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The Pinpoint™ GT Safety Introducer Needle is intended for patients requiring percutaneous access to place a guidewire for subsequent placement of catheters or other medical procedures requiring introducer needle access. The Pinpoint™ GT Safety Introducer Needle may be used in any appropriate patient population.

Bard Access Systems, Inc.'s, Pinpoint™ GT Safety Introducer Needle is designed for percutaneous access to introduce a guidewire. The Pinpoint™ GT Safety Introducer Needle contains a magnet which emits a passive magnetic field that can be detected by Ultrasound Systems equipped with Pinpoint™ GT Technology. The Pinpoint™ GT Safety Introducer Needle, when used with the Pinpoint™ GT System 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 provided text describes a 510(k) premarket notification for the Pinpoint™ GT Safety Introducer Needle, arguing for its substantial equivalence to a predicate device. However, it does not include a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-driven device.

The document relates to a physical medical device (introducer needle) and the performance tests described are for the physical properties and safety of this device, not for an AI algorithm's diagnostic or predictive performance.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance for an AI/algorithm.
• Sample size used for the test set and data provenance for AI.
• Number of experts and their qualifications for establishing ground truth for AI.
• Adjudication method for AI.
• MRMC comparative effectiveness study results for AI.
• Standalone performance for an algorithm.
• Type of ground truth used for AI.
• Sample size for the training set for AI.
• How ground truth for the training set was established for AI.

The Pinpoint™ GT Safety Introducer Needle is a physical device, not an AI-powered diagnostic/predictive tool. The "Pinpoint™ GT Technology" mentioned is described as a passive magnet that interacts with an Ultrasound System to create a "virtual image of the needle on the Ultrasound display." This indicates a hardware-software integration for visualization, not an AI algorithm performing diagnostic interpretation or prediction.

What the document does provide regarding acceptance criteria and performance:

The document states that a series of verification and validation tests were performed "in accordance with Design Controls as per 21 CFR §820.30" and various ISO standards and guidance documents.
"The subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device."

Summary of Performance Tests (Bench, Biocompatibility):

Bench Tests:

• Dimensional Analysis
• Assembly Leak
• Hub to Cannula Bond Strength
• Needle Stiffness
• ISO Luer Compliance
• Guidewire Compatibility
• Safety Mechanism Override
• Visual Inspection
• Corrosion
• Usability and Simulated Use
• Blood Flash
• Echogenicity
• Magnet Testing
• Particulate testing (USP )

Biocompatibility Testing:

• Cytotoxicity
• Sensitization
• Intracutaneous
• Acute Systemic Toxicity
• Pyrogenicity
• Rabbit Blood Hemolysis
• Unactivated partial Thromboplastin Time Assay
• Dog Thrombogenicity

The document asserts that the device met the acceptance criteria for these tests (which would be defined by the referenced standards and internal protocols), thereby demonstrating substantial equivalence to the predicate device. Specific numerical acceptance criteria or detailed results of these tests are not provided in this summary document. It only states that the criteria were met.

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