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510(k) Data Aggregation
(271 days)
LightLas 532/810 Multi-Wavelength Medical Laser System is intended to be used for:
- · Pan-retinal photocoagulation for proliferative diabetic retinopathy- with Slitlamp or Endoprobe
- · Laser retinopexy for retinal tear and detachments with Slitlamp or Endoprobe
- · Focal or grid photocoagulation for clinically significant macular edema (CSME)- with Slitlamp
- Focal photocoagulation for choroidal neovascularization (CNV) including but not limited to CNV in the setting of wet
- age-related macular degeneration (wet AMD)- with Slitlamp
- · Trabeculoplasty for primary open angle glaucoma (POAG)- with Slitlamp
LightLas 532/810 Multi-Wavelength Medical Laser System can emit 532 nm wavelength laser beam and 810 nm wavelength laser beam. The 532 nm wavelength source can be delivered through both output ports (Ports 1 and 2) of the laser console, while the 810 nm wavelength source is delivered through Port 1 only. Users may choose either wavelength from a LCD touch screen, and only one output port and one wavelength may be selected for use at a time. Laser wavelength selection of the system is indicated on the panel and controlled by system software.
LightLas 532/810 Multi-Wavelength Medical Laser System is intended for use by ophthalmologists for treatment of ocular pathology, and the system consists of the following functional components:
The provided text describes a medical laser system, the LightLas 532/810, and its substantial equivalence to predicate devices, but it does not contain details about acceptance criteria or a study proving that the device meets specific performance criteria in a way that aligns with your request for AI/algorithm performance analysis.
The document focuses on demonstrating that the LightLas 532/810 is substantially equivalent to existing medical laser systems (Quantel Medical Supra Twin K081946 and LightMed Corporation LightLas 532/670 K103547). The "performance data" section primarily discusses bench testing, electrical safety, EMC, and software verification and validation, which are standard regulatory requirements for medical devices. These are not clinical studies evaluating the laser's therapeutic effectiveness against predefined metrics of success for patient outcomes or diagnostic accuracy.
Therefore, I cannot provide the information requested in your table or answer the specific questions about sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these pertain to the evaluation of AI/algorithmic systems, which is not the subject of this document.
The document states: "The clinical evaluation data demonstrate that LightLas 532/810 Laser System performs comparably to the predicate devices which are currently marketed for the same intended use." However, it does not elaborate on what "clinical evaluation data" entails, what its methodology was, or what specific acceptance criteria were used for therapeutic outcome.
In summary, the provided text describes a traditional medical device (a laser system) and its regulatory review for substantial equivalence, not an AI or algorithmic device with performance criteria as you've outlined.
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