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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 CrossWise™ RF Transseptal Cannula and accessories are used to create an atrial septal defect in the heart. Secondary indications include infusing solutions including heparinized saline and mixtures of 50% contrast media and 50% saline.

The CrossWise RF Transseptal Access System is used to puncture the Fossa Ovalis (FO) to establish transcatheter access from the right atrium to the left atrium. Monopolar radiofrequency (RF) energy is delivered between the CrossWise focal force electrode and a patient return electrode. The unique design of the focal force electrode minimizes trauma to cardiac tissue unless RF energy is applied. A colored sleeve is provided on the CrossWise RF Transseptal Cannula handle to indicate to the user when the tip of the catheter is still within the dilator.

The CrossWise RF Transseptal Cannula is supplied with a compatible dilator and a Super Stiff 0.032" PTFE-Coated Fixed Core J-Tip guidewire for vascular introduction using an over-the-wire technique. The RF Transseptal Cannula is connected to a ValleyLabs Force2 Electrosurgical Generator (Medtronic, Inc) via the CrossWise Multi-Use RF Adapter Cable (packaged separately – Model CW-1001) and a commercially available Electrosurgical Pencil.

This 510(k) clearance letter details the substantial equivalence of new models of the CrossWise RF Transseptal Access System to a previously cleared predicate device. It specifically states that the new models have minor modifications and leverage most of the performance data of the predicate device.

Therefore, the acceptance criteria and study details discussed below refer to the bench testing conducted for these minor modifications, as this is the only performance data explicitly mentioned for the subject device. The document does not contain information about clinical studies with human participants, expert ground truth adjudication, or AI performance, as it is related to a medical device's physical and functional equivalence, not an AI or diagnostic tool.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

The provided 510(k) clearance letter details the acceptance criteria and the non-clinical performance data for the CrossWise RF Transseptal Access System line extensions (Models CW-1085C, CW-1085V, and CW-1013F). The study conducted to prove the device meets these criteria was a series of bench tests.

1. Table of Acceptance Criteria and Reported Device Performance

The letter explicitly states that the new models leverage most of the performance data of the predicate device. The following table summarizes the specific tests conducted for the minor modifications of the new models and the implied performance criteria based on the conclusion of substantial equivalence.

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

• Sample Size: Not explicitly stated in terms of a number of devices or units. The testing refers to "minor modifications" to the dilator hub and compatibility with new introducer sheaths. For bench tests like these, a statistically representative sample size would have been used for each test (e.g., n=3, 5, or 10 units per test configuration), but the exact numbers are not provided.
• Data Provenance: The data is non-clinical bench testing conducted by the manufacturer, Circa Scientific, Inc. The location of the testing is not specified, but it would have been conducted in a laboratory setting under controlled conditions. This is not retrospective or prospective in the clinical sense, as it does not involve patient data.

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

• Not applicable. This document describes the clearance of a medical device (a transseptal access system), not an AI or diagnostic tool that relies on expert interpretation of data to establish ground truth. The acceptance criteria are based on objective engineering and performance standards demonstrated through bench testing.

4. Adjudication Method for the Test Set

• Not applicable. As this is non-clinical bench testing of a physical medical device against engineering standards, there is no expert adjudication process in the manner of medical image interpretation or clinical outcomes. Test results would have been analyzed and verified by qualified engineering and quality personnel.

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

• No. An MRMC study is typically conducted for diagnostic devices or AI systems where human readers interpret patient cases. This clearance is for a physical medical device used in interventional cardiology.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This is a physical medical device, not an algorithm, so the concept of standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

• Engineering and Performance Standards: The "ground truth" for the bench tests would have been established by predefined engineering specifications, internationally recognized standards (e.g., ISO 80369-7, ISO 10993-1, ISO 11070-1), and the performance characteristics of the predicate device. For example, the ground truth for "Dilator Leak Test" would be "no leakage observed under specified pressure," and for "ISO 80369-7 Luer Testing" would be "full compliance with all requirements of the standard."

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set."

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

• Not applicable. As there is no training set, this question is not relevant.

