(171 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (K063867) in: | The Cutera Er:YSGG Handpiece is substantially equivalent to K063867. |
| - Intended Use | - Shares the same general indications for use as K063867. |
| - Technological Characteristics (wavelength, type of laser etc.) | - Handpiece emits laser energy at 2790nm (same as predicate). |
| - Safety and Effectiveness | - Risks and benefits are comparable to the predicate devices. |
| - No new questions of safety or effectiveness | - No new questions of safety or effectiveness are raised. |
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.
§ 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.