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PREDICATE™ III GUIDEWIRE are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

The guidewire is made of an uncoated Nitinol or Stainless Steel core wire that is tapered at the distal tip where a coil is secured over the core. The wire can have a distal coil or a full length coil that is made of Stainless Steel. The guidewire may contain proximal markers.

The provided document describes a 510(k) premarket notification for the Predicate III Guidewire, a Class II medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than a standalone study proving novel performance against specific acceptance criteria. Therefore, most of the requested information about acceptance criteria, study design, expert involvement, and ground truth establishment, which are typical for studies evaluating diagnostic or AI-based devices, is not directly applicable or available in this submission.

However, I can extract information related to the device's qualification testing which serves to ensure it meets its design inputs and performs comparably to the predicate device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met," and "The conclusions drawn from bench testing and biocompatibility testing demonstrate compliance with the design input summary." However, it does not provide a specific table listing quantitative acceptance criteria and the corresponding reported performance values for the Predicate III Guidewire. Instead, it lists the types of tests performed to ensure compliance.

Specific Qualification Tests Performed (acting as evidence for meeting implied acceptance criteria):

• Dimensional
• Guidewire Pull Test
• Camber Resistance
• Visual Inspection
• Wire Fracture Test
• Corrosion
• Wire Flex Test
• ISO Strength of Union
• Particulate Residue Test
• Cytotoxicity (Biocompatibility)
• Hemolysis (Biocompatibility)
• Chemical Characterization (Biocompatibility)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Sample Size: The document does not specify the exact sample sizes used for each of the bench tests or biocompatibility tests. It generally refers to "Test devices."
• Data Provenance: Not applicable. The data is from in-house bench and lab testing of the manufactured guidewires by Lake Region Medical. The country of origin of the data is not explicitly stated but would presumably be the United States, given the company's location (Chaska, MN). The data is generated prospectively as part of product development and verification.

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):

• Not applicable. This is a medical device (guidewire) cleared based on substantial equivalence, not a diagnostic or AI device requiring expert-established ground truth from patient data. The "ground truth" for guidewire performance is established through engineering design specifications and material science.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable for this type of device submission. Adjudication methods are typically used in clinical studies or studies involving human interpretation (e.g., radiology reads).

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-assisted device.

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

• Not applicable. This is not an algorithm or software device. Bench testing constitutes a "standalone" evaluation of the physical device's characteristics against its design specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• The "ground truth" for this device is based on engineering design specifications, material properties, and established medical device performance standards (e.g., ISO standards for guidewires and biocompatibility). Compliance with these predefined technical and safety requirements serves as the "truth" that the device must meet.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. This is not a machine learning or AI device.

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To facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.

The guidewire is made of an uncoated Nitinol or Stainless Steel core wire that is tapered at the distal tip where a coil is secured over the core. The wire can have a distal coil or a full length coil that is made of Stainless Steel. The guidewire may contain proximal markers. The PREDICATE™ III GUIDEWIRE family is bound by the following parameters: Lengths: 30cm – 500cm, Outside Diameter: 0.018" to 0.038", Tips: Straight or Shaped with various flexibilities, Coil Length: Full length, 2cm to 30cm.

The provided text describes a 510(k) premarket notification for the Predicate III Guidewire. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that the acceptance criteria were met, but it does not explicitly list the specific quantitative acceptance criteria for each test. Instead, it states that "all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met."

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

• Sample Size: The document does not specify the exact sample size for the test set (number of guidewires tested). It refers to "Test devices" being manufactured and inspected.
• Data Provenance: The study was conducted by Lake Region Medical for their Predicate III Guidewire. The document does not provide details on the country of origin of the data or whether it was retrospective or prospective, as this is a bench and biocompatibility study of a medical device.

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

This information is not applicable as the evaluation primarily involved bench testing and biocompatibility analysis, not expert-based assessment for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation primarily involved bench testing and biocompatibility analysis, not expert-based assessment requiring adjudication.

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

This information is not applicable. The document describes the premarket notification for a physical medical device (guidewire), not an AI-based diagnostic tool. Therefore, an MRMC study related to human reader performance with AI assistance was not conducted.

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

This information is not applicable for the same reason as point 5. This is a physical guidewire, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by the design input summary requirements and applicable standards (e.g., ISO for biocompatibility and specific tests). For bench testing, the ground truth would be the expected physical, mechanical, and material properties of the guidewire. For biocompatibility, the ground truth is adherence to established biological safety limits.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device and does not involve AI or machine learning algorithms that require a "training set."

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

This information is not applicable for the same reason as point 8.

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