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The CrossWise™ RF Transseptal Cannula and accessories are used to create an atrial septal defect in the heart. Secondary indications include infusing solutions including heparinized saline and mixtures of 50% contrast media and 50% saline.

The CrossWise Multi-Use RF Adapter Cable (Model CW-1001) is used in Transseptal Puncture Procedures (TSP) to connect the CrossWise™ RF Transseptal Cannula (K241414) to a 3/32" electrosurgical (ES) pencil. The cable delivers radiofrequency (RF) energy to the CrossWise™ RF Transseptal Cannula to facilitate septal puncture. The CrossWise RF Transseptal Cannula is connected to a ValleyLabs Force2 ES Generator (K051644) via the CrossWise Multi-Use RF Adapter Cable (Model CW-1001) or CrossWise RF Adapter Cable (Model CW-1002 / K241414) and a commercially available 3/32" ES pencil. The CrossWise Multi-Use RF Adapter Cable has unique connectors on each end which cannot be connected to an improper device and/or accessory. The CrossWise Multi-Use RF Adapter Cable (Model CW-1001) and CrossWise RF Adapter Cable (Model CW-1002) are both compatible with all CrossWise RF Transseptal Access System models. The dimensions for the CrossWise Multi-Use RF Adapter Cable can be found on the package labels. Circa Scientific sterilized the CrossWise Multi-Use RF Adapter Cable via ethylene oxide (EO) for initial use and is intended for multiple patients use, following prescribed reprocessing instructions. The prescribed reprocessing includes cleaning and steam/autoclaye sterilization procedures that have been validated for up to10 uses when users follow the cleaning and sterilization methods described in the Cleaning and Sterilization Instructions sections of the CrossWise Multi-Use RF Adapter Cable IFU. The CrossWise Multi-Use RF Adapter Cable does not come into direct or indirect contact with the patient according to the definitions in Section 3.0 of ISO 10993-1, and Attachment G of the September 2023 FDA Guidance document.

The provided document is a 510(k) Pre-Market Notification for a medical device called the "CrossWise™ Multi-Use RF Adapter Cable." This document primarily focuses on demonstrating the substantial equivalence of the new device to a previously cleared predicate device, especially regarding its reusability and materials.

The request asks for information typically found in studies validating an AI/ML medical device, specifically regarding acceptance criteria and performance data for an algorithm. However, this 510(k) submission does not describe an AI/ML device or algorithm. Instead, it describes a physical medical device (an adapter cable) and the bench testing performed to ensure its safety and effectiveness, particularly its reprocessing capabilities.

Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "number of experts used to establish the ground truth," and "sample size for the training set," are not applicable to this type of device and submission.

However, I can extract information related to the acceptance criteria and the study that proves the device meets those criteria, reinterpreting the request for a physical device rather than an AI/ML algorithm.

Device Description:
The CrossWise™ Multi-Use RF Adapter Cable (Model CW-1001) is used in Transseptal Puncture Procedures (TSP) to connect the CrossWise™ RF Transseptal Cannula to a 3/32" electrosurgical (ES) pencil. The cable delivers radiofrequency (RF) energy to the cannula to facilitate septal puncture. The primary difference from the predicate device is its ability to be reprocessed (cleaned and re-sterilized) for up to 10 uses, and minor material modification to the connector shroud to withstand autoclave temperatures.

1. Table of Acceptance Criteria and Reported Device Performance

For this multi-use physical device, the "acceptance criteria" revolve around its ability to maintain its functionality and safety after repeated reprocessing cycles, showing substantial equivalence to the predicate device.

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

• Test Set Sample Size: The document does not explicitly state the numerical sample size for individual tests (e.g., "n=X cables tested"). It mentions "Devices" were tested and "testing was conducted on devices at 2 aging points: after manufacturing (T=0) and after 6 months of accelerated aging (T=6M AA)." It also states that devices were "subsequently conditioned to reflect the intended reusability of the devices after reprocessing."
• Data Provenance: The data is from non-clinical bench testing performed by the manufacturer, Circa Scientific, Inc., to support the 510(k) submission. There is no indication of country of origin of the data beyond the manufacturer's location (Englewood, CO, USA). The testing is prospective as it's specifically designed to validate the new device's capabilities prior to market clearance.

