(265 days)
An AC-powered slit-lamp biomicroscope and accessories intended for use in the 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 traumas which affect the structural properties of the anterior eye segment.
An AC-powered slit lamp biomicroscope 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.
An AC-Powered slit lamp 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.
The slit lamp illumination is composed of the light source, the slit, collimation and imaging optics, and infrared and ultra violet filters and a dielectric mirror. The slit lamp have the option to combine a background illumination together with the slit illumination.
The patient sits in front of the slit lamp with his chin in the chin rest and his forehead against the forehead band. The chin rest is adjusted in height until the eyes of the patient are level with the black mark of the headrest column. The light is switched on and the brightness is controlled with a knob on the power supply. With the joystick 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. Various maqnifications can be selected on the microscope. For different observations the slit width can be changed, the slit can be tilted horizontally and vertically, and the angle between the illumination unit and the microscope can also be varied horizontally.
The provided document is a 510(k) premarket notification for a Class II medical device, the Z5 and Z2 Slit Lamp Microscopes. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study with acceptance criteria for device performance in diagnosis or treatment.
Therefore, the document does not contain information related to acceptance criteria or studies that prove the device meets such criteria in the context of diagnostic accuracy, which is typically seen for AI/ML devices.
Instead, the performance data provided relates to the physical and technical specifications of the slit lamps and compliance with recognized safety and performance standards.
Here's the breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
Since this is not a diagnostic AI/ML device, there are no diagnostic accuracy acceptance criteria or performance metrics in that sense. The "performance" described relates to technical specifications and safety standards.
| Characteristic / Standard | Acceptance Criteria (Implied by standard compliance) | Reported Device Performance (Z5 & Z2 Slit Lamp Microscopes) |
|---|---|---|
| Radiation Hazards | Compliance with ISO 15004-2:2007 and ISO 10939:2007 | In compliance with these FDA recognized standards |
| Electrical Safety | Compliance with IEC 60601-1 | In compliance with this FDA recognized standard |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | In compliance with this FDA recognized standard |
| Specific Features (Example) | Predicate Device Specifications: | Takagi Slit Lamp Specifications: |
| Z5 Max Brightness (Lux) | BQ900: approx. 450,000 Lux | Z5: approx. 240,000 Lux |
| Z2 Max Brightness (Lux) | SL-2G: Unknown | Z2: approx. 150,000 Lux |
| Z5 Illumination Field Diameter (mm) | BQ900: Φ8, Φ5, Φ3, Φ2, Φ1, Φ0.2 | Z5: Φ14, Φ10, Φ5, Φ3, Φ2, Φ1, Φ0.2 |
| Z2 Illumination Field Diameter (mm) | SL-2G: Φ14, Φ10, Φ5, Φ1, Φ0.3 | Z2: Φ14, Φ8, Φ5, Φ3, Φ0.3 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable or not provided in this 510(k) submission. No clinical test set of patients or medical images is described for performance evaluation of diagnostic accuracy. The "tests" mentioned are engineering and safety compliance tests on the physical device.
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)
This information is not applicable or not provided. There is no ground truth, as typically understood for diagnostic AI/ML devices, described in this submission. The device is a traditional medical instrument.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or not provided.
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
This information is not applicable or not provided. The device is a conventional slit lamp microscope, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable or not provided. The device is an optical instrument requiring human operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable or not provided.
8. The sample size for the training set
This information is not applicable or not provided.
9. How the ground truth for the training set was established
This information is not applicable or not provided.
Summary of why the requested information is largely absent:
The document describes a traditional medical device (slit lamp microscope) and its premarket notification (510(k)) to the FDA. The purpose of a 510(k) for such a device is to demonstrate substantial equivalence to existing, legally marketed predicate devices. This typically involves comparing technical specifications, materials, safety features, and compliance with recognized industry standards (e.g., electrical safety, EMC, radiation hazards). It does not require clinical studies for diagnostic accuracy, particularly those involving "acceptance criteria" or "ground truth" derived from expert consensus on patient data, which are common requirements for AI/ML-driven diagnostic software. The "performance" referred to in this document relates to the physical and technical functionality of the instrument itself.
§ 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.