(70 days)
The Cutera Er:YAG Laser Handpiece is designed for use in applications requiring the excision, incision, ablation, vaporization and coagulation of soft tissue. Indications include: treatment of wrinkles and skin resurfacing.
The Cutera Er: YAG 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 2940nm. The water cooled laser is located in the handpiece and utilizes a computer controlled scanner.
The provided text is a 510(k) summary for the Cutera Er:YAG Laser System. It is a premarket notification for a medical device, which primarily focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a novel study.
Therefore, many of the requested details about acceptance criteria, specific studies, sample sizes, expert involvement, and ground truth establishment are not applicable or not provided in this type of document.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or report device performance in the manner requested. The submission focuses on demonstrating "substantial equivalence" to predicate devices, implying that its performance is expected to be similar.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) summary does not describe a clinical study with a test set. The device is a laser handpiece, and its approval is based on its technological characteristics being similar to already approved predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no mention of a test set requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set, and therefore no adjudication method.
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 applicable. This device is a laser handpiece for surgical applications, not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical laser device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. There is no explicitly defined "ground truth" for the device's performance in the context of a new study presented in this document. The "truth" is implicitly established by the performance and safety profiles of the predicate devices to which it is compared.
8. The sample size for the training set
Not applicable. There is no mention of a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set.
Summary of what the document does provide regarding "acceptance criteria" (implicitly, for regulatory approval):
The "acceptance criteria" for this submission are rooted in demonstrating substantial equivalence to existing, legally marketed predicate devices.
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Implicit Acceptance Criteria:
- Same General Indications for Use: The new device must be intended for the same clinical applications.
- No New Issues with Safety and Effectiveness: The device's design and technological characteristics should not introduce new or different risks compared to the predicate devices.
- No Unique Applications, Indications, Materials, or Specifications: The core aspects of the device should align with the predicates.
- Comparable Risks and Benefits: The known risks and benefits should be similar to those of the predicate devices.
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"Study" Proving Acceptance Criteria:
The "study" in this context is the 510(k) submission itself, which is essentially a comparative analysis and justification rather than a de novo clinical trial. The document states:- "The Cutera Er:YAG Handpiece shares the same general indications for use as the currently marketed predicate devices, and does not raise any issues with safety and effectiveness."
- "There are no unique applications, indication, materials or specification presented in this application."
- "Technologically, the Cutera Er: YAG Handpiece is substantially equivalent to the listed predicate devices. Therefore the risks and benefits for the Cutera Er:YAG Handpiece are comparable to the predicate devices."
- "The Cutera Er:YAG Handpiece was found to be substantially equivalent to currently marketed devices. The Cutera Er:YAG shares similar indications for use, design features, and similar functional features as the currently marketed predicate devices."
Predicate Devices Used for Comparison:
§ 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.