Search Results

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:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Ask a specific question about this device

ALADDIN is intended for biometric determination of the following ocular measures: axial length, corneal radius, corneal cylinder axis, anterior chamber depth, white-to-white (WTW) and pupil diameter of the human eye. ALADDIN also measures corneal topography. For patients who are candidates for intraocular lens (IOL) implantation, ALADDIN also aids in the calculation of the appropriate IOL power and type to be implanted.

Not Found

The provided text is a 510(k) Premarket Notification for the ALADDIN device, which is an ophthalmic device. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria.

The document is a letter from the FDA to Visia Imaging S.r.l. (c/o Ms. Marisa Testa) acknowledging the review of their 510(k) premarket notification for the ALADDIN device. It states that the device is substantially equivalent to legally marketed predicate devices. The document outlines regulatory requirements for the device and includes an "Indications for Use" statement.

Therefore, I cannot provide the requested information from the provided text. The document describes regulatory approval based on substantial equivalence, not the results of a study demonstrating adherence to specific acceptance criteria.

Ask a specific question about this device

Aladdin Monitoring Oxygen/Air Mixer is intended to mix and air and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmeter (1 to 10 LPM). the device is intended for use within the hospital or institutional environment.

Aladdin Monitoring Oxygen/Air Mixer is intended to mix and air and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmeter (1 to 10 LPM).

This document is a 510(k) premarket notification letter from the FDA to Hamilton Medical, Inc. for the Aladdin II Monitoring Oxygen/Air Mixer. It primarily discusses the regulatory classification and marketing authorization for the device. It does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about device performance, sample sizes, ground truth establishment, or expert reviews as requested in the prompt.

Therefore, I cannot provide the requested information based on the given text. The text does not describe a study or device performance data.

Ask a specific question about this device

Ask a specific question about this device