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The CenterCross ULTRA LV Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.

The CenterCross Ultra LV Catheter is a sterile, single lumen over-the-wire support catheter to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature to facilitate exchange of guidewires and other interventional devices. The CenterCross Ultra LV Catheter consists of an outer shaft and a removable handle/inner shaft assembly that allows for manual device manipulation. A key element of the device is an expandable and retractable nitinol structure, which, when deployed by the physician, expands to the artery wall to aid interventionalists in establishing greater support near the treatment site.

The provided text is related to a 510(k) premarket notification for a medical device called the "CenterCross Ultra LV Catheter." This document describes the device, its intended use, and its equivalence to a predicate device. It does not present acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML model's performance.

Instead, this is a regulatory submission for a physical medical device. The "testing and evaluations" mentioned are for the physical properties and performance of a catheter, not for an AI algorithm. Therefore, I cannot extract the information required for your request, as it pertains to AI/ML model evaluation.

Specifically, the document does not contain:

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Sample sizes for a test set or data provenance for an AI/ML model.
• Information about experts establishing ground truth for an AI/ML model.
• Adjudication methods for an AI/ML model.
• Details about a multi-reader multi-case (MRMC) comparative effectiveness study for an AI/ML device.
• Standalone performance of an AI algorithm.
• The type of ground truth used for an AI/ML model.
• Sample size for a training set of an AI/ML model.
• How ground truth for a training set of an AI/ML model was established.

The "testing and evaluations" section refers to bench testing for the physical catheter (Dimensional Inspection, Expansion Force, Simulated Use, Leak, Torque Strength, Tensile Strength), which are standard tests for medical devices of this type, not AI/ML performance metrics.

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The CenterCross ULTRA Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.

The CenterCross Ultra Catheter is a sterile, single lumen over-the-wire support catheter to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature to facilitate exchange of guidewires and other interventional devices.

The CenterCross Ultra Catheter consists of an outer shaft and a removable handle/inner shaft assembly that allows for manual device manipulation. A key element of the device is an expandable and retractable nitinol structure, which, when deployed by the physician, expands to the artery wall to aid interventionalists in establishing greater support near the treatment site.

Subsequent to conventional guidewire placement, atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit. The CenterCross Ultra Catheter in and of itself does not provide therapeutic beyond simple facilitation of guidewire and device support. The CenterCross Ultra Catheter is similar in its design and achieves its intended use by means of the same mechanisms as the predicate device.

This document is a 510(k) premarket notification for the Roxwood Medical CenterCross Ultra Catheter. As such, it is focusing on demonstrating substantial equivalence to a predicate device rather than presenting a study where acceptance criteria for a novel device performance were established and met.

Therefore, many of the requested categories (such as sample size for test set, data provenance, number and qualifications of experts, adjudication method, MRMC study, training set information, and direct effect size of AI improvement) are not applicable to the information provided in this document. This document describes bench testing for performance and characterization, not clinical study results evaluating diagnostic accuracy or reader performance with an AI device.

Here's an extraction of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" paired with "reported device performance" in a manner typical for a clinical study with specific metrics like sensitivity, specificity, or reader improvement. Instead, it states that "All testing was performed in accordance with recognized standards" and the "collective results of the non-clinical testing demonstrate that the CenterCross Ultra Catheter meets the established specifications necessary for consistent performance for its intended use and is substantially equivalent to the predicate device."

The types of testing performed and confirmed to meet specifications are:

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

Not applicable. This document refers to bench testing of a medical device, not a study involving human subjects or data collected from patients. Therefore, there is no "test set" in the context of patient data, nor data provenance (country of origin, retrospective/prospective).

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

Not applicable. Ground truth for a device's physical and mechanical performance is established through engineering specifications and recognized testing standards, rather than expert consensus on patient data.

4. Adjudication Method for the Test Set

Not applicable. This concept applies to human reader studies where disagreement needs to be resolved.

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 a conventional medical device (catheter), not an AI-powered diagnostic tool.

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.

7. The Type of Ground Truth Used

The "ground truth" for the device performance is based on established engineering specifications, recognized industry standards, and relevant regulatory requirements for the physical, mechanical, and biological properties of percutaneous catheters. This includes objective measurements of dimensions, forces, material integrity, and biological safety as detailed in the testing categories.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not an AI model requiring a training set.

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

Not applicable.

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The MultiCross Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary or peripheral vasculature and for guidewire exchange.

The MultiCross Catheter consists of an inner shaft, outer shaft, and a proximal handle that allows for manual device manipulation and a means for flushing the catheter lumen. A key element of the device is an expandable and retractable nitinol scaffold, which, when deployed by the physician, expands to the artery wall to aid the user in establishing greater support near the treatment site.

