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The HEINE mini 3000® LED 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® LED Ophthalmoscope is a battery powered hand-held device to provide illumination and viewing optics in order to examine the retina of a patient's eve. 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 is a 510(k) premarket notification for a medical device, the HEINE mini3000® LED Ophthalmoscope. It primarily focuses on demonstrating substantial equivalence to a predicate device (Piccolight® E50 Ophthalmoscope), rather than providing a detailed study proving the device meets specific acceptance criteria via clinical performance data.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in the typical sense of performance metrics for a diagnostic accuracy study (e.g., sensitivity, specificity, AUC). Instead, it compares the technical specifications and intended use of the HEINE mini3000® LED Ophthalmoscope to a predicate device, Piccolight® E50 Ophthalmoscope, to establish substantial equivalence.

Study Proving Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is a premarket notification (510(k)) for substantial equivalence. It does not involve a clinical trial or performance study in the way a new diagnostic algorithm would. Instead, it argues that the HEINE mini3000® LED Ophthalmoscope is as safe and effective as a legally marketed predicate device (Piccolight® E50 Ophthalmoscope) because:

• Its intended use is the same.
• Its technological characteristics are similar, and any differences (e.g., LED vs. halogen, additional apertures, red-free filter) do not raise new questions of safety or effectiveness and in some cases offer benefits.
• It complies with relevant consensus standards for medical devices and ophthalmic instruments (ISO 10942, ISO 15004-2, IEC 60601-1, IEC 60601-1-2).

Specific Information Requested:

1. A table of acceptance criteria and the reported device performance: See above. The acceptance criteria here are demonstrated "sameness" or justified differences compared to the predicate, and compliance with recognized standards.

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 / No specific test set in the clinical performance sense. This submission is based on engineering design, technical specifications, and compliance with international standards, rather than clinical performance data from a "test set" of patients or images. The "data" provenance would be internal engineering tests and standard compliance reports.

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. No ground truth was established by experts for a clinical performance test set in this context.

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

   • Not applicable. No clinical test set or adjudication was performed for this type of submission.

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:

   • No. This device is a manual ophthalmoscope, not an AI-assisted diagnostic tool.

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

   • No. This device is not an algorithm; it's a physical medical instrument requiring human operation.

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

   • Not applicable. The "ground truth" for this submission revolves around engineering specifications, safety testing (e.g., electrical safety, optical radiation hazards), and comparison to the predicate device's established safety and effectiveness.

8. The sample size for the training set:

   • Not applicable. No "training set" in the context of machine learning or clinical study data was used.

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

   • Not applicable.

In summary, this document demonstrates substantial equivalence for a medical device by comparing its design, intended use, and technical specifications to those of a legally marketed predicate device, and by showing compliance with relevant safety and performance standards. It is not a clinical study assessing diagnostic performance or AI effectiveness.

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