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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 X-Wire Guidewire is indicated for general intravascular use within the peripheral and neuro vasculature to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Imperative Care's X-Wire Guidewires are guidewires with shapeable tips to aid in accessing the peripheral and neuro vasculature. The guidewires are available in 200cm - 300cm lengths, standard (S) and support (T) stiffness profiles, and 0.014", 0.018" and 0.024" diameters. The distal portion of the guidewire tip includes a radiopaque marker to facilitate fluoroscopic visualization. A hydrophilic coating on the distal segment and PTFE coating on the proximal segment serve to reduce friction during manipulation in vessels. The X-Wire Guidewire is supplied with a shaping mandrel, introducer, and torque device.

This document is a 510(k) clearance letter for a medical device and therefore does not contain acceptance criteria and study data in the format typically found in clinical efficacy studies for AI/software devices. The acceptance criteria and "study" described herein relate to the safety and performance of the physical guidewire device (X-Wire Guidewire) based on bench testing, biocompatibility testing, sterilization validation, and shelf-life testing, rather than a clinical study evaluating the performance of an AI algorithm.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document summarizes the performance testing done in Table 2: Summary of Bench Tests and Performance Specifications and Table 3: Biocompatibility Test Summary – X-Wire Guidewire.

Table: Acceptance Criteria and Reported Device Performance (Synthesized from document)

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HydroPICC Single Lumen: Indicated for short-or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 5.0 ml/s

HydroPICC Dual Lumen: Indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for a maximum power injection flow rate of 5.0 ml/s

HydroMID Single Lumen: Indicated for short term access(

The HydroMID catheters are a family of midline catheters comprised of a radiopaque, hydrophilic catheter with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in the manufacture of catheters. Catheters are provided packaged in kit configurations with the appropriate accessories for placement in the respective clinical environments. The maximum power injection flow rate for the lumen is indicated on the extension tube clamp. HydroMID has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. Reduction of thrombus accumulation and thrombotic occlusions were evaluated using an in vitro model. Pre-clinical in vitro evaluations do not necessarily predict clinical performance with respect to thrombus formation.

The HydroPICC catheters are a family of peripherally inserted central catheter (PICC) comprised of a radiopaque hydrophilic catheter material with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in the manufacture of catheters. Catheters are provided packaged in kit configurations with the appropriate accessories for placement in the respective clinical environments. The maximum power injection flow rate for the lumen is indicated on the extension tube clamp. HydroPICC has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. Reduction of thrombus accumulation and thrombotic occlusions were evaluated using an in vitro model. Pre-clinical in vitro evaluations do not necessarily predict clinical performance with respect to thrombus formation.

The purpose of this 510(k) is to add an additional statement to the indications for use.

The provided FDA 510(k) clearance letter (K243458) details the HydroPICC and HydroMID catheters. The focus of this submission is to add a statement to the indications for use regarding the anti-thrombogenic properties of the MIMIX® Technology incorporated into these catheters. The acceptance criteria and supporting studies are described below:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this 510(k) submission is to demonstrate that the expanded Indications for Use statement, specifically concerning the anti-thrombogenic properties of the MIMIX® Technology, does not introduce new questions of safety or effectiveness and is supported by non-clinical data. The reported device performance is based on in vitro studies.

Note: The FDA letter explicitly states: "The clinical impact has not been evaluated in human clinical trials. This device is not intended for the treatment of existing vein thrombosis." This indicates that the acceptance criteria are based solely on in vitro performance for the anti-thrombogenic claims, not on in vivo clinical outcomes.

Study Details for Acceptance Criteria

The provided document does not fully delineate separate "test sets" for the in vitro studies in the way one might for an AI/algorithm-based device. Instead, the "studies" themselves are the performance evaluations for the stated acceptance criteria.

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

   • The document lists several in vitro tests.
   • Sample Size: The specific number of devices or experimental replicates used in each in vitro test is not explicitly stated in the provided text.
   • Data Provenance: All studies are indicated as "in vitro" (meaning conducted in a test tube, culture dish, or other controlled environment outside of a living organism). The country of origin is not specified but is presumably where Access Vascular Inc. conducts its research and development or contracts with testing facilities.

