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The Branchor X Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravascular catheter into a selected blood vessel in the neuro vasculature, and injection of contrast media.

The balloon provides temporary vascular occlusion during these procedures.

The Branchor X Balloon Guide Catheter can also be used as a conduit for retrieval devices.

The Branchor X Balloon Guide Catheter is a variable stiffness catheter that has a radiopaque marker at the distal end of the balloon to facilitate fluoroscopic visualization and indicate the balloon position, a branched connector at the proximal end, and is equipped with a braid reinforced lumen. A balloon is attached to the distal end, and the dimensions of the balloon guide catheter and recommended balloon injection volume are provided on the product label.

The outer surface of this balloon guide catheter is coated with a hydrophilic coating for enhanced lubricity when the surface is wet. The shaft lumen is provided with PTFE coating, with the exception of the connector section. This allows the guidewire and other devices to easily move through the section.

The Branchor X Balloon Guide Catheter is packaged with a luer-activated valve, a syringe, a three-way stopcock, a rotating hemostasis valve (RHV), and a peel-away accessories.

The provided text is a 510(k) clearance letter for a medical device, the Branchor X Balloon Guide Catheter. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving novel efficacy or safety through large-scale clinical trials.

As such, the document details non-clinical bench testing and biocompatibility testing to show that the new device performs comparably to the predicate and meets established safety standards. It explicitly states that "Animal study was not deemed necessary to demonstrate substantial equivalence" and "Clinical study was not deemed necessary to demonstrate substantial equivalence."

Therefore, the information regarding acceptance criteria and the "study that proves the device meets the acceptance criteria" will be focused on these non-clinical tests. There is no information about human-in-the-loop studies (MRMC), standalone AI performance, ground truth establishment for a training set (as there's no AI component mentioned), or expert adjudication, simply because these types of studies were not required for this particular 510(k) submission.

Here's the breakdown of the available information:

Acceptance Criteria and Device Performance Study for Branchor X Balloon Guide Catheter

The device, Branchor X Balloon Guide Catheter, demonstrates substantial equivalence to its predicate device, the Branchor Balloon Guide Catheter (K221951), through extensive non-clinical bench testing and biocompatibility assessment. The aim of these studies was to confirm that the new device met pre-established acceptance criteria, functioned as intended, and had a safety and effectiveness profile similar to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test were "All samples met the acceptance criteria," indicating a 100% success rate for the tested samples against predefined engineering and safety specifications.

Biocompatibility Testing:

2. Sample Size and Data Provenance

• Sample Size: The document repeatedly states "All samples met the acceptance criteria" for non-clinical tests. However, the exact numerical sample size for each specific test (e.g., how many catheters were tested for burst pressure) is not specified in this 510(k) summary.
• Data Provenance: The device manufacturer is ASAHI INTECC CO., LTD., located in Japan, with a US presence. The testing is non-clinical bench testing and refers to ISO standards. The data is not from human patients and therefore does not have a country of origin in the typical sense (e.g., patient demographics). All testing appears to be prospective as it was conducted specifically to support this 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This device is a physical medical instrument, not a diagnostic or AI-driven software. The "ground truth" for its performance is established through engineering and material science standards and physical measurements, not interpretation by human experts (e.g., radiologists interpreting images).

4. Adjudication Method for the Test Set

• Not Applicable. As the tests are non-clinical, objective measurements against engineering specifications, there is no need for expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not Applicable. No MRMC study was conducted. This type of study involves human readers (e.g., radiologists) evaluating cases, often with and without AI assistance, to assess diagnostic performance. This device is a catheter and does not involve image interpretation or AI assistance for human readers.

6. Standalone (Algorithm Only) Performance Study

• Not Applicable. This device is a physical catheter, not an algorithm or AI software. Therefore, no standalone algorithm performance study was performed or is relevant.

