(90 days)
Propper Insight™ Binocular Indirect Ophthalmoscope is an AC-adapter powered or rechargeable battery powered 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 Propper Insight™ Binocular Indirect Ophthalmoscope is an AC-powered or rechargeable battery-powered indirect ophthalmoscope that complies with standard ISO 10943:2012, Ophthalmic Instruments - Indirect Ophthalmoscopes.
The Propper Insight 100 is a Binocular Indirect Ophthalmoscope (abbreviated - BIO), worn on the medical professional's head containing illumination and viewing optics intended to examine the media and the retina of the eye when used in conjunction with an ophthalmic lens.
The illumination part of the Propper Insight™ Binocular Indirect Ophthalmoscope consists of a LED (Light Emitting Diode) source, lenses, a selection of red-free, amber and cobalt blue filters, three sizes of light apertures, diffuser and illumination mirror. The device has optomechanical system for adjustment of illumination level, which is based on the relative positions of two polarizer filters.
The viewing part consists of viewing lenses, and mirrors that are adjustable to obtain views of the patient eye fundus.
The illumination part and the viewing part are combined in the metal housing (BIO Module) which is attached to the headband with the pivot bracket mechanism. The attachment mechanism allows the BIO Module to be pivoted between in-use (down) and out-of-use positions (up). The attachment mechanism also allows adjustment of the BIO Module relative to the user's eyes for the most optimal viewing path. The attachment mechanism includes a magnetic securement of the BIO Module in both in-use and out-of-use positions. Part of the magnetic securement operates an electric contact to automatically provide power to the illumination source in the in-use position.
The BIO Module and the power cable connector (AC-powered version), or the BIO Module and the rechargeable battery are attached to the adjustable headband.
This is a medical device submission for a Binocular Indirect Ophthalmoscope (BIO), not an AI/ML device. Therefore, the questions related to AI/ML specific criteria like acceptance criteria tables, sample sizes for training/test sets, ground truth establishment methods, expert adjudication, MRMC studies, and standalone performance are not applicable.
The document describes the device, its intended use, and establishes substantial equivalence to a predicate device.
Here's what information can be extracted based on the provided text, and why other parts of your request are not applicable:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This device is a traditional medical instrument, not an AI/ML diagnostic or predictive tool. As such, there aren't "acceptance criteria" in the sense of performance metrics (like sensitivity, specificity, accuracy) that are common for AI/ML algorithms. Instead, regulatory approval for such a device is based on demonstrating safety, effectiveness, and substantial equivalence to a legally marketed predicate device. This involves meeting recognized standards (like ISO 10943:2012), conducting bench testing, and verifying manufacturing quality. The document states the device "complies with standard ISO 10943:2012, Ophthalmic Instruments - Indirect Ophthalmoscopes," which acts as the primary "acceptance criteria" for its design and performance characteristics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. As this is a traditional medical hardware device (an ophthalmoscope), there is no "test set" of data in the context of AI/ML or image analysis. The evaluation for substantial equivalence would involve engineering bench testing, electrical safety testing, and potentially user studies for usability, but not a dataset for an algorithm.
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" or expert review of data is involved in the evaluation of this hardware device in the way it would be for an AI/ML algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or data adjudication process as described for AI/ML.
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
- Not Applicable. This is not an AI-assisted device, so no MRMC study comparing human readers with and without AI assistance would have been performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a standalone hardware device used by a human clinician; it does not involve a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No "ground truth" in the context of clinical data assessment is relevant for this hardware device submission. Its performance is assessed against engineering standards and functional requirements.
8. The sample size for the training set
- Not Applicable. No training set, as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. No training set or ground truth establishment relevant to AI/ML.
Summary of what is present in the document:
- Device Name: Propper Insight™ Binocular Indirect Ophthalmoscope (BIO) Kits (Models 199185 and 199285)
- Regulatory Class: II (Product Code: HLI)
- Intended Use: "Propper Insight™ Binocular Indirect Ophthalmoscope is an AC-adapter powered or rechargeable battery powered device for medical professionals containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye."
- Predicate Device: Heine OMEGA 500 binocular Indirect ophthalmoscope, LED version (K123316)
- Substantial Equivalence Basis: The Propper Insight™ BIO is deemed substantially equivalent to the predicate device because:
- Both are designed for the same purpose.
- Both use similar light sources (LED).
- Both have the same indications for use.
- Both have very similar operational principles and design.
- The new device does not introduce new potential hazards or safety risks.
- The device "complies with standard ISO 10943:2012, Ophthalmic Instruments - Indirect Ophthalmoscopes." This compliance serves as the primary technical validation for the device's performance and design.
§ 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.