(14 days)
Pinpoint™ GT Needle Guide Kits are intended to be used with Site~Rite® Ultrasound Systems.
Pinpoint™ GT Needle Guides provide guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure.
Site~Rite® Probe Covers sheathe the transducer and isolate a site of surgical penetration from microbial and other contamination.
Pinpoint™ GT Needle Guide Kits consist of the following single use sterile disposables: a set of Pinpoint™ GT Needle Guides, conductive gel, a Site~Rite® Probe Cover, and elastic bands to secure the probe cover to the ultrasound probe.
The provided text describes a 510(k) premarket notification for the Pinpoint™ GT Needle Guide Kits. It outlines the device's intended use, technological characteristics, and safety and performance testing. However, the document does not contain information about an AI/algorithm-driven device, nor does it present "acceptance criteria" and "reported device performance" in the context of an AI study with human readers and ground truth established by experts.
The document primarily focuses on the physical and mechanical aspects of a sterile, single-use needle guide kit used with ultrasound systems, comparing it to a predicate device. The "tests" mentioned are for device validation and verification, such as "Needle Guide Depth Accuracy," "Force to Insert a Needle," and "Packaging Integrity." These are engineering and manufacturing tests, not clinical performance studies involving AI or human interpretation of diagnostic images.
Therefore, I cannot fulfill your request for the specific information regarding AI models, sample sizes for test/training sets, expert consensus, adjudication methods, or MRMC studies, as none of this information is present in the provided text.
The document discusses:
- Device: Pinpoint™ GT Needle Guide Kits
- Intended Use: To be used with Site~Rite® Ultrasound Systems to guide a needle for placement of its tip in a specific structure, and probe covers to sheath the transducer and isolate the surgical site.
- Predicate Device: Site~Rite® Needle Guide Kits and Probe Cover Kit.
- Modifications from Predicate: New packaging, modified needle guides (including insertion funnel and stabilizing notches, and different colorant formulations but same base materials), additional probe cover offering (96" vs 48" length, dimensional changes and different material formulation), and labeling updates.
- Testing: Verification and validation tests conducted per design controls, guidance documents, and internal protocols. These tests focus on the physical performance and safety of the needle guides and probe covers (e.g., loading, force to insert/remove needle, depth accuracy, material compatibility, damage, retention, packaging integrity, sterile barrier integrity, and biocompatibility/sterilization standards).
In summary, the provided document does not support a response to your prompt because it describes a physical medical device (needle guides), not a software or AI-driven diagnostic device that would necessitate the type of performance study criteria you've outlined.
§ 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.