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The Outback® Catheter is intended to facilitate placement and positioning of guide wires / catheters within the peripheral vasculature. The Outback® Catheter is not intended for use in the coronary or cerebral vasculature.

The Outback® catheter is a sterile, single use device comprised of three primary elements. 1) guide tip, [deployment shaft], 2) catheter shaft and 3) deployment handle with a control knob. Upon proximal retraction of the guide via the control knob, the guide's curved ip is positioned coaxially within the nosecone. In this configuration the catherer may be tracked over a guide wire to the sclected vascular site. The guidewire is then retracted into the guide, allowing the curved guide tip to be advanced from the nosecone end port. The radiopaque nosecone and guide tip facilitate placement into the selected region of the vascular site, with fluoroscopic guidance. Upon proper placement of the guide tip, the guide wire may be advanced through the guide and into the desired location. The guide tip is then retraced into the nosecone, and the catheter is proximally retraced leaving the guide wire in place in the vasculature.

The provided text describes a 510(k) summary for the Outback® Catheter, a percutaneous catheter intended to facilitate placement and positioning of guide wires/catheters within the peripheral vasculature. The document clarifies that this device is not for use in coronary or cerebral vasculature.

However, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and study results in the manner requested. The 510(k) process primarily relies on showing that a new device is as safe and effective as a legally marketed predicate device, often by citing similarities in design, materials, intended use, and performance claims. Performance testing is usually done to verify that the device meets its design specifications and functions as intended, but these studies may not be presented with the same level of detail as a de novo or PMA submission.

Therefore, the requested information, such as detailed acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods for a human-in-the-loop or standalone AI study, is not available in the provided text. The document does not describe any studies that would involve AI or human reader performance.

Based on the provided text, here is what can be inferred and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable. The document describes a medical device (catheter) submitted for 510(k) clearance, not an AI or diagnostic imaging device that would typically involve a "test set" in the context of AI performance. The studies mentioned are likely engineering and functional tests to demonstrate equivalence, but details are not provided.

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

• Not Applicable. This information is for AI or diagnostic performance studies, which are not described in the document.

4. Adjudication method for the test set:

• Not Applicable. This information is for AI or diagnostic performance studies, which are not described in the document.

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 is not mentioned. This document pertains to a physical medical device (catheter), not an AI-based diagnostic tool.

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

• No. This document pertains to a physical medical device (catheter), not an AI algorithm. "Standalone performance" in this context would refer to internal validation of the catheter's components and overall function (e.g., strength, flexibility, material compatibility), but no specific study details are provided.

7. The type of ground truth used:

• Not Applicable in the traditional sense of AI/diagnostic imaging. For this catheter, "ground truth" would be related to whether the device physically performs its intended function (e.g., successful guide wire placement, material integrity, sterility). These are typically assessed through bench testing, simulated use, and potentially animal or cadaver studies, but details are not provided in this summary. The primary "ground truth" for 510(k) is demonstrating substantial equivalence to a legally marketed predicate device based on design, materials, and intended use.

8. The sample size for the training set:

• Not Applicable. There is no mention of a "training set" as this is not an AI or machine learning device.

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

• Not Applicable. There is no mention of a "training set."

Summary of the Study (as described in the 510(k) summary):

The "study" described in the 510(k) summary is a design and engineering data review to demonstrate substantial equivalence to existing predicate devices (LuMend Outback® Catheter cleared via 510(k) K040771 and K032298).

The core of the "study" is a comparison:

• Device Under Review: Outback® Catheter (K043534)
• Predicate Devices: K040771 and K032298

The summary states: "A few minor changes have been made (see detailed device description), however, the principle of operation, intended use, fundamental design, and function of the product remains basically the same. Additional material options have been added. This version of the Outback® Catheter is clearly substantially equivalent to the previously cleared Outback device."

This means the "study" likely involved:

• Engineering verification and validation (V&V) testing to ensure the minor changes and new materials did not adversely affect performance and that the device still met its design specifications. These tests would involve bench testing for mechanical properties, functional performance (e.g., deploying the guide tip, allowing guidewire passage), and biocompatibility.
• A comprehensive comparison of the new device's specifications (intended use, technological characteristics, materials, design, performance data) against those of the predicate devices.