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

• This concept is not applicable to this type of device validation. "Ground truth" established by experts (e.g., radiologists interpreting images) is relevant for AI/ML diagnostic tools. For this physical device, the "ground truth" is defined by established engineering and medical device standards for performance, sterilization, and material properties. The engineers and quality assurance personnel conducting and overseeing these tests are inherently acting as the "experts" whose work ensures compliance with these standards.

4. Adjudication Method for the Test Set

• This concept is not applicable. Adjudication methods (e.g., 2+1, 3+1 consensus) are used for resolving disagreements in expert interpretations, typically in diagnostic or prognostic AI/ML studies. For bench testing of a physical device, results are typically objectively measured against pre-defined engineering specifications, not subject to subjective interpretation and adjudication.

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 is not applicable. An MRMC study is designed to evaluate the impact of an AI diagnostic tool on human reader performance. The device here is a physical adapter cable, not an AI/ML algorithm.

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

• This is not applicable. A standalone performance evaluation is performed for AI/ML algorithms. The device submitted is a physical product. Its "standalone" performance is assessed via the bench tests (e.g., electrical resistance, tensile strength) without human interaction being part of the performance metric itself, but this is a fundamentally different type of evaluation from an AI algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this physical device is based on engineering specifications, material science properties, and established medical device performance standards (e.g., ISO 11135, ISO 17665, AAMI TIR12, ANSI/AAMI ST79, ANSI/AAMI ST98, IEC 60601-2-2). The physical and functional characteristics of the cable are objectively measured and compared against these pre-defined benchmarks to ensure safety and effectiveness for its intended use. There is no "pathology" or "outcomes data" in the sense of clinical study that establishes efficacy for this specific component; rather, component performance ensures the overall system works.

8. The Sample Size for the Training Set

• This is not applicable. There is no "training set" as this is not an AI/ML device that learns from data.

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

• This is not applicable as there is no "training set."

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The VersaCross™ RF Wire is indicated for creation of an atrial septal defect in the heart.

The subject VersaCross™ RF Wire is a single-use device that is supplied sterile to the user. The subject device is comprised of an RF Wire and separately cleared Connector Cable (K023334) that are packaged together. The RF Wire is indicated for the creation of an atrial septal defect in the heart. The RF Wire delivers radiofrequency (RF) power in a monopolar mode between its distal active electrode and a commercially available external Disposable Indifferent (Dispersive) Patch (DIP) Electrode/grounding pad. The RF Wire is used with a separately cleared compatible generator, such as the Baylis RF Puncture Generator (K12278). The VersaCross™ RF Wire is comprised of a core stainless steel wire. The RF Wire body is covered with an insulating material to facilitate smooth advancement of the device in conjunction with providing electrical insulation. The floppy distal end of the RF Wire is curved and the active tip is rounded to be atraumatic to cardiac tissue unless RF energy is applied. A marker coil and radio-opaque band is positioned on the distal curve and distal tip, respectively, to facilitate RF Wire placement at the target puncture site during procedures under appropriate imaging quidance such as fluoroscopy, echocardiography and/or electroanatomic mapping (EAM) quidance. The main body of the RF Wire provides a rail for advancing ancillary devices into the left atrium following creation of an atrial septal defect. The RF Wire features visible proximal markers along its length to assist with aligning the wire tip in compatible transseptal sheath and/or dilator assemblies. The proximal end of the RF Wire is bare metal to facilitate connection with the included connector cable. The other end of the included connector cable connects to the compatible Baylis RF Puncture Generator.

The provided document is an FDA 510(k) clearance letter and a 510(k) summary for the VersaCross™ RF Wire. This document pertains to the clearance of a medical device and describes its testing and comparison to a predicate device, rather than the evaluation of an AI/ML powered device.

Therefore, the information typically requested for AI/ML device evaluations (such as acceptance criteria for AI performance, sample sizes for test sets, establishment of ground truth by experts, MRMC studies, standalone performance, training set details, etc.) is not provided in this document.

