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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.

Ask a specific question about this device