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The Ventrax™ Delivery System is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart.

The Ventrax™ Delivery System is designed to provide a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations. It provides support for positioning and maintaining the position of catheters at specific locations in the heart. The sheath may be used for percutaneous entry. The system consists of four components: a sheath, a pigtail dilator, a straight dilator and a J-tipped Amplatz guidewire.

VENTRAX™ DELIVERY SYSTEM COMPONENTS
A. 8.5F Guiding Sheath Introducer: provides a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations. The sheath has an integrated valve to restrict blood loss, and a sideport for flushing and withdrawing blood.
B. Mating Pigtail Dilator: designed to conform to the sheath introducer inner diameter, has a tapered tip, has a pigtail at the distal end to assist aortic valve crossing, has an integrated valve to restrict blood loss, and has a sideport for flushing.
C. Mating Straight Dilator: designed to conform to the sheath introducer inner diameter and has a tapered tip. Usage of this straight dilator is optional. This straight dilator is intended to be used only when access is unsuccessful after using the mating pigtail dilator.
D. 0.035" X 220cm J-tipped Amplatz guidewire: provide path for sheath and dilator advancement.

This looks like a 510(k) summary for a medical device called the Ventrax™ Delivery System. However, this submission does not contain information about software with AI/ML components. The document focuses on the substantial equivalence of the Ventrax Delivery System to a previously cleared predicate device with respect to its physical design, materials, and mechanical performance. There is no mention of accepting criteria related to AI/ML device performance, or any studies designed to prove AI/ML performance.

Therefore, I cannot provide an answer based on the prompt's request for acceptance criteria and study details related to AI/ML. The provided text does not contain any of that information.

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The Ventrax™ Delivery System is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart.

The Ventrax Delivery System is designed to provide a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations. It provides support for positioning and maintaining the position of catheters at specific locations in the heart. The sheath may be used for percutaneous entry. The system consists of four components: a sheath, a pigtail dilator, a straight dilator and a Jtipped Amplatz guidewire.

Ventrax Delivery Systems Components:

A. 8.5F Guiding Sheath Introducer: provides a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations. The sheath has an integrated valve to restrict blood loss, and a sideport for flushing and withdrawing blood.

B. Mating Pigtail Dilator: designed to conform to the sheath introducer inner diameter, has a tapered tip, has a pigtail at the distal end to assist aortic valve crossing, has an integrated valve to restrict blood loss, and has a sideport for flushing.

C. Mating Straight Dilator: designed to conform to the sheath introducer inner diameter and has a tapered tip. Usage of this straight dilator is optional. This straight dilator is intended to be used only when access is unsuccessful after using the mating pigtail dilator.

D. 0.035" X 220cm J-tipped Amplatz guidewire: provide path for sheath and dilator advancement.

Based on the provided text, the document is a 510(k) summary for a medical device (Ventrax Delivery System) and does not contain the detailed information about acceptance criteria and the study that proves the device meets those criteria in the way typically expected for an AI/software device. The document describes a physical medical device (a catheter delivery system) and its substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/software device. The provided text does not mention any AI component, nor does it detail a study with a test set, expert ground truth, MRMC studies, or standalone algorithm performance, as these are primarily relevant to software/AI device evaluation.

The "SUMMARY OF NON-CLINICAL TESTING" section (page 5) states: "Verification and validation testing of the Ventrax Delivery System was conducted to ensure that the subject device is safe and effective and meets the performance specifications and user needs considered essential for its intended use. Required performance testing was determined based on risk assessment, recognized consensus standards, FDA guidance documents and the anticipated clinical environment."

This generally refers to physical performance testing (e.g., strength, durability, flow rates) relevant to a catheter, not diagnostic accuracy studies with human readers or AI algorithms.

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The Ventrax Delivery System is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart

The Ventrax™ Delivery System is designed to provide a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations. It provides support for positioning and maintaining the position of catheters at specific locations in the heart. The guiding sheath introducer may be used for percutaneous entry. The System consists of four components: a sheath, a pigtail dilator, a straight dilator and a J- tipped guidewire.

The provided text is a 510(k) Premarket Notification for the Ventrax™ Delivery System. It describes the device, its intended use, comparison to a predicate device, and various performance tests conducted. However, this document does not contain information about an AI-powered device or a study involving human readers or AI assistance.

Therefore, I cannot provide detailed answers to questions 1 through 9, as they are specifically geared towards the evaluation of an AI/ML-based medical device.

Based on the provided text, here's what can be inferred about the device's assessment, focusing on the device rather than an AI component:

• Type of Device: The Ventrax™ Delivery System is a non-AI percutaneous catheter system.
• Purpose of Assessment: The assessment is for substantial equivalence to a legally marketed predicate device (AMPLATZER® TorqVue® Delivery System K072313) to demonstrate safety and effectiveness for its intended use.
• Studies Conducted: The studies are primarily bench testing and biocompatibility testing to ensure the physical and biological properties of the device meet established standards.

Here's an attempt to answer the questions based on the available information, noting the absence of AI/ML specifics:

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

The document lists numerous performance tests, but it does not explicitly state specific acceptance criteria values or detailed reported performance results for each test. Instead, it indicates that "Performance testing of the Ventrax™ Delivery System was conducted based on the risk analysis and when applicable on the requirements of the following standards." The conclusion states that the device "meets the requirements that are considered essential for its intended use."

Without specific numerical acceptance criteria and performance data, a table cannot be fully constructed. The performance data listed are categories of tests, not their outcomes.

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

• Sample Size: The document does not specify exact sample sizes for each bench or biocompatibility test. It lists the types of tests performed.
• Data Provenance: Not specified, but given it's a premarket notification for the US market, the testing would generally align with US regulatory requirements. The studies are prospective in the sense that they are conducted on new device samples specifically for regulatory 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 question is not applicable as the device is not an AI/ML device requiring expert interpretation for ground truth establishment. The "ground truth" for this type of device is established by objective measurements against engineering specifications and biological standards.

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

Not applicable, as this refers to expert adjudication in AI/ML performance evaluation studies. The device's performance is objectively measured against standards.

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

Not applicable. This is not an AI-powered device, and no MRMC study involving human readers and AI assistance was performed.

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

Not applicable. This is not an AI algorithm. Its performance is inherent to its physical design and material properties.

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

The "ground truth" for this device is based on engineering specifications, material science standards, and established biological safety parameters defined by the listed ISO, ASTM, and AAMI standards. For example, a "Sheath Shaft Tensile Strength" test would have an engineering specification as its ground truth, not an expert consensus.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

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

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