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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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This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

The VASSALLO® GT Peripheral Guide Wires in this submission are steerable guide wires with a maximum diameter of 0.014 inches (0.36mm) and available in 190cm and 300cm lengths. These devices have a solid core with a hydrophilic coil-type distal end. When wet, the hydrophilic coating increases the lubricity of the quidewire surface. Some models also include silicone coating on the distal tip. The coil is partly or entirely radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy. The core shaft surface is coated with Polytetrafluoroethylene (PTFE). About 2cm of the distal end can be shaped. A detachable extension wire (hereafter "extension wire") is available to connect with the proximal end of the quide wire with a length of less than 300 cm. A Torque device is included in the same package.

This document is a 510(k) summary for the VASSALLO® GT Guide Wire. It details the device's characteristics, intended use, and substantial equivalence to predicate devices, based on non-clinical testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The in vitro bench tests demonstrated that the VASSALLO GT met all acceptance criteria". However, it does not provide a specific table of acceptance criteria with corresponding performance values. It only lists the types of tests performed.

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

The document does not specify the sample size used for each non-clinical test.
The data provenance is from non-clinical laboratory testing performed on the VASSALLO® GT. The country of origin for the manufacturing company (Filmecc Co., Ltd.) is Japan. The type of study is bench testing (in vitro), not human subject testing (prospective or retrospective).

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

This question is not applicable as the study described is non-clinical bench testing, not a clinical study involving expert interpretation of data or images. Ground truth for non-clinical tests is established by adhering to testing standards and specifications.

4. Adjudication Method for the Test Set

This question is not applicable as the study described is non-clinical bench testing. Adjudication methods are typically relevant for clinical studies where human interpretation or consensus is required.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document focuses on non-clinical bench testing of a guide wire, not an AI-assisted diagnostic device. Therefore, there is no discussion of human readers, AI assistance, or effect sizes in that context.

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

This question is not applicable. The device is a medical guide wire, not an algorithm or software requiring standalone performance evaluation.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" or reference for evaluating performance would be predefined engineering specifications, international standards, and performance characteristics of predicate devices. The document states that the device "met all acceptance criteria" and "performed similarly to the predicate and reference devices," implying comparison against these types of benchmarks.

8. The Sample Size for the Training Set

This question is not applicable. There is no mention of a "training set" as this is a physical medical device undergoing bench testing, not an AI/machine learning model.

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

This question is not applicable as there is no training set for a guide wire.

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This product is intended for use in the percutaneous introduction of catheters. Not for use in the coronary arteries or intracranial vessels.

The ASAHI Silverway consists of a one-piece core wire and a coil assembly that extends the entire length of the device. The coil assembly consists of an inner coil and an outer coil, soldered to the core wire. In addition, coatings are applied on the surface of the ASAHI Silverway. The distal and proximal sections are coated with silicone. The intermediate section is coated with hydrophilic coating. The ASAHI Silverway has a nominal outer diameter of 0.89mm (0.035in) and is available in various lengths from 150cm to 300cm and tip shapes.

This document describes the premarket notification (510(k)) for the ASAHI® Silverway® guidewire. The acceptance criteria and study details are focused on non-clinical performance given the type of device and the 510(k) pathway, which establishes substantial equivalence rather than independent safety and effectiveness.

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

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

The document states that the ASAHI Silverway "met all acceptance criteria" and "performed similarly to the predicate devices." While specific numerical acceptance criteria (e.g., minimum tensile strength in Newtons, maximum torque to twist in degrees) are not explicitly listed in the public summary, the general categories of tests performed indicate the areas for which acceptance criteria would have been established.

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

• Sample Size: The document does not explicitly state the specific number of units tested for each non-clinical test. It generally refers to "non-clinical laboratory testing."
• Data Provenance: The tests were "non-clinical laboratory testing" presumably conducted by or for ASAHI INTECC CO., LTD. Given the company's address (Japan), the testing was likely performed in Japan or by a qualified lab contracted by them. The studies are by nature prospective in that new guidewires were manufactured and then tested according to predefined protocols.

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

This section is not applicable to this type of regulatory submission. For a guidewire, "ground truth" is typically defined by engineering specifications, material properties, and performance benchmarks established through industry standards (e.g., ISO, ASTM) and comparison to predicate devices, rather than expert human interpretation of complex data (like medical images).

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

Not applicable. As this is non-clinical laboratory testing against pre-defined engineering and material standards, there is no need for expert adjudication in the way it might be applied to, for example, classifying medical images. Test results are objective measurements.

