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The Charter(TM) Guidewires are intended for use in the coronary and peripheral vasculature.

The Charter™ Guidewire is a disposable medical device designed for single use only. It consists of a PTFE coated 140cm, 180cm, or 300cm 0.014", 0.016" or 0.018" diameter stainless steel core wire, one end of which is reduced in diameter over a 43cm approx. segment in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness and can be varied to produce various levels of support.

The distal part of the reduced section is covered with a 3cm, 0.010" platinum tungsten spring coil. This provides greater visibility on x-ray equipment. A 39cm approx. length of black / grey Estane 88A radiopaque heat shrink polymer tubing is applied over the tapered distal end of the wire and ground to form a constant outer diameter, OD, equivalent in diameter to the main core body.

Coatings are placed on the device to improve the lubricity and ease in its advancement through the guide catheter and the blood vessel

The provided text describes a 510(k) application for the Charter™ Guidewire. This is a medical device, not an AI/ML powered device, therefore the criteria for AI/ML powered devices cannot be fully satisfied by the provided information.

However, I can extract the acceptance criteria and the study type conducted based on the available text.

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

Acceptance Criteria and Device Performance

Study Information (Based on a medical device, not an AI/ML framework):

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

   • The study involved in vitro bench testing.
   • The sample size for these tests is indicated as "n" (which is not a specific number but typically implies a sufficient number for statistical validity in bench testing).
   • The documentation does not specify provenance like country of origin for the "data" as it pertains to physical device testing, not patient data. It is a prospective bench test conducted by the manufacturer to assess device properties.

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

   • This question is not applicable to this type of device and study. "Ground truth" in the context of AI/ML or diagnostic studies refers to a verified diagnosis or outcome. For a physical medical device like a guidewire, the "ground truth" is established by direct measurement and adherence to engineering specifications and performance standards through well-defined bench test methodologies.

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

   • This is not applicable. Adjudication refers to resolving disagreements between human readers or between an AI and human readers in diagnostic tasks. The bench tests described are objective measurements against defined acceptance criteria.

4. 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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving image interpretation by human readers, often assisted by AI). The Charter™ Guidewire is a physical interventional device, not a diagnostic one.

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

   • N/A. This refers to AI algorithm performance. The Charter™ Guidewire is a physical device, and its "performance" is measured by its physical and mechanical properties described in the bench tests, not by an algorithm.

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

   • The "ground truth" for this device's performance is based on pre-defined product specifications and industry standards for guidewire performance, as outlined in the "In vitro bench testing" section, specifically referencing the "FDAs guidance document 'Coronary and Cerebrovascular Guidewire Guidance, Jan 1995'". The device's performance is measured against these objective, quantifiable criteria.

7. The sample size for the training set:

   • This is not applicable. There is no "training set" in the context of a physical medical device's performance testing. Training sets are used to develop and train AI/ML models.

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

   • This is not applicable as there is no training set for this type of device.

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The guidewires are intended to facilitate the placement and exchange of balloon catheters or other interventional devices within the peripheral vasculature during Percutaneous Transluminal Angioplasty (PTA) or other intravascular interventional procedures.

The Victory Guidewire range are a disposable medical device designed for single use only. The device is intended to facilitate the placement of percutaneous devices during Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature. The family consists of a PTFE coated 195cm or 300cm, 0.014" or 0.018" diameter stainless steel core wire, one end of which is reduced in diameter in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness and can be varied to produce 6 various levels of support.

The provided document is a 510(k) summary for the Victory Guidewire. It describes the device, its intended use, and the non-clinical performance testing conducted to demonstrate its substantial equivalence to predicate devices. However, this document does not describe a study involving an AI/Machine Learning device or its acceptance criteria and performance against those criteria. Instead, it describes:

1. Acceptance Criteria and Reported Device Performance: This section outlines the in-vitro bench tests performed and states that the results met the defined acceptance criteria and performed comparably to predicate devices. The acceptance criteria themselves are not explicitly detailed with specific numerical thresholds but are implied to be part of the "product specification."

