(151 days)
The SLIT LAMP SL-2000 is intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. This device 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-2000 is used to magnify the eyeball, eyelid, and eyelash of patients for observation, using slit illumination light.
The SL-2000 comprises the main unit that incorporates the microscope unit, illumination unit, base plate unit, and power supply box.
This document is a 510(k) premarket notification for the Nidek Co., Ltd. Slit Lamp SL-2000. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific clinical acceptance criteria. Therefore, much of the requested information regarding specific performance metrics, clinical study design, and ground truth establishment is not present in this document because it is not typically required for a 510(k) submission for a device like a slit lamp.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table of quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity) for the slit lamp, as it is a diagnostic tool observed by a human, not an automated diagnostic system. Instead, it focuses on demonstrating that the device meets safety and performance standards equivalent to predicate devices. The "performance" mentioned primarily refers to compliance with international standards for ophthalmic instruments and electrical safety.
| Feature/Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Ophthalmic Performance | Compliance with ISO 15004-1 (Ophthalmic instruments - Slit-lamp microscopes - Part 1: Requirements for slit-lamp microscopes) | Performed, results demonstrate no new questions of safety/effectiveness. |
| Compliance with ISO 15004-2 (Ophthalmic instruments - Slit-lamp microscopes - Part 2: Requirements for illumination safety) | Performed, results demonstrate no new questions of safety/effectiveness. | |
| Ergonomics/Optical | Compliance with ISO 10939 (Ophthalmic instruments - Slit-lamp microscopes - Requirements and test methods) | Performed, results demonstrate no new questions of safety/effectiveness. |
| Eyepieces | Range of total magnification equivalent to predicate devices with 12.5x eyepieces. No new safety/effectiveness questions with optional 16x eyepieces. | 12.5x standard, 16x optional. Total magnification range with 16x eyepieces is equivalent to predicate device range. |
| Field of View Diameter | Range of field of view diameter almost equivalent to predicate device (Zeiss SL 130). Compliance with specifications. | Range nearly equivalent to Zeiss SL 130. Verified and found to comply. |
| Ametropia Compensation | Compensates ±8 D, equivalent to predicate devices. | Compensates ±8 D. |
| Interpupillary Adjustment | Meets range for interpupillary adjustment of 55 mm to 72 mm as required by ISO 10939:2007. | Range of 50 mm to 78 mm. Meets ISO 10939:2007 requirements. |
| Illumination | Width of slit image, slit rotation, angle of incidence, brightness control method same as Zeiss SL 130. Length of slit image range within predicate devices. LED light source. Compliance with ISO 15004-2. Filters (blue, red free, neutral density, barrier for fluorescent observation - yellow). IR cut filter (no heat absorption needed with LED). | Same as Zeiss SL 130 for width, rotation, incidence, brightness control. Length of slit image within predicate range. Uses LED light source, complies with ISO 15004-2. Provided with specified filters. IR cut filter works with LED. |
| Software | Verification and Validation | Performed, results demonstrate no new questions of safety/effectiveness. |
| Usability | Compliance with IEC 60601-1-6 (Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability) and IEC 62366 (Medical devices - Application of usability engineering to medical devices) | Performed, results demonstrate no new questions of safety/effectiveness. |
| Electrical Safety | Compliance with AAMI/ANSI ES60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | Performed, results demonstrate no new questions of safety/effectiveness. |
| EMC | Compliance with IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests) | Performed, results demonstrate no new questions of safety/effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail specific "test set" sample sizes in the context of clinical performance data for diagnosis of diseases. The testing described is primarily limited to bench testing and compliance with engineering and safety standards. There is no mention of clinical data or patient samples being used in the validation tests outlined.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as a clinical test set with ground truth established by experts is not described in this document for a device like a slit lamp in a 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable, as a clinical test set with expert adjudication is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
Not applicable. The Slit Lamp SL-2000 is a manual observation device, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI improvement metrics are relevant or discussed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is a manually operated medical device without an AI algorithm.
7. The Type of Ground Truth Used
Not applicable in the context of clinical diagnostic accuracy. The "ground truth" for the tests performed would be the specifications and requirements outlined in the referenced ISO, IEC, and AAMI/ANSI standards (e.g., a specific light intensity, magnification, or electrical characteristic).
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/machine learning device.
§ 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.