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The VersaCross Connect Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.

The subject VersaCross Connect™ Transseptal Dilator (VXA-AG) is a single-use device that is supplied sterile to the user.

The subject VersaCross Connect™ Transseptal Dilator (VXA-AG) represents modifications to the legally marketed VersaCross Connect™ Transseptal Dilator (K241720).

The VersaCross Connect™ Transseptal Dilator (VXA-AG) is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The dilator provides torque control and is flexible. The dilator features a tapered tip and a shaft that can be reshaped manually. The echogenic shaft and tip and radiopaque tip maximize visualization of the dilator during manipulation in procedures.

The dilator can be used with separately cleared compatible access sheaths such as Agilis™ NxT Steerable Introducer (K061363 or K081645). The dilator provides support and helps guide separately cleared compatible transseptal wires to the atrial septum for puncture. The dilator subsequently dilates the atrial septal defect to enable larger diameter devices to cross the septum. The subject device can be used by electrophysiologists, interventional cardiologists, and other users trained in catheter techniques for any procedure that requires left atrial access via transseptal puncture. Procedures using the devices are performed in fully equipped catheter labs with imaging equipment, including fluoroscopy and echocardiography under sterile technique.

The provided FDA 510(k) Clearance Letter for the VersaCross Connect™ Transseptal Dilator does not contain information related to an AI/ML-driven medical device. The clearance is for a physical medical device (a vessel dilator) which has undergone design modifications.

Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance, human reader improvement with AI assistance, standalone algorithm performance, and ground truth establishment for training and test sets, is not applicable to this document.

The document details the following for the physical device:

• Device: VersaCross Connect™ Transseptal Dilator
• Purpose: Used for procedures requiring access to the left atrium via the transseptal technique.
• Modifications: Design changes (hub color, dilator shaft dimensions, snap fit hub geometry, hub length) and non-patient contacting material changes from its predicate device (K241720).
• Verification and Validation Activities: These focused on the physical and material properties of the dilator, ensuring it meets performance, safety, and biocompatibility standards. Examples include:
  • Torque Transmission, Dilator Protrusion Length, Shaft Outer Diameter, Flexural Rigidity, etc.
  • Biocompatibility, Sterilization, Pyrogen testing, Packaging integrity.
  • Benchtop validation to confirm performance during normal intended use.
• Substantial Equivalence: The submission demonstrates that the modified device is substantially equivalent to its predicate, sharing the same intended use, indications for use, fundamental scientific technology, operating principles, and mechanism of action. The changes do not raise new questions of safety or effectiveness.

In summary, there is no AI/ML component described or evaluated in this 510(k) clearance document, and thus, no information is available to address the specific questions about AI/ML acceptance criteria and performance studies.

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The HOTWIRE™ is indicated for creation of an atrial septal defect in the heart.

The HOTWIRETM is a sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal electrode segment for the creation of an atrial septal defect in the heart. The HOTWIRE is intended to be used in conjunction with compatible third-party intravascular sheaths and/or dilators, such as the Agilis NXT Steerable Introducer, St. Jude Medical (K081645), and third-party RF electrosurgical generator(s), such as the Valleylab FT10 Electrosurgical Platform (K151649) which utilizes a commercially-available Patient Return Electrode (PRE) which is in compliance with IEC 60601-2-2, such as the Valleylab E7507DB (K822572).

The HOTWIRETM is comprised of a stainless steel core wire. The main body of the wire is jacketed with an insulating polymer that provides electrical insulation and facilitates smooth movement of the device through vascular dilators and/or sheaths. The floppy distal segment of the wire has an atraumatic tip with an uninsulated stainless-steel coil, which serves as an electrode, and also provides fluoroscopic visualization. A tungsten marker coil at the tip provides additional radiopacity. The stiff body of the HOTWIRE™ provides support for advancing wire-guided devices into the left atrium after the distal segment has traversed the septum. The proximal insulated portion of the wire has visual markers that align the electrode tip with 3rd party transseptal sheaths and/or dilators. A portion of the proximal wire is uninsulated for placement of an included Adapter Pin that connects to hand pieces used with compatible third-party RF electrosurgical generators.

The provided document is a 510(k) summary for the HOTWIRE™ RADIOFREQUENCY (RF) GUIDEWIRE, demonstrating its substantial equivalence to a predicate device. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the performance bench testing, animal testing, biocompatibility testing, EMC + Electrical Safety testing, shelf life testing, packaging validation, sterilization validation, and bacterial endotoxin testing conducted to show the device is safe and effective and comparable to the predicate.

