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The AcQCross™ Qx Integrated Transseptal DilatorNeedle is indicated to puncture the interatrial septum to gain access to the left side of the heart whereby various cardiovascular catheters are introduced.

AcQCross™ Qx combines the conventional vessel dilator and transseptal needle into a single device (Figure 1). AcQCross™ Ox consists of an elongated shaft with a tapered tip and central lumen to track over a guidewire. The lumen of AcQCross™ Qx is fitted with a hollow stainless steel transseptal needle (Figure 2). Both the shaft and needle are connected to the proximal handle of AcQCross™ QX. The lumen of the needle will allow for guidewires up to 0.032" in diameter. The needle is affixed to a spring-tensioned actuator in the handle of AcQCross™ QX 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 that allows for monitoring intracardiac electrograms (EGMs) from the needle while in the heart utilizing the EGM adapter cable, and/or allows for the application of radiofrequency (RF) current from an electrosurgical generator to facilitate the septal puncture utilizing the ES adapter cable. AcQCross™ Qx is for single-use only and is provided sterile.

This document is a 510(k) summary for the AcQCross™ Qx Integrated Transseptal Dilator/Needle, a Class II medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against specific acceptance criteria. Therefore, several of the requested sections cannot be fully populated as this type of information is generally not included in a 510(k) summary that relies on demonstrating equivalence to a previously cleared device.

However, I can extract the relevant information regarding performance testing and how substantial equivalence was established.

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

The document does not explicitly state numerical acceptance criteria for the device performance tests. Instead, it relies on demonstrating that the AcQCross™ Qx performs "as intended" and that "minor differences do not potentially impact the safety and effectiveness" compared to the predicate device. The performance tests were conducted in accordance with ISO standards and additional bench testing was performed on the modified standalone device.

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

The document is a 510(k) summary for a medical device that relies on substantial equivalence. It does not contain information about the sample sizes used for the performance tests. The data provenance (country of origin, retrospective/prospective) is also not specified, which is typical for this type of regulatory submission focusing on engineering and bench testing.

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)

This information is not applicable to the type of testing described in this document. The performance tests are engineering-based (biocompatibility, sterilization, electrical safety, bench testing) and do not involve "ground truth" derived from expert medical interpretation.

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

This information is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple experts, which is not the case for the engineering performance tests described.

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

This information is not applicable. The device (transseptal dilator/needle) is a mechanical medical device, not an AI-powered diagnostic tool. Therefore, MRMC studies and "human reader improvement with AI" are not relevant.

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

This information is not applicable as the device is a physical medical instrument, not an algorithm. The phrase "standalone device" in the document refers to the AcQCross™ Qx being cleared for use by itself (with compatible sheaths) rather than only as part of specific introducer sets.

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

Ground truth, in the context of clinical or diagnostic studies, is not applicable here. The "truth" for the performance tests (e.g., biocompatibility showing no toxicity, sterilization achieving SAL, mechanical forces meeting specifications) is established through standardized laboratory testing and engineering validation.

8. The sample size for the training set

This information is not applicable. The device is a mechanical tool; it does not involve training data sets or machine learning algorithms.

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

This information is not applicable as there is no training set for this type of medical device.

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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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