7. Type of Ground Truth Used

• The "ground truth" refers to engineering design specifications, material science standards (e.g., tensile strength, burst pressure limits), and relevant international standards (ISO standards) for medical device performance and biocompatibility. For instance, for dimensional verification, the ground truth is the specified engineering drawing dimensions. For biocompatibility, the ground truth is the absence of toxic, sensitizing, irritant, or pyrogenic effects as defined by ISO 10993 series.

8. Sample Size for the Training Set

• Not Applicable. There is no AI component or machine learning model that requires a training set for this device.

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 FUBUKI XF-R Neurovascular Long Sheath is intended to be used to guide interventional devices for neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular procedure in the neurovasculature. The FUBUKI XF-R Neurovascular Long Sheath is also intended to be used for injection of contrast media.

The FUBUKI XF-R Neurovascular Long Sheath is intended for use only in the neurovasculature.

The FUBUKI XF-R Neurovascular Long Sheath (FUBUKI XF-R) consists of a long sheath and a dilator. The long sheath is a single lumen neurovascular catheter designed for introduction of interventional devices, such as guidewires and other therapeutic devices. The long sheath consists of three sections: (1) a shaft, (2) a protector and (3) a connector. The distal portion of the shaft consists of a soft tip and a soft tube. The proximal part of the shaft is covered by the protector (strain relief) and the connector is bonded to the proximal end of the shaft.

The subject device is provided sterile, by ethylene oxide, and is intended for single use only by physicians who have been adequately trained in neurointerventional procedures.

The outer surface of the long sheath is coated with a hydrophilic polymer and the inner lumen of the shaft (excluding the connector portion) is lined with a fluoropolymer layer to facilitate movement of the guidewire and other devices.

The dilator consists of two parts: (1) a shaft and (2) a connector.

The FUBUKI XF-R is supplied with a dilator and rotating hemostasis valve (RHV) packed in a sterile package.

The provided FDA 510(k) Clearance Letter for the FUBUKI XF-R Neurovascular Long Sheath describes the device and its demonstrated substantial equivalence to a predicate device. However, it does not contain information about a study involving an AI/algorithm or a multi-reader multi-case (MRMC) comparative effectiveness study.

Therefore, many of the requested details regarding acceptance criteria, ground truth, expert opinions, and sample sizes for AI/algorithm performance studies cannot be extracted from this document because such a study was not conducted or reported for this submission. This is a medical device, specifically a catheter, not an AI/software device.

I will provide the information that is available in the document, framed as if it were a typical medical device clearance, rather than an AI/ML clearance.

Here's the breakdown based on the provided document:

Acceptance Criteria and Study for FUBUKI XF-R Neurovascular Long Sheath

This clearance pertains to a physical medical device (a neurovascular long sheath), not an AI/software device. Therefore, the "acceptance criteria" and "study" refer to non-clinical bench testing and biocompatibility testing to demonstrate the device's physical performance, safety, and substantial equivalence to a predicate device. There is no AI component involved in this device or its clearance documentation.

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

The document states that the device met all acceptance criteria, but it does not specify the numerical acceptance criteria for each test. Instead, it lists the types of tests performed and the conclusions.

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

• Sample Size: The document does not specify the exact number of devices tested for each non-clinical bench or biocompatibility test. It only states that testing was "performed." For biocompatibility, it refers to standard ISO test methods (e.g., "Rabbit Pyrogen Test" implies a certain number of rabbits, but the exact count isn't given).
• Data Provenance: Not explicitly stated, but typically, non-clinical lab testing data would originate from the manufacturer's own testing facilities or contract research organizations. No geographic origin is mentioned for the data, nor is it specified if the tests were retrospective or prospective; however, given that these are physical device tests for a 510(k) submission, they would inherently be prospective (i.e., new tests conducted specifically for this submission).

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

This information is not applicable to this type of device clearance. "Ground truth" in the context of expert consensus, pathology, or outcomes data is typically reserved for diagnostic devices, particularly those involving image interpretation or clinical decision support, or AI/ML-driven devices. For a physical medical device like a catheter, "ground truth" is established through standardized engineering and biological tests (e.g., tensile strength, fluid flow, material composition, biological response), rather than expert clinical interpretation of data.

