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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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The Erbium 2000 laser family is designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. Surgical specialties and applications include: general surgery, plastic surgery, aesthetic surgery, dermatology, urology, gynecology, genitourinary, ENT, pulmonary surgery, thoracic surgery, podiatry, oral & maxillofacial surgery, opthamology (including oculoplasty), small and large joint arthroscopy, microdiscectomies, and endoscopic procedures.

Phantom Erbium lasers are composed of the following components:

• a laser console .
• a counterbalanced articulated arm and handpiece .
• a control / display panel ●
• a finger trigger or foot petal control ●
• ● a laser head w / beam optics
• a CPU control system
• . a power supply
• an internal cooling system
  Models range from 5 to 50 Watts average power.

This 510(k) summary (K972915) for the Erbium 2000 Laser Family does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving the device meets them. This document is a premarket notification for substantial equivalence, not a clinical study report.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

This document does not specify formal acceptance criteria in terms of specific performance metrics (like percentage of efficacy or adverse event rates) against which the device was measured. Instead, it refers to performance standards for safety and electrical compatibility, and claims substantial equivalence to predicate devices for its intended uses.

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

The document does not describe a specific test set or clinical study with a defined sample size for evaluating the Erbium 2000 Laser Family's clinical performance. As a 510(k) submission, the primary evidence presented for substantial equivalence often relies on comparison to existing, legally marketed predicate devices, rather than new, large-scale clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not available in the provided document. There is no mention of a test set or ground truth established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not available in the provided document, as no specific test set or clinical study involving adjudication is described.

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

This is not applicable. The device described is a surgical laser, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. The device is a physical surgical laser system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not available. The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than presenting clinical trial data that would require a defined "ground truth."

8. The sample size for the training set

This information is not applicable/not available. Training sets are relevant for machine learning algorithms. The Erbium 2000 is a laser device, and its development would involve engineering and physical testing, not machine learning training.

9. How the ground truth for the training set was established

This information is not applicable/not available.

Summary of the Study (as described in the document):

The document does not describe a "study" in the sense of a clinical trial used to prove the device meets specific performance criteria. Instead, it is a 510(k) Premarket Notification which argues for "substantial equivalence" of the Erbium 2000 Laser Family to previously cleared predicate devices.

The "study" or evidence provided to the FDA largely consists of:

• Device Description: Detailing the components and functionality of the Erbium 2000.
• Indications For Use: Stating the proposed clinical applications, which are broad surgical procedures for soft tissue and skin resurfacing.
• Performance Standards Compliance: Declaring adherence to safety and electrical standards (UL544, UL2601.1, IEC601.1, IEC825, 21 CFR 1040.10 & 1040.11). This demonstrates safety and electrical compatibility, but not clinical efficacy in terms of treatment outcomes.
• Predicate Device Comparison: Listing numerous predicate devices (with K-numbers where known) for a range of laser systems. The core of a 510(k) is to demonstrate that the new device is as safe and effective as these previously marketed devices for the same intended use. This comparison is typically based on technological characteristics, intended use, and existing performance data of the predicate devices, rather than new clinical data for the submitted device itself.

In essence, the "proof" the device meets acceptance criteria is the FDA's determination of substantial equivalence to legally marketed predicate devices, implying that if the predicate devices were accepted, and the new device is sufficiently similar and meets relevant safety standards, it too can be accepted. The document does not provide a separate, dedicated clinical study report.

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