(142 days)
The iView™ is intended to be used by or under the direction of qualified medical personnel during prenatal monitoring, to visualize fetal features in a reconstructed 3D image that they may wish to exam more closely during routine 2D fetal diagnostic ultrasound imaging examinations, and to assist patient's understanding in communicating diagnostic results in a form that may be more easily understood. It does not provide quantitative measurements or diagnostic interpretations.
The subject device may only be used in an adjunctive capacity with standard diagnostic ultrasound imaging techniques and that no clinical decisions or diagnostic interpretations should be made based solely on the use of this device.
3D image reconstructed from this software is referring use only and is not responsible for any diagnosis.
Adds 3D imaging capability to commercial 2D ultrasound imaging systems
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study proving the device meets those criteria.
The document is a 510(k) summary for the OnDemandSoft iView, which focuses primarily on establishing substantial equivalence to a predicate device (SonoReal system). It includes a comparison table of features between the two devices, but it does not specify any acceptance criteria, performance metrics, or details of a clinical study designed to demonstrate the device meets acceptance criteria.
Specifically, the document lacks information for the following points:
- A table of acceptance criteria and the reported device performance: This is entirely missing. The comparison table is for features, not performance metrics against acceptance criteria.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method: Not mentioned.
- Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone (i.e. algorithm only without human-in-the loop performance) performance: Not mentioned.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
The 510(k) summary generally highlights the device's technical specifications and how they compare to a previously cleared device, focusing on "substantial equivalence" rather than presenting detailed performance study results against predefined 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.