(121 days)
The Atlantis Slit Lamp is an AC-power slit lamp 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 Atlantis Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination There are 2 models 2000 and 2000 Plus. These models differ only in the supplied accessories (beam-splitter, camera mount and observation tube). All models have the same operating characteristics and intended use.
The provided text describes a 510(k) premarket notification for the Atlantis Slit Lamp. The information focuses on demonstrating substantial equivalence to a predicate device rather than conducting a detailed clinical study with specific acceptance criteria related to disease diagnosis performance.
Therefore, many of the requested categories related to clinical study design, ground truth, and AI performance cannot be filled from the provided document.
Here's a breakdown of the available and unavailable information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with ISO 10939:2007, Ophthalmic instruments -- Slit-lamp microscopes | The USOphthalmic, LLC Atlantis Slit Lamp complies with the requirements of listed FDA Recognized Consensus Standards, including ISO 10939:2007. |
| Compliance with IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety | The USOphthalmic, LLC Atlantis Slit Lamp complies with the requirements of listed FDA Recognized Consensus Standards, including IEC 60601-1. |
| Substantial Equivalence to 66 Vision-Tech YZ Slit Lamp (K033190) based on technological characteristics | Demonstrated through an 8-point technological comparison of features, concluding the devices are substantially equivalent. |
| Safety and Effectiveness | Believed to be safe and effective and performs as well as or better than the predicate device due to meeting standards and having essentially identical technological characteristics. |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. No specific clinical test set data is mentioned. The submission relies on technological comparison and compliance with performance standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. No clinical ground truth establishment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No clinical test set adjudication is 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 traditional medical instrument (slit lamp), not an AI-powered diagnostic tool. Therefore, an MRMC study with AI assistance is not relevant or described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware device; thus, standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. For this type of device submission, the "ground truth" is primarily compliance with established performance standards and substantial equivalence to a legally marketed predicate device, rather than a clinical ground truth for diagnostic accuracy.
8. The sample size for the training set:
- Not applicable / Not provided. This is not an AI/machine learning device, so there is no concept of a training set as understood in that context.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. As above, no training set or ground truth establishment for such a set is relevant for this 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.