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The Impress Angiographic Catheter is designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. Angiographic catheters with marker bands may also be used for anatomical measurements.

The Merit Impress Angiographic Catheters with/without hydrophilic coating are intravascular diagnostic catheters that are intended for the administration of contrast for conducting fluoroscopic studies. The catheters are available in a variety of 4F and 5F wire-braided and non-braided configurations ranging in length from 40cm to 125cm. The device may include a marker band to assist anatomical measurements. The devices are available in a variety of tip shapes to cater to variations in physician preference and patient anatomy.

The catheters consist of a shaft with a molded hub assembly. It is the shaft that may be offered with or without a wire-braided reinforcement. The distal tip of the device is tapered for efficient volume flow and dispersion of the contrast media. The distal tip is flexible so as to minimize the potential for vessel trauma.

The provided text is a 510(k) premarket notification summary for the Impress Angiographic Catheter. It outlines the device's characteristics, indications for use, comparison to predicate devices, and the testing conducted to demonstrate its safety and performance. However, this document does not contain information about an AI/algorithm-based medical device study.

The device in question, the "Impress Angiographic Catheter," is a physical medical device used for delivering radiopaque media in the vascular system. The testing described (design verification, design validation, and biocompatibility studies) are standard for physical medical devices and do not involve AI or software performance evaluation against an acceptance criterion that would be typical for an AI/ML product.

Therefore, I cannot provide the requested information regarding acceptance criteria and study proving an AI device meets those criteria based on the provided text. The document focuses on the substantial equivalence of a physical catheter, primarily due to changes in its material composition.

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Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. Angiographic catheters with marker bands may also be used for anatomical measurements.

The Impress Angiographic Catheter with Hydrophilic Coating is an intravascular diagnostic catheter intended for the administration of contrast for conducting fluoroscopic studies. The catheter is available in a variety of 5F braided configurations including lengths from 40 cm to 125 cm, with or without marker bands and with hydrophilic coating. The device is available in variety of tip shapes to cater to variation in physician preference and patient anatomy. The device is intended for single use only and is supplied in a sterile configuration.

The provided text describes a 510(k) premarket notification for a medical device called the Impress Angiographic Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel efficacy or conducting extensive clinical trials as might be seen for entirely new technologies.

Therefore, the acceptance criteria and study described are primarily focused on verifying that the new device performs comparably to the predicate and meets established safety standards for its type. The document does not describe an AI device, so information related to human readers, AI assistance, effect size, or standalone algorithm performance is not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a physical medical device (angiographic catheter), the "acceptance criteria" are not performance metrics in the way one might think for software or AI (e.g., sensitivity, specificity). Instead, they are related to established international and internal standards for medical device design, manufacturing, and safety. The reported device performance is that it met these standards and was found substantially equivalent.

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

The text describes various bench and design validation tests for the physical properties and functionality of the catheter. It does not refer to a "test set" of patient data or studies in the typical sense of evaluating AI or diagnostic software.

• Sample Size: Not explicitly stated as a single "sample size." The testing involves components and finished devices, and the number of units tested for each specific criterion (e.g., tensile strength, burst pressure) would be determined by internal quality control and standard methods specified in the cited ISO/ASTM standards.
• Data Provenance: The data provenance is from laboratory testing performed by Merit Medical Systems, Inc. (the manufacturer). This is not retrospective or prospective patient data, but rather controlled engineering and biological compatibility testing of the device itself.

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

This information is not applicable as the document describes the testing of a physical medical device. There is no "ground truth" derived from expert consensus on medical images or patient outcomes for this type of submission. The ground truth refers to the objective measurements against established engineering and biological standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., reading medical images). Here, the testing involves objective measurements and adherence to specified limits within the cited standards.

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

No, an MRMC study was not done. This device is a physical angiographic catheter, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone algorithm study was not done. This device is a physical catheter, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" used for this device's evaluation is based on:

• Established engineering standards: Specifications for physical properties like dimensions, strength, flow rate, stiffness, etc., as outlined in ISO and ASTM standards.
• Biocompatibility standards: Criteria defined by ISO 10993 series and FDA guidance for evaluating biological response (e.g., cytotoxicity, hemolysis).
• Predicate device's performance: The previous version of the Impress Angiographic Catheter (K093004) served as the benchmark for demonstrating substantial equivalence. The new device must perform at least as well and not introduce new safety concerns.

8. Sample Size for the Training Set

There is no training set as this is not an AI/machine learning device. The device itself is manufactured based on established designs and processes and then verified through testing.

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

This is not applicable as there is no training set mentioned in the context of this device's submission.

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Angiography catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. Angiographic catheters with marker bands may also be used for anatomical measurements.

The Impress® Angiographic Catheters with hydrophilic coating are single lumen catheters offered in 4F and 5F sizes and 40cm to 125cm. The outer surface of the distal segment of the catheter shaft is coated with a hydrophilic coating.

The provided text pertains to a 510(k) premarket notification for a medical device, specifically the Impress® Angiographic Catheter with Hydrophilic Coating. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies with a statistical analysis plan typically associated with novel AI devices.

Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, ground truth types) are not applicable to this document. The submission relies on comparative testing to existing, legally marketed devices.

Here's an analysis based on the information provided:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly list a table of "acceptance criteria" against numerical performance metrics for the device, as would be expected for an AI/diagnostic device. Instead, it states:

The "performance tests" mentioned are likely a series of engineering and biocompatibility tests (e.g., burst pressure, tensile strength, lubricity for the hydrophilic coating) to ensure the device meets its design specifications and operates safely, as opposed to a diagnostic accuracy study. The document emphasizes substantial equivalence to existing predicate devices (Impress® Angiographic Catheter K053171 and Radifocus® Glidecath™ K915414).

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 is a medical device registration (510(k)) for an angiographic catheter, not a diagnostic AI device requiring a clinical test set with patient data. The "tests" refer to device-specific engineering and biological compatibility evaluations.

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. Ground truth establishment by experts is relevant for diagnostic performance studies, which are not detailed here.

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

Not applicable. Adjudication methods are used in clinical studies when establishing ground truth from multiple expert interpretations, which is not described in this 510(k) 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 not an AI-assisted diagnostic device.

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

Not applicable. This is not an AI device.

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

Not applicable. The concept of "ground truth" as relevant to diagnostic accuracy is not discussed. The "truth" here would refer to the device meeting its engineering specifications and being biologically safe and compatible.

8. The sample size for the training set

Not applicable. Training sets are relevant for AI algorithms.

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

Not applicable. Training sets and their ground truth are relevant for AI algorithms.

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