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

Nitinol or Stainless Steel core wire with Palladium coil secured to the ground, flexible (distal) end of the core. The core wire can be either uncoated or coated with PTFE (Polytetrafluoroethylene). Portions of the Guidewire can also be subsequently coated with silicone MDX4-4159 Fluid. The Guidewires are bound by the following parameters: OUTSIDE DIAMETER: .014" - .035", LENGTHS: 60 cm - 500 cm, TIPS: Straight or shaped with various tip flexibilities., COIL LENGTH: 2cm - 30 cm

This document describes a 510(k) premarket notification for a medical device called "Mandrel Guidewire or M-Wires™." The submission aims to demonstrate the substantial equivalence of the new device iterations to a predicate device.

1. Acceptance Criteria and Reported Device Performance:

The document explicitly states that "all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met." However, the specific quantitative acceptance criteria for each test and the detailed reported device performance against those criteria are not provided in the given text. It only vaguely mentions "established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes."

The general performance claim is: "The results of these tests demonstrated the functionality and performance characteristics of these Guidewires are comparable to the currently marketed devices."

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

The document states, "Test pieces were tested and inspected according to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes." However, it does not specify the sample size used for the test set.

Data provenance (e.g., country of origin, retrospective or prospective) is not mentioned.

3. Number of Experts and their Qualifications for Ground Truth Establishment:

This information is not applicable as the document describes non-clinical testing of a physical medical device (guidewire) for substantial equivalence, not an AI/ML-based diagnostic device requiring human expert ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Testing involved physical device characteristics and biocompatibility, not expert adjudication of diagnostic outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable as this submission is for a physical medical device, not an AI-assisted diagnostic tool. No AI component is described.

6. Standalone (Algorithm Only) Performance Study:

This information is not applicable as this submission is for a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" was established by "established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes." This implies objective, measurable standards for physical properties. For biocompatibility, it was based on ISO 10993 series standards.

8. Sample Size for the Training Set:

This information is not applicable as this is a physical medical device, not an AI/ML system requiring a training set.

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

This information is not applicable as this is a physical medical device, not an AI/ML system requiring a training set.

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

Nitinol or Stainless Steel core with Palladium coil secured to the ground, flexible (distal) end of the core. The core wire can be either uncoated or coated with PTFE (Polytetratlyoroethylene). Portions of the Guidewire can also be subsequently coated with silicone MDX4-4159 Fluid. The Guidewires are bound by the following parameters: Outside Diameter: .014" - .035" Lengths: Straight or shaped with various tip flexibilities. Tips: Coil Length: 2cm - 30 cm

The provided text describes a 510(k) premarket notification for Mandrel Guidewires (M-Wires), seeking substantial equivalence to existing predicate devices. However, the document does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the specifics of a study proving the device meets those criteria.

The document states that "Risk analysis was completed by means of a Failure Mode and Effect Analysis (FMEA) and all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met." It also mentions "LRM performed testing to established requirements. Test pieces were tested and inspected according to established specific inspection criteria requirements for visualitactile, dimensional and mechanical attributes." And "Biocompatibility testing per ISO 10993 series has been performed on the Mandrel device and has been found to be acceptable."

However, it does not explicitly list the predetermined acceptance criteria themselves or the detailed results of the tests against these criteria in a quantitative manner. It only states that the results "demonstrated the functionality and performance characteristics of these Guidewires are comparable to the currently marketed devices" and "support the claim of substantial equivalence to the predicate devices."

Therefore, much of the requested information cannot be extracted from this specific filing.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Note: The document states that the predetermined acceptance criteria were met, but it does not specify the quantitative values for these criteria. The "Reported Device Performance" is a summary statement of comparability and acceptability, rather than specific performance metrics against defined thresholds.

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 for Test Set: Not specified in the provided text. The document only mentions "Test pieces were tested and inspected."
• Data Provenance: Not specified, but likely internal testing conducted by Lake Region Manufacturing, Inc. in Chaska, MN, USA. There is no mention of external data or patient data.
• Retrospective/Prospective: The testing described is prospective, in the sense that the new Mandrel Guidewire iterations were specifically tested to demonstrate equivalence.

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 information is not applicable and not provided. The "ground truth" for this type of device (guidewire) is typically established through engineering specifications, material science, and performance testing against established physical and biological standards, not through expert clinical consensus on images or patient outcomes in the context of a diagnostic AI.

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

• This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation of data where consensus is needed for ground truth. This filing discusses non-clinical engineering and bench testing.

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

• No, an MRMC comparative effectiveness study was not done. This is a medical device (guidewire), not a diagnostic AI algorithm that assists human readers.

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

• This is not applicable. The device is a physical medical guidewire, not an algorithm. The testing described is "standalone" in the sense that it evaluates the physical device's properties (visual/tactile, dimensional, mechanical attributes, biocompatibility).

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

• The ground truth for the non-clinical tests appears to be based on established engineering specifications, material standards, and performance requirements relevant to guidewires, as well as the ISO 10993 series for biocompatibility. This is considered objective, measurable physical properties and material safety standards rather than expert clinical consensus or pathology.

8. The sample size for the training set

• This is not applicable. The Mandrel Guidewires are physical medical devices, not an AI algorithm that requires a "training set."

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

• This is not applicable as there is no training set for a physical medical device.

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