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The GILRAS Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segments.

The GILRAS Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination. There are 3 models GR-SL36, GR-SL54, and GR-SL72. These models differ only in the supplied accessories. All models have the same operating characteristics and intended use.

The provided document is a 510(k) premarket notification for the GILRAS Slit Lamp, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than on providing performance data from a clinical study with acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as it relates to clinical performance metrics like sensitivity, specificity, etc.

Instead, the document demonstrates substantial equivalence through a technological comparison and compliance with recognized standards.

Here's a breakdown of what the document does provide in relation to your request, and why it doesn't fit the typical "acceptance criteria and study" format you've outlined:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly defined in terms of clinical performance (e.g., accuracy metrics). Instead, the "acceptance criteria" are implied by manufacturing specifications and compliance with recognized safety standards (ISO 10939:2007 and IEC 60601-1) and similarity of technological characteristics to the predicate device.

• Reported Device Performance: The document provides a detailed comparison of theGILRAS Slit Lamp's technological characteristics against its predicate device, the 66 Vision-Tech YZ Slit Lamp. This comparison table effectively is the "performance" data in the context of this 510(k) submission, showing how the new device matches or is similar to the predicate.

  Feature	GILRAS Slit Lamp (Reported Performance)
  Intended Use	AC-power slit lamp biomicroscope intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segments.
  Method of Operation	AC-powered
  Exposure Parameters	50000 Lux Maximum, Continuously adjustable from 0 to 50000 Lux
  Maximum temperature of Parts Held by Operator	30°C
  Eyepiece Power	12.5X
  Total Magnification	GR-SL36 - 10X, 16X, 25X; GR-SL54 - 6X, 10X, 16X, 25X, 40X; GR-SL72 - 10X, 16X, 25X
  Stereo Angle	13°
  Diopter Adjustment	-6D to +6D
  Pupillary Adjustment	55mm to 78.5mm
  Slit Width	Continuous from 14mm to 0mm (at 14mm slit becomes a circle)
  Slit Length	Continuous from 14mm to 0mm (at 14mm, slit becomes a circle)
  Slit Angle	0 to 180 degree with horizontal scanning capability
  Aperture Diameters	14, 8, 5, 3, 0.5, and 0.2mm
  Filters	Heat-absorbing, Neutral Density, Cobalt Blue, and Red-Free
  Slit Inclination	5°, 10°, 15°, and 20°
  Illumination Lamp	6V, 20W halogen lamp
  Fixation Target	Green LED
  Brightness Controls	Continuously adjustable from 0 to 50000 Lux
  Patient Contact Materials	Chin-rest paper, Forehead-rest - Polytetrafluoroethylene

2. Sample size used for the test set and the data provenance:

• Not applicable. This document describes a comparison of device specifications, not a clinical study involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No ground truth established from experts for a test set. The "ground truth" here is essentially the predicate device's established technological characteristics and compliance with standards.

4. Adjudication method for the test set:

• Not applicable. No test set or adjudication process described.

5. 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:

• Not applicable. This device is a basic optical instrument (slit lamp), not an AI-powered diagnostic tool. No MRMC study was conducted or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a hardware medical device, not an algorithm.

7. The type of ground truth used:

• For the purpose of this 510(k), the "ground truth" or benchmark is the legally marketed predicate device (66 Vision-Tech YZ Slit Lamp) and recognized industry standards (ISO 10939:2007 and IEC 60601-1). The entire submission hinges on demonstrating that the GILRAS Slit Lamp is "substantially equivalent" to this predicate and meets these standards.

8. The sample size for the training set:

• Not applicable. No training set for an algorithm is mentioned or relevant to this device submission.

9. How the ground truth for the training set was established:

• Not applicable. No training set.

Conclusion:

The K080776 document demonstrates the GILRAS Slit Lamp's "acceptance criteria" by showing its adherence to safety standards and its substantial equivalence in technological characteristics to a predicate device. It does not involve performance studies with clinical acceptance criteria, sample sizes, expert ground truth, or AI-related metrics as typically outlined in your request.

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