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ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA), including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

The ASAHI PTCA Guide Wire ASAHI Gaia Next (hereafter "ASAHI Gaia Next") is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 190cm length. The extension wire may be 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 coils. The coil assembly consists of an inner coil and an outer coil, and the coil assembly is soldered to the core wire. The distal end of the quide wire has a radiopaque outer coil and inner coil 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. The coil assembly construction is similar to predicate device.

The provided text describes the 510(k) premarket notification for the ASAHI PTCA Guide Wire ASAHI Gaia Next. This document focuses on demonstrating substantial equivalence to a predicate device, not on presenting results from a study proving device performance against specific acceptance criteria for a new, novel technology. Therefore, many of the requested categories (such as sample size for test sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or not available from this regulatory submission. This document details non-clinical bench testing to show the device performs similarly to a predicate.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a table of precise quantitative acceptance criteria (e.g., "tensile strength must be >X Newtons") or specific numerical performance results for each test. Instead, it states that the device "met all acceptance criteria" and "performed similarly to the predicate devices" in bench testing.

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

• Sample Size for Test Set: Not specified. The document refers generally to "bench testing" without providing the number of units tested for each non-clinical performance test.
• Data Provenance: The tests are described as "in vitro bench tests." This implies tests were conducted in a laboratory setting. The country of origin of the data is not explicitly stated, but the applicant is ASAHI INTECC CO., LTD from Japan.

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

• Not Applicable. This device is a guide wire, and the evaluation involves non-clinical engineering and biological performance testing, not diagnostic interpretation requiring expert consensus on "ground truth."

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

• Not Applicable. As mentioned above, this is non-clinical bench testing. Adjudication methods are relevant for human-read diagnostic studies.

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 is a medical device (guide wire), not an AI-powered diagnostic tool. No MRMC study was conducted.

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

• Not Applicable. This is a medical device (guide wire), not an AI-powered diagnostic tool. No standalone algorithm performance was evaluated.

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

• For the non-clinical bench tests, the "ground truth" or reference for acceptance is against established engineering and material science standards and performance specifications for guide wires, and comparison to the predicate device. For biocompatibility, it's against established biological safety standards.

8. The sample size for the training set

• Not Applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The testing described is for a physical medical guide wire.

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

• Not Applicable. See point 8.

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The Radifocus Glidewire Advantage Track is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.

The Radifocus Glidewire Advantage Track is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures.

The Radifocus Glidewire Advantage Track consists of a Nickel Titanium alloy and stainless steel core wire. The distal portion from the junction is NiTi and the proximal portion is stainless steel. A polyurethane and hydrophilic coating is applied to the distal portion of the wire while a PTFE coating is applied to the proximal portion. The wire distal segment comes in angled configuration. The wire contains a distal radiopaque gold coil. The wire comes packaged in a plastic holder contained within an individual package. A guide wire inserter is contained within the individual package to assist with the insertion of the wire into a needle or catheter.

During an interventional or diagnostic procedure, the physician will follow the standard procedure of placing an access wire and introducer within a vessel. Once the introducer is placed, the physician may choose a wire such as the Radifocus Glidewire Advantage Track to gain access to the target lesion or therapeutic site. It is also used in conjunction with a catheter which is advanced over the wire to the desired anatomical location.

The provided document is a 510(k) Premarket Notification for a medical device, specifically the Radifocus Glidewire Advantage Track. This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and biocompatibility testing. It does not describe an AI/ML-driven device or a study involving human readers or expert consensus for ground truth establishment. Therefore, most of the requested information regarding AI acceptance criteria and study methodology (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, ground truth types) is not applicable or cannot be extracted from this document.

Here's an analysis based on the information that is present in the document:

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

The document broadly states that "All testing met acceptance criteria" and "The Radifocus Glidewire Advantage Track met the predetermined acceptance criteria" for performance testing. However, the exact acceptance criteria values themselves are not explicitly detailed in a table; rather, it lists the standards against which the tests were conducted (e.g., ISO 11070:2014, FDA Guidance, In-house Standard). For biocompatibility, it states "Results of the testing demonstrate that the device is biocompatible throughout the shelf life of the product."

Table of Acceptance Criteria and Reported Device Performance (as inferred):

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

• Sample Size for Test Set: Not specified in the document. This is a non-clinical submission, and specific sample sizes for each mechanical/biocompatibility test are typically found in detailed test reports, not the 510(k) summary itself.
• Data Provenance: The tests are conducted by the manufacturer, Terumo Medical Corporation (Ashitaka Factory in Japan). The data is generated prospectively through laboratory testing.

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

• Not applicable. This device is a physical medical device (guidewire), not an AI/ML diagnostic tool requiring human expert interpretation or ground truth establishment in the diagnostic sense.

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

• Not applicable, as this is not an AI/ML diagnostic device with human interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is not an AI/ML device, and no MRMC study was performed or is relevant to this submission.

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

• Not applicable. This is not an algorithm. Performance tests mentioned are for the physical guidewire itself.

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

• For this device, "ground truth" equates to the established standards and specifications for medical guidewires (e.g., ISO 11070:2014, in-house standards for physical properties, ISO 10993 for biocompatibility). Test results are compared against these predetermined specifications. There is no diagnostic ground truth (like pathology or expert consensus) involved.

8. The sample size for the training set:

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

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

• Not applicable. No training set is involved.

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The Endura guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature.

The Endura guidewire is a straight tip guidewire with a maximum outer diameter of 0.014" available in 190 cm and 300 cm lengths. The Endura guidewire consists of a bi-metal stainless steel and nitinol core wire covered on the distal end by a radiopaque coil at the distal end of the Endura guidewire has a hydrophilic coating (HPC) and the proximal end is coated with polytetrafluoroethylene (PTFE). The 190 cm length model is compatible with a guidewire extension.

The Endura Guidewire is a medical device intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes used for each individual performance test or biocompatibility test. It mentions that "device samples" passed the biocompatibility tests and that the design was "verified through the following tests." The data provenance can be inferred as originating from Vascular Solutions, Inc., USA, the manufacturer of the device, through prospective testing conducted to demonstrate the device's performance and safety.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This section is not applicable as the Endura Guidewire is a physical medical device. The "ground truth" for its performance and safety is established through laboratory and bench testing, as well as biocompatibility assessments, rather than expert interpretation of data or images.

4. Adjudication Method for the Test Set:

This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments, which is not the case for the pre-market testing of this device.

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

This section is not applicable. An MRMC study is relevant for AI algorithms or diagnostic tools where human reader performance is being evaluated with and without AI assistance. The Endura Guidewire is a physical interventional device, not a diagnostic or AI-powered system.

6. Standalone (Algorithm Only) Performance:

This section is not applicable. The Endura Guidewire is a physical medical device, not an algorithm, so the concept of "standalone algorithm performance" does not apply.

7. Type of Ground Truth Used:

The ground truth for the Endura Guidewire's performance is based on:

• Engineering specifications and test methodologies: Each performance test (e.g., tensile strength, torque response, flexibility, coating adherence) has predefined engineering benchmarks and standards that the device must meet.
• Biocompatibility standards: Compliance with ISO 10993-1 guidelines for biological evaluation of medical devices.
• Sterilization standards: Achieving a Sterility Assurance Level (SAL) of 10-6.

8. Sample Size for the Training Set:

This section is not applicable. The Endura Guidewire is a physical medical device and does not involve AI or machine learning, therefore, there is no "training set."

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

This section is not applicable as there is no training set for this device.

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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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