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The R2P Radifocus Glidewire Advantage 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 subject device, R2P Radifocus Glidewire Advantage, and the predicate device, Radifocus Glidewire (K152740), are both operated through a manual process. The subject device, R2P Radifocus Glidewire Advantage, and the predicate device, Radifocus Glidewire (K152740), exhibit some differences in design and construction. Terumo has confirmed that these differences don't introduce any new concerns in safety and performance compared to the predicate device.

The provided text is a 510(k) summary for a medical device (guide wire) and does not contain any information about an AI/ML-driven device or study results related to acceptance criteria for such a device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI/ML-driven device meets those criteria based on this document. The document describes traditional performance and biocompatibility testing for a physical medical device.

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

The Radifocus® Glidewire Advantage (0.014") consists of a Nickel Titanium alloy core wire. 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 an angled configuration. The Radifocus® Glidewire Advantage (0.014") diameter wire contains a distal radiopaque spring coil. The wire is package 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Radifocus® Glidewire Advantage (0.014"), structured according to your request.

Please note: The provided document is a 510(k) Summary for a medical device (a guide wire), which focuses on demonstrating substantial equivalence to a predicate device through bench testing and biocompatibility assessments. It does not describe a study involving human readers, AI, or advanced clinical outcomes data, as would be typical for an AI/ML-driven diagnostic device. Therefore, several of your requested sections will be answered as "Not applicable" or by indicating that the information is not present in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for many of these tests were "Test method developed in-house" or based on FDA Guidance documents for similar devices. For biocompatibility, the acceptance criteria are generally to be "Non-cytotoxic," "Non-hemolytic," etc. The document explicitly states that the tests were "performed and passed," indicating adherence to their established criteria. For the in-house developed tests, specific quantitative acceptance criteria are not provided in this summary, but the results indicate successful performance.

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

• Test Set Sample Size: The document does not specify exact sample sizes for each bench test (e.g., number of wires tested for torque, friction, etc.). It refers to "tests performed" and methods, implying a sufficient number of samples were used to generate statistically meaningful results for each test.
• Data Provenance: The tests are described as "bench tests" and "biocompatibility testing." This is laboratory-generated data, not patient data from a specific country or origin in the traditional sense. It's prospective in the sense that the tests were deliberately conducted to assess the new device.

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

Not applicable. This submission describes bench and biocompatibility testing, which do not typically involve experts establishing ground truth in the same way clinical studies or image-based diagnostic evaluations do. The "ground truth" for these tests are the established physical/chemical properties or biological reactions according to the specified standards or in-house methods.

4. Adjudication method for the test set

Not applicable. As this involves bench and biocompatibility testing against defined standards, there is no need for expert adjudication. The results are objective measurements or observations interpreted against pre-defined criteria.

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

Not applicable. This device is a physical medical instrument (a guide wire), not an AI-enabled diagnostic tool.

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.

7. The type of ground truth used

The ground truth used for performance testing was based on:

• In-house developed test methods and their established specifications.
• Relevant FDA Guidance documents (e.g., "Coronary and Cerebrovascular Guidewire Guidance - January 1995," "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PCTA) Catheters").
• International Standards for biocompatibility (e.g., ISO 10993 series, ASTM F756-08, USP35).
• Risk analysis performed according to ISO 14971, which helps define acceptance criteria.

8. The sample size for the training set

Not applicable. This refers to a physical medical device submission, not an AI/ML model that requires a training set.

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

Not applicable. No training set was used for this device.

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

The Radifocus Glidewire Advantage consists of a Nickel Titanium alloy core wire. 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 many configurations such as straight, J shaped, and angled. The wire is package in a plastic holder contained within a pouch. A guide wire inserter is contained within the pouch to assist with the insertion of the wire into a needle or catheter.

The provided text describes the 510(k) summary for the Radifocus® Glidewire® Advantage, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria in a clinical setting.

Therefore, many of the requested details, such as the sample size for a test set, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and details about training sets, are not applicable and not found within the provided text. This type of premarket notification relies on non-clinical performance testing and comparison to an already cleared device.

Here's a breakdown of the information that can be extracted from the provided text, along with explanations for the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in the typical sense (e.g., a specific percentage of success or a threshold for a metric). Instead, it states that the performance tests "demonstrate the substantial equivalence" and that "None of the data raises any new issues of safety and effectiveness."

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

• Sample Size for Test Set: Not specified. The document refers to "verification tests" but does not give sample sizes for these tests.
• Data Provenance: Not specified, but given the nature of the tests (mechanical and biocompatibility), it would be laboratory-based data, not human patient data.

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 submission. The performance tests are largely objective physical and chemical evaluations.

4. Adjudication method for the test set

• This information is not applicable to this type of submission. The performance tests are objective evaluations against engineering specifications and biocompatibility standards.

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

• This information is not applicable. This device is a guide wire, not an AI-powered diagnostic tool. No MRMC study was performed or mentioned.

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

• This information is not applicable. This device is a manual medical instrument, not an algorithm.

7. The type of ground truth used

• For the mechanical performance tests (e.g., torque control, bend strength), the "ground truth" would be established engineering specifications or benchmarks derived from empirical data and comparison to the predicate device.
• For biocompatibility, the "ground truth" is compliance with ISO-10993-1.
• For sterilization, the "ground truth" is validation to established standards (ANSI / AAMI / ISO 11135-1994, EN 550) and achieving a Sterility Assurance Level (SAL) of 10-6.

8. The sample size for the training set

• This information is not applicable. This is a physical medical device, not a machine learning algorithm.

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

• This information is not applicable. This is a physical medical device, not a machine learning algorithm.

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