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The LuMend Frontrunner® CTO Catheter and Accessories are intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral and coronary vasculature prior to further percutaneous intervention.

The LuMend Frontrunner® CTO Catheter is a sterile single-use percutaneous catheter consisting of a handle assembly with an integral rotator und a side port for internal device flushing, a proximal braided shaft for push and torque control, a flexible distal shaft which may be manually shaped, an optional guide wire lumen and a radiopaque blunt-shaped distal variable-size tip assembly in various shapes and sizes. A handle lever provides manual adjustment of the size of the tip assembly, and the handle rotator provides rotational control for the shaft and distal tip assembly. The distal assembly consists of a set of bilateral hinged tip pieces. Guidance and tracking of the catheter through the coronary or peripheral vasculature is accomplished by selective manual shaping of the flexible distal shaft, and controlled torquing of the handle rotator and/or the use of a guide wire.

The provided text describes the LuMend Frontrunner® CTO Catheter and Accessories, a Class II Percutaneous Catheter intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral and coronary vasculature prior to further percutaneous intervention.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific, quantifiable acceptance criteria with numerical targets. Instead, it relies on a comparison to a predicate device and general compliance with internal specifications and external standards.

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

The document mentions "in vitro and in vivo data" but does not specify the sample size for any of the tests. It also does not mention the country of origin for the data or whether it was retrospective or prospective.

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

The document does not mention any experts being used to establish ground truth for a test set. The evaluation relies on engineering tests and comparison to a predicate device's established performance.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned as there's no indication of human interpretation or a "ground truth" derived from expert consensus.

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

A MRMC comparative effectiveness study was NOT mentioned or performed. This is a device for facilitating guidewire placement, not an imaging or diagnostic device that typically involves human reader interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This question is not applicable to this medical device submission. The LuMend Frontrunner® CTO Catheter is a physical medical device and does not involve an algorithm or AI that would operate in a "standalone" or "human-in-the-loop" manner. Its function is physical manipulation by a clinician.

7. Type of Ground Truth Used:

The "ground truth," in the context of this device's evaluation, is based on engineering specifications, compliance with FDA guidance documents (FDA's Coronary and Cerebrovascular Guidewire Guidance Document - January 1995), and the established performance characteristics of the predicate device. There is no mention of expert consensus, pathology, or outcomes data being used as "ground truth" for the device's technical performance.

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable to this type of medical device submission. Training sets are typically associated with machine learning algorithms, which are not involved here. The testing described is for a physical device.

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

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

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The LuMend Frontrunner™ CTO Catheter is intended to facilitate the intra-luminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral and coronary vasculature prior to further percutaneous intervention.

The LuMend Frontrunner™ is a sterile single-use percutaneous catheter consisting of a handle assembly with an integral rotator and a side port for internal device flushing, a proximal braided shaft for push and torque control, a flexible distal shaft which may be manually shaped, and a radiopaque blunt-shaped distal variable-size tip assembly in various shapes and sizes. A handle lever provides manual adjustment of the size of the tip assembly, and the handle rotator provides rotational control for the shaft and distal tip assembly. The distal assembly consists of a set of bilateral hinged tip pieces. The Frontrunner catheter does not have a guide wire lumen.

Based on the provided text, here's an analysis of the acceptance criteria and study information for the LuMend Frontrunner™ CTO Catheter:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes for the "in vitro, in situ, and in vivo" tests. It mentions "routine device evaluation" and that the testing "continued" from previous assessments, implying ongoing quality control rather than a single limited test set.

The provenance of the data is not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The document describes engineering and biocompatibility testing, not studies involving expert assessment of images or clinical outcomes.

4. Adjudication method for the test set

This information is not provided in the document. As the tests are largely engineering and biocompatibility focused, an adjudication method in the context of expert review would not typically apply.

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

There is no indication of an MRMC comparative effectiveness study involving human readers or AI in this document. The device is a physical catheter, not an AI-powered diagnostic tool.

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

This is not applicable as the device is a physical medical instrument, not an algorithm.

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

For the in vitro tests (tensile strength, torque strength, torqueability, tip flexibility, coating adherence/integrity), the ground truth was based on internal specification requirements and external standard requirements specified in FDA's Coronary and Cerebrovascular Guidewire Guidance: Document (January 1995).