This document describes a 510(k) premarket notification for the MultiCross Catheter, a medical device. The information provided is primarily focused on demonstrating substantial equivalence to a predicate device, rather than meeting specific performance criteria typically associated with AI/ML-based medical devices.

Therefore, many of the requested categories for AI/ML device acceptance criteria and study details (such as sample size for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance metrics) are not applicable or are not explicitly detailed in this type of FDA submission for a Class II device relying on substantial equivalence to a predicate from manual modifications.

However, I can provide information based on what is available in the document regarding the acceptance criteria and the study that proves the device meets them, understanding that the context is a conventional medical device, not an AI/ML product.

Acceptance Criteria and Device Performance for Roxwood Medical, Inc. MultiCross Catheter (K152957)

This submission relies on demonstrating substantial equivalence of the MultiCross Catheter to its predicate device (MultiCross Catheter K121763) through bench testing rather than clinical study of the device's diagnostic performance (which would be relevant for AI/ML devices). The "acceptance criteria" here refer to meeting established specifications through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Overall Conclusion: "The collective results of the non-clinical testing demonstrate that the MultiCross Catheter meets the established specifications necessary for consistent performance for its intended use and is substantially equivalent to the predicate device." And, "The results of the performance testing confirm that the MultiCross Catheter functions to its specifications and intended use and exhibit the appropriate characteristics of a percutaneous vascular catheter."

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

• Sample Size: The document does not specify the sample size for any of the non-clinical bench tests. It broadly states "Extensive bench testing was conducted."
• Data Provenance: The data is from non-clinical bench testing (simulated environments), not patient data. No country of origin is specified for the data itself, but the applicant is Roxwood Medical, Inc. based in Redwood City, California, USA. The testing would have been conducted by or for the manufacturer. The testing is retrospective in that it was completed prior to submission.

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

• Not Applicable. For a device demonstrating substantial equivalence through bench testing, "ground truth" as it pertains to clinical outcomes or expert consensus on image interpretation is not relevant. The "ground truth" here is meeting engineering and performance specifications. The experts involved would be the engineers and quality control personnel performing and evaluating the bench tests.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1 or 3+1) are used for reconciling discordant expert interpretations in clinical studies. This document reports on bench testing, where performance is measured against predefined specifications, not subjective interpretation.

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

• No. An MRMC study was not performed, nor is it relevant for this specific type of 510(k) submission focused on mechanical and material performance of a catheter. MRMC studies are typically for evaluating the diagnostic performance of imaging devices or AI algorithms with human readers.

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

• Not Applicable. This is a physical medical device (catheter), not an algorithm or AI product. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

• The "ground truth" in this context refers to pre-established engineering specifications and performance benchmarks. The device's characteristics (e.g., tensile strength, open/close force, absence of particulate) are measured against these objective, quantifiable standards. There is no clinical or pathological "ground truth" in the sense of patient outcomes or diagnoses.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of this 510(k) submission for a non-AI/ML device. The device design and manufacturing processes are refined through engineering development, not machine learning training.

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

• Not Applicable. As there is no training set, this question is not relevant.

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The CenterCross Ultra Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.

The CenterCross Ultra Catheter is a sterile, single-use, single lumen over-the-wire support catheter to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature to facilitate exchange of guidewires and other interventional devices.

The CenterCross Ultra Catheter consists of an outer shaft and a removable handle/inner shaft assembly that allows for manual device manipulation. A kev element of the device is an expandable and retractable nitinol structure, which, when deployed by the physician, expands to the artery wall to aid interventionalists in establishing greater support near the treatment site.

Subsequent to conventional guidewire placement, atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit. The CenterCross Ultra Catheter in and of itself does not provide therapeutic benefit beyond simple facilitation of guidewire and device support. The CenterCross Ultra Catheter is similar in its design and achieves its intended use by means of the same mechanisms as the predicate device.

The provided text describes a 510(k) premarket notification for the CenterCross Ultra Catheter. The submission aims to demonstrate substantial equivalence to a predicate device, the CenterCross Catheter (K140910). The information provided is primarily focused on non-clinical bench testing to show that the new device performs to specifications and is comparable to the predicate.

Here's an analysis based on the categories requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific quantitative acceptance criteria or detailed numerical performance results for the CenterCross Ultra Catheter. Instead, it states that "All testing was performed in accordance with recognized standards" and "The collective results of the non-clinical testing demonstrate that the CenterCross Ultra Catheter meets the established specifications necessary for consistent performance for its intended use and is substantially equivalent to the predicate device."

