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The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system. It is also used to lead a guide wire or a catheter into the target site.

The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is a two-layer construction comprised of a stainless steel mesh sandwiched between layers of polyurethane polyamide elastomer. The polyurethane polyamide elastomer contains barium sulfate for visibility and contrast under fluoroscopy. There is a hydrophilic coating on the distal portion of the device. The length of the coating is determined by the product code number.

This document describes a 510(k) premarket notification for a medical device, the RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP). Given the nature of a 510(k) submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to prove performance against specific acceptance criteria through a clinical study in the way one might for a novel device requiring a PMA.

Here's an analysis of the provided text in response to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present specific quantitative acceptance criteria in the way a clinical trial might for a new device's performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating that the device's performance characteristics are substantially equivalent to the predicate device.

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

The submission does not describe a test set or data provenance in the context of a clinical study or a performance evaluation against a specific set of clinical data. This is because the submission is for a 510(k) where substantial equivalence is being claimed with a predicate device with no changes in design or materials. The "performance" section refers to a risk/hazard analysis and a justification of equivalence, not a new comparative study using a clinical test set. The biocompatibility and sterilization validation are described, which would use specific samples for those tests, but not a general "test set" for overall device performance in a clinical sense.

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

This information is not applicable and not provided. As explained above, there was no clinical "test set" requiring ground truth established by experts for performance evaluation in this 510(k) submission.

4. Adjudication Method for the Test Set

This information is not applicable and not provided for the same reasons as #3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI

This information is not applicable and not provided. This device is a manual, physical catheter; it does not involve AI or any software requiring a multi-reader multi-case study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable and not provided. This device is a medical catheter and does not involve any algorithms.

7. The Type of Ground Truth Used

This information is not applicable and not provided for a clinical performance test set. The "ground truth" here is essentially the already-cleared performance and characteristics of the predicate device (K915414, the Terumo Angiographic Catheter) against which the current device is deemed substantially equivalent due to being the same design and materials.

8. The Sample Size for the Training Set

This information is not applicable and not provided. Since there's no machine learning or AI algorithm involved, there's no concept of a "training set."

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

This information is not applicable and not provided for the same reasons as #8.

Summary of the Study Proving Acceptance Criteria (Substantial Equivalence):

The "study" in this context is the 510(k) submission itself, which argues for substantial equivalence to a predicate device (K915414, the Terumo Angiographic Catheter).

• Proof of Equivalence: The key "proof" lies in the explicit statement: "The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) in this submission is the same device that was cleared under K915414, the Terumo Angiographic Catheter. There are no changes in the design or materials."
• Risk Analysis: A risk/hazard analysis (according to EN ISO 14971) was performed to ensure that the identical device (now with a slightly different name/marketing) still meets safety standards and that its performance characteristics remain acceptable and equivalent to the already-cleared predicate.
• Biocompatibility Testing: Blood contacting materials were tested according to ISO 10993 to confirm biocompatibility.
• Sterilization Validation: Sterilization processes were validated according to EN ISO 11135-1 to ensure sterility.
• Manufacturing Controls: Ongoing manufacturing controls (visual, functional, dimensional, sterility tests) are in place to ensure consistent quality.

Conclusion:

This 510(k) submission represents a situation where the device is claimed to be identical in design and materials to a previously cleared predicate device. Therefore, the "acceptance criteria" are largely met by demonstrating that the device is the predicate device, and the "study" is the documentation proving this identity and confirming standard manufacturing and biological safety aspects. No new clinical performance studies comparing it to a control or evaluating its accuracy against a ground truth dataset were required or performed because the device itself is not new.

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The PROGREAT Catheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels in the lower and upper extremities and all coronary vessels. The PROGREAT Catheter is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The Catheter should not be used in cerebral vessels.

The PROGREAT catheter is available with or without the following accessories: guide wire, inserter, mandrel (stylet), syringe, wire stopper, and Y-connector. The catheter consists of metal coil reinforced multi-layer polymer tubing. The coil is embedded in the catheter wall the entire length of the catheter. This increases the flexibility, kink resistance, and pressure resistance of the catheter. The inner layer of the catheter is made of PTFE (polytetrafluoroethylene) to ensure smooth movement of devices such as the guide wire. The outer surface of the catheter is coated with a hydrophilic polymer which becomes lubricious when wet with saline solution or blood.

The provided text describes a 510(k) premarket notification for the PROGREAT Catheter, asserting its substantial equivalence to a predicate device, the GT LEGGIERO (K981359). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance tests conducted to demonstrate this substantial equivalence.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table labeled "acceptance criteria." Instead, it lists "verification tests" performed to demonstrate substantial equivalence to the predicate device. For each test, it implicitly states that the performance was satisfactory to deem the device substantially equivalent, meaning it met an internal standard set by the manufacturer to compare to the predicate.

