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The Guiding Catheter is indicated to provide a pathway through which therapeutic devices are introduced. The catheter is intended to be used in the peripheral vascular system.

The Guiding Catheter is a single-use percutaneous catheter intended to be used in the peripheral vascular system to provide a pathway through which therapeutic devices are introduced. The Guiding Catheter is available in a variety of curves to accommodate various anatomies. The Guiding Catheter is comprised of a braid-reinforced catheter shaft terminating in an atraumatic, radiopaque tip. The device includes a proximal hub with luer fitting for fluid infusion and/or aspiration as well as strain relief. The catheter is a single use disposable device. The Guiding Catheter has an inner diameter of 6F, an outer diameter of 7F, and is compatible with an 0.035" guidewire.

This document describes a 510(k) premarket notification for a medical device called a "Guiding Catheter." It aims to demonstrate substantial equivalence to a predicate device, the Medtronic Launcher Guide Catheter (K022764).

Here's an analysis of the provided text in relation to acceptance criteria and the study that proves the device meets them:

I. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are not explicitly stated as quantitative targets in the typical "acceptance criteria" table format (e.g., sensitivity > X%, specificity > Y%). Instead, the document focuses on demonstrating that the Guiding Catheter is substantially equivalent to a legally marketed predicate device. This means the device must perform comparably to the predicate device and raise no new questions of safety or effectiveness.

The document presents a comparison of technological characteristics as the primary "performance" data, indicating how the proposed device aligns with the predicate.

Here's a table summarizing the characteristics presented and the conclusion of equivalence:

II. Study Proving Device Meets Acceptance Criteria

The study described is the 510(k) premarket notification process, which involves demonstrating substantial equivalence through a combination of comparative analysis and various performance tests.

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

   • The document mentions "Bench testing, including dimensional evaluation, tensile testing, torque testing, kink resistance testing, packaging testing, tip joint fatigue testing, burst proof testing, high pressure dynamic testing, particulate testing." It states, "All testing was performed on test units representative of finished devices."
   • It also lists "Simulated Use testing" and "In Vivo Testing."
   • Sample Size: The exact sample sizes for each type of testing (bench, simulated use, in vivo) are not specified in the provided text. It only indicates "test units representative of finished devices."
   • Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given it's a premarket notification for a new device, the testing would typically be prospective, conducted by the manufacturer or a contract research organization.

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

   • This section is not applicable in the context of this 510(k) submission. The "ground truth" here isn't based on expert interpretations of medical images (as would be the case for an AI/CADe device). Instead, the "ground truth" is adherence to engineering specifications and performance comparable to a predicate device, verified through various physical and mechanical tests.

3. Adjudication Method for the Test Set:

   • Not applicable. There's no human "adjudication" in the sense of consensus reading for medical images. The "adjudication" is achieved through standardized testing protocols (e.g., ASTM, ISO) and comparison of quantitative results to predefined engineering standards or the performance of the predicate device.

4. 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 relevant for AI/CADe devices where human readers' performance with and without AI assistance is evaluated. This submission is for a physical medical device (catheter) and relies on bench and in-vivo performance testing, not human reading performance.

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

   • Not applicable. This pertains to AI/CADe algorithms. The device here is a physical Guiding Catheter.

6. The Type of Ground Truth Used:

   • For the Guiding Catheter, the "ground truth" is established through:
     • Engineering Specifications/Standards: The device must meet specific physical and mechanical properties (dimensions, tensile strength, torque, kink resistance, burst pressure, etc.).
     • Predicate Device Performance: The device's performance characteristics are compared against those of the legally marketed predicate device to demonstrate substantial equivalence.
     • Biological Compatibility Standards: Adherence to ISO 10993-1 for biocompatibility using in vitro and in vivo models.
     • Simulated Use and In Vivo Testing: Direct measurement of the device's functional performance in environments mimicking its intended use.

7. The Sample Size for the Training Set:

   • Not applicable. There is no "training set" in the context of this device's development and testing as described. Training sets are relevant for machine learning algorithms.

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

   • Not applicable. As there is no training set mentioned, the establishment of ground truth for it is irrelevant to this submission.

In summary, the document demonstrates that the Guiding Catheter meets "acceptance criteria" by proving its substantial equivalence to a predicate device through a comprehensive set of bench tests, simulated use tests, and in vivo tests, all performed on representative finished devices, and ensuring compliance with relevant biocompatibility standards. The framework of this 510(k) submission is to show that the new device is as safe and effective as a previously cleared device, rather than to demonstrate a specific quantitative improvement over a baseline or human performance.

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The Guiding Catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vasculature.

The TXM Guiding Catheter is a guiding catheter, for application in intravascular vessels. It consists of a lubricous inner liner made from Teflon, a stainless steel braid over the inner liner. The outer shaft consists of durometer hardness and different lengths of colored Polyether block amide. A Polycarbonate hub is attached to the proximal end of the Guiding Catheter. A strain relief is placed at the proximal end of the Guiding Catheter and over the distal end of the device shafts will have an outer diameter of 5 French sizes (0.070") and 6 French sizes (0.082) respectively for each catheter. The 5 French sizes will have an inner diameter of 0.058" and the 6 French sizes will have an inner diameter of 0.070". The device is available in length of 100cm. The device is supplied sterile and is intended for single use.

This document is a 510(k) premarket notification for a guiding catheter, indicating its substantial equivalence to a predicate device. It doesn't describe the evaluation of an AI/ML powered device, but rather a traditional medical device (catheter). Therefore, most of the requested information regarding AI/ML device evaluation (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable or cannot be extracted from this document.

However, I can extract the acceptance criteria and results for the bench testing and biocompatibility testing as presented for this traditional medical device.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, the "acceptance criteria" are implied by meeting the specified standards or internal test methods, and the "reported device performance" is a simple "Pass" or "Fail" against those criteria.

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 refers to "non-aged devices (T=0)" and "devices subject to 3 years of accelerated aging (T=3)" for bench testing, but the specific number of devices tested for each test is not detailed. The data provenance is also not specified, as this is a device submission focused on bench and biocompatibility testing, not 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)

Not applicable. This is a traditional medical device (catheter) and does not involve AI/ML or expert evaluation for establishing ground truth.

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

Not applicable. This is a traditional medical device (catheter) and does not involve AI/ML or expert adjudication for test sets.

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 traditional medical device (catheter) and does not involve AI/ML.

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

Not applicable. This is a traditional medical device (catheter) and does not involve AI/ML.

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

The "ground truth" for this device's evaluation is primarily based on meeting the specifications outlined in recognized international and national standards (e.g., ISO 10555, ASTM F640-12, ISO 10993 series, USP) and internal test methods. For example, for tensile strength, the ground truth is simply whether the device withstood the specified force according to the standard. For biocompatibility, it's whether the biological responses fall within acceptable limits defined by the ISO 10993 series.

8. The sample size for the training set

Not applicable. This is a traditional medical device (catheter) and does not involve AI/ML or training sets.

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

Not applicable. This is a traditional medical device (catheter) and does not involve AI/ML or training sets.

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