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

The HOTWIRE™ 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, and third-party RF electrosurgical generator(s). The HOTWIRE™ 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 and echogenic 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 third-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 HOTWIRE™ + Handpiece Kit 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™ + Handpiece Kit is intended to be used in conjunction with compatible third-party intravascular sheaths and/or dilators, and the HOTWIRE™ System RF Generator, 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 HOTWIRE™ 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 and echogenic 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 third-party transseptal sheaths and/or dilators. A portion of the proximal wire is uninsulated for placement of an included handpiece that connects with the HOTWIRE™ System RF Generator.

This FDA 510(k) clearance letter and summary describe a physical medical product, the HOTWIRE RF Guidewire, not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML system (which typically involves metrics like accuracy, sensitivity, specificity, AUC, and studies like MRMC with ground truth establishment) is not applicable here.

The document details the device's technical specifications, design, materials, and extensive non-clinical bench top and in vivo performance testing to demonstrate its safety and effectiveness and its substantial equivalence to a predicate device.

Key points from the document regarding the device's performance and testing:

• Acceptance Criteria & Performance (General): The document states: "All test requirements were met as specified by applicable standards and test protocols." and "The HOTWIRE™ met all specified criteria and did not raise new safety or performance questions." This implies that predefined performance criteria for each test were successfully achieved. While a specific table of quantitative acceptance criteria versus reported performance (like a sensitivity/specificity table for an AI) isn't provided, the text confirms successful completion of various engineering and in vivo tests.

• Study Type: The studies performed are primarily non-clinical benchtop testing and in vivo animal testing (porcine model). These are designed to verify the device's physical and functional properties, and its performance in a biological environment.

• Sample Size:

  • Test Set (In vivo): A "porcine model" was used for in vivo testing. The specific number of animals or trials is not explicitly stated.
  • Training Set (for manufacturing/design, not AI): Not applicable in the AI sense. The design and manufacturing process for the guidewire would be iterated and refined through various engineering tests and material evaluations.

• Data Provenance:

  • Benchtop Testing: Likely conducted in a lab environment.
  • In vivo Testing: Utilized a porcine (pig) model.
  • Retrospective/Prospective: Not applicable in the context of an AI study. These are experimental tests designed to evaluate hardware performance.

• Experts for Ground Truth / Adjudication / MRMC:

  • These concepts are not applicable for a physical medical device clearance. "Ground truth" for a physical device is established through engineering specifications, material properties, and direct measurement of its physical and functional performance (e.g., tensile strength, RF power delivery, ability to create a defect in a model).
  • MRMC studies are specifically for evaluating human reader performance (e.g., radiologists) with or without AI assistance in diagnostic tasks.

• Standalone Performance: The benchtop and in vivo tests can be considered a demonstration of the device's "standalone" performance, meaning its inherent functional capabilities independent of human interpretation or diagnostic aid. For example, the "Arc integrity test," "Tensile strength test," and "In vivo testing" directly assess the device's intended function and safety characteristics.

• Type of Ground Truth: For this device, the "ground truth" is based on:

  • Engineering Specifications: Defined parameters for dimensions, material strength, electrical insulation, etc.
  • Direct Measurement: Quantification of physical properties (e.g., tensile strength, torque strength).
  • Functional Validation: Assessment of the device's ability to perform its intended action (deliver RF power, create a defect) in a controlled environment (benchtop) and a biological model (in vivo).
  • Compliance with Standards: Meeting requirements of relevant industry and regulatory standards (e.g., IEC 60601-2-2 for the RF Generator, ASTM standards for packaging).

• How Ground Truth for Training Set was Established: N/A as this is not an AI/ML device. The "training" of the device itself refers to its design and manufacturing process, which is refined based on engineering principles and test results.

Summary of Relevant Performance Data from the document:

The document lists several categories of testing, highlighting that all requirements were met:

• RF Guidewire Testing:
  • Visual and dimensional inspection
  • Simulated use test
  • Arc integrity test
  • Tensile strength test
  • Torque strength test
  • Torquability test
  • Fracture resistance test
  • Flexing test
  • Tip flexibility test
• Handpiece Testing:
  • Cable flex test
  • Cable tensile strength test
  • EEPROM functionality test
  • Cable length dimensional inspection
  • Retention test
  • Activation button test
• In vivo Testing:
  • Utilized a porcine model.
  • Evaluated subject device design performance during normal intended use.
  • Included compatibility with commercially-available introducer sheaths, intracardiac echocardiography (ICE) catheters, and fluoroscopic visualization.
• Shelf life testing: Accelerated aging for 1 year, all acceptance criteria met.
• Packaging validation: Acceptance criteria met, ensuring protection and sterile barrier.
• Sterilization validation: Achieved an SAL of 10⁻⁶ using gamma radiation.

In conclusion, while the request's structure is tailored for AI/ML devices, the provided document outlines a comprehensive set of engineering and biological tests demonstrating the physical guidewire's safety and performance, affirming its substantial equivalence to a predicate device.

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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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