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The Lunderquist Fixed Core Wire Guides are intended to facilitate placement of devices used during diagnostic and interventional procedures.

The Lunderquist® Fixed Core Wire Guide, subject of this submission, is a Class II device according to 21 CFR §870.1330; product code DQX (Wire, Guide, Catheter). The subject device consists of a mandril design with a distal spring coil anchored over the distal portion of the mandril and a cannula anchored over the proximal portion of the mandril. The Lunderquist Fixed Core Wire Guide is available with an outside diameter of 0.038 inch and a length of 120 centimeters (cm). The tip portion of the subject device is straight. The Lunderquist® Fixed Core Wire Guide is a packaged, sterile device intended for single patient use.

The document provided describes the K181353 submission for the Lunderquist® Fixed Core Wire Guide. It is a Class II medical device, product code DQX (Wire, Guide, Catheter), intended to facilitate the placement of devices during diagnostic and interventional procedures. The submission outlines various performance tests conducted to demonstrate that the device met applicable design and performance requirements and supports substantial equivalence to its predicate device, the Mandril Wire Guides (K171997).

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that for each of the performance tests, "The predetermined acceptance criteria were met." However, the specific quantitative acceptance criteria or the reported device performance values are not provided in the text. The document only confirms qualitative success in meeting these criteria.

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

The document does not specify the sample sizes used for any of the performance tests. It also does not mention data provenance in terms of country of origin or whether the studies were retrospective or prospective. These were laboratory-based performance tests, not clinical studies with patient data.

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

This information is not applicable and not provided in the document, as the studies described are laboratory-based device performance tests against pre-defined engineering and safety standards, not studies involving expert interpretation of medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document, as the studies described are laboratory-based device performance tests against pre-defined engineering and safety standards, not studies involving human judgment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document describes laboratory performance tests of the device itself, not studies comparing human reader performance with or without AI assistance.

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

This concept is not applicable to the device described. The Lunderquist® Fixed Core Wire Guide is a physical medical instrument, not a software algorithm. Therefore, "standalone" algorithm performance is not a relevant metric. The tests performed are analogous to "standalone" performance of the physical device.

7. The Type of Ground Truth Used

The ground truth for these performance tests was based on established ISO and ASTM standards, as well as FDA guidance documents (e.g., ISO 10993-1:2009, ISO 11070:2014, ASTM F640-12, FDA Coronary and Cerebrovascular Guidance (1995)). This represents a "standard-based" ground truth, where the device's physical and mechanical properties are measured against predefined acceptable ranges or thresholds.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The Lunderquist® Fixed Core Wire Guide is a physical medical device, not an AI/ML algorithm that requires a training set. The tests described are for verification and validation of the device's physical properties.

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

This information is not applicable and not provided, as the device is not an AI/ML algorithm requiring a training set with established ground truth.

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Disposable Reuter Tip Deflecting Wire Guides are intended for use in curving or deflecting catheter tips for pulmonary angiography, selective angiography, translumbar aortography, repositioning of central venous catheter tips and other vascular and non-vascular applications.

Reuter Tip Deflecting Wire Guides are intended for use with the Reuter Tip Deflecting Handle assembly for curving or deflecting catheter tips for pulmonary angiography, translumbar aortography, bronchography, bronchography, repositioning of central venous catheter tips and other vascular and non-vascular applications.

The Reuter Tip Deflecting Wire Guides, subject of this submission, are Class II devices according to 21 CFR §870.1330; product code DQX (Wire, Guide, Catheter). The subject devices are available with outer diameters of 0.025 and 0.035 inches, lengths of 80 - 145 centimeters, and a curved tip.

The subject device includes two configurations indicated by prefixes TDW and DTDW. Both configurations are constructed with stainless steel mandrils, coils, and internal handles. The coils cover the entire mandril and are secured using distal and proximal anchor points. The internal handle is permanently affixed to the proximal end of the wire guide and is designed to mate with the tip deflecting handle. The internal handle of the wire guide is not patient contacting.

The Reuter Tip Deflecting Wire Guide configuration with the TDW prefix is a disposable wire guide designed to be used with the Reusable Reuter Tip Deflecting Wire Guide handle which is not subject of this submission.

The Disposable Reuter Tip Deflecting Wire Guide configuration with the DTDW prefix is designed with a deflecting handle permanently affixed to the proximal end of the wire guide. The deflecting handle is manufactured from polycarbonate and stainless steel materials.

The purpose of the handle is to operate in a retracting motion thereby causing the tip of the connected wire guide to deflect to the specified radius.

The side-arm flushing adapter (Class II 510(k) exempt under product code DTL) is supplied with the Disposable Reuter Tip Deflecting Wire Guides as an accessory. The flushing adapter may be used to flush a catheter being used with the subject device during diagnostic and interventional procedures.

The subject device is a packaged, sterile device intended for single patient use.

This document is a 510(k) summary for the Reuter Tip Deflecting Wire Guide, which is a medical device. The information provided primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report of a new AI/software-based device. Therefore, many of the requested categories for AI/software studies are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

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 sample size for each test. It mentions "The following tests were performed...", implying a certain number of units were tested for each criterion, but the exact count is not given.
• Data Provenance: Not applicable. These are physical performance tests of a device, not data analysis tests. The testing would have been performed by Cook Incorporated or a contracted lab.

