(205 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 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 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 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 provided document describes a 510(k) premarket notification for the Marco Ultra M3 and Marco Ultra M4 slit lamp biomicroscopes. This notification focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical performance or diagnostic accuracy enhancements. Therefore, the document does not contain details about acceptance criteria, a study proving device performance in terms of diagnostic accuracy, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to AI/diagnostic performance.
Instead, the "acceptance criteria" for this type of submission are primarily related to safety, electrical compatibility, and optical performance in comparison to predicate devices, and the "study" is a series of tests to confirm compliance with recognized standards.
Here's an analysis of the provided information, focusing on what is present:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide a table of acceptance criteria in the context of diagnostic performance or AI accuracy. Instead, it demonstrates compliance with recognized safety and performance standards. The "performance" reported are the characteristics of the device itself and its adherence to these standards.
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance (Compliance) |
|---|---|
| Adherence to ISO 15004-2:2007 (Ophthalmic instruments — Fundamental requirements and test methods — Part 2: Light hazard protection) | In compliance with ISO 15004-2:2007 for radiation hazards. |
| Adherence to ISO 10939:2007 (Ophthalmic instruments — Slit-lamp microscopes) | In compliance with ISO 10939:2007 for radiation hazards. |
| Adherence to IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | In compliance with IEC 60601-1 for electrical safety. |
| Adherence to 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) | In compliance with IEC 60601-1-2 for electromagnetic compatibility. |
The document also provides a comparison of technological characteristics between the proposed devices (MARCO ULTRA M3, MARCO ULTRA M4) and their predicate devices (Slit Lamp BM900, Z2 Slit lamp microscope). These comparisons are used to argue for substantial equivalence, implying that the new devices perform safely and effectively within the established range for such devices. Examples of characteristics compared include:
- Brightness Controls: Variable control vs. Light intensity control knob, Maximum brightness (e.g., 240,000 Lux for M3 vs. 450,000 Lux for BM900; 150,000 Lux for M4 vs. 150,000 Lux for Z2).
- Slit image width: 0-14mm continuous for all proposed models vs. 0-8mm for BM900 and 0-14mm for Z2.
- Slit image length: 1-14mm continuous for all proposed models vs. 1-8mm for BM900 and 1-14mm for Z2.
- Illumination field Diameter: Specific discrete values compared (e.g., φ10,φ5, φ3, φ2, φ1, φ0.2 mm for M3 vs. φ8,φ5,φ3,φ2,φ1,φ0.2 mm for BM900).
- Radial movement of the slit light illumination: Horizontal ±90° for all, Vertical 0°,5°,10°,15°,20° for M3 vs. 0-20° for BM900, and Vertical "don't apply" for M4 vs. Z2.
- Light source: LED for all.
- Background illumination: None for M3 vs. Option for BM900; Mounted in Slit lamp unit for M4 vs. None for Z2.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests performed are compliance tests against established engineering and safety standards, not clinical trials with patient data.
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 provided in the document. As stated above, the "tests" are technical compliance tests, not clinical evaluations requiring expert consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. The document details technical compliance testing, which does not involve adjudication of expert interpretations.
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 provided. The device in question is an AC-Powered Slit-lamp Biomicroscope, which is a foundational diagnostic instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The device is an optical instrument for direct human examination, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable as the document describes technical compliance testing for an optical instrument, not a diagnostic device relying on ground truth for performance evaluation in a clinical sense. The "ground truth" here would be the specifications and requirements defined by the referenced international standards.
8. The sample size for the training set
This information is not applicable as the device is an optical instrument and does not involve machine learning or AI that would require a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as #8.
§ 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.