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 medical guidewire, not an AI/imaging device. Therefore, no MRMC study or AI assistance evaluation would be relevant or expected.

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

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

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

The "ground truth" for this device's performance is based on:

• Engineering specifications and design requirements: Did the device meet its designed dimensions, material properties, and functional characteristics?
• International standards: Adherence to relevant ISO (e.g., ISO 11070 for catheter guidewires, ISO 10993 for biocompatibility) and ASTM standards.
• Performance of predicate devices: Substantial equivalence is demonstrated by performing "similarly to the predicate devices." The predicates themselves would have established a benchmark for acceptable performance.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no training set in the AI sense. The "training" in manufacturing comes from process validation and quality control, but not a data-driven model training.

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

Not applicable for the same reason as point 8.

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The ASAHI Corsair Armet is intended to provide support to facilitate the placement of guide wires in the peripheral vasculature, and can be used to exchange one guide wire for another.

The ASAHI Corsair Armet is also intended to assist in the delivery of contrast media into the peripheral vasculature.

This device should not be used in coronary vasculature or neuro vasculature.

The ASAHI Corsair Armet consists of a distal tip, a shaft tube that is inserted into vasculature, a protector, and a connector for catheter control and infusion of contrast media. The device has a hydrophilic coating on the outer surface of distal tip and the shaft tube to provide a smooth transition in blood vessels. The distal tip of the Corsair Armet has a tapered shape. PTFE is applied to the inner lumen of the catheter for the purposes of a smooth transition and exchange of guidewires.

This document is a 510(k) summary for the ASAHI Corsair Armet. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific clinical acceptance criteria in a human study. Therefore, much of the requested information (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable or provided in this type of regulatory submission.

However, I can extract the acceptance criteria and the summary of non-clinical performance data provided.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

A series of non-clinical laboratory bench tests were performed on the ASAHI Corsair Armet. These tests were designed to evaluate the physical and mechanical properties of the device against predefined acceptance criteria for each test parameter.

Missing Information (Not provided in this 510(k) Summary):

2. Sample size used for the test set and the data provenance: This document does not detail the specific sample size (number of devices tested) for each bench test, nor does it refer to human "test sets" or data provenance in terms of country of origin or retrospective/prospective nature, as this is pre-market non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context is based on engineering specifications and performance standards for medical devices, not expert human interpretation of clinical data.
4. Adjudication method for the test set: Not applicable. The results are objective measurements from bench tests against defined 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: Not applicable. This device is a percutaneous catheter, not an AI-powered diagnostic or assistive technology for human interpretation.
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.
7. The type of ground truth used: For the non-clinical tests, the "ground truth" or reference was established by pre-defined engineering and performance specifications and standards relevant to percutaneous catheters.
8. The sample size for the training set: Not applicable. This is a physical device, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

Summary from the Document:

The ASAHI Corsair Armet underwent non-clinical laboratory testing, which included evaluating its appearance/dimensions, corrosion resistance, force at break, liquid leakage under pressure, air leakage, leak and damage under high static pressure, radio-detectability, torque transmission, slide durability, kink resistance, and torque durability.

The document states: "The in vitro bench tests demonstrated that the ASAHI Corsair Armet met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended, and is substantially equivalent to the predicate devices."

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The Asahi SUOH PTCA Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi SUOH PTCA Guide Wire is not to be used in the cerebral blood vessel.

The Asahi SUOH PTCA Guide Wire is A steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 180 cm and 300 cm length. The extension wire is connected to the end of the guide wire outside the body. The guide wire is constructed from a stainless steel core wire with a platinum-nickel and stainless steel coil. The core wire and coil are soldered. The distal end of the guide wire has a radiopaque tip to achieve visibility, and is available in a straight configuration and can be made to easily bend with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. The proximal section of the guide wire is coated with PTFE.

The provided text does not describe acceptance criteria or a study proving that a device meets acceptance criteria. Instead, it is a 510(k) summary for the Asahi SUOH PTCA Guide Wire, focusing on its substantial equivalence to predicate devices based on technical characteristics and performance data.

Specifically:

• There is no table of acceptance criteria and reported device performance.
• There are no details about sample size, data provenance, number of experts, adjudication methods, or specific study types like MRMC or standalone algorithm performance.
• The text mentions "mechanical and functional bench testing" and a "long history of use in medical devices" for biocompatibility, but it does not provide details about the methodology, results, or specific criteria involved in these evaluations.
• There's no information about training set size or how ground truth was established for a training set, as this type of submission (for a medical device like a guide wire) typically relies on engineering tests and comparison to existing, cleared predicate devices rather than AI/machine learning model validation.