2. Sample size used for the test set and the data provenance: The document details "In vitro bench tests" for the device, which are performed on physical samples of the guidewire. It does not refer to a "test set" in the context of data for an AI/ML model. The sample sizes for these bench tests are not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as the study involves physical product testing, not human-interpreted data for establishing ground truth for an AI/ML model.
4. Adjudication method: Not applicable for this type of device testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used: The "ground truth" for the bench tests would be the established engineering specifications and performance characteristics of the predicate devices and the industry standards (e.g., FDA guidance, ISO 10993-1).
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Study Description:

The study described is a series of in vitro bench tests conducted to demonstrate the substantial equivalence of the Victory Guidewire to predicate devices. The tests were performed with reference to the FDA's guidance document "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995".

The specific bench tests performed include:

• Tensile Strength
• Torque Strength
• Outer Diameter & Length Measurement
• Torque Response
• Catheter Compatibility
• Coating Adherence/Coating Integrity
• Particulate Testing
• Tip Flexibility

In addition to these mechanical and physical tests, biological safety was established through biological risk assessment, chemical characterization, and biocompatibility testing in compliance with ISO 10993-1.

The conclusion of the study was that the Victory Guidewire met the predefined acceptance criteria and performed comparably to its predicate devices, thus demonstrating substantial equivalence.

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The Charter™ Guidewires are intended for use in the coronary and peripheral vasculature.

The Navilyst Medical Guidewire is a disposable medical device designed for single use only. It consists of a PTFE coated 140cm or 180cm, 0.014" or 0.018" diameter stainless steel core wire, one end of which is reduced in diameter over a 43cm approx. segment in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness and can be varied to produce various levels of support.

The distal part of the reduced section is covered with a 3cm, 0.010" platinum tungsten spring coil. This provides greater visibility on x-ray equipment. A 39cm approx. length of black / grey Estane 88A radiopaque heat shrink polymer tubing is applied over the tapered distal end of the wire and ground to form a constant outer diameter, OD, equivalent in diameter to the main core body. Coatings are placed on the device to improve the lubricity and ease in its advancement through the guide catheter and the blood vessel

The provided text describes the 510(k) application for the Navilyst Charter Guidewire, focusing on its substantial equivalence to predicate devices based on in vitro bench testing and biological safety evaluations. There is no mention of a diagnostic device, AI/ML algorithm, or clinical study involving human readers or ground truth established by experts.

Therefore, most of the requested information cannot be extracted from the given text.

Here is what can be inferred:

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

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

• Sample Size: Not specified for each test. The document states "Charter™ Guidewires (in its various configurations)" were tested, implying multiple units were used.
• Data Provenance: In vitro bench testing. The country of origin for the data is not specified, but the applicant is Brivant Ltd, Ireland. The testing was prospective for the Charter Guidewire.

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

Not applicable. No experts were used for establishing ground truth as this was an in vitro bench testing study for a medical device (guidewire), not a diagnostic algorithm.

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

Not applicable. No adjudication method was used as this was an in vitro bench testing study.

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 MRMC comparative effectiveness study was conducted. This document describes the approval of a medical device (guidewire), not a diagnostic AI.

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

Not applicable. This is not for an algorithm.

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

Not applicable. The "ground truth" for the bench tests would be the established engineering specifications and performance standards for guidewires, as referenced by the "FDAs guidance document "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995" and the product specification.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/ML algorithm.

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

Not applicable. There is no training set mentioned.

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The Cruiser-18 Guidewires are intended for use in the peripheral vasculature. The Cruiser-18 guide wire is not intended for use in the coronary or cerebral vasculature. Patients judged not acceptable for percutaneous intervention (PPCI).

The guide wire is a disposable medical device designed for single use only. It consists of a 0.018" diameter stainless steel core wire, one end of which is reduced in diameter over a 13cm segment in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness. This reduced section is covered with a spring coil of equivalent diameter to the main core body. The coiled segment consists of a stainless steel coil placed over a radiopaque coil made of a platinum tungsten alloy. This coil provides greater visibility on x-ray equipment. The profile of the reduced section is varied to provide a range of products with mixed stiffness.

