(14 days)
Slit Lamp AIA-11 Series and AIA-12 Series are 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 in to the patient's eye through a control diaphragm a thin, intense beam of light. Slit lamp examination is done to look at the front parts of the eye, including the cornea, lens, iris and the front section of the vitreous gel.
Slit Lamp AIA-11 Series (AIA-11, AIA-11 3S, AIA-11 5S, AIA-11 Zoom) have the same operating characteristics and intended use. These models differ only in the number of Magnification.
Slit Lamp AIA-12 Series (AIA-12, AIA-12 3S, AIA-12 5S, AIA-12 Zoom) have the same operating characteristics and intended use. These models differ only in the number of Magnification.
The device and accessories are indicated as a noninyasive aid in the examination and diagnosis of the eye conditions. It is also used to fit the contact lenses.
The provided text describes a 510(k) submission for the Slit Lamp AIA-11 and AIA-12 Series. It details the device, its intended use, and claims substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a specific study proving the device meets those criteria with performance metrics.
The submission focuses on fulfilling regulatory requirements by:
- Identifying the device and its various models.
- Stating its intended use (eye examination of the anterior eye segment to aid in diagnosing diseases or trauma).
- Describing its technology and how it operates.
- Claiming substantial equivalence to legally marketed predicate devices.
- Listing compliance with recognized consensus standards (ISO 10939:2007, ISO 15004-2:2007, IEC 60601-1).
- Including warnings and precautions related to optical radiation safety (photo-toxicity).
Therefore, I cannot populate the table or answer most of the questions as the necessary information regarding acceptance criteria and performance study details is NOT present in the provided document.
However, based on the information provided, I can infer some elements:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample size used for the test set and data provenance:
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified. This document is a 510(k) summary, which generally relies on established performance of predicate devices and compliance with standards, rather than new extensive clinical studies with specific test sets.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set:
- Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
- No MRMC comparative effectiveness study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This device is a manual medical instrument (Slit Lamp), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable and was not conducted.
7. The type of ground truth used:
- Not specified. Given it's a physical examination device, ground truth would typically be established through clinical diagnosis by an ophthalmologist using the device.
8. The sample size for the training set:
- Not applicable as this is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.