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

This is not applicable. Adjudication methods are relevant for clinical trials or multi-reader studies where there might be disagreement in expert assessment (e.g., image interpretation). For bench and biocompatibility testing, results are quantitative or qualitative based on predefined scientific standards and validated test methods.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specific to diagnostic devices, especially those that involve human interpretation assisted by algorithms (AI). This submission is for a physical percutaneous catheter, not a diagnostic or AI-assisted device. Therefore, a discussion of human reader improvement with AI assistance is not relevant to this device.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an algorithm or software.

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

The "ground truth" for this medical device is based on:

• Predefined engineering specifications and performance standards (e.g., dimensions, strength, lubricity).
• Validated test methods outlined in ISO standards (e.g., ISO 10555-1 for catheters, ISO 10993 series for biocompatibility).
• Chemical and material analysis.
• Biological responses observed in animal models (for biocompatibility).

This is fundamentally different from a ground truth established by expert clinical consensus, pathology, or outcomes data for diagnostic devices.

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.

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

This is not applicable. There is no "training set" or "ground truth for a training set" as this is not an AI/ML device.

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This guide wire 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 guide wire is intended for use only in the neuro vasculature.

The CHIKAI Nexus 014 consists of a stainless-steel tapered core wire, with an inner coil and outer coil made of radiopaque Pt-Ni alloy and stainless-steel. Surrounding the inner coil and the distal core wire is a radiopaque Pt-Ni alloy and stainless-steel outer coil. The radiopaque distal tip enables the user to view the position of the tip under X-ray fluoroscopy. Outer and inner coils are soldered to the tapered core wire with Ag-Sn solder. A similar coil design is used with other ASAHI guide wires, such as the predicate CHIKAI black (K141751).

Additionally, the CHIKAI Nexus 014 employs hydrophilic, polyurethane, PTFE, and silicone coatings which are used in the predicate and reference devices.

The nominal outer diameter of the CHIKAI Nexus 014 is 0.36 mm (0.014 inch). The device is available in two lengths: 215 cm and 300 cm.

Both sizes are available with straight, pre-shape, and angled designs.

Acceptance Criteria and Study to Prove Device Meets Criteria for CHIKAI Nexus 014

The provided FDA 510(k) clearance letter and summary for the CHIKAI Nexus 014 detail performance testing to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating human reader performance with an AI device. The CHIKAI Nexus 014 is a catheter guide wire, a physical device, and not an AI/software as a medical device (SaMD) that would involve human readers or AI-assisted interpretation of images.

Therefore, many of the requested categories (e.g., number of experts, adjudication methods, MRMC study, standalone performance for an algorithm, ground truth for training/test sets for an AI) are not applicable to the information provided for this specific physical medical device.

The acceptance criteria and performance data provided relate to the physical and functional characteristics of the guide wire.

1. Table of Acceptance Criteria and Reported Device Performance

Device: CHIKAI Nexus 014 (Catheter Guide Wire)

Study Proving Device Meets Acceptance Criteria

The study described is a series of non-clinical, bench-top performance tests, and biocompatibility assessments comparing the CHIKAI Nexus 014 to its predicate device, the ASAHI Neurovascular Guide Wire CHIKAI black (K141751), and other reference devices. The goal was to establish substantial equivalence for a physical medical device.

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

• Sample Size: The document repeatedly states "All samples met the acceptance criteria" or "The samples are visually inspected..." or "All samples are performed/tested..." indicating that multiple samples were used for each test, but the exact number of samples for each specific test is not explicitly quantified (e.g., "n=X").
• Data Provenance: The data are from laboratory bench testing and biocompatibility testing. Given "ASAHI INTECC CO., LTD." is based in "Aichi, Japan," it's highly probable the testing was conducted prospectively at their R&D facilities or authorized contract labs, likely in Japan or globally recognized testing centers.

