Search Results

The peripheral nerve block Pinpoint™ GT Needle is intended for use in injecting local anesthetics and/or analgesics into a patient to provide regional anesthesia and/or to facilitate the placement of a catheter.

The peripheral nerve block Pinpoint™ GT Needle may be used in any appropriate patient population.

Bard Access Systems, Inc's Pinpoint™ GT Needle is designed to inject anesthetic for regional anesthesia. The Pinpoint™ GT Needle contains a magnet which emits a passive magnetic field that can be detected by ultrasound systems equipped with Pinpoint™ GT Needle Technology. The Pinpoint™ GT Needle, when used with an ultrasound system equipped with Pinpoint™ GT Needle Technology, creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion process.

The subject device can be used with or without ultrasound assisted procedures and may be used with the Pinpoint™ GT Needle Technology at the discretion of the clinician.

The document describes the Pinpoint™ GT Needles, which are peripheral nerve block needles intended for injecting local anesthetics and/or analgesics for regional anesthesia or catheter placement. The device contains a passive magnet that can be detected by compatible ultrasound systems to provide a virtual image of the needle.

All the information provided in the input is related to the Pinpoint™ GT Needles and its comparison against a predicate device (SonoTAP Needle) and a reference device (Pinpoint™ GT Safety Introducer Needle).

Here's the breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document states that the subject device configurations met all predetermined acceptance criteria derived from the listed verification tests, demonstrating substantially equivalent performance as compared to the predicate device. However, specific numerical acceptance criteria and their corresponding reported performance values are not explicitly provided in a direct table format with thresholds. Instead, a list of performance tests conducted and the standards utilized is given, implying that meeting these standards constitutes the acceptance criteria.

2. Sample sizes used for the test set and the data provenance

The document does not specify the sample sizes used for each individual test or the overall "test set." It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). The testing methods are primarily focused on device performance tests against recognized standards (e.g., ISO, ASTM, USP) and internal protocols, rather than clinical data from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The testing described is primarily focused on engineering performance and material compatibility, not clinical ground truth established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided in the document. Adjudication methods are typically associated with clinical studies involving human interpretation or assessment, which is not the primary focus of the performance tests described here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC comparative effectiveness study involving human readers or AI assistance in this document. The Pinpoint™ GT Needle incorporates a "passive magnet" feature that works with an "ultrasound system equipped with Pinpoint™ GT Needle Technology" to create a "virtual image of the needle." This describes a technology for enhanced visualization during a procedure, not an AI-assisted diagnostic or interpretive system that human readers would interact with in an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable to the device described. The Pinpoint™ GT Needle is a physical medical device (a needle) that assists in a medical procedure, not a standalone algorithm. Its magnetic feature is designed to be used in conjunction with an ultrasound system and the clinician, so there is always a human in the loop.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests described is rooted in established international standards (ISO, ASTM, USP) and internal Bard protocols for medical device quality, safety, and functionality. These standards define physical, chemical, and mechanical properties that the device must meet, effectively serving as the ground truth for engineering and material performance. For example, "Needle Lumen Patency" is tested against requirements specified in ISO 7864:1993. Biocompatibility is tested against ISO 10993 series.

8. The sample size for the training set

This information is not provided and is not applicable. The Pinpoint™ GT Needle is a physical device, and the described evaluation involves functional and safety testing, not machine learning model training.

9. How the ground truth for the training set was established

This information is not provided and is not applicable as there is no mention of a "training set" or machine learning model.

Ask a specific question about this device