(203 days)
Ultrast Gel is an in vivo biocompatible sterile sterile couplant intended for use as a scanning gel in surgical procedures, biopsies and similar sterile applications.
Ultrast Gel is used to couple sound waves between the patient and medical imaging electronic transducers during intracavitary medical diagnostic ultraging procedures, transcutaneous ultrasound image guided biopsy and aspiration, intracavity ultrasound imaging, and gel infusion sonography.
Ultrast Gel is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel or other fluid, alone or in combination with a transducer cover, where sterility, in vivo biocompatibility and bioelimination are required.
ULTRAST Gel is available by prescription only for use by healthcare providers trained in performing the indicated procedure.
The Ultrast Gel device, manufactured for Ultrast, Inc. is a phase changing hydrogel ultrasound coupling agent comprised of hydroxy-propylcellulose, sodium chloride, sodium citrate, and water. HCl may be added to adjust pH if necessary. The gel is viscous at room temperature, but subsequently liquefies as its temperature rises and reaches body temperature. In addition to general lubricating/coupling properties, the gel may be instilled in the uterine cavity through a standard intrauterine insemination (IUI) catheter to provide excellent ultrasonographic visualizations, after which point it liquifies and passes out of the uterine cavity.
The gel is contained in a single use 5cc capped syringe enclosed in a peel pouch to maintain sterility.
The provided text is a 510(k) Premarket Notification summary for Ultrast Gel, a medical device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/human-in-the-loop study.
The "Performance Data" section primarily addresses biocompatibility testing, electrical safety/EMC (not applicable, as it's not a software/electrical device), software verification/validation (not applicable), and bench testing related to the physical properties of the gel (appearance, pH, viscosity, syringe force, acoustic properties, and package integrity). There is no mention of a study involving human readers, AI assistance, ground truth establishment by experts, or MRMC studies.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves the device meets them in the context of AI/human-in-the-loop performance. The information required for your request (AI performance, human reader improvement, expert adjudication, ground truth type, sample sizes for training/test sets related to AI) is simply not present in this regulatory document, as the device is a physical gel, not an AI software.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.