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The AXIALIS Ophthalmic Ultrasound System and the probes that are indicated for diagnostic imaging and biometric measurement of the eye including:

• · Axial Length measurement of the eye by ultrasonic means.
• · Implanted IOL power calculation, using the Axial Length measurement.
• · Measurement of corneal thickness by ultrasonic means.

The AXIALIS Ophthalmic Ultrasound System is an ultrasonic system for ophthalmology which consists of a base and probes. The base performs the same calculations and displays as the predicate device, the Quantel Medical COMPACT TOUCH. The A-scan probe for biometry and pachymetry is identical to the predicate device.

The provided text is a 510(k) summary for the Quantel Medical AXIALIS Ophthalmic Ultrasound System. It details the device's indications for use, its substantial equivalence to a predicate device (Quantel Medical Compact Touch Ophthalmic Ultrasound System), and the performance data submitted for its clearance.

However, the document focuses on non-clinical testing related to electrical safety, EMC, usability, and specific requirements for ultrasonic medical diagnostic equipment, as well as hardware and software validation. It does not contain information about clinical performance studies regarding diagnostic accuracy, sensitivity, specificity, or how the device's measurements compare to a "ground truth" or to human readers' performance.

Therefore, I cannot fully answer your request based on the provided text, especially regarding:

• Acceptance criteria and reported device performance related to diagnostic accuracy. The text mentions "biometric measurement of the eye," but no data on the accuracy of these measurements is provided.
• Sample size used for a clinical test set or data provenance.
• Number of experts, qualifications, or adjudication methods for establishing ground truth.
• Any multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth used (clinical/pathology/outcomes data).
• Training set size or ground truth establishment for a training set.

The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and non-clinical performance (safety, EMC, usability, software validation) rather than direct clinical accuracy studies with human participation.

To answer your questions, clinical study data would be required, which is not present in this 510(k) summary.

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