The document focuses on non-clinical performance testing for a physical medical device (a guidewire) to demonstrate its safety, effectiveness, and substantial equivalence to an existing predicate device. The tests described are mechanical, electrical, thermal, biocompatibility, sterilization, pyrogenicity, packaging, and benchtop validation, all of which are standard for traditional medical devices.

Summary of available information relevant to device testing (but not AI/ML performance):

• Device Name: VersaCross™ RF Wire
• Predicate Device: ProTrack™ RF Anchor Wire (K150709)
• Purpose of Testing: To demonstrate safety, effectiveness, and substantial equivalence of the subject device to the predicate device.
• Type of Ground Truth Used: Not applicable in the context of AI/ML. For a physical device, "ground truth" would relate to meeting pre-defined physical, chemical, electrical, and biological specifications and performance criteria.
• Sample Size for Training/Test Sets: Not applicable in the context of AI/ML. The document refers to "verification and validation activities" and "test protocols" for specific mechanical, electrical, and other physical tests, but does not specify sample sizes for these tests in the way one would for an AI/ML model's test set. The tests performed are laboratory-based and follow established standards (e.g., ISO, IEC).

In conclusion, this document does not contain the information required to answer your specific questions regarding acceptance criteria and study details for an AI/ML powered device.

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The CrossWise™ RF Transseptal Cannula and accessories are used to create an atrial septal defect in the heart. Secondary indications include infusing solutions including heparinized saline and mixtures of 50% contrast media and 50% saline.

The CrossWise RF Transseptal Access System is used to puncture the Fossa Ovalis (FO) to establish transcatheter access from the right atrium to the left atrium. Monopolar radiofrequency (RF) energy is delivered between the CrossWise focal force electrode and a patient return electrode. The unique design of the focal force electrode minimizes trauma to cardiac tissue unless RF energy is applied. A colored sleeve is provided on the CrossWise RF Transseptal Cannula handle to indicate to the user when the tip of the catheter is still within the dilator.

The CrossWise RF Transseptal Cannula is supplied with a compatible dilator and a Super Stiff 0.032" PTFE-Coated Fixed Core J-Tip guidewire for vascular introduction using an over-thewire technique. The RF Transseptal Cannula is connected to a ValleyLabs Force2 Electrosurgical Generator (Medtronic, Inc) via the CrossWise RF Adapter Cable (packaged separately - Model CW-1002) and a commercially available Electrosurgical Pencil.

The CrossWise RF Transseptal Cannula is designed to facilitate injection of heparinized saline and/or contrast solution. The dimensions for the CrossWise RF Transseptal Cannula can be found on the device label. The CrossWise RF Transseptal Access System offers four configurations compatible with various commercially available guide sheaths (Table 5). All four configurations require use of a single model (CW-1002) CrossWise RF Adapter Cable Model which is packaged separately.

This document does not describe a study involving device performance metrics relevant to AI/ML, such as sensitivity, specificity, or F1 score, or any human reader studies using AI assistance. The provided text is a 510(k) summary for a medical device (CrossWise RF Transseptal Access System) to demonstrate substantial equivalence to predicate devices, focusing on non-clinical performance data like biocompatibility, sterilization, electrical safety, and bench testing.

Therefore, many of the requested categories related to acceptance criteria, device performance, ground truth, and human reader studies cannot be populated from the given text.

Here's a breakdown of the information that can be extracted:

1. A table of Acceptance Criteria and the Reported Device Performance:

The document doesn't provide specific numerical acceptance criteria for performance metrics in a table format. Instead, it states that the device was tested to conform with various international standards and that "The nonclinical bench data support the safety of the device and demonstrate that the CrossWise RF Transseptal System performs as intended in the specified use conditions."

The types of tests performed and the general findings are:

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

• Test Set Sample Size: Not specified in terms of number of devices or number of tests for each type, other than "Devices were subjected to 2X sterilization and distribution simulation". The document states "Design verification testing was performed on the CrossWise RF Transseptal Access System with CrossWise RF Adapter Cable at two time points: immediately after manufacturing (T=0) and after six months of accelerated aging (T=6M AA)."
• Data Provenance: Not explicitly stated, however, the testing appears to be internal validation performed by the manufacturer, Circa Scientific, Inc., or a contract lab on their behalf. It is non-clinical (bench).