Here's the information requested, based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are primarily established by demonstrating compliance with recognized performance standards and showing substantial equivalence to a legally marketed predicate device. The reported device performance is presented as a summary of various tests, all of which "passed testing" or "met the requirements."

Study Details:

The document describes pre-market testing to establish substantial equivalence for a medical device (HOTWIRE™ RF Guidewire) rather than a study typically associated with AI/software devices (which would involve human readers, ground truth establishment, etc.). Therefore, many of the requested points are not applicable in this context.

Here's how the information aligns with the provided document:

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

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

   • Sample Size: The document repeatedly states "All test samples passed testing," but does not specify the exact number of samples used for each test. This information is typically detailed in the full test reports, not the 510(k) summary.
   • Data Provenance: Not explicitly stated but assumed to be laboratory testing conducted by or for the device manufacturer (Atraverse Medical, Inc.). The animal testing was a GLP (Good Laboratory Practice) study, implying a controlled, prospective design for that component. Country of origin not specified, but the submission is to the U.S. FDA.

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. This device is a guidewire, not an AI/software device requiring human expert annotation for ground truth. "Ground truth" here refers to objective measurements and biological responses verified through standard laboratory and animal testing protocols.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This pertains to expert review and consensus for data labeling/ground truth in AI/software studies, not physical device performance testing.

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 physical medical device (guidewire), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a physical medical device. The "standalone" performance is established through bench and animal testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's performance is established through:

   • Validated Test Methods and Standards: (e.g., ISO 11070 for tensile strength, ISO 10993 series for biocompatibility, IEC 60601 series for electrical safety).
   • Visual Inspection and Dimensional Measurements: Objective assessments against defined specifications.
   • Biological Responses: Measured in in vitro and in vivo (animal) models, such as cytotoxicity, sensitization, pyrogenicity, hemolysis, and thrombogenicity.
   • Functional Performance: Assessment of characteristics like trackability, handling, and radiopacity in simulated and animal use.

8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

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The Amplatzer™ Steerable Delivery Sheath is indicated to facilitate the delivery of the Amplatzer Amulet Left Atrial Appendage Occluder.

The Amplatzer Steerable Delivery Sheath is a sterile (EO), single use sheath designed to provide a pathway through which a device may be delivery sheath is available in one size, 14F. The sheath will be used to deliver an Amplatzer Amulet™ Left Atrial Appendage Occluder. The Amplatzer™ Steerable Delivery Sheath is comprised of three components: a sheath to deliver the device, a dilator to ease penetration of tissue, and a 2X to 1X Flush Adapter to facilitate connection of additional device components.

The sheath is comprised of the distal tip, sheath body and sheath handle. The distal tip design utilizes a dual fixed curve in two dimensions, resulting in a three-dimensional geometry. The sheath body is radiopague for visibility under fluoroscopy and includes a marker band located in the distal tip to aid with visualization during device deployment and recapture. The Steerable Sheath device has been designed with a bi-directional distal tip which is controlled by pull-wires along the sheath body connected to the device handle to provide better co-axial alignment between the appendage and sheath. Additionally, a hemostasis valve and side port are integrated in the device handle. The sheath has an effective length of 75 cm and 98.5 cm overall length. The sheath is compatible with a 0.35″ guidewire and a 19F introducer.

The provided text describes a submission for a medical device called the Amplatzer™ Steerable Delivery Sheath, but it does not contain acceptance criteria for an AI/ML powered device or a study proving its performance against such criteria.

The document is a 510(k) summary for a traditional medical device (a catheter delivery system) and focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. It includes information on biocompatibility, bench testing, sterilization, packaging, and a design validation study in an animal model.

Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria or an AI/ML-specific study.

Here's why the document doesn't fit your request:

• No AI/ML Component: The Amplatzer™ Steerable Delivery Sheath is described as a physical medical device (catheter) used to deliver another device. There is no mention of any artificial intelligence or machine learning component in its design or function.
• Focus on Substantial Equivalence: The entire submission is built around demonstrating that the new device is "substantially equivalent" to existing predicate devices, which is a standard regulatory pathway for non-novel medical devices. This typically involves comparing design, materials, indications for use, and performance through established test methods, not AI model metrics.
• Study Types: The studies mentioned (biocompatibility, bench testing, animal model design validation, human factors) are typical for hardware medical devices and do not involve AI performance evaluation metrics (e.g., accuracy, sensitivity, specificity, AUC).