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

   • For in vitro studies of this nature (evaluating properties like thrombus accumulation), the "ground truth" is typically established by the experimental setup, validated measurement techniques, and potentially statistical analysis.
   • No specific number of experts or their qualifications are mentioned as having established "ground truth" for these in vitro tests in the context of expert consensus, as might be the case for image-based diagnostic devices. The results are based on objective physical or biological measurements.

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 typically used in clinical studies or studies involving subjective expert review (e.g., radiology image interpretation) to resolve discrepancies in independent assessments. As these are in vitro physical/biological tests, such adjudication methods are not relevant or mentioned.

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:

   • Not applicable. This device is a medical catheter, not an AI software/algorithm requiring human reader interpretation. No MRMC study was conducted or is relevant for this device.

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

   • Not applicable. This device is a physical medical device (catheter) with a material technology, not an AI algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this submission.

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

   • The ground truth for the in vitro studies described (e.g., "Assessment of PICC Catheter Thrombosis," "Thrombosis Accumulation Report") is based on objective measurements of physical and biological phenomena (e.g., quantification of thrombus accumulation, pressure required to remove occlusions) within controlled laboratory environments. This is a form of empirical scientific measurement, rather than expert consensus, pathology, or outcomes data.

7. The sample size for the training set:

   • Not applicable. There is no mention of a "training set" because this is a physical medical device, not an AI/machine learning model that requires training data.

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

   • Not applicable. As no training set is mentioned, the method for establishing ground truth for it is also not applicable.

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The 0.014" Willow Guidewire is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Like the predicate device, the 0.014" Willow Guidewire is a single-use product with a shapeable tip available in straight and pre-shaped configurations, used to gain intravascular access to facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for neuro and peripheral diagnostic and interventional procedures. The wire can be torqued to facilitate navigation through the vasculature. The 0.014" Willow Guidewire comes in three stiffness profiles: Soft, Standard and Support.

The provided FDA 510(k) clearance letter and summary for the 0.014" Willow Guidewire do not describe a study involving an AI/Machine Learning device.

Instead, this document describes a traditional medical device (a guidewire) and its clearance process through substantial equivalence to a legally marketed predicate device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biocompatibility bench testing, not clinical performance studies for an AI algorithm.

Therefore, many of the questions related to AI/ML device performance (like sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, effect size of AI assistance) are not applicable to this document.

However, I can extract the relevant information regarding the acceptance criteria and the engineering study (bench performance testing) for the 0.014" Willow Guidewire.

Acceptance Criteria and Study for the 0.014" Willow Guidewire

The 0.014" Willow Guidewire is a traditional medical device, not an AI/ML device. Therefore, the "acceptance criteria" and "study" refer to engineering specifications and bench performance testing, along with biocompatibility testing, to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by "Acceptance criteria were met" or "considered acceptable" for each test. The reported device performance is that these criteria were successfully achieved.

Information Not Applicable (NA) to this Device/Submission:

The following questions are specifically targeted at AI/ML medical devices and are not relevant to the 0.014" Willow Guidewire, which is a traditional physical medical device.

2. Sample size used for the test set and the data provenance: NA (This is a physical device, not an AI/ML algorithm requiring a data test set.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: NA (No "ground truth" in the AI/ML sense is established for this type of device.)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: NA (No adjudication method described for physical device 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: NA (No MRMC study or AI assistance involved.)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: NA (Not an algorithm.)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): NA (Ground truth is not a concept applied in this context; performance is measured against engineering specifications and predicate characteristics.)
8. The sample size for the training set: NA (No training set for a physical device.)
9. How the ground truth for the training set was established: NA (No training set or ground truth in this context.)

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Stedi Guidewire is intended for use to introduce and position catheters during interventional procedures within the chambers of the heart, including transcatheter aortic valve replacement (TAVR).

The Medtronic Stedi™ Extra Support Guidewire (herein after referred as Stedi Guidewire) is design for use to introduce and position catheters during interventional procedures within the chambers of the heart, including transcatheter aortic valve replacement (TAVR) procedures.

