(86 days)
CYMA Co2 laser systems when used in non fractional mode is intended use for Incision, Excision, Ablation, Vaporization and Coagulation of body soft tissues including intraoral tissues, in medical specialties including Dermatology and Plastic surgery, Otorhinolaryngology(ENT), Gynecology, Neurosurgery, Dental and Oral Surgery and Genitourinary Surgery . When used in Fractional mode intended use for Skin Resurfacing.
The CYMA Co2 laser System are emitting a invisible infrared laser with maximum power of 30 watt at 10.63 um and consist of .Infrared light laser oscillation in tubes ; Power supplies, with non contacted mode hand pieces, LCD touch screen display, on this panel also has key switch, emergency red button and the operation led are inserted and consists of main function, Optic main Bench assemble, Fiber optic Hand pieces, Co2 laser Scanner laser tube : placed in the mixed crystals of copper pipe to the heater and produces a laser beam, Resonator : amplifies the beam, Cooling system, LCD control Panel, Foot Pedal Switch Microcontroller manages the voltage and the Co2 laser Source. This converted light energy creates the Co2 infrared laser and exhaust from the crystal is amplified into a specific wave length. Laser energy produced is delivered to the tissue by means of an articulated arm and a specially designed multi spot Hand Piece. The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using Foot Switch.
The provided document is a 510(k) summary for the CYMA Co2 laser, which is a medical device for surgical procedures. It details the device's classification, intended use, and comparison to a predicate device. However, it explicitly states under "6. Performance test" that “Clinical data is not presented in this submission.”
Therefore, based solely on the provided document, the following information related to acceptance criteria and performance studies for an AI/device (as implied by your request template) cannot be extracted:
- A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria for clinical outcomes are provided, as no clinical data was submitted.
- Sample sized used for the test set and the data provenance: No test set data or provenance is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described for a test set.
- Adjudication method for the test set: Not applicable as no test set data is presented.
- 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: This is not an AI-assisted device, and no such study is described.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no clinical ground truth data is presented.
- The sample size for the training set: Not applicable as no training set for an algorithm is mentioned.
- How the ground truth for the training set was established: Not applicable as no training set for an algorithm is mentioned.
What the document does state regarding "Performance test" is limited to:
The device's performance is demonstrated through adherence to the following mandatory and voluntary standards:
- IEC60601-1 part 1: General requirement for basic safety and essential performance.
- IEC60601-1-2: 2007 E M C test
- IEC60601-2-22 Part 2, Particular requirements for safety of diagnostic and Therapeutic laser
- IEC60825-1: 2nd ED, Equipment classification and requirement.
The document concludes that the proposed device shows "no significant different compare to the predicate device" in terms of safety and effectiveness, based on "every Safety test report." This suggests that the device meets safety and performance standards equivalent to similar legally marketed devices, primarily through engineering and bench testing, rather than human-centric clinical performance studies.
§ 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.