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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 Glidewire 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 is a guide wire which is designed to fit inside a percutaneous catheter for the purpose of directing a catheter through the blood vessel. It is provided sterile and is intended for single use only. It consists of a Nickel Titanium alloy core wire; a polyurethane coating (containing tungsten) and a hydrophilic polymer coating are applied to the entire wire. There are two shaft configurations: standard and stiff. There are two distal tip shapes: straight and angled, and two types of flexible part lengths of the tip: 3 and 5cm. The Radifocus Glidewire is packaged in a plastic holder that is contained within an individual package. A guide wire inserter is included within the individual package to assist with the insertion of the guide wire into a catheter.

The provided text describes a 510(k) premarket notification for a medical device called the "Radifocus Glidewire". This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials for a novel device.

Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of an AI/Software as a Medical Device (SaMD), as implied by the detailed questions about ground truth, expert adjudication, MRMC studies, and standalone performance, does not directly apply to this document.

The document describes performance testing for a physical medical device (a guide wire) to ensure it meets established engineering and material standards and demonstrates substantial equivalence to a predicate device. It does not involve AI or software development that would require an AI-specific validation study as outlined in your prompt.

Here's a breakdown of why the requested information cannot be extracted from this document, and what is provided:

Why the requested information for AI/SaMD is not applicable/available:

• No AI or Software Component: The Radifocus Glidewire is a physical guide wire. There is no mention of any AI algorithm, software, or digital health component.
• No "Acceptance Criteria" for AI Performance: The "acceptance criteria" discussed in the document relate to physical properties and performance tests of the guide wire (e.g., surface, radiodetectability, fracture test, tensile force, torque strength, biocompatibility, sterilization). These are not AI performance metrics like sensitivity, specificity, AUC, or F-measure.
• No "Ground Truth" for AI/Imaging Data: Since there's no AI interpreting images or patient data, there's no need for establishing ground truth through expert consensus, pathology, or outcomes data, nor for training/test sets sourced from specific countries or collection methodologies (retrospective/prospective).
• No "Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study": This type of study is relevant for evaluating human reader performance with and without AI assistance in interpreting diagnostic images. It's not applicable to a physical guide wire.
• No "Standalone (Algorithm Only) Performance": This refers to the performance of an AI algorithm in isolation. It's not relevant here.
• No "Sample Sizes for Training/Test Sets" or "Adjudication Methods" for AI: These concepts are tied to machine learning model development and validation, which is absent from this submission.

What the document does provide regarding "acceptance criteria" and "proof":

The document details the non-clinical tests performed to demonstrate the device's performance and substantial equivalence to the predicate device.

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

   The document provides tables of performance tests based on ISO standards and FDA guidance documents, stating that all samples tested met the standard applicable to each test, and the subject device complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents. It doesn't provide specific numerical values for each test result, but rather a statement of compliance.

   Test	Standard / Acceptance Criteria (Implicitly Met)	Reported Device Performance
   ISO 11070:2014-based Tests:
   Surface	Section 4.3 of ISO 11070:2014	Met the standard applicable to the test. No new issues of safety and effectiveness were raised.
   Radiodetectability	Section 4.5 of ISO 11070:2014 & ASTM F640-12	Met the standard applicable to the test. Only non-aged sample was tested.
   Fracture Test	Section 8.4 of ISO 11070:2014	Met the standard applicable to the test. No new issues of safety and effectiveness were raised.
   Flexing Test	Section 8.5 of ISO 11070:2014	Met the standard applicable to the test. No new issues of safety and effectiveness were raised.
   Peak Tensile Force of Guidewire (ISO)	Section 8.6 of ISO 11070:2014	Met the standard applicable to the test. No new issues of safety and effectiveness were raised.
   FDA Guidance & In-house Standard-based Tests:
   Peak Tensile Force of Guidewire (FDA/In-house)	3.a of Coronary and Cerebrovascular Guidewire Guidance, January 1995 & In-house Standard	Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents.
   Torque Strength	3.b of Coronary and Cerebrovascular Guidewire Guidance, January 1995 & In-house Standard	Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents.
   Torqueability	3.c of Coronary and Cerebrovascular Guidewire Guidance, January 1995 & In-house Standard	Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents.
   Tip Flexibility	3.d of Coronary and Cerebrovascular Guidewire Guidance, January 1995 & In-house Standard	Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents.
   Sliding Resistance/Coating Integrity	3.e of Coronary and Cerebrovascular Guidewire Guidance, January 1995 & In-house Standard	Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents.
   Particulate Evaluation	VIII.A.13 of Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010; USP; In-house Standard	Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents.
   Product Dimension	In-house Standard	Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents.
   Biocompatibility	ISO 10993-1:2009 (Externally Communicating Devices, Circulating blood, Limited Contact

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The Radifocus Glidewire Endoscopic Wire is intended to be used for selective cannulation of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.

The Radifocus Glidewire Endoscopic Wire is an endoscopic guide wire that is provided sterile and is intended for single use only. It consists of a Nickel Titanium alloy core wire, and a polyurethane containing tungsten and hydrophilic polymer that are applied to the entire wire. There are two shaft configurations: standard and stiff; the stiff shaft has a slightly thicker core wire than that of the standard shaft. The wire distal segment comes in angled or straight configurations and is packaged in a plastic holder that is contained within an individual package. A guide wire inserter is contained within the individual package to assist with the insertion of the wire into an endoscope or catheter.