Here's an analysis of the provided text regarding the Cruiser-18 Guidewire, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) Summary for a medical device. This type of submission relies heavily on bench testing and comparison to predicate devices to demonstrate substantial equivalence, rather than extensive clinical studies or AI algorithm performance evaluations as might be found for software as a medical device. Therefore, many of the requested points related to AI, clinical trials, and multi-reader studies will not be applicable.

Acceptance Criteria and Study Overview for Cruiser-18 Guidewire

1. Table of Acceptance Criteria and Reported Device Performance

Study that Proves the Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as "In vitro bench tests" carried out to demonstrate equivalence with reference to the FDA's guidance document "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995." The results demonstrated that the Cruiser-18 Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device.

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

• Sample Size for Test Set: Not specified. The document refers to "in vitro bench tests" and "performance evaluations" but does not detail the number of units or samples tested for each criterion.
• Data Provenance: The tests are in vitro bench tests, meaning they were conducted in a laboratory setting, not with human subjects. The data does not originate from a specific country in terms of patient data, but rather from laboratory testing performed by Brivant Ltd (located in Ireland). The study is inherently prospective in the sense that the tests were designed and executed to evaluate the new device.

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

This is not applicable as the device is a physical medical device (guidewire) being evaluated through bench testing against engineering specifications, not an AI algorithm requiring expert consensus for ground truth on medical images or diagnoses. The "ground truth" here is defined by engineering specifications and predicate device performance.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the evaluation involves physical measurements and functional tests against predefined specifications, not subjective expert judgment that would require an adjudication method.

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

Not applicable. This is a physical guidewire, not an AI algorithm intended to assist human readers in interpreting medical cases. No MRMC study was conducted or is relevant.

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

Not applicable. This device is not an algorithm. Its performance is inherent to its physical properties and function as a guidewire, operated manually by a clinician.

7. Type of Ground Truth Used

The ground truth used for these performance evaluations is based on:

• Product Specifications: Predefined engineering and performance criteria for the guidewire.
• Predicate Device Performance: Performance characteristics established from the legally marketed predicate devices (Brivant Guidewire K060551 and Courier Guidewire K073082).
• Regulatory Guidance: Referenced the FDA's "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995."

8. Sample Size for the Training Set

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

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

Not applicable. No training set was used.

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The Parodi Guidewire is designed to direct a catheter to the desired anatomical location during diagnostic or interventional procedures.

The Parodi Guidewire Assembly is a disposable medical device designed for single use only. It is a multi-component system which can be manipulated to vary the stiffness characteristics as required during a procedure. The device is available in 2 main configurations: 2-piece system: Comprising a 0.014" guidewire and Outer 0.035" member. 3-piece system: Comprising a 0.014" guidewire, Outer 0.035" member and an Intermediate stiffener. A 3-piece system is depicted in figure 1 below. The Intermediate Stiffener is not present in a 2-piece system. A hydrophilic coating is applied to the distal portion of the wire of the 0.014" guidewire and the 0.035" outer assembly. PTFE coating is applied to the proximal portions of these devices. The wire is packaged in a polyethylene hoop contained within a sealed pouch. A torque device is included within the pouch to assist with torquing the device if required.

The Parodi Guidewire is a medical device used to guide catheters during diagnostic or interventional procedures. The device's performance was evaluated through in vitro bench testing to ensure it met acceptance criteria and performed comparably to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for the in vitro bench tests. The tests were performed "in vitro," indicating they were laboratory-based and not on human subjects. The data provenance is not explicitly stated in terms of country of origin, but the submitting company is Brivant Ltd. based in Galway, Ireland, suggesting the testing was likely conducted in a similar region or organized by the company. The study was a non-clinical, in-vitro study.

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

This information is not applicable. The study involved in-vitro bench testing of physical characteristics and biocompatibility, not clinical evaluation requiring expert interpretation of results to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for in-vitro bench testing. The evaluation would have involved objective measurements and comparisons against predefined criteria.

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

No. This was an in-vitro bench testing study of a physical device, not an AI or imaging-related study that would involve human readers or MRMC analysis.

6. Standalone Performance Study

Yes, a standalone performance evaluation was conducted for the device. The "in vitro bench testing performance evaluations demonstrated that the Parodi Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate." This indicates the device's performance was assessed independently against established criteria.