Summary of Tested Aspects:

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

The document only mentions "Extensive bench testing" but does not specify the sample sizes (n) for each of the non-clinical tests conducted.
The data provenance is non-clinical bench testing, meaning it was performed in a laboratory setting. There is no information regarding country of origin or whether the data is retrospective or prospective, as these terms are typically relevant for clinical studies.

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

This section is not applicable as the document describes non-clinical bench testing, not a study involving human subjects or expert assessment for ground truth determination. The "ground truth" for these tests would be the established engineering specifications and recognized standards themselves.

4. Adjudication Method for the Test Set

This section is not applicable as the document describes non-clinical bench testing. Adjudication methods are typically used in clinical studies for resolving discrepancies in expert opinions or outcomes.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The submission focuses on non-clinical bench testing to demonstrate substantial equivalence, not a clinical study involving human readers and AI assistance.

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

This section is not applicable. The device is a medical catheter, not an algorithm or AI. The testing described is bench testing of the physical device.

7. The Type of Ground Truth Used

For the non-clinical bench tests, the "ground truth" is implicitly the established engineering specifications and recognized industry standards that the device was tested against. The document states, "All testing was performed in accordance with recognized standards."

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical medical catheter, not an AI model that requires a training set.

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

This section is not applicable for the same reason as above; it is a physical device, not an AI model.

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The MicroCross Catheter is intended for use as a conduit for the exchange/support of guidewires in the peripheral and coronary vasculatures. The MicroCross Catheter is also intended to infuse and contrast agents.

The MicroCross Catheter is a sterile, single lumen over-the-wire catheter to be used for the exchange and support of guidewires in the peripheral and coronary vasculatures. The MicroCross Catheter also infuses and delivers saline and contrast agents.

The MicroCross Catheter consists of a catheter shaft and a proximal hub that provides strain relief. The MicroCross Catheter is offered with a working length of 155cm and is compatible with 0.018" diameter guidewires, 5F guide catheters, and 4F introducer sheaths.

This document describes the premarket notification (510(k)) for the Roxwood Medical, Inc. MicroCross Catheter. The submission aims to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with numerical targets and reported performance values for each criterion. It lists several non-clinical tests performed, implying that the device met internal specifications for each. These tests are:

The document states: "All testing was performed in accordance with recognized standards. The collective results of the non-clinical testing demonstrate that the MicroCross Catheter meets the established specifications necessary for consistent performance for its intended use and is substantially equivalent to the predicate device."

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

The document does not specify the exact sample sizes used for each non-clinical test. The testing is described as "extensive bench testing," and the data provenance is implicitly from laboratory (bench) testing, not human or animal subjects. Details such as country of origin are not applicable as this relates to bench testing.

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

This information is not applicable. The device is a physical medical catheter, and "ground truth" in the context of expert review for medical image analysis or similar diagnostic devices is not relevant here. Performance was assessed via engineering and material testing standards.

4. Adjudication Method for the Test Set

This information is not applicable for non-clinical bench testing of a physical medical device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in diagnostic performance evaluations, which is not the case here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The MicroCross Catheter is a physical catheter, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human reader performance with or without 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. The MicroCross Catheter is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through adherence to recognized engineering and material standards, as well as the specifications required for the device's intended function. For example, for "Dimensional Inspection," the ground truth would be the design specifications, and the device's measured dimensions would be compared against these. For "Tensile Strength," the ground truth would be the specified minimum tensile strength, and the device's tested strength would need to meet or exceed this.

8. The Sample Size for the Training Set

This product is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set."

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

This information is not applicable, as there is no training set for this physical medical device.

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The MicroCross Catheter is intended for use as a conduit for the exchange/support of guidewires in the peripheral and coronary vasculatures. The MicroCross Catheter is also intended to infuse and contrast agents.
The MicroCross Catheter is intended for use as a conduit for the exchange/support of guidewires in the peripheral and coronary vasculatures. The MicroCross Catheter is also intended to infuse and deliver saline and contrast agents.

The MicroCross Catheter is a sterile, single lumen over-the-wire catheter to be used for the exchange and support of guidewires in the peripheral and coronary vasculatures. The MicroCross Catheter also infuses and delivers saline and contrast agents.
The MicroCross Catheter consists of a catheter shaft and a proximal hub that provides strain relief. The MicroCross Catheter is offered in working lengths of 150cm and 155cm and is compatible with 0.014" diameter guidewires, 5F guide catheters, and 4F introducer sheaths.
Subsequent to conventional guidewire placement, interventional tools such as angioplasty, stent, and atherectomy devices, may be used to provide therapeutic benefit. The MicroCross Catheter in and of itself does not provide therapeutic benefit beyond simple facilitation of guidewire support. The MicroCross Catheter is similar in its design and it achieves its intended use by means of the same mechanisms as the predicate device.

