OPTYSE OPHTHALMOSCOPE

• K Number: K061278
• Device Name: OPTYSE OPHTHALMOSCOPE
• Manufacturer: OPHTHALMOS LTD.
• Date Cleared: 2006-05-16 ( 8 days)
• Product Code: HLJ
• Regulation Number: 886.1570
• Type: Abbreviated
• Panel: OP
• Reference & Predicate Devices: K925756

Intended Use

The Optyse™ Lens Free Ophthalmoscope is a direct ophthalmoscope intended to be used by trained professionals to examine the fundus or the inside of the back of the eye.

Device Description

The Optyse™ is a compact battery-powered handheld direct ophthalmoscope for use by trained personnel for viewing the fundus or the inside of the back of the eye of a patient.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Clarity of View	Equivalent performance
   Ability to Visualize Abnormalities	Equivalent performance

2. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not explicitly stated, but described as "user studies comparing the effectiveness of the Optyse™ with legally marketed ophthalmoscopes."
   • Data Provenance: Not explicitly stated, but the studies were conducted by "practising optometrists," suggesting they involved real-world clinical use. It is prospective as it describes clinical performance which would be observed during testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

   • Number of Experts: Not explicitly stated.
   • Qualifications of Experts: The ground truth was established by "practising optometrists." The specific number or their experience level (e.g., years of experience) is not provided.

4. Adjudication Method for the Test Set:

   • Not explicitly stated. The document mentions "user studies comparing the effectiveness," which might imply a qualitative assessment rather than a formal adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Not applicable/Not performed. The submission describes "user studies" that assessed "equivalent performance" by optometrists using the device in comparison to other ophthalmoscopes. This is not presented as an MRMC study designed to quantify human reader improvement with or without AI assistance.

6. Standalone Performance:

   • Yes, a standalone performance was done for the device itself.
     • Non-clinical tests: The Optyse™ device underwent compliance testing to two engineering standards: ISO 10942:1998 (Ophthalmic Instruments – Direct Ophthalmoscopes) and IEC 60601-1:1988 (Medical Electrical Equipment - Part 1 Requirements for Safety (General)). Declarations of conformity were provided for both.
     • Clinical performance: User studies were conducted to compare the device's effectiveness.

7. Type of Ground Truth Used:

   • Expert consensus/clinical assessment by "practising optometrists" regarding "clarity of view and ability to visualise abnormalities."

8. Sample Size for the Training Set:

   • Not applicable/Not stated. The Optyse™ is a hardware medical device (an ophthalmoscope), not an AI/algorithm. Thus, it does not have a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as it's a hardware device and not an AI/algorithm that requires a training set.

Regulation Number and Section

§ 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.