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The AcQCross™ Qx Integrated Transseptal Dilator/Needle 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. AcQCross™ Qx consists of an elongated shaft with a tapered tip and central lumen to track over a guidewire. The lumen of AcQCross™ Ox is fitted with a hollow stainless steel transseptal needle. 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™ Ox 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 an FDA 510(k) premarket notification for a medical device called the AcQCross™ Qx Integrated Transseptal Dilator/Needle. It's a submission seeking clearance for new models of an existing device, asserting substantial equivalence to a previously cleared predicate device (K210685).

Based on the provided information, the request is to "Describe the acceptance criteria and the study that proves the device meets the acceptance criteria." However, it's crucial to understand that this document describes a submission for a device (a physical medical tool), not a PREDICATE AI/ML device or a study proving AI/ML model performance in the context of typical AI acceptance criteria (e.g., sensitivity, specificity, AUC).

Therefore, I cannot directly extract "acceptance criteria" and "study results" in the way one would for an AI/ML diagnostic or predictive model, nor can I fill out the table with metrics like sensitivity, specificity, accuracy, etc. The "performance data" section of this document refers to bench testing of a physical medical device.

I will interpret the request within the context of the provided document, focusing on the device's functional performance and the evidence provided to the FDA for its substantial equivalence, which is how "acceptance criteria" and "study proving it meets criteria" are addressed for this type of medical device.

Acceptance Criteria and Study for the AcQCross™ Qx Integrated Transseptal Dilator/Needle (K220047)

The document describes the acceptance criteria and supporting studies in terms of substantial equivalence to a predicate device (AcQCross™ Qx, K210685). The "acceptance criteria" are implicitly met if the new models perform "as intended" and present "no unacceptable risks" compared to the predicate, with specific focus on dimensional modifications facilitating compatibility with different transseptal sheaths. The "study that proves the device meets the acceptance criteria" refers to bench testing and leveraging existing data from the predicate device.

1. Table of Acceptance Criteria (Functional Performance) and Reported Device Performance

For this physical medical device, "acceptance criteria" are related to its mechanical and electrical function, material compatibility, and sterile presentation, demonstrating it functions similarly to the predicate device despite minor dimensional changes. The "reported device performance" refers to the successful completion of these tests.

• Shaft to handle tensile
• Length compatibility
• Snap engagement
• Kink resistance
• Needle actuation
• Visual inspection
• Aspiration/flushing
• Electrical continuity
  (Other tests leveraged from predicate: Dimensional Verification, Surface Inspection, Tip Curve Retention, System Leak- Air Leakage- Luer Fitting, Needle to Button Tensile, Luer to Hypotube Tensile, Pushability/Trackability, Corrosion Resistance, Radiopacity). The nonclinical bench data support the safety of the device and demonstrate that it performs as intended. |

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

• Test Set: The document does not specify exact sample sizes for each bench test (e.g., number of devices tested for tensile strength, kink resistance, etc.). However, it indicates these tests were performed on "AcQCross™ Ox" (the new models) focusing on the dimensional modifications.
• Data Provenance: The studies are bench testing conducted by the manufacturer (Acutus Medical, Inc.). This is not "data" in the sense of patient data (retrospective/prospective, country of origin). It's engineering and performance testing of the physical product.

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

This question is not applicable in the context of this device. "Ground truth" established by experts (e.g., radiologists for image interpretation) is relevant for diagnostic AI/ML devices. For a physical medical device like a transseptal dilator/needle, the "truth" is determined by engineering specifications and objective bench test results, often against recognized standards (e.g., ISO standards). No human expert "labels" or "interprets" a performance test in this manner.

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

This question is not applicable. Adjudication methods (concensus among multiple readers) are relevant for clinical studies, particularly in diagnostic imaging. For bench testing of a physical device, results are typically quantitative measurements and characterizations against pre-defined engineering limits or established standards.

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 question is not applicable. An MRMC study is relevant for evaluating the impact of AI on human performance in diagnostic tasks. This submission is for a physical, interventional medical device, not an AI/ML diagnostic tool. There is no "human-in-the-loop" performance improvement measured.

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

This question is not applicable. This refers to an AI algorithm's independent performance. The AcQCross™ Qx is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance testing is based on engineering specifications, direct measurements, and compliance with recognized industry standards (e.g., ISO 11070:2014, ISO 10555-1:2013 for general requirements, AAMI/ANSI/ISO 10993-1:2009 for biocompatibility, ISO 11135:2014 for sterilization, ANSI/AAMI IEC 60601 series for electrical safety/EMC). For example, a "kink resistance" test's ground truth would be whether the device meets a pre-defined maximum kink angle or maintains patency under a certain force, rather than an expert opinion.

8. The sample size for the training set:

This question is not applicable. This device does not use an "AI training set." Its design is based on engineering principles and knowledge gained from the predicate device, not machine learning.

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

This question is not applicable as there is no AI training set.

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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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