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Merit Medical guide wires are used to facilitate the placement of devices during diagnostic and interventional procedures.

Merit InQwire® Amplatz Super Stiff Guide Wires are intended to facilitate the placement of devices during diagnostic and interventional procedures. The guide wires consist of a Blue PTFE (Polytetrafluoroethylene) coated flat wire coil, with an inside core wire. The core wire enhances the "Super Stiff" characteristic of the guide wire. The core wire extends the full length of the coil and is welded to the coil at three (3) points; a) the distal end, b) the proximal end and c) a spot weld approx. 22cm from the distal end. These welds are designed to provide integrity and ensure that the guide wire components remain together The outside coil is PTFE coated and this Blue PTFE coating extends from the distal tip of the wire to within 7cm of the proximal tip, which remains uncoated. The Merit InQwire® Amplatz Super Stiff Guide Wires are offered in 0.035-inch and 0.038-inch outer diameter with a 1cm, 3cm, 3.5cm ,4cm, 6cm and 7cm straight and J tip configuration and are available in lengths from 75cm to 260cm. The wires will be provided in a spiral hoop dispenser sized appropriately for the wires diameter and length. The dispenser has a standard flush port luer adapter that accepts any standard luer lock or slip tip syringe to facilitate flushing of the guide wire prior to use. A J-straightener is provided on the dispenser to facilitate the advancement of the wire tip into other devices.

The provided text describes testing conducted for the InQwire Amplatz Super Stiff Guide Wire (K170700) to demonstrate its substantial equivalence to predicate devices, not specifically for a software algorithm. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not directly applicable.

However, I can extract the information that is present regarding the acceptance criteria and the study performed for this medical device.

1. Table of acceptance criteria and the reported device performance

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

The document does not specify the exact sample sizes used for each performance test. It states that "A battery of testing was conducted" and implies these were laboratory-based tests comparing the subject device to existing predicate devices.

• Sample Size: Not specified.
• Data Provenance: The tests are implied to be conducted by the manufacturer, Merit Medical Systems, Inc., which has locations in South Jordan, UT, USA, and Galway, Ireland. The data is from laboratory testing of the physical device, not patient data (retrospective or prospective).

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)

This is a physical medical device, not an AI/software device requiring expert interpretation of results for ground truth. Therefore, this information is not applicable. Ground truth was established through validated engineering and scientific testing methods against established standards.

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

This is not applicable as it refers to expert consensus for interpreting results, which is not relevant for the performance testing of a physical guide wire.

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 is not applicable as this is not an AI/software device.

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

This is not applicable as this is not an AI/software device.

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

The ground truth for the reported tests was established by:

• Reference to predicate devices (Merit InQwire® Amplatz Super Stiff Guide Wire [K163575] and Amplatz Super Stiff Guidewire [K843012]).
• Adherence to industry standards and guidance documents (e.g., FDA guidance Coronary and Cerebrovascular Guide Wire Guidance, ISO 11070:2014, ISO 11135:2014, ASTM F1980-07, ISO 10993-1:2009, ISO 11607-1:2006).
• Risk analysis.

The "ground truth" for a physical device is its measurable physical and chemical properties and performance characteristics against established benchmarks.

8. The sample size for the training set

This is not applicable as this is not an AI/software device.

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

This is not applicable as this is not an AI/software device.

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Merit Medical guide wires are used to facilitate the placement of devices during diagnostic and interventional procedures.

The guide wires consist of a Blue PTFE (Polytetrafluoroethylene) coated flat wire coil, with an inside core wire. The core wire enhances the "Super Stiff" characteristic of the guide wire. The core wire extends the full length of the coil and is welded to the coil at three (3) points; a) the distal end, b) the proximal end and c) a spot weld approx. 22cm from the distal end. These welds are designed to provide integrity and ensure that the guide wire components remain together The outside coil is PTFE coated and this Blue PTFE coating extends from the distal tip of the wire to within 7cm of the proximal tip, which remains uncoated.

The Merit InQwire® Amplatz Super Stiff Guide Wires are offered in 0.035-inch outer diameter with a 7cm straight tip configuration and are available in lengths from 75cm to 260cm. The wires will be provided in a spiral hoop dispenser sized appropriately for the wires diameter and length.

The dispenser has a standard flush port luer adapter that accepts any standard luer lock or slip tip syringe to facilitate flushing of the guide wire prior to use. A J-straightener is provided on the dispenser to facilitate the advancement of the wire tip into other devices.

The provided text describes a 510(k) premarket notification for a medical device, the "InQwire Amplatz Super Stiff Guide Wire." It details the device's characteristics, its comparison to predicate devices, and the performance testing conducted to demonstrate substantial equivalence.

Based on the document, here's a breakdown of the requested information:

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

The document states that performance testing was conducted based on risk analysis and in accordance with protocols based on guidances and industry standards. It explicitly says: "these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence." And "All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria."

However, the document does not provide a specific table detailing numerical acceptance criteria and a corresponding column for reported device performance values. It lists the types of tests performed but not the quantitative results or specific thresholds.

