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The Venture 0.014" catheters are indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the coronary and peripheral vasculature. The OTW version (Model 5821) may also be used for manual delivery of saline solution or diagnostic contrast agents.

The Venture 0.014" catheters are single lumen catheters with a radiopaque deflectable distal tip designed to provide guidewire support during interventional procedures in the coronary and peripheral vasculature. The Venture 0.014" catheters are compatible with 0.014" guidewires and are available in two configurations. The rapid exchange configuration consists of a hypotube shaft with a rapid exchange (RX) lumen and deflectable tip on the distal segment. The over the wire configuration consists of an over-the-wire (OTW) lumen that runs the entire length of the catheter with a deflectable tip. The Venture 0.014" catheter tips are deflectable 90° by rotating a deflection knob on the control handle of the proximal end and a hydrophilic coating on the distal end of the catheter enhances deliverability to the target vasculature. The Venture 0.014" catheters are sterilized with ethylene oxide.

This is a 510(k) summary for a medical device (Venture 0.014" Catheter), not an AI/ML device study. Therefore, many of the requested categories for AI/ML device studies are not applicable or cannot be extracted from this document.

However, I can extract the acceptance criteria and performance data for the device's functional integrity as described in the document.

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 specify exact sample sizes for each bench test. It generically states "The results of the verification tests met the specified acceptance criteria."
• Data provenance is not explicitly stated, but these are bench tests performed by the manufacturer, Vascular Solutions, LLC. This is not a study on patient data.

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

• Not applicable. This is not an AI/ML study involving expert ground truth for medical images or clinical outcomes. These are engineering bench tests.

4. Adjudication method for the test set:

• Not applicable. This is not an AI/ML study involving expert interpretation or adjudication.

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 not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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

• For the bench tests, the "ground truth" is established by engineering specifications and standards for device performance (e.g., specific force, angle, integrity measurements).
• For biocompatibility, the ground truth is established by the results of standardized biological tests according to ISO 10993-1.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no training set in the AI sense.

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

• Not applicable.

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The Venture 038 catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the peripheral vasculature. It may also be used for manual delivery of saline solution or diagnostic contrast agents.

The Venture 038 catheter is an over-the-wire single lumen catheter with a radiopaque deflectable distal tip. The deflectable distal tip is actuated by rotating a knob on the control handle of the proximal end of the catheter. The Venture 038 catheter has a working length of 120 cm or 70 cm and has a hydrophilic coating on the distal 45 cm of the catheter. The Venture 038 catheter provides support to 0.035" guidewires and is compatible with 6F introducer sheaths and 8F guide catheters.

The provided document is a 510(k) summary for the Venture 038 catheter, a medical device. It does not describe an AI/ML powered device or a study involving human readers or AI assistance. Therefore, many of the requested fields are not applicable.

1. Table of acceptance criteria and the reported device performance

Note: The document states "The results of the verification tests met the specified acceptance criteria," but it does not explicitly list the specific quantitative or qualitative acceptance criteria for each test. Instead, it generally indicates that the device passed these tests.

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

This information is not provided in the document. The document describes bench tests and biocompatibility tests, not studies with test sets in the context of AI/ML or clinical 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 applicable as the document describes a physical medical device and its bench testing, not an AI/ML algorithm requiring expert ground truth for a test set.

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

This information is not applicable as the document does not describe a study involving adjudication of a test set by human experts.

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

This information is not applicable as the document describes a physical medical device and its bench testing, not an AI/ML powered device or a MRMC study.

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

This information is not applicable as the document describes a physical medical device and its bench testing, not an AI/ML algorithm.

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

This information is not applicable as the document describes a physical medical device and its bench testing, not an AI/ML algorithm requiring a ground truth in that context. The "ground truth" for the device's performance would be the physical properties and functional results observed during the bench tests, compared against design specifications and relevant standards.

8. The sample size for the training set

This information is not applicable as the document describes a physical medical device and its bench testing, not an AI/ML algorithm requiring a training set.

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

This information is not applicable as the document describes a physical medical device and its bench testing, not an AI/ML algorithm.

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The Twin-Pass catheter is intended to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and to subselectively infuse/deliver diagnostic agents.

The Twin-Pass Torque is a dual lumen catheter consisting of an over-the-wire (OTW) lumen that runs the full length of the catheter, exiting just proximal to the distal tip, and a rapid exchange (RX) delivery lumen on the distal segment. The two exit ports are each marked by a radiopaque platinum-iridium marker band and the device shaft has two positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, which are not visible under fluoroscopy.

This document is a 510(k) premarket notification for the "Twin-Pass Torque" catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing a clinical study with acceptance criteria for device performance based on patient outcomes or diagnostic accuracy. Therefore, information regarding reader studies, ground truth establishment, or multi-reader multi-case analyses is not applicable.

Here's an breakdown of the available information:

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

The document lists performance tests conducted to establish substantial equivalence. For each test, the document states that "The results of the verification tests met the specified acceptance criteria." However, the specific numerical acceptance criteria or detailed numerical performance results are not provided in this summary.

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 describes performance tests (bench testing), not a clinical trial with a "test set" in the context of patient data. The sample sizes for these engineering and biocompatibility tests are not specified in this summary. The data provenance is also not specified, but given it's bench testing, it would originate from the manufacturer's testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a study assessing diagnostic accuracy or human interpretation. It's about mechanical and biological performance of a medical device.

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

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document does not describe a MRMC study or an AI-powered device.

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

Not applicable. This document is for a physical medical device (catheter), not an algorithm or AI.

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

For the performance tests, the "ground truth" would be the engineering and physical standards and specifications established for the device's functional characteristics (e.g., kink resistance, tensile strength) and the biological response standards for biocompatibility (e.g., ISO 10993-1).

8. The sample size for the training set

Not applicable. There is no software or algorithm involved that requires a training set.

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

Not applicable.

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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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