(87 days)
- For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins.
- The MYDON C laser system is also indicated for the treatment of wrinkles.
- The MYDON C is also indicated for the removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB).
- The MYDON C laser system is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
- The intended use of the integral cooling system in the MYDON C laser handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
The MYDON C is a 1064 nm solid-state long-pulsed Nd: YAG laser system. The beam is directed to the treatment area by a transmission system which is connected to the laser device and consists of a multifunction hose system and a tightly connected hand unit. In the multifunction hose system both laser radiation carrying quartz fiber as well as the cooling and signal leads are contained. The MYDON C transmission system includes skin cooling integrated into the hand unit and cools the area of skin that the laser covers. When the applicator is placed against the skin, its shape and the integrated hand unit cooling system cool the treatment area before, during and after the application of the laser pulse, all in a single step.
The hand unit inserts allow for various treatment types and parameter ranges. MYDON C offers the 1.5 and 3 mm hand unit inserts specifically for the treatment of vascular lesions, the 5 mm hand unit insert for the treatment of both vascular lesions and wrinkles, the 7 mm and 10 mm hand unit inserts for hair removal.
The provided document is a 510(k) summary for the MYDON C laser system. It describes the device, its indications for use, and a comparison to predicate devices, ultimately stating "Performance Data None presented." Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria.
Here's an analysis of why each requested point cannot be addressed by the provided text:
- A table of acceptance criteria and the reported device performance: Not present. The document explicitly states "Performance Data None presented."
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not present. No performance data or studies are presented.
- 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 present. No ground truth establishment is detailed as there's no performance study.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present. No test set or adjudication method is 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 present. The device mentioned is a laser system, not an AI or imaging diagnostic tool, and no clinical studies are presented.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This question is irrelevant as it's not an algorithm, but a physical laser device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present. No ground truth is discussed.
- The sample size for the training set: Not present. No training set is mentioned as no performance study is detailed.
- How the ground truth for the training set was established: Not present. No training set or ground truth establishment is detailed.
In summary, the provided 510(k) document for the MYDON C laser system does not include any performance data, clinical study details, acceptance criteria, or information related to expert review or ground truth establishment. The approval is based on substantial equivalence to predicate devices, rather than new clinical performance data from the applicant.
§ 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.