Search Results

Ask a specific question about this device

Soft tissue treatments and in particular skin treatments require a device that can cover large and variable areas in a safe and homogeneous way. The SofTouch provides the ability to cover large and small areas of soft tissue while having perfect control of the emission placement and the emission reproducibility. The ability of the physician to identify the area to be treated by watching the aiming beam, while controlling the shape and the size that best fits the treated area will enhance the precision and safety of the treatment. The timing of the emission placement on the tissue is done by the SofTouch hardware and software to avoid errors and to increase precision and homogeneity. SofTouch is a hand held device that is flexible enough to allow the physician the freedom to choose the area of treatment without being restricted by the system.

Adding the SofTouch to any laser will convert the system into a sophisticated easy to use aesthetic surgery tool that can perform the widest range of cosmetic procedures. SofTouch may be used for a variety of soft tissue ablation procedures, including aesthetic laser surgery where layer by layer of micro-ablation is required. SofTouch introduces an extra dimension of control for precise tissue resnoval using lower power than previously thought possible. The SofTouch aiming beam mode visually displays the area about to be treated on the tisme. While watching the aiming beam, the physician can change the shapes and sizes he selects to use. The aiming beam outline will change in a concurrently to continuously display the area that is about to be treated.

Filling the area is done using a precise computer control motion that deflects the laser beam on the tissue to ensure maximum accuracy and homogeneity. Coordinating the laser emission is done by the SofTouch while leaving the physician in full control of laser emission at all times.

This document is a 510(k) summary for a medical device called "SofTouch," a laser accessory. It does not contain the information you requested about acceptance criteria and a study proving device performance against those criteria.

The 510(k) summary focuses on:

• Device Description: What the device is and what it does (converts a laser system into an aesthetic surgery tool for soft tissue ablation).
• Intended Use: How the device is meant to be used (soft tissue and skin treatments, covering large and variable areas safely and homogeneously).
• Technological Characteristics: How it compares to predicate devices, its features (microprocessor controlled scanning, aiming beam, precise computer control), and its purported benefits (increased control, precise placement, homogeneous application of laser energy, decreased physician fatigue, better fluence at lower power).

There is no mention of:

• Specific acceptance criteria for quantifiable performance metrics.
• Any study (clinical or otherwise) designed to measure device performance against defined criteria.
• Performance data, sample sizes, ground truth establishment, expert qualifications, or adjudication methods.
• Multi-reader multi-case studies or standalone algorithm performance.

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document is strictly a regulatory summary for market clearance, not a performance study report.

Ask a specific question about this device