(56 days)
MD-320W Ultrasound Biomicroscope is intended to be used in clinical ophthalmology for ultrasonic diagnosis on the anterior segment of eyes.
The device is intended to be used in hospitalmology clinics. The operators should be trained professionals and have basic capabilities for PC operation.
It is not allowed to use UBM on patients with eye trauma, inflammation or infection.
MD-320W Ultrasound Biomicroscope is an ultrasonic imaging system with high-resolution. It consists of AC-DC power adapter, main unit, 50MHz sector scan probe, footswitch, USB cable and two user-selectable APPs:
MD3XUBM.AP1-C V1.0 APP (included in MD3XUBM-C V1.0) runs on the windows operating system of the PC and allows the user to control probe scanning, image acquisition and display via the PC user interface.
MD3XUBM.AP1-S V1.0 APP (included in MD3XUBM-S V1.0) runs on the operating system of the legally marketed MD-2300S Ultrasonic A/B Scanner for Ophthalmology (K152318) and allows the user to control probe scanning, image acquisition and display via the MD-2300S user interface.
Under the excitation of electric pulse, the 50MHz ultrasound transducer emits ultrasonic pulse into eye and receives reflective echo from the surfaces of different tissue, thus forming real-time two-dimensional image of eye tissue.
This FDA 510(k) summary for the MD-320W Ultrasound Biomicroscope details its substantial equivalence to a predicate device but does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria. The provided text focuses on comparing the new device's technological characteristics and intended use to a predicate device (VuPad Ophthalmic Ultrasound System), highlighting non-clinical testing for safety, EMC, and acoustic output.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Whether a standalone performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any specific performance study.
- The sample size for the training set.
- How the ground truth for the training set was established.
The document only states that "The software and essential performance have passed verification and validation, and the results comply with the related requirements as per the FDA Guidance document 'Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' issued in June 27, 2019." This is a general statement about compliance with guidance and does not provide specific performance metrics or study details.
In summary, the provided text describes regulatory approval based on substantial equivalence to a predicate device, focusing on technical specifications and general safety/EMC testing, rather than detailed performance study data against specific acceptance criteria.
§ 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.