For the biocompatibility and catheter compatibility tests, the ground truth would also be related to established biocompatibility standards and compatibility specifications for medical devices.

8. The sample size for the training set

This is not applicable. The device is a physical catheter, not an AI model that requires a training set. The "testing" described refers to engineering and performance verification, not algorithm training.

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

This is not applicable as there is no training set for an AI model. For the device itself, the "ground truth" for its performance is aligned with the internal and external device specifications and standards.

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The LuMend Frontrunner™ CTO Coronary Catheter is intended to facilitate the intra-luminal placement of conventional guide wires beyond stenotic lessons (including chronic total occlusions) prior to PTCA of stent intervention.

The LuMend Frontrunner™ CTO Catheter is a sterile single-use percutaneous catheter consisting of a handle assembly with an integral rotator and a side port for internal device flushing, a proximal braided shaft for push and torque control, a flexible distal shaft which may be manually shaped, and a radiopaque blunt-shaped distal variable-size tip assembly in various shapes and sizes. A handle lever provides manual adjustment of the size of the tip assembly, and the handle rotator provides rotational control for the shaft and distal tip assembly. The distal assembly consists of a set of bilateral hinged tip pieces. The Frontrunner catheter does not have a guide wire lumen. Guidance and tracking of the catheter through the coronary or peripheral vasculature is accomplished by selective manual shaping of the flexible distal shaft, and controlled torquing of the handle rotator.

The provided text describes a medical device, the LuMend Frontrunner™ CTO Catheter, and its substantial equivalence to a predicate device. However, it does not contain detailed acceptance criteria or a study design to prove the device meets those criteria in the format requested. The document outlines general testing performed but lacks specific performance metrics, sample sizes, or expert qualifications for ground truth establishment commonly found in studies proving device performance against acceptance criteria.

The information provided focuses on demonstrating substantial equivalence to a previously cleared device, rather than proving performance against specific acceptance criteria with a detailed study.

Here's an analysis of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information:

• Specific numerical values or ranges for "internal specification requirements" and "external standard requirements" for each test.
• Quantitative data on how the predicate device performed for comparison.

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

• Sample Size: Not specified for any of the in vitro or in vivo tests. The document only mentions "in vitro, in situ, and in vivo test data."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Missing: This information is not provided. The document outlines device testing but does not detail a process for establishing "ground truth" with expert review, as would be common for diagnostic or AI-assisted devices. Since this is a catheter for mechanical intervention, expert ground truth labeling might not be directly applicable in the same way as for image-based diagnostic AI.

4. Adjudication Method for the Test Set:

• Missing: Not applicable in the context described. The testing appears to be functional and engineering-focused rather than involving subjective expert interpretation that would require adjudication.

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

• No: An MRMC comparative effectiveness study was not mentioned. The device described is a physical catheter, not an AI-assisted diagnostic tool where human reader performance would be a primary metric.

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

• Not Applicable: This is not an algorithm or AI device. It is a physical medical device (catheter).

7. The Type of Ground Truth Used:

• Missing (or not directly applicable in the usual sense): For a physical device, "ground truth" typically refers to established engineering standards, physical measurements, and biological responses (e.g., in animal models for in vivo testing). The document states "All data continued to fall well within internal specification requirements, as well as external standard requirements and predicate performance expectations." This implies that the ground truth for these physical and biological tests was defined by these established specifications and the performance of the predicate device.

8. The Sample Size for the Training Set:

• Not Applicable: This is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

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

• Not Applicable: As above, this is not an AI/machine learning algorithm.

Summary of Missing Information:

The provided document is a 510(k) summary for a medical device (catheter). It details the device's description, intended use, and comparison to a predicate device to establish substantial equivalence. It confirms various in vitro and in vivo tests were conducted to ensure the device meets internal and external specifications and performs comparably to the predicate. However, it does not provide the granular detail typically found in a study designed to demonstrate performance against explicit acceptance criteria, especially concerning sample sizes, expert qualifications, or ground truth establishment in the context of diagnostic or AI-based devices. The focus is on demonstrating safety and effectiveness through substantial equivalence and meeting general engineering and biocompatibility standards.

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