The Stedi Guidewire has a 0.035" diameter and is 275cm in length and composed of two primary components: a core, and a coil. Both components are made of stainless steel. The core wire component is a piece of stainless-steel wire which is ground on the distal end to fit into the coil and provide flexibility. The coil and the ground core are joined in two locations: a proximal bond and a distal weld. The distal end of the Stedi Guidewire is comprised of a preformed 540° curved tip is available in 2 sizes (3cm and 4cm). The Stedi Guidewire has a polytetrafluoroethylene (PTFE) coating applied to the entire length of the device in order to aid in lubricity.

The Stedi Guidewire is sterilized using ethylene oxide, nonpyrogenic, disposable, and for single use only.

Based on the provided FDA 510(k) clearance letter for the Medtronic Stedi Extra Support Guidewire, here's a detailed breakdown of the acceptance criteria and the study information.

It's important to note that the provided document is a 510(k) clearance letter, which focuses on demonstrating substantial equivalence to a predicate device. For medical devices like guidewires, the "studies" primarily consist of non-clinical (bench) performance testing to ensure the new device meets established safety and performance requirements, rather than clinical trials with human subjects in the way AI/software devices typically undergo. Therefore, many of the questions related to human readers, ground truth, and training sets are not applicable in this context.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Medtronic Stedi Extra Support Guidewire are demonstrated through various non-clinical (bench) performance tests. The FDA guidance "Coronary, Peripheral and Neurovascular Guidewires Performance Tests and Recommended Labeling (October 10, 2019)" was utilized to establish these tests. The conclusion states that the device "met all design input requirements based on the intended use."

Here's a table summarizing the types of tests conducted, which imply the acceptance criteria were met by the device's performance in these areas:

Study Details

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

   • Sample Size: The document does not specify exact sample sizes for each non-clinical test. However, it indicates "samples were analyzed according to predetermined acceptance criteria" for the various bench tests. In medical device bench testing, sample sizes are typically determined statistically to ensure sufficient power to detect differences or to demonstrate compliance with specifications.
   • Data Provenance: The data is generated from non-clinical bench testing performed by Medtronic Inc. This is not clinical data (i.e., no patient data is involved). It is prospective in the sense that the tests were designed and executed to evaluate the new device.

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

   • N/A. For this type of medical device (guidewire), ground truth is established through engineering specifications, material science standards (e.g., ISO standards), and performance benchmarks derived from predicate devices and historical data. It does not involve human expert consensus in the diagnostic sense. The "experts" are the engineers, material scientists, and testers who design and conduct the tests and interpret the results against predetermined specifications.

3. Adjudication method for the test set:

   • N/A. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies or studies involving human interpretation of data (e.g., image analysis). For bench testing of a guidewire, results are quantitative or qualitative against predetermined engineering specifications, and "adjudication" typically refers to the pass/fail criteria established for each test.

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. This is a physical medical device (guidewire), not an AI/software device that assists human readers/clinicians, so an MRMC study is not applicable.

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

   • N/A. This is a physical medical device, not an algorithm. The "standalone" performance is the device's performance in the bench tests, independent of its use in a patient for the initial testing and FDA clearance.

6. The type of ground truth used:

   • The "ground truth" for each test is based on pre-established engineering specifications, material standards (e.g., ISO), and performance characteristics derived from the predicate device and FDA guidance documents. For example, the "ground truth" for tensile strength is a minimum force value, for biocompatibility it's compliance with ISO 10993, and for dimensions it's adherence to specified tolerances.

7. The sample size for the training set:

   • N/A. This is a physical medical device undergoing non-clinical testing, not a machine learning model, so there is no "training set."

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

   • N/A. As there is no training set for a physical device, this question is not applicable.

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The Aristotle 14 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Aristotle 18 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Aristotle 24 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Zoom Wire 14 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Aristotle Colossus Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Scientia Vascular's Aristotle 14, Aristotle 18, Aristotle 24, Zoom Wire 14, and Aristotle Colossus Guidewires ("the guidewires") are steerable guidewires with a shapeable tip to aid in accessing the neuro and peripheral vasculatures. The guidewires are supplied sterile, for single use only.

The distal portion of each guidewire's tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. All guidewires have a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels.

