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The RXI Guider ™ Catheter Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The Guider Catheter Introducer set contains a fixed-curve 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 catheter positioning within the cardiac anatomy. The Guider Catheter Introducer is an elongated shaft with central lumen capable of accepting the Lancer dilator/needle as well as various catheters. The Guider 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 pressuremonitoring. 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 a 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 ECC adapter cable. The guidewire included in the set 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 touch- proof connectors on the ends.

The provided text describes the "Guider Catheter Introducer" and its testing for substantial equivalence to a predicate device. However, it does not describe an AI/ML powered medical device. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable or cannot be extracted from this document.

The document primarily focuses on non-clinical testing (biocompatibility, sterilization, packaging, shelf life, and performance testing) and an animal study to demonstrate the device meets safety and performance requirements and is substantially equivalent to a predicate.

Here's the information that can be extracted, with notes where the requested categories are not applicable.

Acceptance Criteria and Device Performance (Summary from various sections)

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

As provided above. The document generally states "Pass" or "All protocol requirements/specifications were met" rather than specific numerical acceptance criteria for many tests, except for biocompatibility where "Non-Hemolytic", "Non-Reactive", etc., serve as the criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Test Set Sample Size: Not explicitly stated numerically for most non-clinical tests. For the animal study, it mentions "2 canines" for in vivo thrombogenicity and "A single animal study" for the overall device performance comparison, but doesn't quantify the number of devices or trials within that study.
• Data Provenance:
  • Biocompatibility and animal study: American Preclinical Services, Inc., Minneapolis, MN, USA.
  • Sterilization: Steris Isomedix, Minneapolis, MN, USA.
  • Environmental Conditioning, Distribution Simulation, Accelerated Aging, Peel Strength, Bubble Leak Testing: Distribution Dynamic Labs, Inc. (DDL) in Eden Prairie, MN, USA.
  • Particulate testing: Nelson Labs, Salt Lake City, UT, USA.
  • Electrical testing: Medical Equipment Compliance Associates, LLC. (MECA), Franklin, WI, USA.
  • All other testing: Internally at CRI-Devices in Maple Grove, MN, USA.
  • The studies are prospective, conducted specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable for this type of device. This device is a catheter introducer, which is a physical medical instrument, not an AI/ML software device or diagnostic tool that requires expert-established ground truth on patient data. The "ground truth" here is the performance of the device against engineering specifications and regulatory standards, assessed by testing laboratories and the FDA.

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

• Not applicable. This refers to methods for resolving discrepancies in expert opinions for ground truth establishment in AI/ML studies. This document concerns physical device testing against predefined specifications.

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 is an AI/ML-specific study type. The document describes an animal study comparing the device to a predicate device, not human reader performance with AI. The animal study showed the device "performed for the selected parameters substantially equivalent to the commercially available St. Jude Medical Swartz™ Braided Transseptal Guiding Introducer (K052644)."

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

• Not applicable. This relates to AI/ML algorithm performance. The device is a physical medical instrument.

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

• Not applicable in the AI/ML context. For physical device testing, the "ground truth" is established through adherence to recognized national and international standards (e.g., ISO, ASTM, AAMI) and internal performance specifications. For the animal study, the ground truth was the performance of the legally marketed predicate device under specific physiological parameters.

8. The sample size for the training set:

• Not applicable. There is no AI/ML component, thus no training set.

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

• Not applicable. No training set exists.

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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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The intended use for the PeriVac Kit is as follows: The PeriVac Kit is intended for use in pericardial aspiration and drainage in the presence of pericardial effusion and tamponade.

The PeriVac Kit is designed to provide all of the necessary components for site preparation, local anesthesia, puncture, aspiration and/or drainage, collection, and dressing for the completion of pericardial fluid aspiration. The kit is comprised of finished components and packaged to provide convenience for the user. The PeriVac Kit is comprised of 21 components pre-assembled and packaged to eliminate delays when initiating emergency pericardial aspiration of fluid. For customer convenience, the PeriVac Kit will be made available in four packaging configurations with the only difference between the kits being the catheter types and the inclusion of Lidocaine and Providone-Iodine solution. This submission addresses two components of the PeriVac Kit.

The provided text describes a 510(k) submission for a medical device, the PeriVac Kit, and its comparison to a predicate device. However, it does not contain information regarding acceptance criteria, study design, or performance metrics that would typically be associated with AI/ML device studies. This document is a regulatory submission for a traditional medical device (pericardiocentesis kit), not an AI/ML powered device.

Therefore, I cannot extract the requested information as it is not present in the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device based on device characteristics and intended use, rather than presenting performance data from a clinical or non-clinical study in the context of acceptance criteria.

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