This document is a 510(k) premarket notification for a medical device called the Radifocus Glidewire Endoscopic Wire. It is a submission to the FDA demonstrating substantial equivalence to a predicate device, not a study describing acceptance criteria and device performance in the context of an AI-based system. Therefore, most of the requested information regarding AI study specifics like sample sizes for test and training sets, expert consensus, MRMC studies, and standalone performance is not applicable to this document.

However, I can extract and describe the acceptance criteria and the studies that prove the device meets these criteria, as presented in the document, which are related to the physical performance and safety of the guidewire.

Acceptance Criteria and Device Performance for the Radifocus Glidewire Endoscopic Wire

The device is a medical guidewire (non-AI), so the acceptance criteria are based on physical performance, biocompatibility, and sterility, rather than diagnostic accuracy or AI performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance:

Regarding the specific questions you asked for an AI study, the following are not applicable to this 510(k) submission for a non-AI medical device (guidewire):

2. Sample sizes used for the test set and the data provenance: Not applicable. Device is a physical guidewire, not an AI system processing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device refers to the physical and chemical properties meeting specified standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

However, to address the core of "the study that proves the device meets the acceptance criteria" based on the document:

The studies that prove the device meets the acceptance criteria are non-clinical bench tests and material assessments. These include:

• Performance Testing per ISO 11070: 2014: This standard covers "Sterile single-use intravascular introducers, dilators and guidewires." Tests performed included Radiodetectability, Fracture Test, Flexing Test, and Peak Tensile Force of Guidewire. These tests were conducted on both non-aged and accelerated aged samples.
• Performance Testing per Terumo's Internal Standards: These tests included Flexibility Test of Distal Tip, Torque transmission, Sliding Resistance/Coating, Integrity (Product appearance), and Bending Strength. These were based on the predicate device's expected performance.
• Biocompatibility Testing: Assessed in accordance with ISO 10993-1, classifying the device and confirming material compatibility through comparison to the predicate device's established safety record and identical material composition.
• Sterilization Validation: Demonstrated compliance with ISO 11135 for Ethylene Oxide sterilization, ensuring a Sterility Assurance Level (SAL) of 10^-6 (although the document stated 10^-9, which is a higher level of assurance) and meeting residual EO/ECH limits per ISO 10993-7 for limited exposure devices.
• Pyrogen Testing Validation: Conducted using Limulus Amebocyte Lysate (LAL) testing (Photometric Quantitative Method) in accordance with USP and FDA guidance.
• Risk Analysis: Performed according to ISO 14971 to identify and mitigate potential risks.

These non-clinical tests collectively demonstrate that the Radifocus Glidewire Endoscopic Wire is safe and effective and substantially equivalent to the predicate device, fulfilling the regulatory requirements for the 510(k) submission. No clinical trials were conducted or required for this submission.

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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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The RADIFOCUS Glidewires for coronary use with platinum (or gold) coil are used to facilitate the placement of ballon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).

The RADIFOCUS Glidewires for coronary use with platinum (or gold) coil have a core of titanium nickel alloy coated with polyurethane which is second coated with a hydrogel. The wires are 180cm and 300cm in length and come in 0.014", 0.016" and 0.018" diameters respectively. The platinum coil wire, 300cm length, is used exclusively for exchange purposes. The wires also possess a radiopaque marker at the tip of the wire. This coil is made of an amalgam of platinum and iridium or gold. The coil is entirely coated with polyurethane with tungsten. The distal portion of the wire is gradually tapered from 10 to 30 cm in length providing increasing flexibility at the distal portion of the wire.

The provided document describes a submission for substantial equivalence for a medical device, the RADIFOCUS® Glidewire® for coronary use. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone performance for an AI/ML device is not applicable to this document.

However, I can extract information related to the device's performance testing demonstrating substantial equivalence to a predicate device.

Here's a summary of the performance information provided:

Device: RADIFOCUS® Glidewire® for coronary use with platinum (or gold) coil

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

Since this is a substantial equivalence submission, there are no explicit "acceptance criteria" against numerical targets like those for a novel device. Instead, the performance tests demonstrated equivalence to a predicate device (K953533). The document states:

"The Terumo PTCA guide wires (represented in this submission) tested are substantially equivalent to the cleared Terumo RADIFOCUS® Glidewires® for coronary use with platinum (or gold) coil K953533."

"For all other physical characteristics the Terumo PTCA guide wires represented in this submission were found to be equivalent to the cleared Terumo RADIFOCUS Glidewires for coronary use with platinum (or gold) coil K953533."

"The Terumo PTCA guide wires represented in this submission exhibit a higher pushing resistance that can be associated with the higher crossability." (This is noted as a difference that does not raise new safety/effectiveness concerns).

*Note: Coating Adherence and Coating Flake tests were not performed for this submission as "none of the coating features of the Terumo PTCA guide wires represented in this submission are different from the cleared Terumo PTCA guide wires K953533."

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

• Sample Size: Not specified. The document only states "The Terumo PTCA guide wires (represented in this submission) tested...".
• Data Provenance: Not specified. The tests are physical performance tests of the device itself, not clinical data from patients.

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

• Not Applicable. This is a physical device performance study, not a study requiring expert clinical review or interpretation for ground truth.

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

• Not Applicable. No adjudication was explicitly mentioned for mechanical device testing.

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

• Not Applicable. This is not an AI/ML device, and 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 not an AI/ML algorithm.

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

• For the physical tests (Tensile Strength, Torque Transmission, etc.), the "ground truth" is the measured physical properties of the device relative to the predicate device. There is no biological or clinical "ground truth" as described in the prompt.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device; there is no training set mentioned.

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

• Not Applicable. As there is no training set.

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