Table of Performance Tests Conducted (Acceptance Criteria and Numerical Performance Not Specified):

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

The document does not specify the sample size for any of the performance tests. It also does not mention data provenance such as country of origin of the data or whether the studies were retrospective or prospective. The testing appears to be primarily bench testing (in vitro) rather than human or animal studies, given the type of device and tests.

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

This section is not applicable as the document describes performance testing of a physical medical device (guide wire), not an AI/ML algorithm that requires expert "ground truth" for interpretation of images or other clinical data. The "ground truth" here is the physical performance of the device against engineering and material standards.

4. Adjudication method for the test set

This is not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in human-AI reader studies. The performance tests described measure physical properties and do not involve 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

This is not applicable. The device is a guide wire, not an AI/ML diagnostic or assistive tool. Therefore, no MRMC study involving human readers and AI assistance would have been performed.

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

This is not applicable. The device is a physical medical instrument, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance testing is based on engineering standards, in vitro testing protocols, and comparison to legally marketed predicate devices. This includes:

• FDA guidance (e.g., Coronary and Cerebrovascular Guide Wire Guidance January 1995)
• Industry standards (e.g., ISO 11070:2014, ISO 11135-1:2014, ASTM F1980-07, ISO 10993-1:2009, ISO 11607-1:2006)
• Bench testing methodologies to evaluate physical and material properties (e.g., tensile strength, flexibility, radiopacity, coating adherence, biocompatibility, corrosion).

8. The sample size for the training set

This is not applicable. The device is a physical product, not an AI/ML model that requires a training set.

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

This is not applicable for the same reason as #8.

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Merit Medical guide wires are used to facilitate the placement of devices during diagnostic and interventional procedures.

InQwire® Diagnostic Guide Wires are intended to facilitate the placement of devices during diagnostic and interventional procedures. The quide wires have a continuous PTFE (Polytetrafluoroethylene) coated coil, inside core wire and a safety wire. The core wire is fixed at the proximal end only and extends to a specified distance from the distal end. The distal segment of the core wire has a profiled taper. The core wire enhances the stiffness of the guide wire. The safety wire extends the full length of the guide wire and is welded at both the distal and proximal end. The safety wire is designed to provide integrity and ensures that the guide wire components remain together.

The InQwire® Diagnostic Guide Wires are offered in 0.035 inch or 0.038 inch outer diameter with different tip configurations (straight or J-tip), single ended or double ended (either end of the wire can be placed into the patient), standard or firm shaft, and are available in lengths from 50cm to 260cm. The wire is placed inside a loop flush dispenser, also referred to as a hoop. The dispenser has a female Luer connection which facilitates solution flushing through the hoop to hydrate the guide wire. The guidewires are secured in the hoop dispenser by a locking J-tip straightener.

This modification details a supplier process change relating to removal of perfluorooctanoic acid (PFOA), used in the manufacture of the PTFE (Polytetrafluoroethylene) coating. More specifically PFOA is a processing aid used for the polymerization process of PTFE, which is flashed off during the oven curing process and therefore not part of the finished InQuire® Diagnostic Guidewire. Due to environmental concerns relating to PFOA, the U.S. Environmental Protection Agency has instructed that all processors of PTFE no longer make, buy or use PFOA(2010/2015 PFOA Stewardship Program). PFOA material is used in the manufacture both the intermediate layer and top layer of the PTFE(Polytetrafluoroethylene) coating.

This document describes the 510(k) summary for the Merit InQwire® (IQ) Diagnostic Guide Wire, specifically addressing a change in the PTFE coating manufacturing process.

Here's an analysis of the provided text:

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

The document states that "Performance testing of the subject Merit InQwire® Diagnostic Guide Wire was conducted based on risk analysis. A battery of testing was conducted in accordance with protocols based on requirements outlined in guidance's and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate 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)

The document does not specify the sample size used for the tests. It also does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective. Given the nature of a 510(k) submission for a device modification (supplier process change), the tests would primarily be laboratory-based verification and validation.

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)

This information is not applicable to the provided document. The study described is a series of engineering and biological performance tests, not a clinical study involving expert interpretation of medical data. Therefore, there is no "ground truth" established by medical experts in this context.

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

This information is not applicable. Adjudication methods are typically used in clinical trials where multiple readers assess cases. This document describes laboratory-based performance testing of a medical device.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document pertains to the 510(k) submission for a guide wire, which is a physical medical device, not an AI-assisted diagnostic tool. Therefore, there is no mention of human readers or AI assistance.

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

No, a standalone (algorithm-only) performance study was not done. This document is about a physical medical device.

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

The concept of "ground truth" as derived from expert consensus, pathology, or outcomes data is not applicable here. The "ground truth" for this device's performance is established by the specifications and measurable outcomes of the engineering and biological tests conducted against established industry standards and FDA guidance. The "truth" is whether the device meets the predetermined physical and chemical parameters.

8. The sample size for the training set

This information is not applicable. This is not a study involving machine learning or AI, so there is no training set in that context.

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

This information is not applicable, as there is no training set for an AI/machine learning model in this context.

Ask a specific question about this device

Ask a specific question about this device