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

• N/A for this type of device. This device is a physical guidewire, not an AI or imaging device requiring expert interpretation for ground truth. "Ground truth" here refers to the measured physical and performance characteristics determined by established test methods and standards.

4. Adjudication Method for the Test Set:

• N/A. Adjudication methods like 2+1 or 3+1 are typical for subjective human assessments (e.g., in reading medical images) to establish a consensus ground truth. For objective physical device testing, results are typically quantitative measurements against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance:

• N/A. This is a physical guidewire, not an AI-powered diagnostic or assistive tool for human readers. No human clinical performance study (like an MRMC) involving "human readers" or "AI assistance" was conducted as part of this 510(k) submission.

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

• N/A. This applies to AI algorithms. The performance of this guide wire was evaluated through bench testing against established physical and mechanical properties.

7. The Type of Ground Truth Used:

• For performance testing: Objective engineering measurements and observations against predetermined specifications and widely accepted industry standards (e.g., "All samples met the acceptance criteria" implying specific numerical or qualitative thresholds were achieved). The FDA guidance document "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling," October 2019, served as a reference for the test methods, which implicitly defines the "ground truth" of what constitutes acceptable performance for such a device.
• For biocompatibility testing: Established laboratory test results compared against ISO 10993 series standards and control samples.

8. The Sample Size for the Training Set:

• N/A. This is not an AI/ML device that requires a training set. The "design" of the device is based on engineering principles and comparison to existing predicate devices, not data-driven machine learning.

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

• N/A. As above, no training set or ground truth in the context of an AI/ML model was established for this device.

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PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA). The PCI Guide Wires are not to be used in the neurovasculature.

SION blue PLUS is steerable guide wire with a maximum diameter of 0.36mm (0.014 inches) and available in 190cm and 300cm lengths. The guide wire is constructed from stainless-steel core wire with platinum-nickel and stainless-steel coils. The coils assembly consists of an inner coil and an outer coil, as well as a safety wire which is soldered to the inner and outer coils and the core wire. The distal end of the guide wire has a 3cm radiopaque tip to achieve visibility and is available in a straight, Pre-shape and J-shape to bend with the vessel curve. A silicone and hydrophilic coatings are applied to the distal portion of SION blue PLUS. The proximal sections of the SION blue PLUS are coated with PTFE. The extension wire is connected to the end of the guide wire outside of the body for 190cm model.

This FDA 510(k) clearance letter pertains to a conventional medical device (a guide wire), not an AI/ML-enabled device. Therefore, the information requested about acceptance criteria, study data, ground truth establishment, expert adjudication, and MRMC studies, which are typical for AI/ML device clearances, is not present in this document.

The document details non-clinical bench testing for the SION blue PLUS guide wire to demonstrate its substantial equivalence to a predicate device.

Here's a breakdown of the available information based on your request, highlighting what is included and what is not applicable to this type of device submission:

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

The document states that "The in vitro bench tests demonstrated the SION blue PLUS met all acceptance criteria and performed similarly to the predicate/reference devices." However, it does not provide a specific table of acceptance criteria with corresponding performance data. It lists the types of tests performed:

• Dimensional Verification
• Visual Inspection
• Simulated Use/Human body Phantom
• Tensile Strength (including Tip Pull test)
• Torque Strength
• Torqueability
• Coating Integrity
• Particulate Evaluation
• Lubricity/Catheter Compatibility
• Corrosion Resistance
• Kink Resistance
• Tip Flexibility
• Radiopacity

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

• Sample Sizes: Not specified. For physical device bench testing, sample sizes are typically determined by engineering standards and statistical power analysis for the specific tests (e.g., n=3, n=5, n=10 per test) but are not typically detailed in 510(k) summaries as they are for clinical or AI/ML studies.
• Data Provenance: Not applicable in the sense of clinical study data provenance (country, retrospective/prospective). The data comes from in vitro bench testing conducted by the manufacturer, ASAHI INTECC CO., LTD. (Global Headquarters and R&D Center in Seto, Aichi, Japan).

