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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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