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To facilitate the placement of devices for diagnostic and interventional procedures. These guidewires are not intended for PTCA use.

PTFE quidewire is designed to facilitate the placement of devices for diagnostic and interventional procedures. The guidewire is intended for single use.

The guidewire is: .032" diameter and is 200cm in length. The guidewire is composed of three primary components: PTFE coating, a coil and a core. The core and coil are made of 304 stainless steel (ASTM A313). The coil is coated with low-friction polytetrafluoroethylene (PTFE). The coil provides the outer shell while the core is fit inside the inner diameter of the coil. The core provides the stiffness to the guidewire body and flexibility in the J-tip. The core and coil are secured together using a weld on both the distal and proximal of the guidewire.

The guidewire is sterilized using ethylene oxide. The guidewire is loaded into a dispenser hoop and is provided with a J-straightener, which is used to aid the insertion of the delivery device. There are no accessories packaged with the guidewires.

The provided text is a 510(k) summary for a PTFE Guidewire. It details the device description, indications for use, comparison with a predicate device, and a summary of non-clinical (bench) performance testing.

However, the provided text describes the regulatory clearance process for a physical medical device (a PTFE Guidewire), not an AI/ML-driven device. As such, it does not contain the information requested in points 1-9, which are specific to the acceptance criteria and study design for software-as-a-medical-device (SaMD) or AI-enabled medical devices.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, or effect size.
6. Standalone (algorithm only) performance.
7. Type of ground truth (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document focuses on engineering and material testing (e.g., torque strength, tip flexibility, biocompatibility, packaging integrity) to demonstrate substantial equivalence to a predicate guidewire, which is standard for hardware medical devices. It explicitly states:

• "Non-clinical (bench) performance testing was performed in order to demonstrate that the PTFE Guidewire met applicable design and performance requirements..." (Page 5, Section VII)
• It lists various physical and material tests, such as "Tip Flexibility," "Torque Strength," "Particulate Residue," "Corrosion Resistance," "Lubricity/Device Compatibility," "Radiopacity," etc., and confirms that "The predetermined acceptance criteria were met" for each.

The document does not describe any AI/ML components, image analysis, diagnostic capabilities, or human-in-the-loop studies that would necessitate the types of criteria and study designs outlined in your prompt.

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