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The SilverSpeed™, Mirage™, X-celerator™ Exchange , and X-pedion™ Hydrophilic Guidewires are indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.

The Hydrophilic Guidewire is a stainless steel guidewire with a radiopaque, platinum distal coil. The guidewire is hydrophilically coated on the distal portion. For the Xcelerator ™ Hydrophilic Guidewire labeled as an "Exchange" quidewire, the proximal portion is coated with polytetrafluoroethylene (PTFE). The Exchange guidewire facilitates the exchange of one interventional device for another, while maintaining guidewire position in the anatomy.

The following modifications have been made to the device:

• Change in the degree of polymerization with the base coat . material.
• . Elimination of Brown Oxide pigment from base coat material.

The provided text describes a 510(k) premarket notification for a Hydrophilic Guidewire and its substantial equivalence determination. It does not include details of a clinical study or acceptance criteria with associated performance metrics for a device to meet specific performance targets. Instead, it focuses on non-clinical (bench and biocompatibility) testing to support changes to an existing device, and then a determination of substantial equivalence to predicate devices.

Therefore, many of the requested sections (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to the information provided.

However, I can extract the information related to the non-clinical performance and substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission primarily relying on substantial equivalence and non-clinical testing for minor device modifications, the "acceptance criteria" are implied by successful completion of standard evaluations and demonstration of comparable performance to predicate devices. Specific quantitative targets for each test are not explicitly detailed in the provided text.

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

• Sample Size (Test Set): Not specified for any of the non-clinical tests. The text indicates "no clinical or animal testing was performed" beyond the specified biocompatibility and bench tests. The dog study (thromboresistance) is an animal study, but its sample size is not mentioned.
• Data Provenance: The tests are standard laboratory/bench tests and an animal study. No human clinical data from any country is presented. The testing would have been conducted by the manufacturer or contracted labs.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. The "ground truth" here is determined by objective physical and chemical testing standards and biological responses in laboratory settings, not by expert interpretation of patient data.

4. Adjudication Method for the Test Set

• Not applicable. As above, this pertains to clinical data interpretation, not objective non-clinical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a MRMC comparative effectiveness study was not done. The submission explicitly states "no clinical or animal testing was performed as there is no change in the indications for use or the fundamental scientific technology of the device," except for the listed biocompatibility and bench tests.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a physical medical device (guidewire), not a software algorithm.

7. The Type of Ground Truth Used

• For biocompatibility: Established ISO and ASTM standards, and direct biological responses (e.g., cytotoxicity, sensitization, hemolysis, pyrogenicity, in-vivo thromboresistance in dogs).
• For bench testing: Engineering specifications, performance characteristics comparable to predicate devices, and internal quality control standards.
• For shelf-life: Stability and performance measurements over time, extrapolated from accelerated aging data.

8. The Sample Size for the Training Set

• Not applicable. This is for a physical device, not an AI/ML model that requires a training set. The "training" for this device's development would be engineering design, material science, and manufacturing process development.

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

• Not applicable. See point 8.

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