The provided text describes the MicroCross Catheter, a percutaneous catheter, and its substantial equivalence to a predicate device. However, it does not describe any clinical studies involving AI algorithms or human readers. The acceptance criteria and testing summarized are for the physical device itself, not for an AI's performance.

Therefore, I cannot provide information on the following points for an AI device based on this document:

• A table of acceptance criteria and the reported device performance for an AI.
• Sample size used for the test set and data provenance for an AI.
• Number of experts used to establish ground truth for the test set and their qualifications for an AI.
• Adjudication method for an AI test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI.
• The sample size for the training set for an AI.
• How the ground truth for the training set was established for an AI.

However, I can provide the acceptance criteria and a summary of the study for the physical device as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance (for the MicroCross Catheter)

The document lists various non-clinical tests performed to demonstrate the device's performance and substantial equivalence. The "acceptance criteria" are implied to be the established specifications met by the device during these tests, leading to a conclusion of proper functioning and substantial equivalence. Specific quantitative acceptance criteria or detailed numerical performance metrics for each test are not provided in this summary. Instead, the document states that the device "meets the established specifications necessary for consistent performance."

Study Proving Device Meets Acceptance Criteria:

The study was a series of extensive non-clinical (bench) tests conducted on the MicroCross Catheter.

Summary of the Study:

The study involved various tests designed to evaluate the physical, mechanical, functional, and biological performance characteristics of the MicroCross Catheter. These tests are listed in the table above and include assessments such as dimensional inspection, hydrophilic coating, simulated use, contrast flush injection, leak, torque strength, kink resistance & flexibility, pressurized flow rate, tensile strength, Luer compliance, corrosion, particulate, LAL, biocompatibility, sterilization adoption, and packaging and shelf-life.

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

• Sample Size: Not specified quantitatively in the document. The general term "extensive bench testing" is used.
• Data Provenance: Not applicable in terms of geographical origin or retrospective/prospective clinical data, as these were lab-based bench tests performed by the manufacturer, Roxwood Medical, Inc.

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

This is not applicable as the "ground truth" for these physical device tests is based on engineering specifications, recognized standards, and direct measurement/observation of physical properties and performance, not expert human interpretation of medical images or patient data.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review of medical cases where ambiguity exists. For bench testing, results are typically determined by established test methods and direct measurement against predefined specifications, not by consensus among human adjudicators.

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

No, this was not done as the document describes a physical medical device, not an AI algorithm.

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

No, this was not done as the document describes a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical testing was based on:

• Established engineering specifications
• Recognized industry standards (e.g., for biocompatibility, sterility)
• Direct physical measurements and functional performance evaluations (e.g., flow rates, tensile strength).

8. The Sample Size for the Training Set:

Not applicable. This device is a physical catheter, not an AI algorithm that requires a training set.

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

Not applicable. There is no training set for this physical device.

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The CenterCross Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.

The CenterCross Catheter is a sterile, single-use, single lumen over-the-wire support catheter to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature to facilitate exchange of guidewires and other interventional devices.

The CenterCross Catheter consists of an inner shaft, outer sheath, and a proximal handle that allows for manual device manipulation and a means for flushing the catheter lumen. A key element of the device is a temporarily expandable and retractable nitinol structure, which when deployed by the physician expands to the width of the artery to aid interventionalists in establishing greater support near the treatment site.

Subsequent to conventional guidewire placement, atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit. The CenterCross Catheter in and of itself does not provide therapeutic benefit beyond simple facilitation of guidewire support. The CenterCross Catheter is similar in its design and it achieves its intended use by means of the same mechanisms as the predicate devices.

The provided text is a 510(k) Premarket Notification for the CenterCross Catheter, which is a medical device. This type of document is a submission to the FDA demonstrating that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the new device to existing ones rather than establishing novel acceptance criteria or conducting studies to prove independent performance against such criteria as one might find for a truly novel device or an AI/software as a medical device (SaMD).

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance simply does not apply or is not detailed in this type of regulatory submission.

However, I can extract the information that is present:

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

The document does not present a formal table of "acceptance criteria" and "reported device performance" in the way one might expect for a diagnostic or algorithmic device. Instead, it lists general "Nonclinical Testing Summary" categories. The "acceptance criteria" are implied to be "meeting established specifications" which allow for a substantial equivalence determination, rather than specific quantitative thresholds. The "reported device performance" is summarized as the device "meets the established specifications necessary for consistent performance for its intended use" and "functions to its specifications and intended use."