The guidewires are provided with an accessory kit consisting of an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve), a torque device (to attach to the proximal portion of the guidewire to facilitate gripping and manipulation of the guidewire during use), and a shaping mandrel (to aid in shaping the flexible tip of the guidewire). These accessory devices are included to facilitate use of the guidewires and are not intended to contact the patient's body.

This document describes a 510(k) clearance for several guidewire devices, not an AI/ML medical device. Therefore, the information requested about acceptance criteria and studies related to AI/ML device performance (such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, etc.) is not applicable and cannot be extracted from this document.

The document primarily focuses on establishing substantial equivalence for physical medical devices—guidewires—by comparing their technological characteristics and performing non-clinical performance tests (biocompatibility, sterilization, bench performance).

Here's a breakdown of why this document does not contain the requested information about an AI/ML device:

• Device Type: The clearance is for "Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire" which are physical catheter guide wires. These are traditional medical devices, not software or AI/ML devices.
• Study Types: The studies described are "Biocompatibility," "Sterilization," and "Bench Performance Testing" (Visual Inspection, Coating Integrity, Corrosion Resistance, Agent Compatibility, Simulated Use, Particulate). These are mechanical and biological tests relevant to physical devices, not algorithmic performance.
• Missing Information: All points you requested regarding AI/ML performance are absent because they are not relevant to this type of device clearance:
  • No acceptance criteria for AI performance metrics (e.g., sensitivity, specificity, AUC).
  • No test or training set sample sizes for AI data.
  • No information about experts establishing ground truth for images or data used by an AI.
  • No adjudication methods.
  • No MRMC comparative effectiveness studies.
  • No standalone algorithm performance.
  • No ground truth type related to AI (e.g., imaging labels, pathology).

The document explicitly states:

• "No animal testing was deemed necessary to support the substantial equivalence of the subject devices."
• "No clinical testing was deemed necessary to support the substantial equivalence of the subject devices."

This indicates that the clearance relies on non-clinical data and comparison to predicate devices, which is common for guidewires, especially when the changes are minor (like a different PTFE coating).

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Indicated for short-or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 5.0ml/s

The HydroPICC 4F Single Lumen Catheter is comprised of a radiopaque hydrophilic catheter material with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in the manufacture of catheters are provided packaged in kit configurations with the appropriate accessories for placement in the respective clinical environments. The maximum power injection flow rate for the lumen is indicated on the clamp. HydroPCC has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions f thrombus accumulation and thrombotic occusions were evaluated using in vitro and in vivo models. Pre-clinical in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.

The provided text is a 510(k) summary for the HydroPICC 4Fr Single Lumen Marked catheter, where the purpose of the submission is to modify the power injection ratings in the indications for use. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing details of a study against specific acceptance criteria for a new device's performance.

Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving device meets acceptance criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document discusses "comprehensive data demonstrating the safety and efficacy" and "rigorous testing protocols" including "in vitro" data to support the modified power injection rating, and states that "the form, fit, and function of these devices have not changed from their previous clearances." However, it does not provide specific details of these tests or their results in a measurable, quantifiable way that would allow for the completion of the requested table and study breakdown.

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To facilitate the placement of devices for diagnostic and interventional procedures. These guidewires are not intended for PTCA use.

PTFE quidewire is designed to facilitate the placement of devices for diagnostic and interventional procedures. The guidewire is intended for single use.

The guidewire is: .032" diameter and is 200cm in length. The guidewire is composed of three primary components: PTFE coating, a coil and a core. The core and coil are made of 304 stainless steel (ASTM A313). The coil is coated with low-friction polytetrafluoroethylene (PTFE). The coil provides the outer shell while the core is fit inside the inner diameter of the coil. The core provides the stiffness to the guidewire body and flexibility in the J-tip. The core and coil are secured together using a weld on both the distal and proximal of the guidewire.

The guidewire is sterilized using ethylene oxide. The guidewire is loaded into a dispenser hoop and is provided with a J-straightener, which is used to aid the insertion of the delivery device. There are no accessories packaged with the guidewires.

The provided text is a 510(k) summary for a PTFE Guidewire. It details the device description, indications for use, comparison with a predicate device, and a summary of non-clinical (bench) performance testing.

