(15 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic. The OIS provides real-time, high-resolution images of the intraocular anatomy and is, therefore, useful in evaluation of pathologies of the anterior segment such as trauma, tumors, cysts, and glaucoma. It can also be used during ophthalmic surgery to monitor the changes in anatomical structures such as the anterior angle, Schlemm's canal and related outflow structures of the eye, for glaucoma management.
The Ophthalmic Imaging System (OIS) is an ultrasound system designed for noninvasive imaging of the anterior segment of the eye through the use of standard ultrasound imaging pulse-echo techniques. The system consists of a handpiece containing a high-frequency transducer, connected to interfacing electronics in the Transducer Interface Module (TIM) which is in turn connected to a personal computer with video display. Software developed by iScience Surgical runs on the computer controlling the system and generating the image. The OIS is used with a sterile disposable tissue interface (Imaging Gel Cap) which is attached to the handpiece for direct contact with the eye during imaging. The OIS may also be used with a sterile Sheath Adapter Assembly for sterile field applications.
The provided text is a 510(k) summary for the iScience Surgical Ophthalmic Imaging System (OIS). It does not contain information about acceptance criteria or a study that proves the device meets such criteria. Instead, it focuses on the device description, its intended use, and its substantial equivalence to predicate devices, which is the basis for 510(k) clearance.
Therefore, I cannot provide the requested information from the text provided as it does not contain details about:
- Acceptance criteria and reported device performance: This document discusses the intended use and technological characteristics but no specific performance metrics or acceptance thresholds.
- Sample size, data provenance, number of experts, adjudication method for a test set: These details are typically found in a clinical study report, which is not present here.
- MRMC comparative effectiveness study: No mention of such a study.
- Standalone performance study: No mention of such a study.
- Type of ground truth: Not applicable as no performance study is described.
- Sample size for the training set: Not applicable as no AI/algorithm training is described.
- How ground truth for the training set was established: Not applicable.
The document is a regulatory submission demonstrating substantial equivalence to existing devices, not a performance study report with 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.