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The PathBuilder™ Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.

PathBuilder™ Transseptal Needle is consisted of thin section, curved section, main body, pointer flange, hub and stylet. The distal end of PathBuilder™ Transseptal Needle is curved for easy positioning within the heart when used together with the catheter introducer. The outer diameter of needle stepped down within the curved section for better fitness to the dilator which fixes the maximum length of the needle into the dilator. The distal tip of the needle is beveled to facilitate the transseptal process. The proximal end of PathBuilder™ Transseptal Needle is with a pointer flange which indicates the curve orientation of the needle. And a hub is equipped for aspiration, fluid injection/infusion etc. The stylet is straight. The proximal end of the stylet is curved to lock on the hub when inserted into the needle lumen. The stylet is used to help insert the needle into the dilator.

The provided document is a 510(k) premarket notification for the "PathBuilder™ Transseptal Needle". This document describes the device and its equivalence to a predicate device, but it does not include any information about an AI/ML device.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about a study proving an AI/ML device meets acceptance criteria. The document explicitly states: "No clinical study was used to support this submission."

The closest information provided related to performance testing is for the transseptal needle device (not an AI/ML system):

Non-Clinical Performance Testing:

• Biocompatibility Verification: Verified as per ISO 10993-1:2018 and FDA guidelines. Tests included Cytocompatibility, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility, Complement Activation, and Thrombogenicity.
• Bench Validation: Included visual inspection, dimensional verification, packaging testing (visual inspection, sealing strength, dye penetration), and mechanical failure/performance (joint forces). Compatibility of the needle and dilator was validated with compatibility, puncture force, radio detectability, and luer fitting. All samples were sterilized and aged prior to testing. All tested samples passed bench testing.
• Cleaning and Sterilization Validation: Performed in accordance with ISO 11135:2014, AAMI TIR 28:2009, and FDA guidance.
• Shelf Life Validation: Demonstrated a shelf life of three years.

Since no AI/ML device is described, I cannot answer questions 2 through 9 regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

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