However, the provided text describes the regulatory clearance process for a physical medical device (a PTFE Guidewire), not an AI/ML-driven device. As such, it does not contain the information requested in points 1-9, which are specific to the acceptance criteria and study design for software-as-a-medical-device (SaMD) or AI-enabled medical devices.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, or effect size.
6. Standalone (algorithm only) performance.
7. Type of ground truth (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document focuses on engineering and material testing (e.g., torque strength, tip flexibility, biocompatibility, packaging integrity) to demonstrate substantial equivalence to a predicate guidewire, which is standard for hardware medical devices. It explicitly states:

• "Non-clinical (bench) performance testing was performed in order to demonstrate that the PTFE Guidewire met applicable design and performance requirements..." (Page 5, Section VII)
• It lists various physical and material tests, such as "Tip Flexibility," "Torque Strength," "Particulate Residue," "Corrosion Resistance," "Lubricity/Device Compatibility," "Radiopacity," etc., and confirms that "The predetermined acceptance criteria were met" for each.

The document does not describe any AI/ML components, image analysis, diagnostic capabilities, or human-in-the-loop studies that would necessitate the types of criteria and study designs outlined in your prompt.

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Synxess Neurovascular Guidewire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guidewire is intended for use only in the neuro vasculature.

The Synxess Neurovascular Guidewire is available in diameters of 0.014 inch (0.35 mm) and 0.010 inch (0.25 mm) and has 200 cm length. The device is comprised of a core wire, coils, and coatings, and is supplied with a shaping mandrel and a torque device. The guidewire distal tip is straight and shapeable. The device is provided sterile and is for single use.

The provided text describes a 510(k) premarket notification for a medical device, the Synxess Neurovascular Guidewire, and details the non-clinical testing performed to establish substantial equivalence to predicate devices. It does not describe an AI/ML-driven device or a study involving human readers and AI assistance. Therefore, many of the requested points in the prompt (e.g., AI performance metrics, MRMC study, expert ground truth establishment for AI, training set details) are not applicable to this document.

However, I can provide information based on the provided text regarding the device's acceptance criteria and the study that proves it meets them, focusing on the non-clinical performance testing conducted for a guidewire.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance for Synxess Neurovascular Guidewire

The acceptance criteria for this non-AI device are based on passing various performance bench tests and biocompatibility tests in accordance with relevant international standards and FDA guidance. The study proving the device meets these criteria is the battery of non-clinical tests performed.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test are implicitly "Pass" or "Met acceptance criteria" as defined by the referenced standards and guidance documents. The reported device performance for all listed tests was successful.

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of guidewires) used for each individual performance bench test or biocompatibility test. It only states that the device "passed all performance bench testing." For biocompatibility, some tests specify animal models (e.g., guinea pig, rabbits, mice, dogs), but the specific number of animals is not provided.
• Data Provenance: The document generally indicates that the tests were performed in accordance with "internal requirements, referenced guidance and international standards." The country of origin for the data is implied to be from the manufacturer, Enlight Medical Technologies (Shenzhen) Co., Ltd., located in China. The data would be considered prospective as it was generated specifically for this 510(k) submission.

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

• This question is not applicable as this is a physical medical device (guidewire), not an AI/ML-driven diagnostic device requiring expert clinical interpretation for ground truth. The "ground truth" for these tests is defined by the physical and chemical properties measured against established engineering and biological standards.

4. Adjudication Method for the Test Set

• This question is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human interpretation of medical images or patient data requires consensus, which is not relevant here.

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

• No. An MRMC study was not performed because this is a physical medical device, not an AI/ML-driven system that assists human readers in diagnostic tasks. The document explicitly states: "No clinical testing was deemed necessary to support the substantial equivalence of the subject device."

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

• Not applicable. This is not an algorithm-only device.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by engineering standards (e.g., measurements of tensile strength, torqueability, flexibility, dimensions) and biological/chemical standards for biocompatibility (e.g., cytotoxicity assays, pyrogen tests, hemolysis assays). These are objective, quantifiable measures against predefined acceptance criteria from international standards (e.g., ISO 11070, ISO 10993 series) and FDA guidance.

8. The Sample Size for the Training Set

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

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

• Not applicable. This is a physical device, not an AI/ML model.

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