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For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature

Utilizing a proprietary process, LRM produces a PTFE coated stainless steel steerable core. The proximal portion of the core wire is coated with PTFE to provide lubricity and improve wire handling. A platinum alloy coil, placed within the confines of the outer coil and over-wrapping the ribbon section, provides radiopacity in the distal tip. The coils are secured in their location by solder, which is attached to the core. The proximal end of the outer coil is attached to the core with braze, and the distal end has a mid-point of the outer coil which is attached to the core with solder. On the models with markers, two additional radiopaque markers that are .009" platinum coils in a 5mm length are provided. The distal portion may be either a 30 cm long stainless steel coil with a 2 cm long inner platinum coil to provide radiopacity or a 30 cm long platinum coil (for radiopacity). The product is offered with a shapeable straight tip or in a preshaped configuration. The guidewires are coated with MDX (silicone).

This looks like a 510(k) submission for a guidewire, which is a medical device, not a software algorithm or AI device. Therefore, many of the requested categories for AI/algorithm studies (such as MRMC studies, number of experts for ground truth, sample size for training sets, etc.) are not applicable.

However, I can extract information related to the device's performance, acceptance criteria, and the studies performed to demonstrate equivalence to a predicate device.

Here's the closest representation of the requested table and information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Description:

To demonstrate substantial equivalence for the proposed steerable PTCA guidewire, Lake Region Manufacturing, Inc. (LRM) performed various tests based on:

• FDA guidance: "Coronary and Cerebrovascular Guidewire Guidance" (January 1995)
• ISO 11070: "Sterile Single-use Intravascular Catheter Introducers"
• Internal test protocol requirements

The testing aimed to ensure that changes made to the device (addition of marker coil bands, removal of PTFE sections for positioning aid) met predetermined acceptance criteria, comparing it against their predicate device (510(k) K970376). The "RESULTS" section explicitly states: "ALL TEST RESULTS WERE WITHIN PRESCRIBED SPECIFICATION LIMITS."

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

• Sample Size: The document does not specify the exact sample size for each test. It generally refers to "Test pieces" and "Configurations, including straight and shaped distal tips were inspected."
• Data Provenance: The data is prospective as the tests were performed on "Test pieces...produced following current manufacturing processes and procedures" specifically for this submission. The origin is Lake Region Manufacturing, Inc. in Chaska, MN, USA.

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

• Not Applicable. This is a medical device (guidewire) performance testing, not an AI/algorithm study requiring expert-established ground truth for image interpretation or diagnosis. The "ground truth" here is the physical measurement and performance against established engineering and regulatory specifications.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is not an AI/algorithm study involving human interpretation of data where adjudication would be relevant. The "adjudication" is inherent in whether the physical tests met the predefined engineering and regulatory specifications.

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. This is not an AI/algorithm device. No MRMC study was performed.

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

• Not Applicable. This is not an AI/algorithm device.

7. The type of ground truth used:

• The "ground truth" used for this device testing is based on engineering specifications, established regulatory guidance (FDA, ISO), and validated internal test protocols. It's about meeting physical and functional performance criteria rather than diagnostic accuracy against a clinical outcome.

8. The sample size for the training set:

• Not Applicable. This is not an AI/algorithm device, so there is no "training set."

9. How the ground truth for the training set was established:

• Not Applicable. This is not an AI/algorithm device, so there is no "training set" or ground truth for one.

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