(71 days)
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.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.