(73 days)
The MERILAS 532a is indicated for use in retinal photocoagulation, iridotomy and laser trabeculoplasty.
The methods for delivery of the laser treatment beam to the desired tissue in the eye are:
- Slit lamp delivery device (also identified as: slit lamp adapter) such as the SLA-. BMBQ
- Laser indirect ophthalmoscope .
- . Endo fiber
The delivery method can be altered by exchanging the appropriate delivery device and connecting it to the base laser unit. The Autokey connector which belongs to each delivery device ensures that the base laser unit always gets the necessary information about the attached delivery device. The required delivery device has to be connected to the base laser unit before turning on the base laser unit.
During the start up procedure the MERILAS 532« identifies the attached delivery device and internally sets the appropriate parameters. The MERILAS 532α laser itself has built in sensors which do not allow the laser to fire if the delivery device fitted is not suitable in anwav.
For better viewing of the status of the laser unit when space is limited the display unit including the input devices can be removed from the base laser unit and placed on a more convenient space where good access as well as good viewing is possible. The maximum distance the display unit can be placed away from the base laser unit is 1 m due to maximum cable length.
After adjusting the desired parameters on the display of the base laser unit the treatment mode can be selected. In the treatment mode the red aiming beam (635 nm), generated by a laser diode, gets started and indicates the user to which area the treatment beam will be released. The physician selects the target tissue by aiming the red aiming beam to the desired tissue before releasing the treatment pulse.
The treatment laser is a diode pumped Nd: YVO laser which gets frequency doubled by using a KTP crystal. It is radiating at 532 nm. The transmission of the laser light gets achieved by focusing the laser light into an optical fiber and transmitting it to the delivery device. Laser power up to 2.5 W can be delivered out of the fiber. The laser delivery time can be adjusted from 10 ms up to 5 s.
The system can be operated from a 90-260 VAC, 50/60Hz single-phase power outlet. The mechanics of the MERILAS 532« is build out of anodized aluminium, painted sheet metal, and copper.
The optional slit lamp adapter SLA-BMBQ guides the laser beam from the laser unit into the illumination set of a slit lamp and focuses to the desired treatment area. The diameter of the spot can be adjusted in a range from 50 um to 5 mm by turning the dial wheel at the slit lamp adapter.
The mechanics of the SLA-BMBQ is build out of anodized aluminium.
This document is a 510(k) summary for the MERILAS 532α Ophthalmic Surgical Laser, confirming its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through testing with human readers or standalone algorithm performance.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document focuses on regulatory clearance based on substantial equivalence to an existing device, not on specific performance studies against pre-defined acceptance criteria for a new clinical or AI-driven application.
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.