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The Progreat 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 Progreat is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The Progreat should not be used in cerebral vessels.

The Progreat catheter consists of metal coil reinforced multi-layer polymer tubing with a hydrophilic coating. The guidewire is comprised of an alloy core wire with radiopaque marker and hydrophilic coating. The subject 2.4 Fr Progreat catheter and 0.018" guidewire will be marketed as a combined unit and will be an extension of the existing Progreat product family. The design and technological characteristics of the subject 2.4 Fr Progreat with 0.018" guidewire are identical to the predicate 2.7 Fr Progreat with 0.021" guidewire.

The Progreat catheter is available with or without accessories. The accessories to the catheter are supplied in different configurations depending on the product code:

• The Guidewire has a super-elastic alloy core and is surface coated with a hydrophilic polymer.
• I The Inserter is used to assist the physician in the placement of the guidewire within the catheter.
• I The Catheter Mandrel (stylet) is used in the shaping of the catheter for procedures that require a catheter with a tip configuration other than straight.
• I The Syringe is used in the priming of the catheter.
• . The Wire Stopper can be clipped onto the guide wire to adjust the length of the guidewire that extends past the catheter tip.
• I The Catheter Stopper S can be clipped onto the catheter to adjust the insertion length of the catheter.
• . The Y-connector can be used to connect a power injector unit to the end of the catheter for infusion of contrast media.

The provided text is a 510(k) summary for the Progreat catheter, which is a medical device. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML-driven medical device.

Therefore, many of the requested criteria for AI/ML device studies (such as types of ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document.

However, I can extract information related to the device's technical specifications and the non-clinical tests performed to assess its performance against predetermined criteria.

Description of the Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria

This 510(k) submission for the Progreat (2.4 Fr Catheter with 0.018" Guidewire) aims to demonstrate substantial equivalence to its predicate device (K033583, Terumo Progreat). The acceptance criteria for this submission are primarily focused on ensuring that the modified device maintains the safety and effectiveness of the predicate device and conforms to applicable external and internal standards. The study supporting this is a series of non-clinical performance tests.

1. Table of Acceptance Criteria and the Reported Device Performance

The document states that "Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life." While the specific numerical acceptance criteria for each test are not explicitly detailed in this summary, the types of performance tests conducted serve as the basis for these criteria.

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

The document does not explicitly state the specific sample sizes for each non-clinical test conducted. It mentions that tests were performed on "non-aged and accelerated aged samples." The provenance of the data is from Terumo Corporation's Ashitaka Factory in Japan, where the device is manufactured and where these non-clinical tests were presumably conducted. This is retrospective in the sense that the testing was performed on manufactured devices to support the 510(k) submission.

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

This information is not applicable as the device is a physical medical instrument, not an AI/ML diagnostic tool requiring expert interpretation for ground truth. Performance was assessed against engineering specifications and industry standards.

4. Adjudication Method for the Test Set

This information is not applicable for a physical device's non-clinical performance testing. Adjudication methods like 2+1 or 3+1 typically apply to human interpretation of diagnostic images or data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted, and such a study is not applicable for this type of medical device (intravascular catheter). This type of study is relevant for evaluating the impact of AI assistance on human reader performance in diagnostic tasks.

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

A standalone algorithm-only performance assessment was not conducted, as this device is a physical catheter and not an algorithm. This criterion is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests effectively refers to predetermined engineering specifications, design requirements, and relevant industry standards for intravascular catheters (e.g., ISO standards for medical devices, internal Terumo specifications). The tests confirm if the device meets these established benchmarks.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" applies to machine learning models, not to the manufacturing and testing of a physical medical device.

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

This information is not applicable for the reasons stated above.

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The Progreat™ 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, visceral vessels, and all coronary vessels. The Progreat is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis in procedures including but not limited to Uterine Fibroid Embolization. The Progreat should not be used in cerebral vessels.

The Progreat catherer 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.

This document outlines an application for clearance of a medical device, the Progreat™ catheter, based on substantial equivalence to a previously cleared device (K033583). As such, it does not contain a study report for the device meeting specific quantitative acceptance criteria in the way a medical AI product might.

Therefore, many of the requested sections (2-9) regarding sample size, ground truth, expert adjudication, and comparative effectiveness studies are not applicable to this type of regulatory submission (a 510(k) for substantial equivalence of a physical device with minor changes/expanded indications where no new performance data was required).

However, I can extract information related to the device description, intended use, and the basis for its perceived performance and safety as presented.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This submission is based on substantial equivalence to a prior device where no new performance testing data (i.e., a "test set") was required for the expanded indications. The performance is deemed identical to the predicate device due to identical design and materials.

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. As no new performance studies were conducted, there was no test set requiring expert-established ground truth.

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

• Not Applicable. No test set was used for performance evaluation in this submission.

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 physical medical device (catheter), not an AI diagnostic tool. No MRMC study was conducted.

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

• Not Applicable. This is a physical medical device (catheter), not an algorithm.

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

• Not Applicable. Ground truth, in the context of performance studies for diagnostic or AI devices, is not relevant here as no such studies were performed for this substantial equivalence application. The "ground truth" for this device's safety and effectiveness relies on the previously cleared device's performance, safety, and the adherence to recognized standards for biocompatibility and sterilization.

8. The sample size for the training set

• Not Applicable. This is a physical medical device. There is no "training set" in the context of AI or machine learning.

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

• Not Applicable. As there is no training set, this question is not relevant.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" here is not an empirical performance trial but rather a demonstration of substantial equivalence to a previously cleared predicate device (K033583) and adherence to recognized standards.

The principal arguments for meeting acceptance criteria are:

• Identical Device: The Progreat™ catheter submitted in K033913 is explicitly stated as being the "identical device" cleared under K033583, with no material or design changes. This implies that its performance characteristics (e.g., flexibility, kink resistance, pressure resistance, smooth movement of guide wires) are the same as the predicate.
• Expanded Intended Use with No New Safety/Effectiveness Issues: The new application expands the intended use to include additional vessels and specific procedures like Uterine Fibroid Embolization. However, the submitter asserts that "There were no new issues of safety and effectiveness with regards to the new indication. No additional testing was deemed necessary." This implies that the existing safety and performance profile of the identical device is considered sufficient for these expanded indications.
• Adherence to Standards:
  • Risk Management: A risk/hazard analysis was performed according to EN1441 and ISO 14971, indicating a structured approach to identifying and mitigating risks.
  • Biocompatibility: Blood-contacting materials were tested in accordance with ISO-10993, and results demonstrated they are biocompatible.
  • Sterilization: Sterilization conditions were validated to a Sterility Assurance Level (SAL) of 10^-6 according to AAMI/ANSI/ISO 11135, and ETO residuals meet regulatory limits.
• Accessories: The accessories supplied with the Progreat™ are also the "same as the ones used with the currently cleared device K033583."

In essence, the "proof" that the device meets acceptance criteria is the argument of substantial equivalence based on:

1. Being the exact same device as a previously cleared one.
2. Demonstrating that the expanded indications for use do not introduce new safety or effectiveness concerns.
3. Compliance with established regulatory standards for biocompatibility, sterilization, and risk management.

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