(263 days)
The CeeMax™ Slit Lamp (Halogen Lamp Series/LED Illumination series) is an AC powered microscope and accessories intended for the use in the examination of the anterior eye segment, from cornea, endothelium to posterior capsule. Slit Lamp which is intended for that is used to aid the diagnosis of diseases or traumas which affect the structure or properties of the eye.
The CceMax™ Slit Lamp's (Halogen Lamp Series/LED Illumination series) with models of 801, 802, 901, 902, 8015S, 802SS, 901SS, 902SS are similar in design, function, materials, operation, and electro-optical electro-optical performance to other conventional AC-powered slit lamp biomicroscope.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting study for the CeeMax™ Slit Lamp:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is limited in its explicit detail of acceptance criteria with numerical targets. Instead, it relies heavily on demonstrating substantial equivalence to predicate devices for key characteristics. The performance testing section mentions "certifications of electrical safety, flammability, and bench test of radiation outputs." This implies that the acceptance criteria for these aspects were met by adhering to established standards.
| Acceptance Criteria Category | Specific Criteria (Inferred/Stated) | Reported Device Performance (CeeMax™ Slit Lamp) |
|---|---|---|
| Intended Use | Same as predicate devices: Examination of anterior eye segment, aid diagnosis of diseases/trauma affecting eye | "Same" as predicate devices (YZ5F (K033190) and SL-15 (K061330)). Intended for use in examination of anterior eye segment, from cornea, endothelium to posterior capsule; aids diagnosis of diseases or traumas. |
| Method of Operation | Similar to predicate device (tabletop) | "Same as the predicate device YZ5F (K033190) table top." |
| Exposure Parameters | Halogen lamp exposure same as predicate; LED exposure similar to predicate | Halogen lamp exposure parameters are the same as predicate device. LED exposure parameters are similar to the predicate device (detailed description provided). |
| Flammability | Uses Thermosetting phenol formaldehyde resin for specific parts (e.g., lamp cap) | Uses Thermosetting phenol formaldehyde resin. |
| Brightness Control | From zero to full power illumination control | "Same" as predicate (implies from zero to full power illumination control). |
| Light Source | Halogen lamp and/or white LED | Halogen lamp and white LED. |
| Beam Geometry | Standard slit opening range same as predicate | "The same as the YZ5F (K033190)." |
| Radiation Safety | Halogen lamp exposure same as predicate; LED exposure similar to predicate | Halogen lamp exposure parameters are the same as predicate device. LED exposure parameters are similar to the predicate device (detailed description provided). |
| Optical Radiation Hazard | No hazard / warning in manual for specific conditions | "No, Warning in the manual regarding the caution and particularly for the aphakic diagnostic." |
| Electrical Safety | Compliance with EN(IEC) 60601-1 | Complies with EN(IEC) 60601-1. |
| Electrical EMC | Compliance with EN(IEC) 60601-1-2, EN6100-3-2, EN6100-3-3 | Complies with EN(IEC) 60601-1-2; EN6100-3-2; EN6100-3-3. |
| Light Output Wavelength | Halogen: Visible light 460nm-700nm; LED: 450nm-650nm | Halogen Lamp emits Visible light covers 460nm to 700nm. The LED light source covers 450nm to 650nm. |
| Light Source Power | Halogen: 12V, 30W; LED: 12V, 10W (similar to predicate's 12V, 6W) | Halogen: 12V, 30W; LED: 12V, 10W. |
2. Sample Size Used for the Test Set and Data Provenance
The summary focuses on bench testing and compliance with standards rather than clinical performance data involving a "test set" of patients or cases. Therefore:
- Sample Size: Not applicable in the context of clinical cases. The testing would have involved individual units of the device and components.
- Data Provenance: Not applicable in the context of clinical cases. The testing is described as premarket "performance testing" including "certifications of electrical safety, flammability, and bench test of radiation outputs." This implies laboratory-based testing on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The study does not involve clinical data that would require expert-established ground truth. The "ground truth" here is compliance with engineering and safety standards.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set or subjective interpretations requiring adjudication are described.
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 device is a Slit Lamp, a diagnostic instrument that aids human examination. It does not incorporate AI, nor does the submission describe any MRMC study comparing human performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a manual optical instrument; it does not have a standalone algorithm component.
7. The Type of Ground Truth Used
The "ground truth" for this submission is compliance with recognized electrical safety (EN(IEC) 60601-1), EMC (EN(IEC) 60601-1-2, EN6100-3-2, EN6100-3-3) and radiation output standards, along with demonstrated equivalence of design and function to legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. This device is an optical instrument, not an AI/machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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.