The conclusion of the summary states: "The Asahi SUOH PTCA Guide Wire characteristics are substantially equivalent to the specified predicate devices and other currently marketed devices for the same indication for use." This indicates that the primary "acceptance criterion" demonstrated is substantial equivalence to legally marketed predicate devices, rather than meeting specific performance thresholds through a detailed clinical or AI-centric study.

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To facilitate the placement of balloon dilatation catheters during perculaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal blood vessel transluminal coronary angloplasty (1 YOA) and poroculared in the cerebral blood vessel.

The Asani PTCA Guide Wiles are stechable gelde is constructed from a 0.014" and available in 150 cm and oo of the guide wire has a radiopaque tip that is stainless steel core wire. The distal end of the guide wire The coating stainless steel core wire. The distar end of the gd with the vessel curve. The coating available straight and is made soft to easily bend with wire guide wire. The available straignt and is thade soll to casily bonion of the wire guide wire. The (Hydrophilie or onlooms) is coated with PTFE.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Asahi PTCA Guide Wire:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantitative acceptance criteria are not explicitly stated or defined. The submission focuses on demonstrating substantial equivalence to predicate devices. The performance data section broadly states:

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

This information is not provided in the document. The submission references "bench testing" but does not detail the sample sizes of devices or test conditions.

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

This information is not applicable as the document describes a medical device (guide wire), not an algorithm or diagnostic tool that requires expert-established ground truth on a test set (e.g., medical images). The testing appears to be physical or mechanical bench testing.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3.

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

This information is not applicable. The device is a physical medical instrument (guide wire), not a diagnostic algorithm where human readers assess cases.

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

This information is not applicable. The device is a physical medical instrument, not a software algorithm.

7. The Type of Ground Truth Used

For this device, the "ground truth" would relate to its physical and functional properties meeting specifications. The document states:

• "Biocompatibility": Demonstrated by a "long history of use in medical devices" for its components. This implies a historical record of safe and successful use in similar applications.
• "Functioning as intended": Established through "bench testing." This likely involves engineering specifications and performance metrics for parameters like tensile strength, flexibility, lubricity, etc. However, the specific parameters are not detailed in the summary.
• "Substantial equivalence": Established by comparing its characteristics and materials to previously cleared predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument, not a machine learning model that requires a training set.

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

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

Summary of the Study and Acceptance:

The submission for the Asahi PTCA Guide Wire (K052339) is a 510(k) premarket notification, which aims to demonstrate that the new device is "substantially equivalent" to legally marketed predicate devices.

The "study" described is primarily focused on bench testing to demonstrate:

• The device's materials are the same as existing predicate devices and have a long history of biocompatible use.
• The device functions as intended.
• The device's characteristics are substantially equivalent to the specified (presumably for the predicate devices) specifications.

The acceptance criteria, while not quantified with specific thresholds, are met by demonstrating this substantial equivalence and satisfactory performance in bench testing, allowing the FDA to conclude that the device is as safe and effective as its predicates. The FDA's acceptance is conveyed in the letter from November 30, 2005, stating that the device is "substantially equivalent."

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To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel.

The Asahi PTCA Guide Wire Fielder is steerable guide wire with a maximum diameter of 0.36mm (0.014 inches) and available in 180 cm and 300 cm length. The wire is constructed from a stainless steel core wire. The core wire and coil are soldered. The distal tip of the guide wire has a radiopaque tip to achieve visibility, and is made flexible to bend easily at the vessel curve. There is polyurethane coating covered with hydrophilic coating applied to the distal section of the guide wire. The proximal section of this guide wire is coated with PTFE.

The provided text describes a 510(k) premarket notification for the Asahi PTCA Guide Wire Fielder. It states that "Bench and biocompatibility testing were conducted according to the recommendations from relevant FDA guidance to demonstrate that the Asahi PTCA Guide Wire Fielder met the acceptance criteria and performed equivalent to the predicate devices." However, it does not provide a table of acceptance criteria or specific reported device performance metrics. It also does not detail the methodology of the study or the provenance of data, only that testing was conducted.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's a summary of what can be extracted and what cannot:

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

• Cannot be provided. The text states that "bench and biocompatibility testing...met the acceptance criteria and performed equivalent to the predicate devices" but does not explicitly list the criteria or the specific device performance results.

2. Sample sized used for the test set and the data provenance

• Cannot be provided. The text mentions "bench and biocompatibility testing" but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

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

• Cannot be provided. There is no mention of expert involvement in establishing ground truth for any testing described.

