteria: The document mentions general performance (e.g., "performs as intended") and compliance with recognized consensus standards (electrical, EMC, biocompatibility). However, it does not list measurable acceptance criteria (e.g., "power output must be within +/- 5% of target," "ablation depth will be X mm +/- Y mm in Z tissue after N pulses," "complication rate not to exceed X%").
• Reported Device Performance against specific criteria: Without specific criteria, there are no reported performance values to compare against them.
• Details of the "Study" (if it can be called that in this context): The document refers to "testing" (software verification, electrical safety, biocompatibility) but not to a clinical or comparative performance study in the way typically discussed for AI/diagnostic devices.
• Sample Size (test set, training set): Not mentioned for any type of performance data.
• Data Provenance (country, retrospective/prospective): Not mentioned.
• Number of experts and their qualifications: Not applicable, as there's no mention of expert-derived ground truth or human reader studies.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or reported.
• Standalone (algorithm only) performance: Not applicable, as this is a physical laser device, not an AI algorithm.
• Type of ground truth used: Not applicable, as there's no diagnostic or predictive algorithm being evaluated in a clinical context.
• How ground truth for training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device, not a research paper detailing the performance of a diagnostic algorithm against specific clinical acceptance criteria. It affirms compliance with general safety and performance standards for market authorization but does not delve into the kind of detailed performance metrics you've requested.

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