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

• Not applicable. This is a non-AI/ML medical device submission based on physical and electrical performance. Ground truth would be based on instrument readings, standardized methods, and expert evaluation of physical properties, not clinical expert consensus.

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

• Not applicable for this type of device and 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:

• No. This is not an AI/ML device.

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

• No. This is not an AI/ML device.

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

• For the non-clinical performance data, the "ground truth" is based on:
  • Validated test methods outlined in international standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety, ISO 11135 for sterilization).
  • Objective measurements from laboratory equipment and physical inspection.
  • Functional verification against design specifications.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML 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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The Cross Vascular RF Transseptal Needle and Connection Cable are used to create an atrial septal defect in the heart. Secondary indications include infusing solutions including heparinized saline and mixtures of 50% contrast media and 50% saline.

The Cross Vascular RF Transseptal Needle is used in transseptal surgical procedures to puncture the fossa ovalis and gain access from the right side of the left atrium. The RF Transseptal Needle within a compatible transseptal introducer set (Table 4) along with radiofrequency (RF) energy from the RF Generator is used to facilitate the septal puncture. The RF Transseptal Needle delivers RF power in a monopolar mode between the device's distal electrode and a commercially available external Patient Return Electrode (PRE) which is in compliance with IEC 60601-2-2. The RF Transseptal Needle is loaded through a compatible transseptal sheath and dilator (Table 4) and is connected at its proximal end to the Cross Vascular RF Generator via the Cross Vascular Connection Cable. The distal end of the needle contains a small through hole to facilitate injection of contrast solution. The active tip is specially shaped to be atraumatic to the cardiac tissue until RF energy is applied.

This document is a 510(k) Premarket Notification from the FDA regarding the "Cross Vascular RF Transseptal Needle" and "Cross Vascular Connection Cable." It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with performance metrics.

Therefore, much of the requested information about acceptance criteria, study details, sample sizes for test and training sets, expert involvement, and ground truth establishment, including specific performance metrics for AI algorithms, is not applicable or unavailable in this document. This document describes a medical device, not an AI-powered diagnostic or assistive technology.

However, I can extract the information that is present and indicate where the requested information is not provided.

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a table with specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) and corresponding reported device performance in the manner typically seen for diagnostic algorithms. Instead, it describes various non-clinical performance data and compliance with standards.

For medical devices like the Cross Vascular RF Transseptal Needle, "acceptance criteria" are typically met by demonstrating compliance with recognized standards and performing bench, biocompatibility, and electrical safety testing. The "reported device performance" in this context refers to the successful completion of these tests, indicating the device functions as intended and safely.

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

This information is not provided in the document. The document describes bench testing and compliance with standards, which would involve a number of units, but specific sample sizes for these tests are not detailed. The data provenance is internal to Cross Vascular Inc. and its testing partners (e.g., labs for biocompatibility, electrical safety). This is not a study involving patient data, so "country of origin of the data" or "retrospective/prospective" does not apply in the context of clinical data.

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

This information is not applicable/not provided. The "ground truth" concept, in the way it is typically used for AI-powered diagnostic devices requiring expert consensus on images or outcomes, does not apply here. The device is a physical medical instrument. Bench testing and compliance with standards typically involve engineers, quality assurance personnel, and certified laboratories verifying physical and functional properties, rather than medical experts establishing a "ground truth" for a dataset.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods like "2+1, 3+1" are relevant for expert review of cases in clinical studies or AI algorithm validation, especially when establishing ground truth. This document pertains to the physical and functional performance of a medical device, where 'adjudication' in this sense is not relevant.

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/not provided. An MRMC study is relevant for evaluating the impact of AI in diagnostic or assistive tools on human performance. This device is an RF transseptal needle, a surgical instrument, not an AI software.

