(29 days)
Ellipse Ydun system is intended to be used in dermatology, as tabled below:
- Ydun is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
Ellipse Ydun is a platform/console capable of driving the Ellipse Frax 1550 applicator, which is a 1550 nm Laser diode-based applicator cleared by FDA under K161162.
The Ydun system consists of a console containing power unit and control electronics with control and display panel, including software. The Frax 1550 applicator connects to the system and have built in Laser diodes emitting 1550 nm light in a fractionated pattern.
The provided text describes a 510(k) premarket notification for the Ellipse Ydun system, a laser surgical instrument. The document focuses on demonstrating substantial equivalence to a predicate device (Ellipse Nordlys with Frax 1550) rather than presenting a performance study with acceptance criteria for an AI/algorithm-driven device.
Therefore, the information required to populate a table of acceptance criteria and reported device performance (especially for an AI algorithm), details on test set provenance, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not present in the provided text.
The document primarily outlines:
- Device Name: Ellipse Ydun
- Regulation Number: 21 CFR 878.4810 Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
- Regulatory Class: Class II
- Product Code: GEX
- Intended Use/Indications for Use: "Ydun is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures."
- Technological Comparison: The Ellipse Ydun is described as being "identical to the predicate device in that the Frax 1550 applicator/handpiece being used is the same as used by the predicate device and the Ellipse Ydun console driving the Frax 1550 is of the same technological design."
- Performance Standards: The device was tested according to and complies with various electrical safety, laser product, and quality management standards (e.g., US FDA 21 CFR 1040.10 and 1040.11, IEC 60601-1, IEC 60825-1, ISO13485).
Conclusion:
Based on the provided text, there is no information about an AI/algorithm-driven device, acceptance criteria or performance studies of the kind typically performed for software/AI-based medical devices. The submission is for a hardware device (laser instrument) seeking substantial equivalence based on its technological similarity to an existing predicate device and compliance with relevant safety and performance standards for hardware.
Therefore, I cannot fulfill the request for the table or other detailed information related to "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm, as such information is not contained within this document.
§ 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.