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K Number
K142837
Device Name
HEINE SIGMA 250 & HEINE SIGMA 250 M2
Manufacturer
HEINE Optotechnik GmbH & Co. KG
Date Cleared
2015-01-29

(121 days)

Product Code
HLJ
Regulation Number
886.1570
Type
Abbreviated
Panel
OP
Reference & Predicate Devices
K123316
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The HEINE SIGMA® 250 (M2) are battery powered indirect ophthalmoscopes for medical professionals, containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye.

Device Description

The HEINE SIGMA® 250 (M2) are indirect ophthalmoscopes, worn on the user's head to provide illumination and viewing optics in order to examine the media and the retina of a patient`s eye. The indirect ophthalmoscopes are battery operated.

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) premarket notification for an ophthalmoscope, which is a physical diagnostic device, not an AI/software-based device.

Therefore, it does not include:

  1. Acceptance criteria or device performance for an AI algorithm.
  2. Sample sizes for test sets, data provenance, or details about training sets.
  3. Information on expert involvement (number, qualifications, adjudication methods) for establishing ground truth.
  4. Details on AI-specific studies like MRMC comparative effectiveness or standalone algorithm performance.
  5. Types of ground truth used in the context of AI models (e.g., pathology, outcomes data).

The document focuses on demonstrating substantial equivalence to a predicate ophthalmoscope based on intended use, technological characteristics, and safety standards for the physical device. It mentions "non-clinical performance testing" for the ophthalmoscope itself, referring to compliance with ISO standards for optical radiation and fundamental requirements, not the performance of a diagnostic AI.

§ 886.1570 Ophthalmoscope.

(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.