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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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