(58 days)
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:
The following information is NOT available in the provided text:
- A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance metrics are detailed.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method: Not mentioned.
- 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.
- 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.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.