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The XO Cross is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The XO Cross catheter is a single-lumen support catheter designed to support a quidewire during access of the peripheral vasculature, allowing for exchange of guidewires during vascular access procedures, and providing a conduit for the delivery of saline solutions or diagnostic contrast agents. The shaft and tip are both radiopaque to track the location of the XO Cross catheter within the vasculature, while under fluoroscopy. It is available in various lengths (90cm, 135cm, 150cm, 175cm) and ranges in diameter from 2 Fr (0.7 mm) to 4 Fr (1.35 mm) with a tapered polymer tip at its distal end.

The provided text is a 510(k) summary for the XO Cross Support Catheter. It outlines the device description, indications for use, and a comparison to a predicate device. However, it does not contain detailed information about specific acceptance criteria or the study data that proves the device meets those criteria, especially in the context of device performance metrics with numerical values or statistical analyses.

The document states that "All necessary verification steps met pre-determined acceptance criteria to confirm substantial equivalence" and "All data met pre-determined acceptance criteria" for functional tests, but it does not specify what those criteria are beyond general statements. It also doesn't describe the methodology of any studies that would demonstrate these criteria were met in a quantifiable way.

Therefore, I cannot populate the table or answer most of the specific questions as the required information is not present in the provided text.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific quantitative acceptance criteria for each functional test (e.g., maximum acceptable cytotoxicity index, specific force required for kink resistance in design verification).
• Quantitative results of the functional tests against the specific criteria.
• Any performance testing related to guidewire support strength, catheter trackability, pushability, or other in-use functional attributes beyond basic material and design verification.

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

• Missing. The document does not describe any specific "test set" in terms of patient data or clinical samples that would have a sample size or provenance. The "functional/safety testing" refers to laboratory-based verification, and no sample sizes for these tests are 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 would typically be relevant for studies involving qualitative assessments, such as image interpretation or clinical diagnosis. The described testing is primarily laboratory-based engineering and biocompatibility testing. No "ground truth" established by experts in this context is mentioned.

4. Adjudication method for the test set

• Not applicable. See point 3.

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 device is a physical medical device (support catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant.

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

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

7. The type of ground truth used

• For the functional/safety testing, the "ground truth" would be the standards and specifications (e.g., ISO 10993, ISO 10555) that the device must meet, as well as the manufacturer's own internal design requirements. These are objective engineering and biological standards. There is no "expert consensus," "pathology," or "outcomes data" ground truth described for the tests mentioned.

8. The sample size for the training set

• Not applicable. This device is a physical medical device. There is no concept of a "training set" as there would be for AI/machine learning models.

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

• Not applicable. See point 8.

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The TXM Support Catheters are percutaneous, single lumen catheters designed for use in the peripheral vascular system. TXM Support Catheters are intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The TXM Support Catheter is an over the wire (OTW) single lumen catheter with atraumatic tapered tip. The distal tip catheter shaft has 6 radiopaque markers (including the tip) that works as an aid to estimate positioning within the vasculature. It consists of a lubricious inner liner made from Teflon, and stainless steel braid over the liner and an outer layer that consists of clear Nylon 12 polymer. One gold marker band is positioned on the proximal side of the tip. A polycarbonate hub is attached to the proximal end of the TXM Support Catheter. The TXM Support Catheter system is offered in 8 models, four with a straight tip and four with an angled tip, and the angled tip configuration has an angle of 30°. All models will have an outer diameter of the 4 French size (0.052") and an inner diameter of 0.039" tapered down to 0.0355" towards the distal tip so that is compatible with a 0.035" guidewires. The device is available in lengths of 65cm, 90cm. 135cm, and 150cm. The catheter is coated with a lubricious hydrophilic coating. The device is supplied sterile and is intended for single use only.

This document describes the TXM Support Catheter and its substantial equivalence to a predicate device, focusing on bench and biocompatibility testing. It is a 510(k) submission, used for medical devices that are substantially equivalent to a legally marketed predicate device.

Here's an analysis of the provided text in relation to your request about acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a summary of bench testing performed on the TXM Support Catheter. For each test, it lists the applicable standard or internal test method and indicates "Pass" for both non-aged (T=0) and accelerated-aged (T=2) devices. While it doesn't explicitly state quantitative acceptance criteria for each test in a compact table, the "Pass" result implies that the device met these criteria.

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

The document mentions "Testing was performed on non-aged devices (T=0) as well as on devices subject to 2 years of accelerated aging (T=2)." However, the specific sample sizes for each test are not provided. The data provenance indicates that these were bench tests, meaning they were performed in a laboratory setting. There is no information regarding country of origin of the data as it's not clinical data, and the tests are inherently prospective in nature for a new device.

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

This report describes bench testing for a medical device (catheter), not a diagnostic or prognostic algorithm involving human interpretation of medical images or data. Therefore, the concept of "ground truth established by experts" and their qualifications as you might typically find in AI/CADe submissions is not applicable here. The "ground truth" for these tests is defined by the technical specifications, standards (like ISO or ASTM), and internal test methods that define acceptable performance for physical and material properties.

4. Adjudication Method for the Test Set:

Similar to point 3, adjudication methods are not applicable for these types of bench tests. The evaluation of test results against predefined acceptance criteria is typically a technical assessment by engineers or technicians, not a consensus-based adjudication process.

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

No, a MRMC comparative effectiveness study was not done. This document is for a physical medical device (catheter), not an AI or imaging diagnostic software. Therefore, the concept of human readers improving with or without AI assistance is not relevant.

6. Standalone (Algorithm Only) Performance:

No, a standalone (algorithm only) performance study was not done. This is a physical support catheter, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for the performance testing cited is based on engineering specifications, recognized industry standards (ISO, ASTM), and internal test methods. These standards and specifications define the expected physical, chemical, and functional properties of the device. For example, for "Air Leakage," the ground truth is defined by the criteria within ISO 10555-1.

8. Sample Size for the Training Set:

Not applicable. This document describes a physical medical device, not an AI or machine learning model that requires a training set.

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

Not applicable. As there is no training set for a physical device, there is no ground truth to be established for it in this context.

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