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

• Not applicable. This information is relevant for AI/ML device evaluations where human experts establish ground truth for image interpretation or diagnosis. For a physical device like a guide wire, performance is measured against engineering specifications and industry standards, not against "expert ground truth" in a clinical diagnostic sense.

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

• Not applicable. Adjudication methods are typically used in clinical or AI/ML studies where multiple human readers might disagree on a diagnosis or interpretation, requiring a consensus mechanism. This is not relevant for bench testing of a physical medical device.

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. An MRMC study is a type of clinical study used to evaluate the diagnostic performance of a device (often AI-enabled) by comparing multiple readers' interpretations across multiple cases, sometimes with and without AI assistance. This device is a physical catheter guide wire, not a diagnostic or AI-assisted device.

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

• Not applicable. This refers to the evaluation of an AI algorithm's performance independent of human interaction. Since SION blue PLUS is a physical guide wire, this concept does not apply.

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

• Not applicable in the clinical sense. For this device, "ground truth" equates to the pre-defined engineering specifications, performance standards, and material properties that the device must meet during bench testing. For example, a tensile strength test would have an acceptance criterion (e.g., withstand X Newtons of force), and the device's measured performance against this criterion is the "truth."

8. The sample size for the training set

• Not applicable. This concept pertains to AI/ML devices where a "training set" is used to develop the algorithm. This device is a physical instrument, not an AI.

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

• Not applicable. See point 8.

In summary, the provided 510(k) clearance letter is for a physical medical device. The types of detailed information requested regarding AI/ML study design, ground truth, expert adjudication, and sample sizes for training/test sets are not relevant to this specific device submission and therefore are not present in the document. The document focuses on demonstrating substantial equivalence through non-clinical bench testing of the device's physical and material properties.

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This product is intended to direct a catheter to the desired anatomical vasculature (excluding coronary and cerebral vessels).

The CROSSLOOP is steerable guide wire with a maximum diameter of 0.018 inches (0.46 mm) and available in various lengths of 200 cm, 235 cm and 300 cm. The CROSSLOOP consists of a stainless-steel (SUS) core wire with a Pt-Ni alloy coil, soldered with Au-Sn solder. The distal tip is loop-structured. The coil is radiopaque to achieve visibility and can be made to bend easily to accommodate vessel tortuosity. A silicone and hydrophilic coating are applied to the distal portion of the guide wire. A hydrophobic coating (PTFE) is applied to proximal portion. The purpose of these surface coatings is to provide lubricity when the guide wire is passed through percutaneous catheters.

The provided text describes a 510(k) premarket notification for a medical device called "CROSSLOOP," a catheter guide wire. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's absolute safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval Application).

Therefore, the information you're asking for, such as "acceptance criteria and the study that proves the device meets the acceptance criteria," "sample size for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how the ground truth for the training set was established," are not directly applicable or available in this document.

This 510(k) summary focuses on non-clinical testing/performance data and biocompatibility to demonstrate that the device is substantially equivalent to existing cleared devices, not that it independently proves clinical efficacy or diagnostic accuracy (as would be the case for an AI-powered diagnostic device, for example).

Here's how to address your points based on the provided text:

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

The document states: "The in vitro bench tests demonstrated the CROSSLOOP met all acceptance criteria and performed similarly to the predicate and reference devices." However, it does not provide a table specifying the precise acceptance criteria or quantitative performance results for each test. It only lists the types of non-clinical tests performed:

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: Not specified for any of the non-clinical tests.
• Data Provenance: The tests are "in vitro bench tests" and "biocompatibility" tests. The manufacturer is ASAHI INTECC CO., LTD. whose global headquarters and R&D center are in Japan. The specific country where the testing was performed is not explicitly stated, but it's likely linked to the manufacturer's R&D facilities. These are laboratory tests, not clinical data, so terms like "retrospective" or "prospective" don't apply in the common clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this type of device and submission. "Ground truth" established by experts (like radiologists for imaging devices) is relevant for AI/ML-powered diagnostic tools or clinical studies, neither of which are described here. The "ground truth" for the non-clinical tests would be the established engineering and materials science standards and specifications.

