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The Flextra™ Steerable Introducer is introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The Flextra Steerable Introducer set contains a steerable introducer, integrated vessel dilator/transseptal needle (component branded as Lancer"), guidewire, and ECG adapter cable. The set is designed to facilitate vascular access to the heart and then provide variable catheter positioning within the cardiac anatomy. The Flextra introducer is an elongated shaft with central lumen capable of accepting the Lancer dilator/needle as well as various cardiac catheters. The shaft has a proximal handle with a rotating actuator that allows the user to change the degree of curvature on the distal tip of the shaft (referred to as steerable tip, deflectable tip, or dynamic tip). Rotating the actuator can deflect the tip, in a planar fashion, +/- 180°. The handle is also fitted with a hemostasis valve to minimize blood loss during catheter introduction, and/or exchange, as well as a sideport with 3way stopcock to allow blood aspiration, fluid infusion, and pressure monitoring. The introducer shaft features distal side holes to facilitate aspiration and prevent cavitation plus an embedded platinum radiopaque tip marker to facilitate fluoroscopic visualization. The Lancer integrated dilator/needle combines the dilator and transseptal needle into a single component. The needle is used to puncture the interatrial septum to gain access to the left atrium. The Lancer consists of an elongated shaft with a tapered tip and central lumen to track over a guidewire in a similar fashion to conventional dilators. The lumen of the Lancer is fitted with a hollow stainless steel transseptal needle and both the shaft and needle are connected to the same proximal handle. The needle lumen will accept guidewire sizes up to 0.032 inches in diameter. Inside the Lancer handle, the needle is affixed to a spring-tensioned actuator that prevents needle extension until the operator purposely advances the needle via a slider button located on the outer surface of the handle. The proximal handle is fitted with a Luer connector to gain access to the central lumen of the needle. The handle is also fitted with an electrical connector to monitor an ECG from the needle while in the heart, utilizing the ECG adapter cable. The guidewire included in the kit is manufactured by Lake Region Medical (K935170) and is supplied in a polypropylene retainer coil with a J-straightener and Luer fitting. The ECG adapter cable included is manufactured by Bioconnect (RF Industries, Inc.), is one (1) meter long, and has male/female DIN 0.080 inch touchproof connectors on the ends.

The provided document describes the predicate device and the new device being submitted for 510(k) clearance, the Flextra Steerable Introducer. It focuses on demonstrating substantial equivalence to the predicate device through various non-clinical tests.

Since this document describes a medical device undergoing premarket notification (510(k)) for substantial equivalence, the "acceptance criteria" are generally established regulatory standards and the "study that proves the device meets the acceptance criteria" refers to the comprehensive non-clinical testing performed to show the device functions as intended and is safe, effective, and performs as well as or better than the predicate device.

Here's a breakdown of the requested information based on the provided text, recognizing that it pertains to a device, not an AI algorithm:

1. Table of Acceptance Criteria and Reported Device Performance

For a medical device, "acceptance criteria" are typically defined by recognized standards and performance specifications derived from these standards or from the predicate device's performance. The "reported device performance" are the results of tests against these criteria.

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

• Biocompatibility: Various numbers per test, e.g., "2 canines" for thrombogenicity.
• Sterilization, Packaging, Shelf Life, Performance Testing: The document refers to "samples" or "test devices" but does not specify the exact number of units used for each test. For accelerated aging, it mentions "test devices."
• Animal Study: "A single animal study was performed that combined the evaluation of another device... to limit the number of animals required." The thrombogenicity test also used "2 canines."
• Data Provenance: The tests were conducted by various vendors and labs primarily in the USA (Minneapolis, MN; Salt Lake City, UT; Franklin, WI; Eden Prairie, MN). The studies are prospective evaluations of the manufactured device.

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

Not applicable to this type of device submission. The "ground truth" for device performance is established by objective measurements against engineering specifications and validated test methods (e.g., ASTM, ISO standards), or by comparison to a predicate device in an animal model. There is no mention of human experts establishing ground truth in the context of diagnostic performance or image interpretation.

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

Not applicable. Adjudication methods like 2+1 (two readers, one adjudicator if disagreement) are typically used in clinical studies or diagnostic performance evaluations for subjective assessments. This document describes objective engineering tests and an animal study.

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

Not applicable. This device is a steerable introducer catheter, not an AI algorithm for diagnostic interpretation. Therefore, no MRMC study or AI-assisted human reader improvement assessment was performed.

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

Not applicable. The device is a physical medical instrument, not an AI algorithm.

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

The "ground truth" for this device's performance is established by:

• Compliance with recognized international and national standards (e.g., ISO, ASTM IEC) for physical, mechanical, chemical, and biological properties.
• Direct measurement and verification against pre-defined engineering specifications.
• Comparison to a legally marketed predicate device (SJM Agilis™ NxT Steerable Introducer, K061363) in an animal model for functional and performance aspects, demonstrating substantial equivalence.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable. See point 8.

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