(36 days)
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.
§ 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.