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The True Form Reshapable Guide Wire is intended to facilitate the placement of catheters within the peripheral and coronary vasculature for various diagnostic and interventional procedures.
The True Form Reshapable Guide Wire should not be used in the neurovasculature

The Merit True Form Reshapable Guide Wire consists of a stainless steel core wire, flattened at the distal end, with a 5cm Gold Plated Tungsten coil attached to the distal tip and is fully jacketed with a radiopaque filled polymer jacket. The True Form Reshapable Guide Wire is fully coated with a hydrophilic coating. The 5cm radiopaque coil is attached to the internal stainless steel core wire with a multitude of solder joints.
The wires are placed within a spiralled hoop dispenser with a flush luer attached and clips to secure the wire within the hoop. Included within the pouch, with the spiralled hooped guidewire, is another pouch containing an Insertion Tool, a Tip Straightener, and a Torque device.
The wire will be offered in straight and angled versions, in various lengths.

The provided text outlines the acceptance criteria and a summary of the study performed for the Merit True Form Reshapable Guide Wire.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of discrete numerical acceptance criteria and corresponding reported device performance values. Instead, it states that 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."

For Biocompatibility, the document explicitly states: "All test results were comparable to the predicate devices and the subject Merit True Form Reshapable Guide Wire met the predetermined acceptance criteria. This has demonstrated that the subject device is substantially equivalent to the predicate devices."

For Performance Testing-Bench, the document lists various tests and implies that the device successfully met the acceptance criteria relevant to each:

• Size Designation
• Radiodetectability
• Tip Shape Testing
• Surface
• Tensile Strength
• Torque Strength
• Torqueability
• Tip Flexibility
• Fracture test
• Flex test
• Lubricity
• Corrosion Resistance
• Device Compatibility
• Tip Curve Shapeability
• Particulate
• Coating Durability
• Packaging

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

The document does not specify the sample sizes used for the test set for any of the performance or biocompatibility tests.
The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned. These studies appear to be bench tests and biocompatibility studies, so data provenance in terms of human subjects or clinical data is not applicable in the same way it would be for a clinical trial.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the tests conducted are primarily bench performance tests and biocompatibility evaluations, not evaluations requiring expert consensus on clinical images or diagnoses.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used for clinical studies involving multiple readers to establish ground truth. As this document describes bench and biocompatibility testing, an adjudication method is not applicable.

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

An MRMC comparative effectiveness study was not performed as the device is a medical guidewire, and the evaluation involved bench testing and biocompatibility rather than human interpretation tasks.

6. Standalone Performance Study

The reported studies are effectively "standalone" in the sense that they evaluate the device's inherent properties (performance and biocompatibility) against established standards and predicate devices, without human-in-the-loop assistance influencing the device's physical performance or biological interaction. Therefore, yes, standalone performance was assessed for the various physical and biological characteristics.

7. Type of Ground Truth Used

The "ground truth" for the tests appears to be defined by:

• Industry standards: e.g., ISO 11070:2014, ISO 11135:2014, ASTM F1980-07, ISO 10993-1:2009.
• FDA guidance documents: e.g., "FDA guidance Coronary and Cerebrovascular Guide Wire Guidance January 1995."
• Comparison to predicate devices: The results were deemed "comparable to the predicate devices" and met "predetermined acceptance criteria" for substantial equivalence.

8. Sample Size for the Training Set

The document describes bench testing and biocompatibility studies, not AI/machine learning development. Therefore, a "training set" in the context of machine learning is not applicable.

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

As there is no training set in the context of machine learning, this question is not applicable.

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The ENROUTE 0.014" Guidewire is intended for use in the peripheral vasculature.

The ENROUTE .014” guidewire is a disposable medical device designed for single use only. It consists of a 95cm PTFE coated 0.014" diameter stainless steel core wire, one end of which is reduced in diameter over approximately 9.5cm in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product an area of reduced stiffness. The very distal tip section is flattened to further reduce stiffness and enable the tip to be shaped.

The distal section is covered with a 5cm platinum tungsten spring coil. This provides for greater visibility on x-ray equipment (radiopacity). A hydrophilic coating is applied to the distal section to enhance lubricity. The product is available in straight configuration

This document describes the 510(k) premarket notification for the ENROUTE 0.014" Guidewire, which is intended for use in the peripheral vasculature. The device demonstrates substantial equivalence to predicate devices (Brivant Guidewire K060551 and Nitrex Nitinol Guidewire K040345) based on technological characteristics, performance testing, and intended use.

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

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

The document does not explicitly state numerical "acceptance criteria" in a table format for each test. Instead, it states that "The performance testing assessment supports that the biocompatibility, shelf life, and functional specifications of the proposed ENROUTE 0.014" Guidewire device were met. The ENROUTE 0.014" Guidewire device test data supports the claims of substantial equivalence to the predicate devices." This implies that the device's performance results were within acceptable ranges to demonstrate substantial equivalence to the predicate devices. The types of tests performed are listed, and for some, the new device had specific data generated ("X") or leveraged data from a predicate ("X").

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 mentions "in vitro bench tests" but does not specify the sample sizes used for each test. The data provenance (country of origin, retrospective/prospective) is not explicitly stated, but the submission is from "Lake Region Medical" in "Galway, Ireland."

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 medical device submission, not an AI/software claim. Therefore, the concept of "ground truth established by experts" as typically understood in AI studies (e.g., radiologists labeling images) does not apply here. The "acceptance criteria" and "performance" are based on engineering specifications and bench testing, not expert consensus on diagnostic interpretations.

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

Not applicable as this is a medical device bench testing study, not an expert-driven AI 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 as this is a medical device bench testing study, not an AI comparative effectiveness study.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for this device is based on engineering specifications, FDA guidance documents (e.g., "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995"), and established performance characteristics of the predicate devices. For biocompatibility, the ground truth is adherence to internationally recognized standards like ISO 10993-1:2009.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. This is a physical medical device, not an AI model.

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