K Number
K973220
Date Cleared
1997-11-04

(69 days)

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

The Rodenstock RO 5000 AR, RO 5000 FDY, and RO 5000 AR/FDY Laser Slitlamps are indicated for diagnostic opthalmologic examination of patients with eye disorders. When interfaced with a laser, the device is used for therapeutic treatment of patients where retinal coagulation is indicated.

Device Description

The above models of the modified Rodenstock RO 5000 are slitlamp instruments fitted with a laser adapters, and motor activated, metal-coated safety filters. When used with a laser, the laser beam and the beam path of the slit projection are coupled coaxially via beam splitter cubes. This results in the laser focus and the slit image being projected in a common plane. The beam splitter is operated by a micromanipulator, and can be adjusted in any desired direction by pneumatically driven elements.

AI/ML Overview

This 510(k) summary does not contain information regarding detailed acceptance criteria or a study proving that the device meets specific performance metrics. It's a submission for substantial equivalence based on technological characteristics and intended use compared to a predicate device, not a performance study report for a new AI/software-driven device.

Therefore, many of the requested sections (1, 2, 3, 4, 5, 6, 7, 8, 9) cannot be filled from the provided text.

Here's what can be extracted from the document:

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

  • Not provided. The document is a 510(k) summary for substantial equivalence of a laser slitlamp, not a performance study for an AI-driven device with specific acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

  • Not applicable. This document describes a physical medical device (laser slitlamp), not a software or AI device that uses a "test set" of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

  • Not applicable. This document describes a physical medical device (laser slitlamp), not a software or AI device that requires expert-established ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

  • Not applicable. This document describes a physical medical device (laser slitlamp), not a software or AI device with a test set requiring adjudication.

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 document describes a physical medical device (laser slitlamp), not an AI-assisted diagnostic tool for which an MRMC study would be conducted to evaluate human reader improvement.

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

  • Not applicable. This document describes a physical medical device (laser slitlamp), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

  • Not applicable. This document describes a physical medical device (laser slitlamp), not a software or AI device that relies on a specific type of ground truth for performance evaluation.

8. The sample size for the training set

  • Not applicable. This document describes a physical medical device (laser slitlamp), not a software or AI device that uses a "training set."

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

  • Not applicable. This document describes a physical medical device (laser slitlamp), not a software or AI device that uses a "training set."

Summary of Device and Regulatory Context (from the provided text):

The document is a 510(k) Premarket Notification for the Rodenstock RO 5000 AR, RO 5000 FDY, and RO 5000 AR/FDY Laser Slitlamps. The core of this submission is to demonstrate substantial equivalence to an existing legally marketed device, the Zeiss SL 130 laser slitlamp.

  • Intended Use: Primarily for diagnostic ophthalmologic examinations and as a laser delivery system for treatment of patients with eye disorders. When interfaced with a laser, it's used for therapeutic applications to perform retinal coagulation. The indications are for retinal treatment only.
  • Technological Characteristics: The devices are slitlamp instruments fitted with laser adapters and motor-activated, metal-coated safety filters. The laser beam and slit projection beam path are coupled coaxially via beam splitter cubes, ensuring the laser focus and slit image are projected in a common plane. The beam splitter is adjustable via a micromanipulator and pneumatic elements.
  • Substantial Equivalence: The submitter asserts that the devices are substantially equivalent to the predicate Zeiss SL 130 laser slitlamp based on similar technological characteristics and intended use, noting that the Rodenstock device's indications are within, but not as broad as, those claimed by the predicate device.

Key Takeaway: This document is a regulatory submission focused on comparing a new medical device to a legally marketed predicate device to establish substantial equivalence, rather than providing detailed performance study data against specific acceptance criteria for a novel technology or AI 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.