(90 days)
The Fotona DUALIS'" Plus Nd: YAG laser system is indicated for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialities of general and plastic surgery and dermatology:
- To effect stable long-term, or permanent, hair reduction in skin types I VI through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a longterm stable reduction in the number of hairs regrowing after a treatment regimen.
- For removal of unwanted hair.
- For coagulation and hemostasis of vascular lesions.
- For incision/excision of soft body tissue in dermatology
- For soft tissue general surgery applications skin incision; tissue dissection; complete or partial resection of internal organs, tumors, lesions, tissue ablation; vessel coagulation
The Fotona DUALIS 8 Plus system is based on the Nd: Y AG laser technology. Within the system, an optical cavity contains the Nd: Y AG crystal, which is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided down an optical fiber delivery system to a focusing handpiece. The laser is used in non-contact mode.
The provided text is a 510(k) premarket notification for the Fotona DUALISXP Plus Nd:YAG Laser System. It includes a summary of safety and effectiveness data and a substantial equivalence review. However, it does not contain information regarding detailed acceptance criteria, a specific study proving the device meets those criteria, or the specific performance metrics requested.
The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Altus Medical Aesthetic Nd:YAG Laser) by comparing design characteristics, intended use, and risk/benefit profiles. It does not present a de novo study with acceptance criteria and a detailed analysis of the device's performance against them.
Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided text.
Here is what can be inferred and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in the document. The basis for acceptance is "substantial equivalence" to a predicate device, implying that its characteristics and performance are comparable.
- Reported Device Performance: Not detailed in terms of specific quantitative metrics (e.g., hair reduction percentage, lesion coagulation rate, incision depth/precision) that would typically be associated with performance studies against acceptance criteria. The document only states that the device is "substantially equivalent" and its "risk and benefits... are comparable to the predicate device."
2. Sample size used for the test set and the data provenance:
- Not applicable/Not provided. No "test set" in the context of a performance study against specific acceptance criteria is described. The submission is a substantial equivalence claim, not a de novo clinical trial demonstrating performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No independent expert review for a test set's ground truth is mentioned. The FDA's review process determines substantial equivalence.
4. Adjudication method for the test set:
- Not applicable/Not provided.
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/Not provided. This device is a laser system for surgical and aesthetic applications, not an AI diagnostic or assistance tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not provided. This is a physical laser device, not an algorithm.
7. The type of ground truth used:
- Not applicable/Not provided. If any "ground truth" concept applies, it would be historical clinical experience and regulatory acceptance of the predicate device's performance and safety profile, rather than a specific ground truth for a new performance study.
8. The sample size for the training set:
- Not applicable/Not provided. There is no mention of a "training set" as this is a hardware device submission, not a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable/Not provided.
In summary, the provided document is a regulatory submission for substantial equivalence based on a comparison to an existing device, rather than a detailed report of a performance study against specific acceptance criteria.
§ 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.