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510(k) Data Aggregation
(253 days)
The HEINE mini 3000 Ophthalmoscope is a battery powered hand-held device for medical professionals, containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye.
The HEINE mini 3000® Ophthalmoscope is a battery powered hand-held device to provide illumination and viewing optics in order to examine the media and the retina of a patient's eye. It consists of an instrument head and a battery handle that can be screwed onto the instrument head. The ophthalmoscope can be either operated by replaceable AA batteries or a rechargeable option in combination with the HEINE mini NT® charger.
This document describes the HEINE mini 3000® Ophthalmoscope and its compliance with relevant standards. Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
The device's acceptance criteria are based on safety limits for optical radiation hazards as defined by the "Ophthalmoscope Guidance" (ISO 10942) and "Ophthalmic instruments - Fundamental requirements and test methods" (ISO 15004-2). The study demonstrates that the HEINE mini 3000® Ophthalmoscope meets these safety requirements.
Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Test Specification | Wavelength | Acceptance Limit (Group 2) | Reported Device Performance | Verdict |
|---|---|---|---|---|---|
| Weighted corneal and lenticular UV, ES-CL, HS-CL | The corneal radiant exposure shall be evaluated by averaging highest localized radiation power incident upon a circular area at the corneal plane with a diameter of 1 mm (7.9 x 10⁻³ cm²). | 250 - 400 nm | 3 mJ cm⁻² | 0.008 µW cm⁻² | PASS |
| Unweighted corneal and lenticular UV, EUV-CL, HUV-CL | The corneal radiant exposure shall be evaluated by averaging highest localized radiation power incident upon a circular area at the corneal plane with a diameter of 1 mm (7.9 x 10⁻³ cm²). | 360 - 400 nm | 1 J cm⁻² (t < 1000 s) | 0.019 µW cm⁻² | PASS |
| Unweighted corneal and lenticular infrared, EIR-CL | The corneal irradiance shall be evaluated by averaging the highest localized radiation power incident upon a circular area at the corneal plane with a diameter of 1 mm (7.9 x 10⁻³ cm²). | 770 - 2500 nm | 100 mW cm⁻² | 1.65 µW cm⁻² | PASS |
| Unweighted anterior segment visible and infrared, EVIR-AS, HVIR-AS | The unweighted anterior segment irradiance shall be evaluated by averaging the highest localized radiation power incident upon a circular area at the corneal plane with a diameter of 0.5 mm (2.0 x 10⁻³ cm²). | 380 - 1200 nm | 20 W cm⁻² | Not applicable | PASS |
| Weighted retinal radiance, Li, A-R | Measurements of radiance shall be the radiant power detectable through a 7 mm diameter aperture at the cornea and shall be averaged over a right circular cone field-of-view of 0.011 rad. However, if the instrument is designed to be used with an eye that is immobilized, a field-of-view of 0.001 75 rad shall be used instead of the 0.011 rad field-of-view. | 305 - 700 nm | 100 J cm⁻² sr⁻¹ | 11 mrad: 1216 mW cm⁻² sr⁻¹1.75 mrad: 2124 mW cm⁻² sr⁻¹ | PASS |
| Weighted retinal visible and infrared thermal radiance, LVIR-R | In the expression for the limit value, under normal intended use conditions, dr, expressed in millimetres, is the minimum retinal image diameter of the source based on the standard eye (see Annex D for instructions on the way to determine the value of dr). If the calculated value of dr is greater than 1.7 mm, the value 1.7 mm shall be used for dr. If the calculated value of dr is less than 0.03 mm, the value of 0.03 mm shall be used for dr. Measurements of radiance shall be the radiant power detectable through a 7 mm diameter aperture at the cornea and shall be averaged over a right circular cone field-of-view of 0.001 75 rad. | 380 - 1400 nm | 29.4 W cm⁻² sr⁻¹ | 1.75 mrad: 19.9 W cm⁻² sr⁻¹ | PASS |
Study Proving Device Meets Acceptance Criteria
The study conducted to prove the device meets the acceptance criteria is a Summary of Non-Clinical Performance Testing. This involved bench testing according to specific international standards.
1. Sample sized used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as this is non-clinical bench testing of the device itself, not a study involving human subjects or data sets. The testing focuses on the physical properties and emissions of a single device or device type.
- Data Provenance: The testing was conducted by Seibersdorf Laboratories in Germany (indicated by the report date "11.06.2013" and the "Issued by Seibersdorf Laboratories" line). This is non-clinical, prospective testing on the physical device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study requiring expert readers or interpretation of medical images. The ground truth is established by the specified international standards and measurement protocols, conducted by the testing laboratory.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring adjudication of expert opinions. The measurements directly compare device performance against defined safety limits in established standards.
4. 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 medical device (ophthalmoscope) and its safety compliance, not an AI-powered diagnostic system.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm. The testing is a standalone assessment of the device's physical properties.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is defined by the safety limits and test specifications set forth in the international standards ISO 10942 and ISO 15004-2. These are established engineering and medical device safety standards.
7. The sample size for the training set:
- Not applicable. This is not a machine learning or AI-based device, so there is no "training set."
8. How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.
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