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The Keeler Wide Angle Ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous, and retina of the eye. It has the same operating principles and intended use as many competitive ophthalmoscopes already in commercial distribution. The device is intended to be used by trained personnel within a medical or school environment.

The Keeler Wide Angle Ophthalmoscope is a hand held indirect monocular device for use by trained personnel for viewing the cornea and retina of a patient. The viewing path in conjunction with the large solid angle projection of the illumination path provides two angles of view which provides larger fields of view than attainable with a conventional direct ophthalmoscope. The viewing optical system composes of two objective lenses, relay components and eyepiece provide an erect, un-reversed image of the patients retina to the doctor. The illumination path of the instrument consists of a filament lamp, a condensing system, two full mirrors and one semi-reflector mirror. The illumination path is imaged iust below the viewing optics axis as they combine at the semi-reflector mirror. The condensing lenses image the lamp filament essentially onto the patient's cornea. The filament image at the corneal plane is small permitting an increase ease of entry into undilated pupil. Any reflections of the filament from the surface of the cornea are trapped on light stops, which are positioned within the viewing optics. This allows the practitioner to obtain reflex free images of the retina.

The provided text describes a 510(k) summary for the Keeler Wide Angle Ophthalmoscope. This type of regulatory submission demonstrates substantial equivalence to a predicate device, rather than proving effectiveness through clinical trials with specific acceptance criteria, sample sizes, or ground truth establishment in the manner of AI/software devices. The document explicitly states: "The effectiveness of the Keeler Wide Angle Ophthalmoscope is the same as current monocular indirect ophthalmoscopes already on the market."

Therefore, the study described is not designed to meet specific acceptance criteria with quantifiable performance metrics such as sensitivity, specificity, or AUC against a defined ground truth, as would be typical for an AI/CADe device. Instead, the effectiveness is established by demonstrating equivalence in intended use and operating principles to existing predicate devices.

However, I can extract the information related to how "effectiveness" was assessed, even if it's not a quantitative study in the sense of AI performance evaluation.

Here's the breakdown of the information based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly quantified. The document refers to "practicing physicians" participating in "assessments" to establish if the device met their needs.
   • Data Provenance: Not specified, but implied to be from clinical use by practitioners. Retrospective or prospective is not mentioned, but "assessments" with "practicing physicians" suggests a prospective evaluation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not explicitly stated as a specific number. The document mentions "the evaluating physicians," implying multiple individuals.
   • Qualifications: "practicing physicians" who were "users of either the Keeler Ophthalmoscope or a competitor's model (all have the same intended use)." No specific experience levels (e.g., "radiologist with 10 years of experience") are provided.

3. Adjudication method for the test set:

   • No formal adjudication method (like 2+1, 3+1) is described. The "assessments" by evaluating physicians led to a qualitative conclusion about meeting needs.

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:

   • No MRMC study was conducted. This device is a manual ophthalmoscope, not an AI-assisted device, so this type of study is not applicable. The comparison was about the device's performance versus predicate devices, not human reader improvement with AI.

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

   • Not applicable. This is a medical instrument, not an algorithm. Its performance is inherently human-in-the-loop as it's operated by a physician.

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

   • Ground Truth: The "ground truth" in this context was qualitative, based on the subjective assessment and feedback from "practicing physicians" regarding whether the device met their "needs" and performed equivalently or better than existing devices for "documentation procedure." It was not based on objective diagnostic criteria like pathology or outcomes data.

7. The sample size for the training set:

   • Not applicable. This is a hardware medical device, not a machine learning model, so there is no concept of a "training set" in the conventional sense for AI.

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

   • Not applicable, as there is no training set for this type of device.

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