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

This information is not applicable/not provided. This device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable/not provided in the sense of expert consensus, pathology, or outcomes data for a diagnostic algorithm. For a physical device, the "ground truth" for testing would be defined by the specifications in recognized standards (e.g., ISO, IEC, ASTM) and the device's design specifications. Performance is measured against these established engineering and safety benchmarks. For example, for biocompatibility, the ground truth is "non-toxic" or "non-hemolytic" as defined by the international standards.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This document does not describe the development or validation of an AI algorithm with training data.

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

This information is not applicable/not provided. This document does not describe the development or validation of an AI algorithm with training data.

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The Reprocessed NRG Transseptal Needle is used to create an atrial septal defect in the heart. Secondary indications include monitoring intracardiac pressures, sampling blood, and infusing solutions.

The reprocessed NRG Transseptal Needle delivers radiofrequency (RF) power in a monopolar mode between its distal electrode and a commercially available Disposable Indifferent (Dispersive) Patch (DIP) Electrode, which is in compliance with IEC 60601-2-2. The NRG Transseptal Needle is loaded through a Transseptal Sheath/Dilator set and is connected at its proximal end to the BMC Radiofrequency Puncture Generator via the BMC Connector Cable and optionally to an external pressure monitoring system via a luer connection. The dimensions for the reprocessed NRG Transseptal Needle can be found on the device label. The distal end of the needle contains a hole to facilitate injection of contrast solution and the monitoring of cardiac pressures. As well, the active tip is specially shaped to be atraumatic to the cardiac tissue unless RF energy is applied.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Reprocessed NRG Transseptal Needle.

Important Note: The provided document is an FDA 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving novel efficacy or performing clinical trials with the same rigor as for a new drug or a high-risk de novo device. Therefore, the "study" described is primarily a series of bench and functional tests to ensure the reprocessed device performs comparably to the original and remains safe. It does not involve human subjects, AI performance, or typical clinical effectiveness measures that would require ground truth established by medical experts for a diagnostic algorithm.

Acceptance Criteria and Reported Device Performance

Given the nature of this submission (reprocessed device seeking 510(k) clearance), the "acceptance criteria" are primarily related to the device's functional integrity, safety, and equivalence to the original predicate device after reprocessing.

Study Information

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

   • The document does not specify numerical sample sizes for each test mentioned (e.g., how many devices were subjected to cleaning validation, electrical safety, etc.).
   • The "data provenance" is derived from internal testing conducted by Innovative Health, LLC, the reprocessor and applicant. It's a retrospective evaluation of reprocessed devices. The country of origin for the data is implicitly the United States, where the company operates.

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

   • This question is not directly applicable to this type of device clearance. The "ground truth" for a reprocessed medical device is its ability to meet engineering specifications and safety standards, not a diagnostic accuracy against expert consensus. These "bench and laboratory tests" are typically performed against pre-defined engineering requirements and international standards by qualified engineers and technicians, not medical experts.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for human evaluation of diagnostic images or clinical scenarios where expert disagreement is possible. For functional and safety testing of a physical device, the outcome is typically an objective pass/fail against a standard, not subject to expert adjudication of subjective interpretations.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This is a reprocessed medical device (a transseptal needle), not an AI diagnostic algorithm or a device requiring human interpretation of data. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this submission.

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

   • Not applicable. This device is a physical medical instrument, not an algorithm.

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

   • The "ground truth" for this device's performance is established by engineering specifications, international performance standards, and safety requirements for medical devices (e.g., ISO, ASTM, IEC standards for biocompatibility, sterility, electrical safety, mechanical strength, etc.). It is not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or therapeutic clinical trial. The premise is that if the reprocessed device consistently meets these defined physical and chemical parameters, it is substantially equivalent and safe for its intended use as the original device.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

   • Not applicable. As there is no AI/ML algorithm or training set, this question is not relevant.

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The Fogarty dilation atrioseptostomy catheter is indicated for enlarging interatrial openings for palliation of several congenital cardiac defects to increase mixing at atrial level or to decompress a hypertensive atrial chamber.

The Miller balloon atrioseptostomy catheter is indicated for enlarging interatrial openings for palliation of several congenital cardiac defects to increase mixing at atrial level or to decompress a hypertensive atrial chamber.