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

This is not applicable. Adjudication methods are typically used in clinical trials involving human observation or interpretation, especially with imaging reads. For bench testing, results are typically quantitative measurements compared against predefined engineering specifications.

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 for AI-assisted diagnostic devices to assess the impact of AI on human reader performance. The "CROSSLOOP" is a physical medical device (catheter guide wire), not an AI/ML software tool.

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

This is not applicable. This question refers to the performance of an AI algorithm in isolation. The CROSSLOOP is a physical medical device.

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

For a physical device like a guide wire, the "ground truth" for non-clinical testing refers to pre-defined engineering specifications, material properties, and performance standards (e.g., tensile strength required to withstand certain forces, flexibility within a specified range, biocompatibility per ISO standards). This is not derived from expert consensus on clinical cases, pathology, or outcomes data, but rather from material science and mechanical engineering principles.

8. The sample size for the training set

This is not applicable. "Training set" refers to data used to train AI/ML models. This device is not an AI/ML product.

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

This is not applicable for the same reason as point 8.

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This product is intended to direct a catheter to the desired anatomical vasculature (excluding coronary and cerebral vessels) during diagnostic or interventional procedures.

The CROSSLEAD 0.018inch is steerable guide wire with a maximum diameter of 0.46mm (0.018inches) and available in various lengths of 100 cm, 200 cm, 235 cm and 300 cm. The quide wire consists of a hybrid nitinol (Ni-Ti) and stainlesssteel (SUS) core wire with a stainless steel inner coil, a stainless steel and Platinum-Nickel (Pt-Ni) outer coil. The coil is radiopaque to achieve visibility and can be made to bend easily to accommodate vessel tortuosity. A hydrophilic and polyurethane coating are applied to the distal portion of the guide wire. A hydrophobic coating (PTFE) is applied to proximal portion. The purpose of these surface coatings is to provide lubricity when the guide wire is passed through percutaneous catheters.

The provided text is a 510(k) Premarket Notification from the FDA regarding the "CROSSLEAD 0.018inch" guide wire. This document primarily focuses on establishing substantial equivalence to predicate devices through non-clinical bench testing and biocompatibility assessments. It does not contain information about a study involving human-in-the-loop performance, expert ground truth establishment for a test set, or a multi-reader multi-case (MRMC) comparative effectiveness study, which are typically associated with the evaluation of artificial intelligence (AI) or software-based medical devices.

Therefore, I cannot fulfill your request for information related to:

• A table of acceptance criteria and reported device performance in the context of an AI/software study. The document lists non-clinical tests and states they met acceptance criteria, but these are for the physical device, not an AI.
• Sample size used for a test set (in the context of an AI study).
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for a test set.
• MRMC comparative effectiveness study or related effect sizes.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document discusses the physical characteristics and performance of a medical guide wire, not a software or AI device that would require such studies. The "non-clinical testing/performance data" section refers to bench tests for the physical guide wire's properties (e.g., tensile strength, torqueability, coating integrity, biocompatibility), not an algorithm's performance on a dataset.

In summary, the provided text does not describe the kind of study you are asking about, which typically pertains to the evaluation of AI/software in medical devices.

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This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. Do not use the guide wire in neurovascular.

The CROSSLEAD 0.014inch is steerable guide wire with a maximum diameter of 0.014inch (0.36mm) and available in various lengths of 100cm, 200cm, 235cm and 300cm. This quide wire consists of a hybrid nitinol (Ni-Ti) and stainless-steel (SUS) core wire with a stainless-steel inner coil and Platinum-Nickel (Pt-Ni) outer coil. The coil is radiopaque to achieve visibility and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. A hydrophobic coating is applied to proximal portion. The basic structure, construction and materials of the CROSSLEAD 0.014inch are similar to those of previously described in the predicate ASAHI Gladius (K150445/K163426) and references; CROSSLEAD Penetration (K230377), MINAMO (K190176) and Astato XS40 (K153443/K163426).

