(243 days)
ALADDIN HW3.0 is intended for biometric determination of the following ocular measures: axial length, corneal radius, corneal cylinder axis, anterior chamber depth (ACD), central corneal thickness (LT), white-to-white (WTW) and pupil diameter of the human eye. ALADDIN HW3.0 also measures corneal topography.
For patients who are candidates for intraocular lens (IOL) implantation, ALADDIN HW3.0 also aids in the calculation of the appropriate IOL power and type to be implanted.
ALADDIN HW3.0 is intended for use by physicians and eye-care professionals and may only be used under the supervision of a physician.
Not Found
This notice does not contain information about acceptance criteria or a study that proves the device meets specific criteria. It is a 510(k) premarket notification letter from the FDA to VISIA Imaging S.r.l. regarding the ALADDIN HW3.0 device.
The letter states that the FDA has reviewed the 510(k) and determined that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use. This means the device is considered safe and effective because it is similar enough to a device already on the market, not necessarily because it has met specific, numerically defined acceptance criteria through a dedicated study detailed in this document.
The document includes:
- Trade/Device Name: ALADDIN HW3.0
- Regulation Number: 21 CFR 886.1850
- Regulation Name: AC-Powered Slitlamp Biomicroscope
- Regulatory Class: Class II
- Product Code: HJO
- Indications for Use: Biometric determination of ocular measures (axial length, corneal radius, corneal cylinder axis, anterior chamber depth (ACD), central corneal thickness (LT), white-to-white (WTW), pupil diameter, and corneal topography). It also aids in IOL power and type calculation for cataract surgery candidates.
However, the provided text does not include any of the following requested information:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
- Whether a standalone performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 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.