LogoFDA 510(k) Search
K Number
K063297
Device Name
LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR
Manufacturer
LIGHTMED CORP.
Date Cleared
2007-09-20

(323 days)

Product Code
HQF
Regulation Number
886.4390
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The indications of use for this device are:

  • Retinal Photocoagulation
  • Pan Retinal Photocoagulation
  • Macular Photocoagulation
  • Laser Trabeculoplasty
  • Laser trabeculoplasty is photocoagulation of trabecular meshwork to treat Open Angle Glaucoma (OAG).
  • Endocoagulation
Device Description

Not Found

AI/ML Overview

This looks like a 510(k) clearance letter for the LightLas 561 Ophthalmic Photocoagulator Laser. This kind of document typically does not contain the detailed study information you are asking for, as 510(k) applications demonstrate substantial equivalence to a predicate device rather than presenting full clinical trial data on device performance against acceptance criteria.

Therefore, I cannot extract the following information from the provided text:

  1. A table of acceptance criteria and the reported device performance
  2. Sample size used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
  4. Adjudication method
  5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size
  6. If a standalone performance study was done
  7. The type of ground truth used
  8. The sample size for the training set
  9. How the ground truth for the training set was established

The document primarily states that the device is "substantially equivalent" to legally marketed predicate devices and lists its "Indications for Use." It does not provide performance metrics or details of studies used to demonstrate specific performance against acceptance criteria for an AI/ML device. The device is a "Photocoagulator Laser," which is a physical medical device, not a software-based diagnostic or AI/ML product that would typically involve the kind of performance metrics and study design you're asking about (e.g., ground truth, reader studies, test/training sets for algorithms).

§ 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.