(57 days)
The Keeler Vamage Plus Indirect Ophthalmoscope is intended to examine the Cornea, aqueous, lens, vitreous and retina of the eye.
The Vantage Plus is a head mounted Binocular Indirect ophthalmoscope designed to be used by trained personnel for illuminating and viewing parts of the eye such as the Cornea and retina when used in conjunction with an ophthalmic lens. The instrument has two main elements i) The illumination element ii) the viewing element. The illumination element consists of a 6Volt, 5Watt Xenon filament lamp, a condensing lens, IR filtration, User filters for diagnostic purposes, variable stop sizes for increasing/decreasing light aperture sizes, a projection lens and an illumination mirror used by the user to direct the light. The binocular Viewing element consists of low powered Viewing Lenses (+2 dioptre) and directional mirrors which are adjustable to obtain optimal views of the eye. The unit has adjustable illumination levels and is powered by the same power sources to that used on the Vantage (Re: 510(k) K942104).
To improve the ease of use of the instrument, the Vantage Plus combines the Aperture selector control and the Viewing mirror adjustments to achieve optimal instrument setting with minimum fuss. This feature is not present on the Vantage (Re: 510(k) K942104).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Keeler Vantage Plus Binocular Indirect Ophthalmoscope, structured according to your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to a predicate device (Vantage Binocular Indirect Ophthalmoscope) rather than presenting a study with specific acceptance criteria that the device meets to establish a new performance benchmark. Instead, it compares the technological characteristics and safety features of the new device against the predicate.
Here's a table based on the provided "Comparison of Indirect Ophthalmoscope Technological Characteristics," where the "Acceptance Criteria" are implied by the predicate device's characteristics and the new device's performance aligns with or is considered equivalent to those.
| Criteria | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Vantage Plus) |
|---|---|---|
| Type | Binocular (Headband Mounted) | Binocular (Headband Mounted) |
| Illumination | 6V, 10 Watt Halogen Filament Bulb (Predicate) | 6V, 5 Watt Xenon Filament Bulb (Different bulb type, but considered equivalent/improved for intended use) |
| Safety Filter IR Blocker | Selectable | Permanent (Considered an improvement for safety) |
| Light Output (60mm patch size) | 954 Lux (Average from selection of bulbs) | 913 Lux (Comparable and within an acceptable range for ophthalmoscopic examination) |
| Blue Filter | Selectable | Selectable |
| Red Free Filter | Selectable | Selectable |
| Diffuser | Selectable | Selectable |
| Light aperture sizes | Large (60mm), Medium (45mm), Small (22mm) | Large (60mm) +/-5%, Medium (45mm) +/-5%, Small (22mm) +/-5% (Within acceptable tolerance of predicate) |
| Inter Pupillary Distance Adj. | 52mm to 76mm | 52mm to 76mm (No change from predicate) |
| Lens Power Viewing Optics | +2 Dioptre | +2 Dioptre |
| Attachments | Hi-Mag, Teaching Mirror | Hi-Mag, Teaching Mirror |
| Power Sources | Wall Pack, Smart Pack, Wireless battery Pack (Compliant with BS EN 60601-1 and 60601-1-2) | Wall Pack, Smart Pack, Wireless Battery Pack (Same as predicate, and stated to be compliant with BS EN 60601-1 and 60601-1-2 with no adverse reports for these products) |
| Quality Approvals | ISO 9001:2000 and BS EN 13485:2003 compliant; full risk analysis, risk management, design verification/validation conducted to meet/surpass product specifications and relevant standards. | Keeler is an ISO 9001:2000 and BS EN 13485:2003 compliant company, follows the stated design process including risk analysis and validation to meet/surpass specifications and comply with relevant standards. |
| Risk Management | Completed as per BS EN ISO 14971:2001 | Completed as per BS EN ISO 14971:2001 |
| Light Hazard | Within limits specified for Optical radiation Hazard (Section 6.3) of BS EN ISO 15004:1998 | Tested in accordance with BS EN ISO 15004:1998 and within specified limits (See separate report under Technical Documentation). |
| Electrical Safety | Power sources compliant with BS EN 60601-1 and 60601-1-2 with no adverse reports. | Power sources are the same as the predicate, compliant with BS EN 60601-1 and 60601-1-2, and Keeler has not received any adverse reports on these products. |
| Explosion Hazard | Low probability; measures taken using non-explosive materials, meeting electrical safety requirements, detailed user instructions. | Low probability; measures taken using non-explosive materials, meeting electrical safety requirements, detailed user instructions. |
| Fire Hazard | Low probability; self-extinguishing materials (HB or VO rated), materials in vicinity of illumination (5W Xenon lamp) designed for high-temperature environments. | Low probability; self-extinguishing materials (HB or VO rated), materials in vicinity of illumination (5W Xenon lamp) designed for high-temperature environments. |
| Surface Temperature | Compliance with BS EN ISO 60601-1 for temperature of external surfaces and controls; caution instruction "Do not remove bulb whilst hot." | Complies with BS EN ISO 60601-1 for temperature of external surfaces and controls; caution instruction "Do not remove bulb whilst hot." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not describe a clinical "test set" in the traditional sense for evaluating diagnostic accuracy or a specific performance metric against a ground truth. Instead, the submission details a technical comparison and safety assessment against a predicate device.
- Test Set/Sample Size: Not explicitly applicable in the context of a clinical performance study. The "measurements" for characteristics like light output and aperture sizes were taken from a "selection of bulbs" and from "440mm from the front of the instrument" on "a fully functional prototype." Specific numbers for how many prototypes were tested for these physical characteristics are not provided.
- Data Provenance: The testing appears to have been conducted internally by Keeler Ltd., located in Windsor, Berkshire, United Kingdom. The data is retrospective in the sense that it's a comparison to an already marketed device, but the testing on the "Vantage Plus" prototype would be prospective for the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided because the submission does not involve a clinical study requiring expert-established ground truth for a diagnostic outcome. The "ground truth" for the technical characteristics is established by the measurements and adherence to international standards.
4. Adjudication Method for the Test Set
Not applicable, as there was no clinical test set requiring adjudication of diagnostic outcomes.
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 MRMC study was performed or mentioned. This device is a manual ophthalmoscope, not an AI-powered diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. The Vantage Plus Binocular Indirect Ophthalmoscope is a medical instrument used by a human operator, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" here is based on:
- Physical measurements and engineering specifications: For characteristics like light output, aperture size, lens power, etc.
- International safety and quality standards: BS EN ISO 15004:1998 (Light Hazard), BS EN ISO 14971:2001 (Risk Management), BS EN 60601-1 and 60601-1-2 (Electrical Safety).
- Performance of the legally marketed predicate device (Keeler Vantage): The predicate's characteristics serve as the baseline for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned for this device.
§ 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.