(33 days)
The VuMax High Resolution Ultrasound System is intended to be used for visualization by ultrasound of the eye and orbit by A-scan and B-scan. It is not intended to be used for determining the nower of timabaned ocular lenses, but it is capable of making intra-ocular measurements.
The VuMax ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultraseunded and to make measurements inside the eye.
The VuMax 35 MHz transducer is for use with the VuMax ultrasound system.
The VuMax 50 MHz transducer is for use with the Vumax ultrasound system.
The VuMax High Resolution Ultrasound System is intended to be used for visualization by ultrasound of the eye and orbit by A-scan and B-scan. It is not intended to be used for determining the nower of timabaned ocular lenses, but it is capable of making intra-ocular measurements.
The system is PC-based, and can be used with a 35 MHz transducer (standard) or a 50 MHz transducer (optional). Because of the higher frequency of the transducers, it is expected that its greatest field of application will be in visualizing the anterior segment, because the focus area is about 11 mm form the transducer plane. The system will visualize other parts of the eye, but the resolution is not as high.
The VuMax is a conventional ophthalmic A and B-scan system using a motor-driven transducer and angle sensor for scanning. The A-scan is derived from the B-scan. There is a choice of transducer frequency of 35 MHz or 50 MHz. It uses a motor-driven 10 MHz transducer with an attached angle encoder. The system is PCbased, and the display is on the computer screen.
The provided text is a 510(k) summary for the Sonomed Inc. VuMax Ophthalmic ultrasonic A and B scan system. It outlines the device description, intended use, technological characteristics, and a brief mention of performance data. However, it explicitly states that clinical tests were "Not required" and that the device's substantial equivalence to a predicate device (Sonomed EZ-Scan AB 5500+) was based on non-clinical tests (ultrasonic emissions and accuracy/validation tests).
Therefore, there is no information available in the provided document regarding acceptance criteria for device performance based on a study, nor any study details that would typically be associated with clinical evaluations of diagnostic accuracy.
Here's a breakdown based on your requested information, highlighting what is not available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable/Not provided within the scope of clinical performance.
The document states "Both ultrasonic emissions tests and accuracy and validation tests have been done," but does not provide specific acceptance criteria or performance metrics for these non-clinical tests in the summary. It also does not list any clinical performance data as clinical tests were stated as "Not required."
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No clinical test set data is provided as clinical tests were not required for this 510(k) clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. No clinical test data or ground truth establishment based on expert review is mentioned, as clinical tests were not required.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set data is provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states that "Clinical tests" were "Not required." Therefore, an MRMC comparative effectiveness study was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is an ophthalmic ultrasound system, which inherently involves human operation and interpretation. The performance evaluation was against a predicate device based on non-clinical data, not a standalone algorithm without human involvement.
7. The Type of Ground Truth Used
Not applicable for clinical performance. For the non-clinical "accuracy and validation tests," the ground truth would likely be established through physical measurements, calibration standards, or simulated targets, rather than clinical ground truth (like pathology or outcomes data). However, the specific type of ground truth for these non-clinical tests is not detailed in the summary.
8. The Sample Size for the Training Set
Not applicable. This device's clearance did not involve AI/ML algorithms requiring a training set in the context of diagnostic performance as described in typical AI device submissions. The "PC-based" nature refers to its operating system, not necessarily an AI component requiring training data for diagnostic interpretation.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As no training set for AI/ML was reported, there's no information on how its ground truth would have been established.
§ 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.