7. Type of Ground Truth Used

For the in-vitro bench tests, the "ground truth" was based on predefined technical specifications and objective measurements of the device's physical properties (e.g., tip flexibility, lateral stiffness, device compatibility) and adherence to recognized standards for biocompatibility (ISO 10993-1).

8. Sample Size for the Training Set

This information is not applicable. The Parodi Guidewire is a physical medical device, not a machine learning or AI model, thus it does not have a "training set" in the context of algorithm development.

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

This information is not applicable for the reasons mentioned in point 8.

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The Streamer Polymer guide wires are intended for use in the coronary and peripheral vasculature to facilitate the selective placement of interventional catheters with compatible guidewire lumen and Biotronik coronary venous leads.

The Biotronik Streamer polymer guide wire is a disposable medical device designed for single use only. It consists of a PTFE coated 195cm 0.014" diameter stainless steel core wire, one end of which is reduced in diameter over a 38cm segment in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness and is varied to produce 3 unique levels of support, standard support, extra support (ES) and extra distal support (XT). There are a total of 8 versions of the guidewire, 2 standard support versions (straight & J), 4 extra support versions (straight and ), Bulach and Berlin) and 2 extra distal support versions (straight & J}. The distal part of the reduced section is covered with a platinum tungsten spring coil of equivalent diameter to the main core body. This provides greater visibility on x-ray equipment. A 30cm length of blue heat shrink polymer tubing is applied over the tapered distal end of the wire and ground to form a constant outer diameter, OD. The polymer jacket over distal coils provides for smoother lead-guidewire interaction.

The provided text describes a 510(k) premarket notification for the "Streamer Polymer Guidewire" and focuses on demonstrating its substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria and performance against them.

Therefore, the requested information for acceptance criteria and specific study details (like sample sizes for test/training, ground truth methods, expert qualifications, MRMC studies, or standalone performance) is not present in the provided document. The document describes a "Summary of Testing" but does not provide granular details on acceptance criteria or the specific methodologies for each test.

Based on the information provided, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the successful tests "demonstrated the Streamer Polymer Guidewires consistently performed within their design parameters, are safe and effective and perform as well as the predicate devices." However, specific quantitative acceptance criteria or detailed performance metrics are not provided.

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

• Sample Size for Test Set: Not provided.
• Data Provenance: The testing was conducted by Brivant Limited, an Irish company. No information on the country of origin of the data or whether it was retrospective or prospective is given.

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

• Not applicable/Not provided. This type of information is typically relevant for studies involving human interpretation (e.g., imaging diagnostics), not for hardware performance testing of a guidewire. The ground truth for guidewire performance is typically based on engineering specifications and physical measurements.

4. Adjudication method for the test set:

• Not applicable/Not provided. This is not relevant for the type of bench testing described for a guidewire.

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 applicable as the device is a medical guidewire, not an AI-powered diagnostic tool involving human readers.

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

• Yes, a standalone performance assessment was done in the sense that the guidewire's physical characteristics were tested independently. However, the details of "algorithm only" performance are not applicable since it's a physical device, not a software algorithm. The "Summary of Testing" lists various physical and mechanical tests:
  • Tensile strength
  • Torque strength
  • Torque response
  • Coating performance
  • Radiopacity
  • Tip flexibility
  • Catheter compatibility testing
  • Accelerated aging
  • Transportation testing
  • Sterilisation validation adoption
  • Biocompatibility testing (in compliance with ISO 10993-1 and ISO 10993-4)

7. The type of ground truth used:

• For the physical tests, the "ground truth" would be the established engineering specifications, material standards, and benchmark performance of predicate devices. The document states that the successful tests "demonstrated the Streamer Polymer Guidewires consistently performed within their design parameters" and "perform as well as the predicate devices."

8. The sample size for the training set:

• Not provided. This is generally not applicable for non-AI medical devices undergoing physical performance testing.

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

• Not applicable/Not provided as there is no specific "training set" in the context of physical product testing for a guidewire in the way it is understood for AI/ML models.

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The CPS Courier Guidewires are intended for use in the coronary and peripheral vasculature.

