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The Cynosure SureScan with the CO3 Er: YAG Laser is used for skin resurfacing, and for the incision, excision, ablation or vaporization of soft bodily tissues. Typical applications include dermatology, plastic surgery, urology, gastroenterology, neurosurgery, gynecology, arthroscopy, general surgery, ENT and opthalmology.

The SureScan with the CO3 Er:YAG Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench.

This 510(k) summary for the Cynosure SureScan with the CO3 Er:YAG Laser does not include any acceptance criteria or details of a study proving the device meets said criteria.

The submission explicitly states:

• Nonclinical Performance Data: None
• Clinical Performance Data: None

This device was cleared based on its substantial equivalence to a predicate device (Cynosure CO3 Er:YAG Laser) in terms of treatment wavelength, pulse duration, pulse energy, and biological effects, not on specific performance criteria demonstrated through a study.

Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets them from the provided text.

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Wavelength range 430-1064 Nanometer

In this wavelength range, SureScan is designed to assist in the partial or full coagulation or denaturization of a variety of benign epidermal vascular and pigmented lesions where precise dosimetry is required to minimize damage to adjacent or underlying tissue layers. SureScan use is restricted for adaptation to those lasers that have received FDA clearance for applications in cutaneous laser surgery for the treatment of benign superficial vascular and pigmented lesions such as port wine stains angiomas, telangiectasia, café-au-lait marks, age spots, lentigines, tattoos and similar conditions.

Wavelength range 1440-10640 Nanometer

In this wavelength range. SureScan is designed to assist in a variety of procedures that require the ablation of soft tissue, where precise removal is required to minimize damage to adjacent or underlying tissue layers. SureScan use is restricted for adaptation to those lasers that have received FDA clearance for soft tissue ablation, such as scars, keloids, warts, skin malformations and similar conditions.

SureScan adapts to laser systems with wavelengths in the visible spectrum from 430nm to 700nm ( blue, green, yellow and red ) and to lasers in the invisible spectrum from 755nm to 2940nm to deliver precise amounts of energy to tissue.

SureScan comes equipped with multiple treatment patterns in multiple sizes. SureScan is programmable to enable adjustment of scan speed across tissue to ensure uniform laser absorption or ablation which significantly reduces thermal damage and thus the potential for post operative scarring.

SureScan also has an adjustable spot overlap density and scanner dwell time feature which allows the surgeon to select individual treatment parameters most suitable for various tissue types and lesions.

SureScan employs a microprocessor controlled, mirror system for scanning the laser beam. SureScan juxtaposes laser beam spots with precisely controlled timing and predetermined amounts of space in between or with spatial overlap of these spots. Depending on the type of laser used and its wavelength, highly controlled tissue coagulation or ablation is achieved with minimal thermal injury.

SureScan's operation is controlled via an existing laser foot switch, to eliminate any adjustment of the internal electronics or workings of the laser. To ensure precise transmission of the laser beam through the SureScan device and subsequent safe delivery of laser energy to tissue, a user controlled adjustment feature allows for realignment of the laser beam due to a misaligned fiber or other delivery system as it is directed through the SureScan hand piece.

As a result, the operator is always assured of optimum beam quality without 'clipping', as the laser beam exits the SureScan hand piece.

Different sized squares, rectangles, triangles, hexagons, parallelograms and lines may be selected and are outlined by the laser systems pilot laser. These various patterns are then automatically covered by the therapeutic laser and coagulate, denaturize or ablate tissue in a single scan cycle. This results in a more predictable and controlled tissue effect to optimize treatment results.

The provided document (K964831) is a 510(k) summary for the SureScan device, a laser accessory. It describes the device, its indications for use, and a technical description. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document is a premarket notification for substantial equivalence, not a clinical study report or a validation study. It focuses on demonstrating that the SureScan device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information in the table or the subsequent points because the document does not contain details about:

1. Acceptance criteria and reported device performance: This document doesn't define specific performance metrics or acceptance criteria for the SureScan device's operation, nor does it report any testing results against such criteria.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, or ground truth details for a test set.
3. Training set sample size or ground truth establishment for a training set.

The document primarily focuses on:

• Device Description: Explaining what the SureScan does (adapts to laser systems for precise energy delivery, offers various treatment patterns, adjustable scan speed, spot overlap, and dwell time).
• Intended Use/Indications: Specifying the wavelengths supported and the types of benign epidermal vascular and pigmented lesions or soft tissue ablation procedures it assists with.
• Substantial Equivalence: Listing predicate devices to which it claims equivalence.

Without a clinical or technical performance study, the requested information cannot be extracted from this document.

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SureScan may be used for a variety of soft tissue ablation procedures where precise removal is required to minimize damage to adjacent or underlying tissue layers.

SureScan converts any CO2 laser, pulsed or CW, into a sophisticated aesthetic surgery laser system for performing a wide variety of laser procedures. It comes equipped with six different patterns in 26 different sizes. It automatically adjusts the scan speed to ensure uniform laser ablation which eliminates charring and thermal damage. The collimated beam ensures constant power density and tissue removal at any working distance. The SureScan has an adjustable spot overlap density for more precision and control. The Scan outline and size are clearly displayed on the tissue, allowing precise placement of the laser energy and subsequent scan shapes.

This 510(k) submission for the SureScan Laser Accessory describes a device that "converts any CO2 laser, pulsed or CW, into a sophisticated aesthetic surgery laser system for performing a wide variety of laser procedures." The document focuses on the device's technological characteristics and intended use, rather than a clinical study with acceptance criteria and performance metrics.

Therefore, the provided text does not contain the information required to populate a table of acceptance criteria and reported device performance, nor details about a study proving the device meets acceptance criteria.

The document, being a 510(k) summary from 1996, primarily focuses on demonstrating substantial equivalence to predicate devices (Lasersonics Parascan and Coherent Computerized Pattern Generator) based on technological characteristics and intended use, rather than a detailed performance study with defined acceptance criteria typically seen in more recent submissions involving novel AI or diagnostic devices.

The information you are requesting about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment would generally be found in a clinical or performance study section, which is not present in this 510(k) summary.

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