All sizes are available with a straight and a pre-shaped design.

This document is a 510(k) Premarket Notification for a medical device (CROSSLEAD 0.014inch guide wire) and does not describe a study involving an AI/Machine Learning enabled device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and performance studies for such devices, including details on test sets, expert ground truth, MRMC studies, or training sets.

The document discusses non-clinical bench testing to demonstrate substantial equivalence to predicate devices, but this is for a physical medical device, not an AI algorithm.

Therefore, I cannot fulfill the request as the provided text does not contain information related to AI/ML device testing and acceptance criteria.

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This device is used to dilate strictures in the pancreatobiliary systems and to dilate openings via the transgastric or transduodenal wall. This device is indicated for adult use only.

The Tornus ES is a rotary-operated dilator designed for use in bile duct/pancreatic duct strictures and via transgastric/transduodenal dilation of openings. The Tornus ES is comprised of stainless-steel coils and polymeric materials. The Dilation and Shaft segments are composed of coils materials that are welded together. The Tornus ES is available for prescription use only.

The provided text describes the performance data for the Tornus ES device, specifically focusing on non-clinical testing and biocompatibility assessments. It does not detail a study involving human subjects or AI assistance, which would typically involve acceptance criteria related to accuracy, sensitivity, specificity, or reader performance metrics. Therefore, several points of your request cannot be fulfilled as they are not applicable to the information provided.

Based on the provided text, primarily pages 8 and 9, here's the information regarding the device's acceptance criteria and the study that proves it meets those criteria:

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

The document provides acceptance criteria specifically for biocompatibility testing, and a general "Pass" for non-clinical performance tests.

Table 1: Non-Clinical Testing Performance

Table 2: Biocompatibility Testing Acceptance Criteria and Results

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

The document refers to "Non clinical laboratory testing" and "in vitro bench tests". This indicates that the testing was performed on units of the device itself and not on patient data. No specific sample sizes for these tests are provided, nor is the country of origin of the data or whether it was retrospective or prospective, as these terms are generally applicable to clinical trials or studies involving patient data, which is not the case here.

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. The testing was non-clinical and benchtop, not requiring human expert interpretation or ground truth establishment in the context of imaging or clinical diagnosis.

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

Not applicable, as this refers to adjudication of ground truth in clinical data, not bench 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 document describes a medical device (a catheter) and its non-clinical performance and biocompatibility. It does not involve AI or human image readers.

6. 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 or AI.

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

For the non-clinical tests, the "ground truth" would be the engineering specifications and performance standards established for the device. For biocompatibility, the ground truth is established by the methods and criteria defined in the ISO 10993 series of standards.

8. The sample size for the training set

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

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

Not applicable.

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This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. Do not use the guide wire in neurovascular.

The CROSSLEAD Tracker is steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 100cm, 200cm, 235cm and 300cm length. This Guide Wire consists of a hybrid Ni-Ti and stainless-steel core wire with a Pt-Ni inner coil and Pt-Ni and stainless-steel outer coil is soldered to the core wire with Ag-Sn solder. The coil has radiopacity to achieve visibility and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. A hydrophobic coating is applied to proximal portion. The basic structure, construction, and material of the CROSSLEAD Tracker are similar to that previously described in the predicate Regalia XS 1.0 (K083146/K163426) and reference devices MINAMO (K190176), ASAHI Gaia Next(K192599) and ASAHI Gladius (K150445/K163426).

The provided text is a 510(k) Summary for a medical device (CROSSLEAD Tracker, a guide wire) and does not contain information about a study proving the device meets acceptance criteria related to AI/ML performance or human reader improvement.

The document details non-clinical laboratory testing performed to demonstrate substantial equivalence to predicate and reference devices, focusing on physical and material properties of the guide wire. These tests are standard for medical devices and are not related to AI/ML or a comparative effectiveness study involving human readers.