If you have a document describing an AI/ML device, I would be happy to analyze it against your criteria. This document, however, does not contain that information.

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The Talon Surgical CardioCurve™ Steerable Sheath is indicated when introducing various cardiovascular devices to the epicardial or endocardial surfaces of the heart, including the left side of the heart through the interatrial septum.

The Talon Surgical CardioCurve Steerable Sheath is a 8.5F sterile, single-use, catheter introducer used for the introduction, withdrawal, and exchange of guidewires and catheters while minimizing blood loss. It is available in lengths of 40, 61, 71 or 82 cm. The introducer is packaged with a custom dilator and a 180 cm, 0.032", super stiff, market cleared guidewire (K935170). A side port with three-way stopcock allows blood aspiration, fluid infusion, and pressure monitoring. An integrated Tuohy Borst adaptor is designed to hold a guidewire or catheter in place. The steerable sheath features distal side holes to facilitate aspiration and minimize cavitation, and a stainless-steel ring for visualization under fluoroscopy.

The handle is equipped with two linked rotating dials used to deflect the tip clockwise and counterclockwise 180°.

The CardioCurve Steerable Sheath shaft is made from barium loaded Pebax and Nylon and includes a radiopaque tip marker for visibility under fluoroscopy and is braided, except for the distal tip, for kink resistance; the handle is made of ABS. The dilator is made of HDPE that is barium loaded for visibility under fluoroscopy

The CardioCurve Steerable Sheath Dilator can be used with a curved transseptal St. Jude Medical BRKTM type needle with stylet if indicated on the package label.

The provided document is a 510(k) summary for the Talon Surgical CardioCurve™ Steerable Sheath. This specific type of document, primarily focused on demonstrating substantial equivalence to a predicate device for FDA clearance, does not contain the detailed, quantitative performance metrics and study design elements typically associated with acceptance criteria and a detailed study proving a device meets those criteria for AI/ML-driven diagnostics.

The document describes performance testing for a catheter introducer (a physical medical device, not an AI/ML diagnostic). The testing ensures the device meets its design requirements and is safe and effective for its intended use, focusing on physical and biocompatibility attributes.

Therefore, I cannot provide the requested information (Acceptance Criteria, Device Performance Table, Sample Sizes, Expert Ground Truth, Adjudication, MRMC studies, Standalone performance, Training set details) as this document does not pertain to an AI/ML diagnostic device and its performance evaluation in the way you've outlined.

The "Performance Testing" section on page 10 lists various types of tests conducted on the physical device, such as:

• Visual Inspection
• Dimensions
• Guidewire Compatibility
• Dilator Compatibility
• Deflection and retention
• Shaft tip buckle
• Air and liquid leakage per ISO 11070:2017
• Hub compatibility with ISO 80369-7
• Stopcock compliance per ISO 594
• Tensile Strength per ISO 11070
• Distribution and Packaging Tests per ASTM D4169:2016 and ISO 11607-1
• Packaging Aging per ASTM F1980
• Biocompatibility per ISO 10993-1 (covering Cytotoxicity, Sensitization, Irritation, Toxicity, Hemocompatibility, and a Thrombogenicity Study in Ovine Model).

The document states: "All testing met the requirements and passed. There are no new questions raised regarding safety or efficacy of the CardioCurve Steerable Sheath."

To reiterate, the information requested is specific to the evaluation of AI/ML diagnostic models, which is not what this FDA 510(k) summary describes.

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The TSP Crosser Transseptal Access System is intended to both puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left side of the heart.

The TSP Crosser System is intended to be used both to puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left heart chambers. The main components of the TSP Crosser System are:

• . Steerable introducer sheath with handle and radiopaque wire loop that is compatible with catheters up to 8F
• . Dilator that is compatible with guidewires up to a maximum diameter of 0.035"
• Transseptal needle with Stylet ●
  The System is provided sterile (EO) and is intended for single use only. The device is designed to provide controlled transseptal access in the cardiac left atrial anatomy. The TSP catheter introducer sheath is an elongated shaft with a central lumen capable of incorporating the needle and stylet assembly, the dilator, as well as allow passage and orientation of operational catheters up to 8F. The introducer incorporates a steerable tip that can be deflected bidirectionally up to 180° with a curvature radius of 22mm. The steerable introducer handle includes a rotating knob that maintains the rotational and longitudinal positioning of the sheath and deflects the sheath's tip 180° on each side. There is a nitinol loop wire positioned at the distal end of the introducer that is visible under fluoroscopy and provides a visual aid to the user when positioning the needle on the fossa ovalis. The introducer contains a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with a three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring.
  The dilator has an outer diameter of 8F and inner diameter of 0.035" and includes a central lumen that facilitates the transseptal needle/stylet in a similar fashion to conventional dilators. The transseptal needle assembly consists of a luminal stainless-steel needle and solid stainlesssteel stylet. The needle is used to puncture the interatrial septum during the catheterization procedure and houses a central lumen that accommodates the stylet.

