Search Results

The Cutera Er: YSGG laser hand piece is designed for use in applications requiring the excision, incision, ablation, vaporization and coagulation of soft tissue. Dermatology and Plastic Surgery Indications include: treatment of wrinkles and skin resurfacing. Opthalmology Indications include: Incision, excision, vaporization and coagulation of tissue surrounding the eye and orbit. The Cutera Fractionated Er:YSGG laser hand piece is designed for use in dermatology for skin resurfacing and for coagulation.

The Cutera Er:YSGG Laser handpiece is an optional handpiece for the currently marketed Xeo and Solera Opus laser systems. The handpiece emits laser energy at a wavelength of 2790nm. The water cooled laser is located in the handpiece and utilizes a computer controlled scanner.

This document is a 510(k) summary for the Cutera Er:YSGG Laser Handpiece (K080530). It focuses on establishing substantial equivalence to a predicate device (K063867) rather than providing detailed acceptance criteria and study results for a new device's performance.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies is not available in this document.

Here's an analysis of what can be extracted from the provided text based on your request:

I. Acceptance Criteria and Device Performance

This document does not present specific acceptance criteria in the form of performance metrics (e.g., accuracy, sensitivity, specificity) for the device. Instead, the "acceptance" is framed around demonstrating substantial equivalence to a predicate device. The performance is assessed by comparing its technological characteristics and intended use to those of the predicate device.

II. Study Details

As this is a 510(k) summary focused on substantial equivalence, a traditional "study" with a test set, sample size, and ground truth in the context of device performance metrics is not described. The "study" implicitly involves a comparison of specifications and intended use of the new device against the predicate.

• Sample size used for the test set: Not applicable/Not provided. The evaluation is based on comparing the device's design and intended use to a predicate.
• Data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable/Not provided.

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

Not applicable. Ground truth as typically understood for performance studies (e.g., diagnostic accuracy) is not established or discussed in this substantial equivalence document.

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

Not applicable.

V. 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 applicable. This device is a laser handpiece, not an AI-assisted diagnostic tool involving human readers.

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

Not applicable. This is a hardware device.

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

Not applicable. The "ground truth" for substantial equivalence is the existing regulatory status and performance of the predicate device.

VIII. The sample size for the training set:

Not applicable. This document does not describe a training set as it pertains to a machine learning algorithm or a clinical trial.

IX. How the ground truth for the training set was established:

Not applicable.

Ask a specific question about this device

The Cutera Er: YSGG Laser Handpiece is designed for use in applications requiring the excision, incision, ablation, vaporization and coagulation of soft tissue.
Dermatology and Plastic Surgery
Indications include: treatment of wrinkles and skin resurfacing.
Opthalmology
Indications include: Incision, excision, vaporization and coagulation of tissue surrounding the eye and orbit.

The Cutera Er:YSGG Laser handpiece is an optional handpiece for the currently marketed Xeo and Solera Opus laser systems. The handpiece emits laser energy at a wavelength of 2790nm. The water cooled laser is located in the handpiece and utilizes a computer controlled scanner.

The provided text does not contain information related to specific acceptance criteria, device performance metrics, or details of a study that proves the device meets such criteria.

The document is a 510(k) summary for the Cutera Er:YSGG Laser System, which focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study against predefined acceptance criteria.

The key points from the provided text are:

• Subject: Cutera Er:YSGG Laser Handpiece
• Purpose: To demonstrate substantial equivalence to predicate devices (Sciton Profile Er:YAG, BioLase Oculase MD, MLT Erbium:YAG, BioLase Waterlase).
• Rationale for Substantial Equivalence: The device shares similar indications for use, design features, and functional features as predicate devices, and is not believed to raise new questions of safety or effectiveness.
• Intended Use: Excision, incision, ablation, vaporization, and coagulation of soft tissue for dermatology/plastic surgery (wrinkles, skin resurfacing) and ophthalmology (tissue surrounding the eye and orbit).

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications, as it is not present in the provided 510(k) summary. This type of information is typically found in clinical trial reports or detailed validation studies, which are not included in this document.

Ask a specific question about this device