The Fogarty dilation atrioseptostomy catheter is a 5 French single-lumen catheter (with 8F uninflated balloon OD) with a wire-wound shaft that may be visualized using fluoroscopy. A latex balloon with a maximum inflated diameter of 15mm is located at the distal end of the catheter. The distal tip has a nominal angulation of 35° to facilitate manipulation of the inter-atrial opening. A removable stylet is provided to increase catheter body stiffness and for temporary straightening of the 35° tip angulation during insertion. The catheter contains a gate valve in order to inflate and deflate the balloon. The catheter shaft has depth markings in 10 cm spacing.

The Miller balloon atrioseptostomy catheter is a 5 French single-lumen catheter (with 9F uninflated balloon OD) with a wire-wound shaft that may be visualized using fluoroscopy. A latex balloon with a maximum inflated diameter of 19mm is located at the distal end of the catheter. The distal tip has a nominal angulation of 35° to facilitate manipulation of the balloon through the inter-atrial opening. A removable stylet is provided to increase catheter body stiffness and for temporary straightening of the 35° tip angulation during insertion. The catheter contains a gate valve in order to inflate and deflate the balloon. The catheter shaft has depth markings in 5 cm spacing. The Miller catheter contains a plug for occluding the vein or percutaneous sheath to reduce venous leakage.

The Fogarty dilation atrioseptostomy catheter and Miller balloon atrioseptostomy catheter are packaged in an identical tube configuration.

The provided text is a 510(k) summary for the Fogarty Dilation Atrioseptostomy Catheter and Miller Balloon Atrioseptostomy Catheter. It focuses on demonstrating substantial equivalence to a predicate device based on design descriptions, intended use, indications for use, and a summary of non-clinical (bench) testing.

This document describes a medical device (catheter) and its regulatory clearance, not an AI/ML powered device, therefore, the information requested about acceptance criteria and studies proving the device meets the criteria in the context of AI/ML performance (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance) is not applicable to the provided content.

The document details the device's physical characteristics, its intended use (enlarging interatrial openings for palliation of congenital cardiac defects), and asserts substantial equivalence to a predicate device based on common intended use and similar technological characteristics, with minor modifications.

Here's what can be extracted regarding "acceptance criteria" from the provided text, interpreted as performance tests for the physical catheter device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes "Performance testing" which acts as the acceptance criteria for the physical device. Specific numerical "reported device performance" values are not provided in this summary; rather, it lists the types of tests performed. It states that the devices meet the established performance criteria.

Regarding the other aspects you asked about, they are not present in this document as it does not concern an AI/ML powered device impacting diagnostic performance:

• Sample size used for the test set and data provenance: Not applicable. These are physical device bench tests.
• Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. Ground truth for a physical device's performance usually comes from engineering specifications and physical measurements.
• Adjudication method: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for diagnostic systems.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a physical catheter.
• The type of ground truth used: For these non-clinical tests, the "ground truth" would be the engineering specifications and established test methodologies for mechanical, material, and sterility properties.
• The sample size for the training set: Not applicable (no AI/ML training).
• How the ground truth for the training set was established: Not applicable (no AI/ML training).

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Recommended for balloon atrioseptostomy, an accepted technique in most pediatric cardiology centers for the palliation of several congenital cardiac defects. Balloon atrioseptostomy is performed in conjunction with diagnostic cardiac catheterization and has been carried out after the diagnosis of several congenital cardiac defects: transposition of the great arteries, total anomalous pulmonary venous drainout pulmonary obstruction, tricuspid atresia, mitral stenosis, mitral atresia, and pulmonary atresia with intact ventricular septum.

Not Found

There is no information in the provided text regarding acceptance criteria or a study that proves a device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the Z-6 Atrioseptostomy Catheter, confirming its substantial equivalence to a predicate device. It defines the indications for use but does not contain details about a performance study, acceptance criteria, sample sizes, expert involvement, or ground truth establishment.

Therefore, I cannot provide the requested information in a table or fulfill the other points as the necessary data is not present in the provided text.

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