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Lake Region's steerable guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature, including the renal vasculature. The steerability feature allows the guidewire to be torqued to facilitate navigation through the vasculature.

This device is a guidewire with a PTFE coated stainless steel core that has been ground at the distal end to provide the appropriate tip flexibility. The coils are joined to the core at the ground end and a distal tip coil is soldered to the core. The proximal PTFE coated portion of the core has two sections of the PTFE removed to aid in estimating guidewire positioning. The product is offered with a shapeable straight tip or in a preshaped configuration. The guidewires are optionally coated with MDX (silicone). The guidewires are bound by the following parameters: Outside Diameter: .014" - .018", Lengths: 130cm - 300cm, Tips: Straight or shaped with various tip flexibilities.

Here's an analysis of the provided text regarding the acceptance criteria and study for the medical device (guidewire):

Important Note: The provided document is a 510(k) summary, which is a premarket notification to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission focuses on showing that a new device is as safe and effective as an existing one, rather than proving efficacy from scratch with extensive clinical trials. Therefore, much of the information typically sought for a study proving device performance (like detailed sample sizes, expert qualifications, MRMC studies, or standalone performance) is often not present in these documents.

Acceptance Criteria and Reported Device Performance

The core of this 510(k) submission is that the proposed device is substantially equivalent to a predicate device. This means the acceptance criteria are implicitly met by demonstrating that the new device performs comparably to the predicate and that any differences do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a numerical sample size for a "test set" in the traditional sense of a clinical study or even a detailed verification/validation study. The testing described is primarily bench testing for "Qualification Testing," focusing on visual/tactile, dimensional, and mechanical attributes.

• Sample Size: Not specified. It refers to "Test pieces" which are likely units of the guidewire product.
• Data Provenance: The testing was performed in-house by Lake Region Manufacturing, Inc. (LRM). It is retrospective in the sense that it evaluates a modified device against established requirements and a predicate's performance. The country of origin of the data would be the USA (where LRM is located).

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

This information is not provided in the 510(k) summary. Given that it's primarily bench testing for substantial equivalence, the "ground truth" would be the engineering specifications and performance characteristics of the predicate device, or industry standards, rather than expert-established ground truth on clinical cases.

4. Adjudication Method for the Test Set:

This information is not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic evaluations where human interpretation of complex data is involved. This document describes physical device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size:

No, an MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. MRMC studies are typically used for diagnostic or screening devices to evaluate reader performance. This device is an interventional tool (guidewire) subject to performance testing against engineering specifications and comparison to a predicate.

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

This question is not applicable to a guidewire. "Standalone performance" usually refers to the performance of an AI algorithm without human involvement. The guidewire is a physical medical device that inherently requires human-in-the-loop operation. The "device performance" is its physical and mechanical characteristics as measured in bench tests.

7. The Type of Ground Truth Used:

The ground truth used for verifying the new device's performance against its own design and against the predicate device is:

• Engineering specifications: The device must meet predefined dimensional, mechanical, and material specifications.
• Predicate device characteristics: The proposed device's performance (visual, tactile, dimensional, mechanical) must be "comparable" to the currently marketed predicate device.
• Established requirements/industry standards: The testing was performed against "established requirements."

8. The Sample Size for the Training Set:

This question is not applicable to this type of device. "Training set" refers to data used to train an algorithm (e.g., in AI/ML). This guidewire is a physical medical device, not a software algorithm, so there is no training set.

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

This question is not applicable for the same reason as #8.

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