(27 days)
The Keeler Slit Lamp is an AC-powered Slit lamp biomicroscope and is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment
This device is intended to be used only by suitably trained and authorised healthcare professionals.
An AC-powered slit lamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into the patient's eye through a control diaphragm a thin, intense beam of light.
This Keeler Slit Lamp has an XYZ translation base that is either mounted onto a custom table top supplied by Keeler or can be mounted on a third parties table top (refraction unit) by suitably trained technicians.
Fitted to the XYZ base is the illumination and observation system; fitted to the table top is the chinrest assembly with fixation target.
The illumination system rotates around its mounting axis and has a number of filters and graticules allowing the user to control precisely the characteristics of the examination light. The magnification body has a magnification change systems and eyepieces adjustable for the user's individual pupillary distance and distance correction.
The patient is seated in front of the slit lamp with his/her chin in the chin rest and forehead against the forehead rest. The chin rest can be adjusted in height to align the eyes of the patient with the optics/light beam.
With the control lever the instrument can be moved back and forward until the slit appears in focus on the cornea. The image can be observed through the microscope. The base unit has a rheostat to control the illumination level.
Various magnifications can be selected on the microscope. For different observations the slit width can be changed, the slit can be tilted horizontally, and the angle between the illumination unit and the microscope can also be varied horizontally.
The Keeler Slit Lamp - H Series is an AC-powered slit lamp biomicroscope intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma affecting the structural properties of the anterior eye segment.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" in a quantitative sense for performance metrics like sensitivity, specificity, or accuracy, as would be common for AI/diagnostic devices. Instead, the focus is on demonstrating substantial equivalence to a predicate device (Haag-Streit Slit Lamp BQ 900, K100202) through comparison of technical specifications and compliance with recognized safety and performance standards.
The "acceptance criteria" can be inferred to be compliance with relevant safety and performance standards and demonstrating that any differences from the predicate device do not affect safety or effectiveness.
| Feature | Predicate Device (Haag-Streit BQ 900) | Keeler Slit Lamp H-Series | Acceptance Criteria (Implicit) | Reported Performance (Keeler H-Series) |
|---|---|---|---|---|
| Intended Use | "An AC-powered slit lamp biomicroscope is an AC-powered device..." | "An AC-powered slit lamp biomicroscope is an AC-powered device..." | Same intended use as predicate. | Same. |
| Operating Principle | Not explicitly detailed, but implied by device type. | Not explicitly detailed, but implied by device type. | Same operating principle as predicate. | Same. |
| Basic Optical Design | Not explicitly detailed, but implied by device type. | Not explicitly detailed, but implied by device type. | Same basic optical design as predicate. | Same. |
| Magnification | 6.3x / 10x / 16x / 25x / 40x | x6, x10, x16, x25 & x40 | Differences are not significant and do not affect safety or effectiveness. | Differences noted (6x vs 6.3x, etc.), but deemed not significant and not affecting safety or effectiveness. |
| Objective lens working distance | 105mm | 107mm | Differences are not significant and do not affect safety or effectiveness. | Differences noted, but deemed not significant and not affecting safety or effectiveness. |
| Field of view | 32.0 @ 6.3x / 20.0 @ 10x / 12.7@ 16x / 8.0@ 25x / 5.1@ 40x | 34.0 @ 6x / 22.0 @ 10x / 14 @ 16x / 8.5 @ 25x / 5.5 @ 40x | Differences are not significant and do not affect safety or effectiveness. | Differences noted, but deemed not significant and not affecting safety or effectiveness. |
| Range of PD adjustment | 52 - 78 mm | 49.0 to 77mm | Range conforms to requirement of ISO 10939 and does not affect safety or effectiveness. | Differences noted, but conformance to ISO 10939 and no affect on safety/effectiveness is reported. |
| Eyepiece dioptric adjustment range | +8 to -8 diopters | +8 to -8 diopters | Same as predicate. | Same. |
| Slit Length | 1-8 mm continuous | 12mm (1mm - 12mm continuously variable) | Difference not significant; sufficient for clinical use (e.g., iris diameter), meets ISO 10939, does not affect safety/effectiveness. | Differences noted, but deemed not significant. 12mm is more than sufficient for clinical use (iris diameter max 6mm), meets ISO 10939, and does not affect safety or effectiveness. |
| Slit Width | 0 - 8 mm continuous | 0-12mm continuously variable | Difference not significant; not critical as long as ≥ 8mm, meets ISO 10939, does not affect safety/effectiveness. | Differences noted, but deemed not significant. Maximum slit width not critical as long as ≥ 8mm, with narrow slits often needed for examination. Meets ISO 10939, and does not affect safety or effectiveness. |
| Light source | 7.5V, 38 W Halogen Lamp, 24VDC 1A LED | 6V 20W Halogen lamp and LED | All light sources conform to ISO 15004-2 (Photo-toxicity) and do not affect safety or effectiveness. | Differences noted, but all light sources conform to ISO 15004-2 and there is no affect on safety or effectiveness. |
| Duration of illumination | Maximum examination times according to ISO 15004-2 and ISO 10939 | Maximum examination times according to ISO 15004-2 and ISO 10939 | Same as predicate, conforming to ISO 15004-2 and ISO 10939. | Same. |
| Light intensity selection | Three selections: Full, 1/4 and 1/16 via neutral density filter. | 0-100% continuous potentiometer | Allows the user to select the necessary light intensity to perform the relevant task, difference not significant. | Differences noted, but deemed not significant as both allow user to select necessary light intensity for the task. |
| Filters | Blue, red-free (green), grey (10%); UV and heat absorption filters permanently mounted. | Clear; red-free; neutral density; diffuser; blue; IR heat absorbing filter permanently installed. | Difference not significant and does not affect safety or effectiveness; both have permanently installed heat absorbing filter. | Differences noted, but deemed not significant and not affecting safety or effectiveness. Both devices have a permanently installed heat absorbing filter. |
| Electrical Ratings | Same as predicate. | Same for input voltage, power output, and output voltage. | ||
| Compliance with Safety Standards | IEC60601-1-2, IEC60601-1, ISO 15004-2 | IEC 60601-1-2, IEC 60601-1, ISO15004-2 | Device must be in compliance with these FDA recognized standards. | In compliance with all listed standards (BS EN ISO 15004-2, BS EN ISO 10939 for radiation hazards, IEC 60601-1 for electrical safety, IEC 60601-1-2 for electromagnetic compatibility). |
The study that proves the device meets the acceptance criteria is described as the "Summary of Performance, EMC and Safety Testing."
2. Sample size used for the test set and the data provenance
The document does not describe a test set involving patient data or clinical samples for performance evaluation in the context of diagnostic accuracy (e.g., retrospective or prospective studies with a specific sample size). Since this is a hardware device (slit lamp biomicroscope), testing primarily focuses on engineering performance, electrical safety, EMC, and radiation safety.
Therefore, there is no mention of:
- Sample size for a test set.
- Data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a viewing instrument, and its "performance" is evaluated against technical specifications and safety standards, not against clinical ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or ground truth adjudication process is described for this type of device.
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 device is an ophthalmic instrument, not an AI-powered diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's acceptance is its compliance with internationally recognized consensus standards for medical electrical equipment and ophthalmic instruments (IEC 60601-1, IEC 60601-1-2, ISO 15004-2, ISO 10939). The testing involved objective measurements against these standards, rather than clinical ground truth like pathology or expert consensus on disease diagnosis.
8. The sample size for the training set
Not applicable. This is a hardware device; there is no training set in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned, no ground truth needed to be established for it.
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.