In addition to these performance tests, the device also met biological and sterilization acceptance criteria:

2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the specified verification tests (e.g., Ease of removal, Frictional resistance, etc.). These are likely internal engineering tests, and the exact number of units tested is not typically disclosed in the public summary. The data provenance is internal to the manufacturer, Terumo Medical Corporation, for the "modified device (PROGREAT catheter)." These would be prospective tests performed during the development and verification phase of the PROGREAT catheter.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in the context of this 510(k) submission. The "ground truth" for the performance tests mentioned (e.g., frictional resistance, kink resistance) would be the physical properties and performance characteristics of the predicate device (GT LEGGIERO K981359) and established engineering standards. There is no mention of human expert consensus being used to establish the "ground truth" for these physical device performance characteristics.

4. Adjudication Method for the Test Set
Not applicable. The verification tests are objective physical and mechanical tests, not subjective evaluations requiring adjudication by 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
Not applicable. This device is a physical medical device (angiographic catheter), not an AI imaging or diagnostic algorithm. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence for the PROGREAT Catheter primarily relied on:

• Predicate Device Performance: The established performance characteristics of the GT LEGGIERO (K981359) served as the benchmark for comparison.
• Engineering Standards: Standardized tests for mechanical properties (e.g., pressure resistance, kink resistance, joint strength) and material properties were used.
• Regulatory Standards: Biocompatibility was assessed against FDA General Program Memorandum #G95-1 (ISO-10993), and sterilization against AAMI/ANSI/ISO 11135.

8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, there is no training set for this type of device submission.

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The GT Leggiero Catheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities and all coronary vessels. The GT Leggiero Catheter is also intended for drug infusion in intraarterial therapy and the infusion of embolic materials for hemostasis. The Catheter should not be used in cerebral vessels.

The GT Leggiero™ Catheter is a multilayer single-lumen catheter 100-150cm in length with a maximum injection pressure of 450 psi. The catheter shaft is reinforced the entire length by helically-cut stainless steel piping. The distal 15cm is fine-worked for high flexibility. The catheter is 2.9Fr. size (~0.96mm in outer diameter) and can be used with a guiding catheter 0.047" (1.20mm) or larger inner diameter. The catheter shaft has an inner diameter of ~0.6mm to admit a 0.018" or smaller sized guide wire. The catheter has a hydrophilic polymer coating on the outer surface with the exception of 30cm from its proximal end. A radiopaque marker (~0.8mm) is incorporated in the catheter tip for increased radiopacity.

The provided text describes the GT Leggiero Catheter, a medical device, and its substantial equivalence to a predicate device. This submission focuses on the physical and performance attributes of the catheter itself, not on an "AI device" or diagnostic software. Therefore, many of the requested points, such as sample size for test sets (as there are no "images" or "cases"), number of experts for ground truth, adjudication methods, MRMC studies, standalone performance studies, etc., are not applicable in this context.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for an AI device's performance does not directly apply here. Instead, the GT Leggiero Catheter's performance was evaluated against the predicate device through a series of physical and functional tests to demonstrate substantial equivalence. The "specifications" table below shows key dimensional characteristics of the device and its predicate. The performance section lists the types of tests conducted.

Note: The acceptance criteria here are implicitly achieving performance comparable or superior to the predicate device in the specified tests, and meeting relevant regulatory and safety standards (e.g., AAMI, ISO-10993 for biocompatibility).

2. Sample Size for the Test Set and Data Provenance

As this is a physical medical device (catheter) and not an AI or diagnostic tool processing data, there is no "test set" in the context of images or patient data. The tests conducted were physical and functional performance tests on samples of the manufactured catheters. The document does not specify the exact number of catheters tested for each performance criterion (e.g., N=X for Flexibility Test).

• Sample Size for Test Set: Not specified for individual tests, but refers to physical samples of the GT Leggiero Catheter.
• Data Provenance: The 'data' refers to the results of physical device testing. The testing would have been conducted by the manufacturer, Terumo Medical Corporation, likely in their labs in the USA (Elkton, MD) where the company is located. This is effectively prospective testing of manufactured devices.

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

This question is not applicable. The "ground truth" for a physical device like a catheter is established through objective engineering measurements and industry standards (e.g., tensile strength in Newtons, flow rate in mL/min, biocompatibility as per ISO standards). There is no "ground truth" established by human experts in the way it applies to diagnostic image interpretation.

4. Adjudication Method for the Test Set

This question is not applicable as there's no diagnostic uncertainty to adjudicate. Test results are objective measurements.

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

This question is not applicable because the device is a physical catheter, not an AI system for diagnostic interpretation. There are no "human readers" interpreting "cases" with or without "AI assistance."

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

This question is not applicable. The device is a physical catheter, not an algorithm. Its performance is inherent to its physical properties and design.

7. Type of Ground Truth Used

For the GT Leggiero Catheter, the "ground truth" for its performance is based on:

• Objective Engineering Measurements: Results from tests like flexibility, tensile strength, maximum pressure, and flow rate.
• Adherence to Standards: Compliance with recognized industry and regulatory standards for sterilization (AAMI) and biocompatibility (ISO-10993).
• Comparison to Predicate Device: The performance and specifications are deemed acceptable if they are substantially equivalent to the legally marketed predicate device (Terumo Angiographic Catheter K915414), which has an established safety and effectiveness profile.

8. Sample Size for the Training Set

This question is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are developed through engineering R&D, not by training an algorithm on a dataset.

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

This question is not applicable for the same reasons as point 8.

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