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. The "ground truth" for these physical device tests is defined by the objective industry standards (ISO, ASTM) and the manufacturer's predetermined acceptance criteria for physical properties. No human experts are establishing "ground truth" in the context of diagnostic interpretation.

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

• Not applicable. This is not an adjudication process for clinical or diagnostic data. The tests are objective measurements against defined standards.

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 document describes a physical medical device, not an AI software.

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

• Not applicable. This document describes a physical medical device, not an algorithm.

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

• Not applicable in the AI/software context. For this medical device, the "ground truth" or reference for evaluating performance is the adherence to established international standards (ISO, ASTM) and internal engineering specifications for physical and material properties.

8. The sample size for the training set

• Not applicable. This is a physical device, not an AI model. There is no concept of a "training set."

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

• Not applicable. This is a physical device, not an AI model.

Summary of the Study per the Document:

The document describes a series of performance tests conducted on the Reuter Tip Deflecting Wire Guide. These tests were designed to demonstrate that the modified device (with new lengths, diameter, and handle configuration) meets applicable design and performance requirements and supports a determination of substantial equivalence to its predicate device. The tests covered various aspects including:

• Biocompatibility
• Corrosion
• Flexing
• Surface Examination
• Fracture
• Tensile strength of the core wire and coil union
• Tensile strength of the handle and wire guide union
• Dimensional accuracy and catheter compatibility
• Radiopacity

For all listed tests, the document explicitly states that the "predetermined acceptance criteria were met," indicating successful completion of the studies and compliance with the specified standards. The study's conclusions support that the modifications do not raise new questions of safety or effectiveness and that the device is substantially equivalent to the predicate.

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The Double Flexible Tipped Wire Guides are used to facilitate the placement of devices during diagnostic and interventional procedures.

The Double Flexible Tipped Wire Guides are Class II devices according to 21 CFR §870.1330; product code DQX (Wire, Guide, Catheter). The Double Flexible Tipped Wire Guides have flexible distal and proximal ends. Double Flexible Tipped Wire Guides are used to facilitate the placement of devices during diagnostic and interventional procedures.

The Double Flexible Tipped Wire Guides, subject of this submission, have been modified from the predicate device, Double Flexible Tipped Wire Guides (K171912), to include an additional diameter of 0.015 inches to the uncoated configurations with lengths of 30, 40, and 60 centimeters. Additionally, the subject device has been modified from the predicate device to include coated configurations for the existing 0.021 and 0.025 inch diameter devices with lengths of 40, 50, and 60 centimeters.

The Double Flexible Tipped Wire Guides are manufactured using a stainless steel core wire, and stainless steel coils. Some configurations include an exterior PTFE coating on the coils.

The modification to the Double Flexible Tipped Wire Guides have been created to provide additional options for physicians in selecting the appropriate wire guide during diagnostic and interventional procedures.

The Double Flexible Tipped Wire Guides are packaged, sterile devices intended for single patient use and labeled with a five-year shelf life.

The provided text describes a 510(k) premarket notification for a medical device called "Double Flexible Tipped Wire Guides." The submission aims to demonstrate substantial equivalence to a predicate device.

However, the provided text does not contain the level of detail required to answer all parts of your request, specifically regarding acceptance criteria and study design for AI/machine learning models in a medical context. The document describes a traditional medical device (wire guides) and the testing conducted relates to the physical and mechanical properties of this device, not to an AI algorithm's performance.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set details) are not applicable to this document as it does not involve an AI/ML device.

Below, I will extract the information that is present and explicitly state when information is not available or not applicable based on the content.

Description of Acceptance Criteria and Study Proving Device Meets Criteria

The device in question is a physical medical device (Double Flexible Tipped Wire Guides), not an AI/ML algorithm. The performance testing revolves around the mechanical and material integrity of the wire guide, not an algorithm's ability to interpret data or images.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that for each test, "The pre-determined acceptance criteria were met." However, it does not explicitly list the specific numerical or qualitative acceptance criteria themselves. It only reports that the device passed.

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

• Sample Size: Not specified in the provided text for any of the tests.
• Data Provenance: Not applicable in the context of data for an AI/ML model. The tests are laboratory/benchtop tests of physical device properties, not data collected from patients.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

• Not Applicable. This device is hardware, not an AI/ML system that requires expert-established ground truth from medical images or data. The "ground truth" here is the physical performance of the device against established engineering standards.

4. Adjudication Method for the Test Set

• Not Applicable. As this is not an AI/ML device, there's no need for adjudication of readings or interpretations. The tests likely followed defined protocols with objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This type of study (MRMC) is relevant for assessing the impact of AI on human readers for diagnostic or interpretive tasks. Since this is a physical medical device, an MRMC study was not conducted and is not applicable.

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

• Not Applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• Engineering Standards and Specifications: The "ground truth" for this device's performance is compliance with established international standards (e.g., BS EN ISO 11070:2014) and FDA guidance documents (e.g., FDA Coronary and Cerebrovascular Guidewire Guidance 1995). The tests aim to demonstrate that the device's physical properties meet these pre-defined engineering requirements. This is sometimes referred to as "benchtop testing" or "performance testing."

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

• Not Applicable. This is a physical device; there is no training set or associated ground truth for an algorithm.

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