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 does not specify sample sizes for non-clinical bench testing. The data provenance is "bench testing" and an "in vivo animal validation study." No human data or specific country of origin for data is mentioned, which is typical for pre-market submissions of physical devices where initial verification and validation are often done in-house or through contract labs. These are typically prospective tests performed for the purpose of the submission.

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 testing described is primarily mechanical and material characterization, and an animal study. "Ground truth" in the context of expert medical interpretation (e.g., for imaging or diagnostic algorithms) is not relevant here.

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

This information is not applicable and not provided. Adjudication methods are typically used for establishing ground truth in clinical studies involving human interpretation or uncertain outcomes, not for bench testing of physical device performance.

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 study was conducted or is mentioned. This type of study is relevant for AI/SaMD devices that assist human readers (e.g., radiologists interpreting images), which is not the nature of the CenterCross Catheter.

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

This is not applicable as the CenterCross Catheter is a physical medical device, not an algorithm or software. Standalone performance for an algorithm is not relevant here.

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

The "ground truth" for the non-clinical testing is based on established engineering specifications, recognized standards, and the expected functional performance of catheters. For the "in vivo animal validation study," the "ground truth" would be the observed physiological response and device performance within the animal model, assessed by researchers or veterinary professionals, but specifics are not detailed.

8. The sample size for the training set:

This is not applicable. "Training set" refers to data used to train machine learning models. The CenterCross Catheter is a physical device and does not involve a training set in this context.

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

This is not applicable since there is no training set for a machine learning model.

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The MultiCross Support Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature and for guidewire exchange.

The MultiCross Support Catheter is a sterile, single-use, triple lumen, over-the-wire, disposable percutaneous support catheter designed for use in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature for guidewire exchange. The MultiCross Support Catheter consists of an inner shaft, outer sheath, and a proximal handle that allows for manual device manipulation and a means for flushing the catheter lumen. A key element of the device is a temporarily deployable and retractable distal Nitinol scaffold, which is visible through fluoroscopy when deployed by the user, and expands to the width of the artery to provide an anchoring to aid the user in establishing greater support near the treatment site. Subsequent to conventional guidewire placement, therapeutic devices such as atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit. The MultiCross Support Catheter by itself does not provide therapeutic benefit beyond simple facilitation of guidewire support.

The provided 510(k) summary for the MultiCross Support Catheter (K121763) describes a medical device, not an AI/ML-driven software or diagnostic tool. Therefore, many of the requested categories in the prompt, which are typically relevant for AI/ML device evaluations (e.g., sample size for test/training sets, ground truth methodology, expert qualifications, MRMC studies, standalone performance, etc.), are not applicable or not explicitly detailed in this type of submission.

This submission focuses on demonstrating "substantial equivalence" to predicate devices through engineering bench testing and an animal study, which are standard for physical medical devices of this type.

Here’s an attempt to address the prompt based only on the provided document, acknowledging that most AI/ML-specific criteria will not be found:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated for bench tests (which would typically involve multiple units tested). For the animal study, the sample size is not numerically provided, but it is referred to as "a GLP animal study."
• Data Provenance: The studies were conducted by Roxwood Medical, Inc. (applicant). The location of the animal study (country of origin) is not specified. The studies are prospective in the sense that they were designed and executed to test the device.

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

• The document refers to a "clinician" who made performance and handling observations in the animal study.
• The qualifications of this clinician are not specified (e.g., radiologist with X years of experience).
• For pathology and histopathology results in the animal study, it's implied that experts (e.g., pathologists) evaluated the tissues, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

• Not applicable as this is a physical device submission. Ground truth regarding safety (e.g., pathology) is established by standard medical/scientific evaluation, not multi-reader adjudication in the context of diagnostic performance.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating the diagnostic performance of software or imaging systems with human readers.

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

• Not applicable. This is a physical medical device; there is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

• For the animal study:
  • Pathology and Histopathology results: Used to establish safety ground truth.
  • Clinician observations: Used to establish performance and handling ground truth.
• For bench testing: The "ground truth" is adherence to engineering specifications and recognized standards for physical performance parameters.

8. The Sample Size for the Training Set

• Not applicable. This is a physical device, and there is no "training set" in the AI/ML sense. Design and development would involve iterative testing, but not a formally defined "training set" for an algorithm.

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

• Not applicable, as there is no training set for an AI/ML algorithm.

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