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LIGHTMED Ultrasound System is a non-invasion diagnostic ophthalmic ultrasound instrument specifically designed for measurements inside the ocular structures including orbital, anterior, posterior segment of eye and axial length for determination of IOL Power.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic

The LIGHTMED Ultrasound System (model name: LIGHTSonic Ultrasound) is a portable ultrasound biometric ruler intended for use in ophthalmic applications. The system allows for the measurement of several key ocular features including axial length (AXL), anterior chamber depth. The device is used by coupling the probe / transducer to the eye either through direct contact or immersion methods. Available modes are A scan, biometric B-scan and UBM.

The A-scan mode of the system features a live A scan trace with storage for up to four scans. There are four (auto/manual) examination modes that use 9 different tissue velocities to calculate individual intraocular distances within the eye (AXL, ACD, Lens, and Vitreous). Other features include: post examination review of scans & measurement; four IOL formulas for lens power calculations; an immersion scanning capability for zero corneal compression of the eye while scanning and storage for up to five different user files.

The B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior-chamber of the eye, particularly when view of the chamber is obscured, such as is the case with cataracts.

The UBM mode can be used with a 35 MHz or a 50 MHz transducer. Because of the higher frequency of the transducer, it is expected that its greatest field of application will be in visualizing the anterior segment, because the focus area is about 11 mm from the transducer plane. The system will visualize other parts of the resolution is not as high. LIGHTMED Ultrasound System is a stand-alone system that runs on a Windows 10 platform and may be networked (by the user) for interface with electronic medical records systems, printing, and other purposes. The system consists of the console, ultrasound probe(s) and transducer, and foot pedal.

This document is a FDA 510(k) premarket notification clearance letter for the LIGHTMED Ultrasound System. It describes the device, its intended use, and demonstrates its substantial equivalence to previously cleared predicate devices.

However, this document does NOT contain a study that proves the device meets specific acceptance criteria based on AI or algorithm performance. The performance data provided are related to:

• Biocompatibility testing: Ensuring the patient contact materials are safe.
• Electrical safety and electromagnetic compatibility (EMC): Compliance with safety standards.
• Software verification and validation testing: Ensuring the software operates correctly and safely.
• Measurement accuracy: A general statement that the system "has been validated and is safe and effective for the intended use" without providing specific accuracy metrics or the study details behind this validation.

There is no mention of an AI component, an algorithm-only (standalone) performance study, a multi-reader multi-case (MRMC) comparative effectiveness study, or detailed acceptance criteria for diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC). The device is described as an "ultrasound biometric ruler" and "a non-invasion diagnostic ophthalmic ultrasound instrument," implying it performs measurements and imaging, but not an AI-driven interpretation or detection system.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets those criteria for an AI/algorithm-driven system, as these details are not present in the provided text.

Based on the provided text, the device is an ultrasound system with A-scan, B-scan, and UBM modes, primarily used for measurements and imaging of ocular structures. Its clearance is based on demonstrating substantial equivalence to existing ultrasound devices and meeting general safety and performance standards for such medical devices.

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