Therefore, I cannot provide the requested table and information as it pertains to AI/ML performance and human reader studies because this information is not present in the provided document.

The "Non-clinical testing/performance data" section (Page 8) lists various physical tests:

• Tensile Strength
• Torque Strength
• Torqueability
• Tip Flexibility
• Coating Integrity
• Catheter Compatibility
• Visual Inspection
• Corrosion Resistance
• Kink Resistance
• Radio-Detectability
• Dimensional Verification
• Coating Integrity / Acute Particulate Characterization

And "Biocompatibility" tests:

• Cytotoxicity
• Sensitization
• Intracutaneous Irritation
• Systemic Toxicity
• USP Rabbit Pyrogen, Material Mediated
• Hemolysis
• Partial Thromboplastin Time
• In Vivo Thromboresistance
• Sc5b-9 Complement Activation

The document states: "The in vitro bench tests demonstrated the CROSSLEAD Tracker met all acceptance criteria and performed similarly to the predicate and reference devices." However, it does not provide the specific numerical acceptance criteria or the reported performance for each of these physical and biocompatibility tests. It also does not discuss any computational or AI-driven aspects, nor does it mention a study involving human readers, sample sizes for test/training sets, or expert ground truth establishment for such studies.

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This microcatheter is a medical device intended for angiography and/or infusion of various substances including diagnosis, embolization and treatment in the peripheral vasculature using an appropriate guide wire. The microcatheter is not intended for use in neurovasculature, coronary arteries and carotid arteries.

The ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3 Microcatheters are sterile single use devices designed for use in the peripheral vasculature. The ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3 consist of a catheter shaft that is reinforced with braid wires to enhance pushability and maintain patency of the inner lumen. A radiopaque marker is fixed on the distal end of the catheter shaft to facilitate location of the catheter during angiography. The distal portion of the catheter shaft is flexible and available in two shapes, straight and angled, to provide improved trackability in tortuous vessels. A hydrophilic coating is applied on the outer surface of the catheter to provide a smooth transition. In addition, accessories, including either a stylet, syringe and RHV (rotating hemostasis valve), or a stylet, syringe, inserter and hemostasis valve are available for use with the ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3.

The provided text describes a 510(k) premarket notification for various microcatheters (ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus, ASAHI Tellus C3). This document serves as a regulatory submission to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than a study proving the device meets acceptance criteria for an AI/ML medical device.

Therefore, the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML-based device cannot be extracted from this document. The document primarily focuses on the mechanical, material, and biocompatibility performance of a physical medical device (microcatheter) and its substantial equivalence to existing devices.

However, I can extract the information related to the performance testing and acceptance criteria for the physical microcatheter device as detailed in the document.

Acceptance Criteria and Device Performance (for the physical microcatheter device)

The document details non-clinical laboratory testing and biocompatibility testing conducted to demonstrate the substantial equivalence of the ASAHI microcatheters.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI/ML-specific details (Items 2-9 from your prompt):

The provided document is a 510(k) summary for a physical medical device (microcatheter), not an AI/ML-driven software device. Therefore, information related to:

2. Sample size for test set and data provenance: Not applicable. Tests were bench/in-vitro and animal studies for device performance and biocompatibility.
3. Number of experts and qualifications for ground truth: Not applicable. Performance data is from physical tests. Biocompatibility standards are specific laboratory tests.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This is for AI-assisted human reading.
6. Standalone (algorithm only) performance: Not applicable. This is a physical device.
7. Type of ground truth used: For non-clinical tests, the ground truth is the physical measurement and functional assessment against specified engineering criteria. For biocompatibility, it's defined by the specific ISO standards and their pass/fail criteria.
8. Sample size for training set: Not applicable (no AI/ML model training).
9. How ground truth for training set was established: Not applicable.

In conclusion, this document demonstrates the safety and effectiveness of a microcatheter through standard predicate comparison, non-clinical bench testing, and biocompatibility studies, which are typical requirements for such devices. It does not contain any information about an AI/ML component or its associated validation studies.

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