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The MRWire Guide Wire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures.

The MRWire Guide Wire is a sterile, disposable guide wire for the introduction and/or placement of diagnostic or interventional devices. The MRWire is constructed from a high strength core composite of glass fibers and polymers, protected by a high-strength aramid fiber mantle and covered with a PTFE extrusion. The distal tip of the MRWire is marked with discrete ring markers for MRI and X-Ray visibility and comes in different configurations such as straight and angled. Guide wires are supplied sterile and nonpyrogenic. The MRWire's diameter is 0.035" (0.89 mm).

The provided text describes a 510(k) submission for a medical device called the "MRWire Guide Wire." This section outlines the device, its modifications from a predicate device, and the non-clinical tests performed to demonstrate its substantial equivalence and safety.

Here's an analysis of the provided text in relation to the requested information:

Key Takeaway: The provided document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance testing. It explicitly states that no clinical tests were performed or included in this submission. Therefore, much of the requested information regarding human-in-the-loop performance, expert ground truth, and patient-data-driven studies is not applicable to this specific submission.

However, I can extract information related to the physical performance testing of the device for manufacturing and safety purposes.

Acceptance Criteria and Device Performance (Non-Clinical)

The document primarily focuses on a comparison to a predicate device and adherence to established standards and in-house criteria for physical and material properties. The "acceptance criteria" here refer to the device meeting or surpassing the performance of the predicate device and complying with relevant ISO standards and FDA guidance documents.

Here's a table summarizing the modifications and the performance outcomes, which serve as the "acceptance criteria" for demonstrating substantial equivalence for these specific changes:

Here's a breakdown of the specific points requested, based on the provided text:

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

• (Provided above in detail)

2. Sample sized 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 precise sample sizes (N-values) used for each non-clinical test (e.g., how many guide wires were tested for tensile strength or torquability). It mentions "MRWire Guide Wire Samples" for performance testing.
• Data Provenance:
  • Country of Origin: Not explicitly stated for the testing location or data collection, but the manufacturer is Nano4Imaging GmbH, located in Aachen, Germany.
  • Retrospective or Prospective: This distinction is not applicable as these are non-clinical, controlled laboratory performance tests on manufactured devices, not studies involving patient data or clinical observation. The tests were performed on "non-aged and accelerated-aged MRWire Guide Wire Samples" to evaluate performance throughout the labeled shelf life.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This device is a physical guide wire, and the testing described is non-clinical performance and material testing (e.g., tensile strength, flexibility, torquability, biocompatibility, MRI compatibility based on physical properties). There is no "ground truth" established by clinical experts in the context of diagnostic interpretation, as this is not an AI/imaging diagnostic device requiring human evaluation of outputs. The "experts" would be the engineers, scientists, and technicians conducting the physical tests and analyzing the results against engineering specifications and regulatory standards.

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

• Not Applicable. As explained in point 3, this is non-clinical performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image interpretation studies where multiple human readers disagree on a diagnosis or finding, and an independent expert or panel resolves the discrepancy to establish a "ground truth." This is not relevant for testing a physical device's mechanical or material properties.

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. The document explicitly states: "This 510(k) does not include data from clinical tests." Therefore, no MRMC study was performed, and this device is not an AI diagnostic tool designed to assist human readers.

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

• Not Applicable. This is a physical medical device (guide wire), not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is irrelevant here.

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

• Not Applicable in the traditional sense of clinical data. For this device, the "ground truth" for its performance and safety is established by:
  • Engineering specifications: The design parameters and expected performance characteristics of the guide wire.
  • Predicate device performance: The previously cleared device serving as a benchmark.
  • Consensus standards: ISO 11070:2014, ASTM F640-12, EN ISO 14125:2011, ISO 10993-1:2009, ISO 11135:2014, ISO 14971:2007.
  • FDA guidance documents: "Coronary and Cerebrovascular Guidewire Guidance, January 1995" and "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, issued December 11, 2014."
  • In-house standards: Developed by Nano4Imaging GmbH to ensure specific performance metrics.
• The "ground truth" is that the device meets or exceeds the performance of the predicate and complies with all relevant safety and performance standards.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is a physical device being evaluated through non-clinical performance testing, not an AI/machine learning model that learns from data.

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

• Not Applicable. (See point 8).

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The MRWire Guide Wire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures.

The MRWire Guide Wire is a sterile, disposable guide wire for the introduction and/or placement of diagnostic or interventional devices. The MRWire is constructed from a high strength core composite of glass fibers and polymers, protected by a high-strength aramid fiber mantle. The distal tip of the MRWire is marked with discrete ring markers for MRI visibility and comes in different configurations such as straight and angled. Additionally, the Pebax® tip extrusion, contains BaSO4 for X-Ray visibility.

Guide wires are supplied sterile and non-pyrogenic. The MRWire's diameter is 0.035" (0.89 mm).

The provided document is a 510(k) summary for the MRWire Guide Wire. It details the device, its intended use, and a comparison with a predicate device to demonstrate substantial equivalence. However, it does not describe a study involving an AI algorithm or human readers for diagnostic performance. Therefore, many of the requested fields, particularly those related to AI model evaluation, ground truth establishment, expert consensus, and MRMC studies, cannot be directly addressed from this document.

Here's an analysis of the provided text in relation to your request:

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

The document lists performance tests, implying certain acceptance criteria were met for each, but it does not quantitatively define these criteria or provide specific numerical results for each test. Instead, it offers a qualitative statement of substantial equivalence.

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

• Preclinical: Swine model, unspecified sample size. Data provenance: Department of Cardiology (Johns Hopkins Division of Medicine), USA (implied as Johns Hopkins is in the US). Prospective testing.
• Clinical: Patients with congenital heart disease, unspecified sample size. Data provenance: German Heart Centre in Munich (Germany). Prospective (ongoing Post-Market Clinical Follow-up study).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document describes device performance testing, not an AI algorithm requiring expert-established ground truth for diagnostic accuracy. The "ground truth" here is the physical performance and safety of the device itself, observed by researchers and clinicians.

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

Not applicable. This is not an AI diagnostic 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

Not applicable. This is a medical device clearance document, not an AI performance study.

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

Not applicable. There is no AI algorithm discussed.

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

The "ground truth" for the device can be considered:

• Physical measurements (e.g., tensile strength, dimensions) compared against design specifications and industry standards.
• Direct observation of device maneuverability and visibility during preclinical (swine) and clinical use.
• Physiological stability of subjects during preclinical testing.
• Safety and effectiveness observations in clinical use.

8. The sample size for the training set

Not applicable. This is not an AI algorithm study. There is no training set mentioned.

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

Not applicable. There is no training set or AI algorithm discussed.

Ask a specific question about this device