Data Provenance: The document does not specify the origin of the data (e.g., country of origin, retrospective/prospective). It would typically be generated by the manufacturer (LuMend, Inc.) through internal testing and design documentation.

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The Outback® Catheter is intended to facilitate placement and positioning of guidewires/catheters within the peripheral vasculature. The Outback® Catheter is not intended for use in the coronary or cerebral vasculature.

The Outback® catheter is a sterile, single use device comprised of three primary elements. 1) guide tip, [deployment shaft], 2) catheter shaft and 3) deployment handle with a control knob. Upon proximal retraction of the guide via the control knob, the guide's curved tip is positioned coaxially within the noscone. In this configuration the catheter may be tracked over a guide wire to the selected vascular site. The guidewire is then retracted into the guide, allowing the curved guide tip to be advanced from the nosecone end port. The radiopaque nosecone and guide tip facilitate placement into the selected region of the vascular site, with fluoroscopic guidance. Upon proper placement of the guide tip, the guide wire may be advanced through the guide and into the desired location. The guide tip is then retraced into the nosecone, and the catheter is proximally retraced leaving the guide wire in place in the vasculature.

This document is a 510(k) summary for the LuMend Outback® Catheter, indicating it's a device for facilitating guidewire and catheter placement in peripheral vasculature. It makes no mention of a study involving artificial intelligence or machine learning, which are typically the subjects of acceptance criteria and performance studies in the context of AI/ML devices. Therefore, I cannot extract the requested information from the provided text.

Specifically, the document:

• Does not include a table of acceptance criteria or reported device performance.
• Does not mention sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods.
• Does not discuss Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Does not specify the type of ground truth used, training set sample size, or how ground truth for training was established.

The provided text focuses on regulatory approval, device description, and comparison to a predicate device based on its intended use and design, rather than a performance study as would be conducted for an AI/ML medical device.

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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 Outback® Catheter is intended to facilitate placement and positioning of guide wires/ catheters within the peripheral vasculature. The Outback® Catheter is not intended for use in the coronary or cerebral vasculature.

The Outback catheter is comprised of four primary elements: 1) guide 2) catheter shaft 3) rotating hemostasis valve (RHV) and 4) deployment handle or control knob. The guide is a single-lumen, steel braided polyimide shaft that can be extended or retracted by the control knob. The tubular catheter shaft houses this guide and is also steel braided polyimide in composition. The rotating hemostasis valve (RHV) has two functions: a one way valve allows for flushing of the catheter while a locking hub at the proximal end of the RHV controls the retracted position of the guide. The fourth component is the deployment handle/control knob that is used to extend or retract the guide. This control knob also functions as a port with a luer fitting for flushing of the guide wire lumen.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is a 510(k) summary for a medical device (Outback® Catheter), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance study results against specific acceptance criteria.

Therefore, I cannot generate the requested table and study description based on this input.

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The LuMend Frontrunner™ GW 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™ GW 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, 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 a 510(k) submission for the LuMend Frontrunner™ GW CTO Catheter. Based on the information, here's a breakdown of the acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify a sample size for a test set in the context of clinical or human performance data related to AI/algorithm assessment. The testing mentioned is for the physical and functional characteristics of the catheter, falling under in vitro, in situ, and in vivo tests. The data provenance is not explicitly stated beyond "in vitro, in situ and in vivo data," but it refers to technical performance rather than patient data.

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

This information is not applicable or not provided in the context of an AI/algorithm study. The acceptance criteria and testing described pertain to the physical device's characteristics and its equivalence to a predicate device, not to an expert-driven assessment of an AI model's output.

4. Adjudication Method for the Test Set

This information is not applicable or not provided as there is no mention of a human-reviewed test set requiring adjudication for an AI/algorithm.

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

No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence to a predicate device through engineering and performance testing, not on evaluating human reader performance with or without AI assistance. This device is a physical catheter, not an AI diagnostic tool.

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

No, a standalone algorithm performance study was not done. This device is a physical catheter, not an AI algorithm.

7. The Type of Ground Truth Used

For the device's performance, the "ground truth" was established by internal specification requirements, external standard requirements (such as those specified in FDA's Coronary and Cerebrovascular Guidewire Guidance Document), and predicate performance expectations. This is based on objective measurements of physical and functional properties, rather than expert consensus, pathology, or outcomes data in a clinical trial setting for a diagnostic aid.

