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The Master-Vu A-Scan provides intraocular measurements of anterior chamber depth, lens thickness, and axial length which can be used with published industryaccepted refractive formulas to calculate associated IOL powers for implanted lenses.

The Master-Vu A-Scan is a portable ultrasonic A-scan system intended for use in ophthalmic applications. The system allows for the measurement of several key ocular features including axial length (AXL), anterior chamber depth, and lens thickness while also aiding in the calculation of associated IOL power for implanted lenses.

The Master-Vu A-Scan system consists of a solid A-probe, a base unit which houses the electronics, a foot pedal switch, and a USB cable which provides a means of interfacing the system with a host computer.

The standard Master-Vu software allows any Microsoft Windows compatible host computer (PC) to function as the control panel of the system. The host computer is not supplied by Sonomed as part of the Master-Vu A-Scan system and must be provided by the end user. Minimum requirements for compatible host computers are supplied in the documentation accompanying the system.

The Master-Vu software is compatible with the Microsoft Windows XP or Microsoft Windows Vista operating systems, and uses the features of the Windows graphical user interface to direct the operation of the system and maintain patient records. Patient data may be analyzed, saved, retrieved, and printed through the computer interface at the operator's discretion. The Microsoft Windows operating system provides an adequate and user-friendly interface for a wide variety of clinical environments.

This looks like a 510(k) premarket notification for the Sonomed Master-Vu A-Scan, where Sonomed is seeking clearance for a new device based on substantial equivalence to a predicate device. This type of document typically does not contain details about specific clinical studies with acceptance criteria and statistical analysis to prove device performance as an AI/ML product.

Instead, 510(k) submissions for devices like this Master-Vu A-Scan (a diagnostic ultrasound system) focus on:

• Substantial Equivalence: Demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is often done by comparing technological characteristics, intended use, and performance data from engineering tests, not typically large-scale clinical trials in the way AI/ML devices require.
• Performance Benchmarking: This usually refers to electrical, mechanical, environmental safety, and performance testing against industry standards (e.g., IEC 60601-1, IEC 60601-2-37, EN/IEC 60601-1-2(2001) as mentioned in the document). It does not involve "acceptance criteria" related to diagnostic accuracy, sensitivity, or specificity in a clinical context.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance because these elements are not typically part of a 510(k) submission for this type of medical device at the time this document was generated (2010).

The document states:
"Electrical, mechanical, environments safety and performance testing according to standard IEC 60601-1, IEC 60601-2-37, and EN/IEC 60601-1-2(2001) are currently pending." (Section 8. Safety, EMC and Performance Data). This implies that compliance with those engineering standards is the primary form of "performance data" for this device, not clinical accuracy metrics.

In summary, the provided document does not contain the specific information you are requesting because it is a 510(k) summary for a diagnostic ultrasound system from 2010, not an AI/ML-driven device with associated clinical performance studies as would be required today.

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The Master-Vu High Resolution Ultrasound System is intended to be used for visualization by ultrasound of the eye and orbit by B-scan.

The Master-Vu High Resolution Ultrasound System is intended to be used for visualization by ultrasound of the eye and orbit by B-scan. The system is PC-based, and is used with a 12 MHz transducer. The computer is a standard pc, and is user-supplied. Computer requirements are supplied in the instructions. The scanner is motor-driven. The system can also make measurements. The Master-Vu is a conventional ophthalmic B-scan system using a motor-driven transducer and angle sensor for scanning. It uses a motor-driven 12 MHz transducer. The system is PC-based, and the display is on the computer screen.

The provided document is a 510(k) summary for the Sonomed Master-Vu Ophthalmic Ultrasound System. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it explicitly states that no clinical tests were required for this submission. Therefore, it does not contain the detailed information necessary to answer most of your questions about acceptance criteria, study design, and performance data from a clinical trial.

Here's a breakdown of what can be answered and what cannot:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document states, "(2) Clinical tests Not required". Therefore, there are no reported clinical performance data or acceptance criteria for such, as they were not evaluated for this 510(k) submission. The submission focuses on non-clinical tests (ultrasonic emissions and accuracy/validation tests) to demonstrate substantial equivalence to the predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. No clinical test set was used or described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be provided. No clinical test set requiring expert ground truth was performed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided. No clinical test set requiring adjudication was performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Cannot be provided. No MRMC study was done, nor is there any mention of AI assistance in this document. This is a conventional ultrasonic B-scan system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Cannot be provided. This device is a conventional ultrasound system and does not appear to involve an "algorithm only" component in the way a diagnostic AI would.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Cannot be provided. No clinical ground truth was established as clinical tests were not required. The "ground truth" for non-clinical tests would involve physical measurements and technical specifications rather than clinical outcomes.

8. The sample size for the training set

• Cannot be provided. The document does not describe any machine learning or AI components that would require a training set.

9. How the ground truth for the training set was established

• Cannot be provided. No training set was involved.

Summary of available information related to acceptance criteria and study:

The Sonomed Master-Vu Ophthalmic Ultrasound System received 510(k) clearance based on demonstrating substantial equivalence to a predicate device (Sonomed EZ-Scan AB 5500+).

The "study" referenced in the document involved:

• Non-clinical tests: Both ultrasonic emissions tests and accuracy and validation tests were done. The acceptance criteria for these tests would be compliance with recognized standards for medical ultrasound devices and performance meeting the specifications of the predicate device.
• Clinical tests: Not required for this 510(k) application. This means the device met the regulatory requirements for safety and efficacy without needing to conduct a clinical trial demonstrating its performance on patient data against clinical acceptance criteria.

The conclusion was that the Master-Vu is "equivalent in safety and efficacy to the legally marketed predicate device" based on these non-clinical tests and technological characteristics.

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