(90 days)
The Slit Lamp SL-2G is an AC-powered slitlamp 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 which affect the structural properties of the anterior eye segment.
The Slit Lamp SL-2G 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. The Slit Lamp SL-2G is composed of the following components: microscope unit, illumination unit, chinrest, table and power unit. The slitlamp biomicroscope is used for the observation of the eye. It has an illumination unit to illuminate the eye, and a binocular stereoscopic microscope to zoom and observe patient's eyes, and also can observe the three-dimensional image.
This submission describes a slit lamp biomicroscope, a medical device used for eye examinations. The acceptance criteria and supporting studies for this type of device are primarily focused on compliance with recognized performance standards related to safety, electromagnetic compatibility, and specific ophthalmic instrument requirements, rather than clinical performance metrics typically associated with AI/software devices. Therefore, many of the requested elements (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training sets) are not applicable in the context of this traditional medical device submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| IEC 60601-1 (Safety) | Conforms |
| IEC 60601-1-2 (EMC) | Conforms |
| ISO 15004-1 (Ophthalmic General) | Conforms |
| ISO 15004-2 (Light Hazard) | Conforms |
| ISO 10939 (Slit Lamp Specific) | Conforms |
| Exposure Parameters | Within predicate specifications: |
| Slit image width | Within specifications |
| Slit image length | Within specifications |
| Illumination field diameter | Within specifications |
| Slit direction | Within specifications |
| Brightness | Maximum 160,000 Lux (within range of predicate's available light sources) |
| Magnification steps | Same as predicate (BP 900) |
| Eyepiece lens magnification | Same as predicate (BP 900) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for this type of device. The "test set" here refers to the device itself undergoing engineering and performance testing against established standards, not a clinical data set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. Ground truth for a physical medical device's compliance with safety and performance standards is established through engineering tests, measurements, and adherence to manufacturing specifications, not typically through expert consensus on a clinical test set.
4. Adjudication Method for the Test Set
Not applicable. The "adjudication method" is not relevant for testing against engineering and performance standards.
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 is a traditional medical device (slit lamp), not an AI/Software as a Medical Device (SaMD). Therefore, no MRMC comparative effectiveness study was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a manual medical device operated by a human, not an algorithm.
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 (IEC, ISO) and its demonstration of similar technological characteristics and performance parameters to previously cleared predicate devices. This involves direct measurement, engineering verification, and comparison of specifications.
8. The Sample Size for the Training Set
Not applicable. This is a hardware medical device, not a machine learning algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this device.
Summary of the Study Proving Device Meets Acceptance Criteria:
The "study" demonstrating the device meets the acceptance criteria is a substantial equivalence comparison to predicate devices, supported by compliance with recognized international consensus standards.
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Substantial Equivalence: The Topcon Slit Lamp SL-2G was compared to the HAAG-STREIT Slit Lamps BM 900/BQ 900/BP 900 (K100202) and BC 900 (K982057).
- Identical Intended Use/Indications for Use: Both the proposed device and predicates are intended for eye examination of the anterior eye segment to aid in diagnosing diseases or trauma.
- Similar Technological Characteristics: Both are AC-powered slit lamp biomicroscopes that project a light beam into the patient's eye.
- Equivalent Performance Parameters: "Exposure parameters including slit image width, slit image length, illumination field diameter and slit direction are all within the specifications of the previously cleared predicate devices."
- Light Source: While the SL-2G uses an LED (max 160,000 Lux), this is noted as one of the available light sources for the predicate BM 900/BQ 900/BP 900 series (which has a maximum brightness up to 450,000 Lux). The SL-2G's brightness is within an acceptable range for a slit lamp.
- Magnification: The SL-2G has the same magnification steps and eyepiece lens magnification as the predicate BP 900.
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Compliance with Standards: The device conforms to the following standards, which define electrical safety, electromagnetic compatibility, and specific requirements for ophthalmic instruments and slit lamp microscopes:
- IEC 60601-1 (General Safety)
- IEC 60601-1-2 (Electromagnetic Compatibility)
- ISO 15004-1 (Ophthalmic Instruments - General Requirements)
- ISO 15004-2 (Light Hazard Protection)
- ISO 10939 (Slit Lamp Microscopes Specific)
The conclusion is that the Topcon Slit Lamp SL-2G is "substantially equivalent" to its predicate devices because it shares the same intended use, similar technological characteristics, and conforms to the same recognized performance standards. This demonstrates that the device meets safety and effectiveness requirements without raising new questions of safety or effectiveness.
§ 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.