8. The Sample Size for the Training Set

This information is not applicable or not provided. Since this is a physical medical device and not an AI algorithm, there is no "training set" in the sense of data used to train a machine learning model.

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

This information is not applicable or not provided for the reasons stated in point 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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The LuMend Frontrunner™ CTO Coronary Catheter is intended to facilitate the intra-luminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) prior to PTCA or stent intervention.

The LuMend Frontrunner™ is a sterile single-use percutaneous coronary catheter consisting of a handle assembly with an integral rotator and a side port for internal device flushing, a proximal and a radiopaque blunt-shaped distal variable-size tip assembly. 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 vasculature is accomplished by selective manual shaping of the flexible distal shaft, and controlled torquing of the handle rotator.

The provided text describes the LuMend Frontrunner™ CTO Coronary Catheter. It outlines the device's description, intended use, and comparison to predicate devices, but it does not include a table of acceptance criteria or a detailed study proving the device meets specific performance metrics.

However, the document states:

"Design analysis, in vitro and in vivo data confirm that basic functional characteristics are substantially equivalent to the predicate devices cited. Device evaluation consisted of testing specified in FDA's Coronary and Cerebrovascular Guidance Document (January 1995) and included in vitro tensile, torque strength, torqueability, tip flexibility, coating adherence/integrity, biocompatibility and catheter compatibility. All data fell well within both internal specification requirements, as well as external standard requirements and predicate performance expectations. In addition to the above testing, a series of clinical studies have demonstrated substantial equivalence in terms of device safety and effectiveness."

Based on this information, I can answer some of your questions and explain why others cannot be fully addressed from the provided text.

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

The document explicitly states: "All data fell well within both internal specification requirements, as well as external standard requirements and predicate performance expectations."

However, specific numerical acceptance criteria (e.g., "tensile strength > X N") and the corresponding precise reported device performance values are not provided in this summary. The summary only gives a high-level statement of compliance.

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

The document mentions "a series of clinical studies" but does not provide details on the sample size for these studies, their design (retrospective or prospective), or the country of origin of the data.

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 provided in the document. The text refers to "clinical studies" but doesn't detail the methodology for establishing ground truth within those studies, nor does it mention expert review processes for a "test set" in the context of AI or diagnostic performance.

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

This information is not provided. The study summary doesn't describe an adjudication process, which is typically relevant for studies involving subjective interpretations or differing expert opinions, often found in diagnostic imaging studies.

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 MRMC comparative effectiveness study is mentioned. This device is a catheter, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI" is not applicable here.

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

This question is not applicable as the device is a physical medical instrument (catheter), not a standalone algorithm.

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

For the "clinical studies" mentioned, the ultimate ground truth would likely be clinical outcomes data, possibly supplemented by angiographic assessments or other objective measures of successful lesion crossing and subsequent intervention. However, the document does not specify the exact nature of the ground truth used. For the in vitro and in vivo testing, the "ground truth" would be the measured physical properties or biological responses against predefined specifications.

8. The sample size for the training set

This question is not applicable as the device is a physical instrument 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 question is not applicable for the same reason as point 8.

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The LuMend Percutaneous Catheter is intended to be used in conjunction with a steerable guide wire in order to access discreet regions of the coronary vasculature. It may be used to facilitate placement of guide wires and other interventional devices.

The LuMend Percutaneous Catheter is a sterile single-use percutaneous coronary catheter consisting of a guide wire lead and handle assembly, proximal and distal shaft and variably curved distal tip. Guidance and tracking of the catheter through the coronary vasculature is accomplished in conjunction with a steerable guide wire.

The provided text describes the 510(k) summary for the LuMend Percutaneous Catheter. It outlines the device, its intended use, and comparison to predicate devices, but it contains limited information about specific acceptance criteria and the detailed study that proves the device meets those criteria.

However, based on the information provided, here's an attempt to answer your questions:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of explicit, quantifiable acceptance criteria with corresponding performance results. Instead, it states that:

The document mentions "internal specification requirements" and "external standard requirements and predicate performance expectations" as the benchmarks, but it doesn't elaborate on what these specific requirements or expectations were. It broadly states that "All data fell well within" these requirements.