The provided text describes a 510(k) premarket notification for the TSP Crosser™ Transseptal Access System. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness from scratch through extensive clinical trials for new medical devices.

Therefore, the document does not provide the kind of detailed information about acceptance criteria, study design (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truths for AI models) that would be present for a novel AI/ML-based device. This device is a physical medical instrument, not an AI model.

The "performance data" section (6.7) refers to bench testing, biocompatibility testing, and in vivo animal studies to assure reliable design and performance, and support substantial equivalence. It also mentions "clinical data collected outside the United States" but doesn't elaborate on its specifics or how it supports the claims for the device.

Given the nature of this document (a 510(k) for a physical medical device and not an AI/ML product), I cannot provide the requested information regarding acceptance criteria for an AI model's performance, sample sizes for AI test/training sets, details on expert ground truth establishment, adjudication methods, or MRMC studies.

The document discusses performance testing in the context of a physical device:

1. Acceptance Criteria and Reported Device Performance (Summary based on the provided text)

Missing Information (Not applicable or not provided in the context of this 510(k) for a physical device):

The following points are pertinent to AI/ML device evaluations and are not found in this 510(k) submission for a physical medical device. Therefore, I cannot answer them from the provided text.

• 2. Sample sizes used for the test set and the data provenance.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
• 4. Adjudication method for the test set.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or what the effect size of human readers improving with AI vs without AI assistance was.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• 8. The sample size for the training set.
• 9. How the ground truth for the training set was established.

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The 82cm Agilis NxT™ Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart via the venous anatomy, including the left side of the heart through the interatrial septum.

The Agilis NxT Steerable Introducer consists of a steerable sheath, dilator and guidewire, which is indicated for introducing various cardiovascular catheters into the heart via the venous anatomy, including the left side of the heart through the interatrial septum. It is an 8.5F asymmetrical bi-directional steerable introducer with a large curl at the distal tip and a useable length of 82 cm. The proximal end of the device sheath is fitted with a hemostasis valve to minimize blood loss during catheter insertion and/or exchange over a quidewire. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating collar to deflect the large curl 90° in the counterclockwise direction and 180° in the clockwise direction. The sheath is filled with radiopaque material for visualization under fluoroscopy.

A dilator and guidewire are packaged with the introducer and are designed to facilitate the introduction and passage of the introducer through the vasculature.

This document describes the acceptance criteria and the study for the 82cm Agilis NxT™ Steerable Introducer.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes bench testing for the device, not a human clinical trial involving a "test set" of patients or data in the typical sense for evaluating diagnostic accuracy or clinical outcomes. The "test set" here refers to the actual devices or components tested.

• Sample Size: The specific sample size for each individual bench test (e.g., how many devices underwent a Shaft Kink test) is not explicitly stated in the provided text. The results are simply reported as "Pass."
• Data Provenance: The tests are conducted by the manufacturer, St. Jude Medical, which implies internal testing. The data provenance is retrospective in the sense that these tests were performed on manufactured devices to verify their specifications. The country of origin of the data is implicitly the manufacturing or testing location of St. Jude Medical, likely the United States (Minnetonka, MN, as listed for the submitter).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the evaluation is based on bench testing of device specifications, not on diagnostic accuracy requiring expert interpretation or ground truth establishment in a clinical context.

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, particularly for interpreting diagnostic images or clinical endpoints where multiple experts might disagree. Bench tests have objective Pass/Fail criteria based on predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not performed. This type of study assesses the impact of a device (like an AI algorithm) on human reader performance, which is not relevant for a steerable introducer device's bench testing.

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

This information is not applicable. The device is an electro-mechanical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the bench tests is the defined product specifications and performance requirements. For example, the "Curve Angle" test would have a specific angle tolerance as its ground truth, and the device either meets it ("Pass") or fails to. For biocompatibility tests, the ground truth is established by standards (e.g., ISO 10993) and the biological response observed meets the defined acceptable limits.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device's development as it is not an AI/ML algorithm. The device design and materials are based on engineering principles and previous predicate devices.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reasons as above.

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