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SureTouch will be used to manipulate and place a pulsed and/or CW laser beam for use in dermatology for treatment of any soft tissue, including ablation, vaporization, and coagulation of soft tissue on the skin.

Adding the SureTouch to a laser will convert the system into a sophisticated, easy to use aestheric surgery tool that can perform the widest range of cosmetic procedures. SureTouch may be used for a variety of soft tissue ablation procedures, including aesthetic laser surgery where of micro-ablation is required. SureTouch introduces an extra dimension of control for precise tissue removal. The SureTouch aiming beam mode visually displays the area about to be treated on the tissue. While watching the aiming beam, the physicians can change the shapes and sizes. The aiming beam outline will change, continuously displaying the area that is about to be treated.

Filling in the displayed area is performed using a precise microprocessor control motion that deflects the laser beam on the tissue to ensure maximum accuracy and homogeneity. The SureTouch coordinates the laser emission while leaving the physician in full control of laser output at all times.

The provided text is a 510(k) Summary for the SureTouch laser scanner, submitted to the FDA in 1998. It describes the device, its intended use, and its technological characteristics. However, the document does not contain information about acceptance criteria, a study proving device performance against such criteria, or any of the specific details requested in your prompt regarding sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies.

This type of FDA submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance metrics from a formal clinical study with acceptance criteria. The claim of improved safety and performance is made based on the device's design and technological characteristics compared to previous models, rather than presented as quantitative results from a specific study against predefined acceptance criteria.

Therefore, I cannot populate the table or answer most of your detailed questions based on the provided text.

Here's what I can extract and state directly from the document:

• Device Name: SureTouch
• Intended Use: To manipulate and place a pulsed and/or CW laser beam for use in dermatology for treatment of any soft tissue, including ablation, vaporization, and coagulation of soft tissue on the skin.
• Substantial equivalence claimed to:
  • Sahar Technologies Inc. SoftScan; 510(k) number K971024
  • Sahar Technologies Inc. SofTouch; 510(k) number K964684
  • Clinicon Corporation SureScan; 510(k) number K962242
  • Lasersonics Parascan; 510(k) number K955734

The following information is NOT available in the provided text:

1. A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance metrics are detailed.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method: Not mentioned.
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: Not mentioned. This device is a laser scanner, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical device, not an algorithm.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

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SoftScan will be used to manipulate and place a pulsed and/or CW laser beam for use in Dermatology for treatment of any soft tissue, including, ablation, vaporization and coagulation of soft tissue on the skin.

Adding the SoftScan 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. SoftScan may be used for a variety of soft tissue ablation procedures, including aesthetic laser surgery where layer by layer of micro-ablation is required. SoftScan introduces an extra dimension of control for precise tissue removal using lower power than previously thought possible. The SoftScan aiming beam mode visually displays the area about to be treated on the tissue. 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 SoftScan while leaving the physician in full control of laser emission at all times.

SoftScan 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.

This document does not contain the information required to complete the request. The provided text is a 510(k) summary for the SoftScan device, which describes its intended use and technological characteristics, and a letter from the FDA stating that the device is substantially equivalent to existing devices.

The document does not include:

• A table of acceptance criteria and reported device performance.
• Details of a study proving device performance against acceptance criteria.
• Information on sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for any studies.
• Information on training set size or ground truth for the training set.

The document mainly focuses on establishing substantial equivalence to predicate devices, rather than presenting detailed performance study results against specific acceptance criteria.

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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.

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