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The ScanTech laser scanning handpiece is designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation and photo thermolysis of soft tissue in medical specialties including: general surgery, plastic surgery, aesthetic surgery, dermatology, ophthalmology including, but not limited to use in oculoplasty.

The ScanTech laser scanning handpiece is designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation and photo thermolysis of soft tissue in medical specialies including: general surgery, plastic surgery, aesthetic surgery, dermatology, ophthalmology (timited to periobital dermis).

The Phantom ScanTech handpiece is intended to be used with the Phantom Family of Medical Lasers to deliver a broad spectrum of laser light energy for use in surgical applications generally requiring the ablation, vaporization, excision, incision and coagulation of soft tissue in a variety of medical specialties.

The Phantom ScanTech handpiece is composed of the following main components: Handpiece with dual galvo X - Y scanning capabilities Control / power cable Laser control / display panel interface CPU based Laser control system CPU controlled power supply Removable spatula-bayonet tip Screw ring attachment for articulated arm

Used in conjunction with the Phantom Family of Medical Lase automated scanning device to accurately and quickly apply computer-controlled patterns of various shapes and sizes. The Physician, or his/her assistant, will select the desired shape, size and density, as well as other operating parameters, from the Phantom laser's interactive touch screen.

This document is a 510(k) summary statement for the Phantom ScanTech laser accessory. It describes the device, its intended use, and substantial equivalence to predicate devices. However, this document does not contain information on acceptance criteria, device performance studies, or any of the detailed aspects of a study proving the device meets acceptance criteria.

The 510(k) summary focuses on demonstrating that the ScanTech is "substantially equivalent" to other legally marketed devices, primarily by comparing its "Indications For Use" and general characteristics to existing laser accessories. It's a regulatory submission to allow marketing, not a scientific publication detailing performance studies.

Therefore, I cannot provide the requested table and study information based solely on the provided text. The document explicitly states:

• No acceptance criteria are listed.
• No device performance metrics are reported.
• No details of a study (sample size, ground truth, experts, adjudication, MRMC, standalone performance, training set) are present.

The document only provides:

• Device Name: ScanTech
• Intended Use/Indications for Use: Surgical applications requiring excision, incision, ablation, vaporization, coagulation, and photothermolysis of soft tissue in various medical specialties.
• Predicate Devices: Coherent (K960032, K951812, K943604, K962242), Clinicon (K964520, K955734, K941841), Laserscope Sahar (K964684, K961935, K960820, K960521), Sharplan (K955621).
• Performance Standards: UL544, UL2601.1, IEC601.1, IEC825, 21 CFR 1040.10 & 1040.11 (These are safety and electrical standards, not typically clinical performance criteria for accuracy or efficacy in the way requested).

To answer your request, a different type of document, such as a scientific paper, clinical trial protocol, or detailed engineering report, would be necessary.

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