4. Adjudication method for the test set

• Cannot be provided. There is no mention of an adjudication method.

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

• Cannot be provided. The device is a PTCA Guide Wire, not an AI or imaging device that would typically involve human reader studies.

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

• Cannot be provided. The device is a medical instrument, not an algorithm.

7. The type of ground truth used

• Cannot be explicitly stated based on the text. For "bench and biocompatibility testing," ground truth would typically be established through standardized methods, specifications, and laboratory measurements. However, the text does not detail how the acceptance criteria for these tests were set or what constitutes "ground truth" for them.

8. The sample size for the training set

• Not applicable. The device is a physical medical instrument, not a machine learning model, so there is no "training set."

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

• Not applicable. As above, there is no "training set" for a physical device.

Summary of available information:

• Study Type: Bench and biocompatibility testing.
• Conclusion: The device "met the acceptance criteria and performed equivalent to the predicate devices." This implies the study aimed to demonstrate substantial equivalence through these tests.
• Predicate Devices: JoWire Neo's PTCA Guide Wire (K022762) and JoWire Asahi PTCA Guide Wire (K031277).
• No new safety or effectiveness issues were raised during the testing.

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To facilitate the placement of balloon dilatation catheters during perculaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel.

'I'he Asahi PTCA Guide Wire Confianza Pro is steerable guide wire with a maximum 0.014" and available in 180 cm and 300 cm length. The extension wire is diameter of connected to the end of the guide wire outside the body. The wire is constructed from a stainless steel core wire. The core wire and coil are soldered. The distal end of the guide wire has a radiopaque tip that is available straight and is made soft to easily bend with the vessel curve. The coating (hydrophilic and silicone) is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with PTFE.

This is a 510(k) premarket notification for a medical device, which typically relies on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data with acceptance criteria for device performance in the same way a PMA (Premarket Approval) application would.

Based on the provided text, the device in question is the Asahi PTCA Guide Wire Confianza Pro.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of
specific, quantifiable acceptance criteria or detailed reported device performance for the Asahi PTCA Guide Wire Confianza Pro.

The document states:
"Bench and biocompatibility testing were conducted according to the recommendations from relevant FDA guidance to demonstrate that the Asahi PTCA Guide Wire Confianza Pro met the acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing."

This indicates that:

• Acceptance Criteria: Existed, but are not explicitly listed in the provided summary. They were likely derived from relevant FDA guidance for guide wires.
• Reported Device Performance: The device "met the acceptance criteria and performed similarly to the predicate devices." No specific numerical performance metrics are provided. The "bench and biocompatibility testing" would have assessed physical properties (e.g., tensile strength, kink resistance, lubricity) and biological safety (e.g., cytotoxicity, sensitization), aiming to show equivalence to the predicate.

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

This information is not provided in the document. The text only mentions "bench and biocompatibility testing," which are typically laboratory-based tests of the device itself, not clinical tests on patient data. There is no indication of a "test set" of patient data in the context of clinical performance.

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

This information is not applicable/provided. Since no clinical test set with patient data is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

This information is not applicable/provided. No clinical test set is described.

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

This information is not applicable/provided. The 510(k) summary focuses on substantial equivalence based on bench testing and biocompatibility, not on a clinical MRMC study. There is no mention of human readers or AI assistance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

This information is not applicable/provided. This device is a physical medical device (guide wire), not a software algorithm. Therefore, "standalone performance" in the context of an algorithm is irrelevant.

7. Type of Ground Truth Used

This information is not applicable/provided in the context of clinical performance. For the bench testing, the "ground truth" would be established specifications and standards for guide wire performance (e.g., material properties, force measurements, kink resistance thresholds). For biocompatibility, it would be established ISO standards for biological evaluation of medical devices.

8. Sample Size for the Training Set

This information is not applicable/provided. As this is a physical device and not an AI/software product, there is no "training set."

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

This information is not applicable/provided. There is no training set for this type of device.

Overall Summary:

The provided document is a 510(k) summary, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This process primarily relies on comparing technological characteristics, materials, and intended use, supported by bench and biocompatibility testing. It does not typically involve the extensive clinical trials or human-reader studies that would provide the type of detailed performance data and acceptance criteria you've asked for, especially for AI or diagnostic devices. The acceptance criteria and performance data mentioned relate to the physical and biological characteristics of the guide wire itself, assessed in a lab setting, rather than its clinical performance in patients as measured by diagnostic accuracy, for example.

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