The Courier Guide wire is a disposable medical device designed for single use only. It consists of a 0.014" diameter stainless steel core wire, the distal end of which is reduced in diameter in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness. The quide wire comes in 5 unique base models distinguished by their distal flexibility portions, the profile varied to provide a range of products of mixed stiffness. This reduced section is covered with a polymer coating of equivalent diameter to the main core body. Underneath the polymer at the distal tip there is a 0.010" platinum/tungsten alloy platinum coil attached to the distal tip of the core by means of solder joints. This provides greater visibility on x-ray equipment.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

• Torque strength: Successfully completed testing.
• Torque response: Successfully completed testing.
• Coating performance: Successfully completed testing.
• Tip flexibility: Successfully completed testing. |
  | Imaging Properties | Sufficient for visibility on X-ray equipment | - Radiopacity: Successfully completed testing. The device incorporates a 0.010" platinum/tungsten alloy platinum coil at the distal tip for greater visibility on x-ray equipment. |
  | Device Compatibility | Compatible with catheters | - Catheter compatibility testing: Successfully completed testing. |
  | Material/Shelf Life | Biocompatible and maintain performance over time | - Accelerated aging: Successfully completed testing.
• Biocompatibility testing: Successfully completed in compliance with ISO 10993-1. |
  | Overall Performance | Safe, effective, and performs as well as the predicate devices | - "The successful tests demonstrated the CPS Courier Guidewires consistently performed within their design parameters, are safe and effective and perform as well as the predicate devices." Implies meeting all relevant performance and safety benchmarks for guidewires, consistent with the predicate. |

Study Proving Acceptance Criteria are Met:

The document describes a series of performance tests. These tests collectively serve as the study demonstrating that the CPS Courier Guidewires meet the (implied) acceptance criteria, primarily by showing substantial equivalence to the predicate device and adherence to design parameters.

Detailed Information about the Study:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a previously cleared predicate device (the Brivant Guidewire). The "study" in this context is a series of engineering and biocompatibility tests rather than a clinical trial involving human subjects or a diagnostic accuracy study.

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 specify the exact sample sizes used for each individual test (tensile strength, torque response, etc.). These are typically described in detailed test reports, which are summarized here.
   • Data Provenance: The document does not explicitly state the country of origin of the data. However, the submitter, Brivant Limited, is located in Galway, Ireland, suggesting the testing was likely conducted in Ireland or by a contract lab working for them. The testing is prospective, as it's being conducted specifically to support this 510(k) submission for a new device design.

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

   • This question is not applicable in the context of this device. The CPS Courier Guidewire is a mechanical device, not a diagnostic or imaging interpretation tool that requires expert human interpretation to establish "ground truth." The ground truth for mechanical and material properties is established through standardized engineering test methods (e.g., measuring tensile strength using a testing machine) and adherence to industry standards (e.g., ISO 10993-1 for biocompatibility).

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

   • This question is not applicable. Adjudication methods like '2+1' or '3+1' are used for resolving discrepancies in human expert interpretation in studies involving diagnostic accuracy or image review. For physical device testing, the results are typically quantitative measurements against predefined specifications; discrepancies would involve re-testing or investigation of the test setup, not expert adjudication of interpretations.

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

   • This question is not applicable. The CPS Courier Guidewire is a medical device (guidewire) used in procedures, not an AI-powered diagnostic or decision-support tool. Therefore, an MRMC study comparing human reader performance with or without AI assistance is irrelevant to this submission.

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

   • This question is not applicable. As previously stated, this 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 is based on engineering specifications, material science principles, and established international standards. For example:
     • Mechanical properties: Ground truth is defined by the physical measurement of properties (e.g., force required for tensile failure, torque applied) and comparison against design specifications and predicate device performance.
     • Biocompatibility: Ground truth is established by meeting the requirements of ISO 10993-1, which involves standard tests for cytotoxicity, irritation, sensitization, etc., interpreted by toxicologists or biologists based on established scientific principles.
     • Radiopacity: Ground truth is the visual confirmation of visibility under X-ray, often quantified by comparing it to known radiopaque materials or the predicate device.

8. The sample size for the training set:

   • This question is not applicable. The concept of a "training set" applies to machine learning algorithms. This device is not an AI/ML product. The tests conducted are for verification and validation of the physical device and its materials.

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

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

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