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

The document does not explicitly state the sample size used for the test set. It mentions "in vitro, in situ, and in vivo test data" but provides no details on the number of units tested for each.

The provenance of the data is not specified (e.g., country of origin). The testing seems to be conducted by the manufacturer, LuMend, Inc., likely within their own facilities or contracted labs. The studies are described as "Design analysis and in vitro data," along with some "in situ and in vivo" testing, suggesting a retrospective analysis of device performance against established standards rather than a prospective clinical trial with human subjects for efficacy.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the context of device performance, as one might see in diagnostic imaging studies. The testing described is focused on physical and mechanical properties of the catheter.

4. Adjudication Method for the Test Set:

Not applicable. The described testing is primarily objective measurement of physical properties against engineering specifications, not subjective assessment 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 testing of the device's physical and functional characteristics, not its impact on human reader performance or diagnostic accuracy.

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

Not applicable. This device is a physical medical instrument (a catheter), not a software algorithm.

7. The Type of Ground Truth Used:

For the "test set" (which appears to refer to the device units undergoing performance validation), the "ground truth" was based on:

• "internal specification requirements"
• "external standard requirements" (e.g., "Guidewire Guidance" Document – January 1995 and FDA standards)
• "predicate performance expectations"

These are essentially engineering specifications, regulatory standards, and performance benchmarks derived from the predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical instrument (a catheter), not a machine learning algorithm that requires a training set.

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

Not applicable. See point 8.

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The Outback Catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Outback Catheter is not intended for use in the coronary or cerebral vasculature.

The Outback catheter features a 6 Fr. steel-braided polyimide and polyurethane shaft through which a single-lumen steel-braided polyimide guide is housed. The guide is extendable and steerable from the tip of the catheter shaft, and features a radiopaque multi-beveled guide tip allowing for visualization under fluoroscopy. A radiopaque index on the catheter shaft is oriented to the steerable guide tip. The proximal end of the Outback Catheter features a rotating hemostasis valve through which the guide is extended and retracted via a rotational handle mechanism.

The provided document is a 510(k) premarket notification for a medical device called the "Outback™ Catheter." This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific acceptance criteria through a highly structured study with performance metrics in the way that an AI/ML device submission would.

Therefore, the requested information, such as "acceptance criteria," "reported device performance," "sample size for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "sample size for the training set" are not applicable to this 510(k) submission.

The document does not contain any information about a study designed to prove the device meets specific performance acceptance criteria in the context of an AI/ML device. Instead, it focuses on demonstrating substantial equivalence to a previously marketed predicate device.

Here's a breakdown of what the document does state in relation to demonstrating equivalence:

1. Acceptance Criteria and Reported Device Performance:

• Not applicable. The document does not define specific performance acceptance criteria for the Outback™ Catheter that would be met through a quantitative study with reported metrics like sensitivity, specificity, etc.
• Instead, the document states: "Results of [costs were introduced] and physical properties are appropriate for the intended use." This refers to internal testing of the device's physical and functional properties to ensure it performs as expected for its intended use, but not against pre-defined clinical performance acceptance criteria.

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

• Not applicable. This information is not relevant to a 510(k) for demonstrating substantial equivalence of a physical medical device. There is no "test set" of data in the AI/ML sense.

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

• Not applicable. No ground truth establishment by experts for a test set is mentioned.

4. Adjudication Method:

• Not applicable.

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

• Not applicable. This type of study is not mentioned as it's typically for assessing the impact of AI on human reader performance, which isn't the focus of this 510(k).

6. Standalone (Algorithm Only) Performance:

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

7. Type of Ground Truth Used:

• Not applicable.

8. Sample Size for the Training Set:

• Not applicable.

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

• Not applicable.

Key takeaway from the document:

The basis for clearance is "substantial equivalence" to the predicate device (Outback™ Catheter (K001577)). The argument is that the new device has "the same intended use and technological characteristics as the Outback Catherer has the battle of scientific testing have ensured that all the predicate device (18001977)." This means the manufacturer performed tests to confirm that the materials, design, and function are comparable to the predicate and suitable for its intended use, rather than a clinical trial to establish new performance metrics against a defined ground truth.

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