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The Concierge® Guiding Catheter is intended for the intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

The Concierge Guiding Catheter is a single lumen catheter that incorporates a Pebax body reinforced with stainless steel wire braid, a PTFE lubricious inner lumen, and a soft radiopaque tip. It is available in 5F, 6F, 7F and 8F sizes, 100cm long and is produced in a variety of shapes.

The provided text describes the 510(k) Summary for the Merit Medical Systems, Inc. Concierge® Guiding Catheter, which is a medical device and not an AI/ML powered device. Therefore, the information required, such as acceptance criteria in the context of AI/ML performance metrics, sample sizes for training/test sets, expert adjudication methods, MRMC studies, and ground truth establishment, is not applicable to this document.

The document discusses the substantial equivalence of the subject device to a predicate device based on its design, intended use, and conventional safety and performance tests. It doesn't involve any AI/ML components or their evaluation.

Here's an analysis of the provided text in the context of the requested information, highlighting why most of it is not relevant:

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

• Acceptance Criteria: The document lists various tests performed (Device Testing, Packaging Testing, Biocompatibility Testing) based on international standards (e.g., ISO 10555-1, ISO 10993-1). The acceptance criteria for these tests are implied to be compliance with these standards and the successful achievement of pre-determined criteria.
  • Examples of tests: Dimensions, Air Leak, Liquid Leak, Catheter Tip Support and Attachment, Tensile, Shaft Kink, Shaft Stiffness, Simulated use testing, Visual Inspection (packaging), Dye Penetration (packaging), Cytotoxicity, Hemocompatibility, Chemical Characterization.
• Reported Device Performance: The document states, "The results of the testing demonstrated that the subject Concierge Guiding Catheters met the pre-determined acceptance criteria applicable to the safety and efficacy of the device." Specific numerical performance metrics for each test (e.g., exact tensile strength achieved, precise leak rate) are not provided in this summary.

2. Sample sizes used for the test set and the data provenance:

• Not Applicable: This type of information (sample size for test sets, data provenance like country of origin, retrospective/prospective) is relevant for AI/ML model validation using datasets. For a physical medical device like a guiding catheter, "sample size" would refer to the number of catheters tested for each physical or biological property, which is not detailed in this summary. The "data provenance" refers to the origin of the test results from the manufacturer's internal testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable: "Ground truth" established by experts is a concept pertinent to AI/ML model evaluation against human interpretations (e.g., radiologists labeling images). For a physical medical device, "ground truth" is typically defined by engineering specifications, material properties, and established medical standards. The testing is performed by engineers/technicians according to established protocols, not by clinical "experts" establishing a "ground truth" in the AI sense.

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

• Not Applicable: Adjudication methods are used in AI/ML validation to resolve disagreements among human annotators or model predictions. This concept does not apply to the direct physical and biological testing of a medical device.

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: MRMC studies are specifically designed to evaluate the impact of AI on human reader performance for diagnostic tasks. This device is a physical catheter, not an AI diagnostic tool, so 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 applies to AI algorithms. The device is a physical catheter, not an algorithm.

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

• Not Applicable in the AI/ML sense: For a physical device, ground truth is based on engineering specifications, physical/chemical properties, and established biological safety standards (e.g., ISO standards for biocompatibility, ASTM for material properties and packaging). There's no "expert consensus" on an image or pathology slide involved.

8. The sample size for the training set:

• Not Applicable: There is no "training set" for a physical medical device like this, as it does not involve 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.

In summary, the provided document describes the safety and performance testing of a physical medical device (Concierge® Guiding Catheter) for regulatory submission, focusing on its substantial equivalence to a predicate device. The framework of acceptance criteria and study design requested is primarily applicable to Artificial Intelligence and Machine Learning (AI/ML) powered medical devices, which is not what this document describes.

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The Concierge® Guiding Catheter is intended for the intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

The 6 French Concierge Guiding Catheter is a single lumen catheter that incorporates a nylon body reinforced with stainless steel wire braid, a PTFE lubricious inner lumen, and a soft radiopaque tip. It is available in 6F size and 100cm length and in a variety of shapes.

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the 6 French Concierge® Guiding Catheter.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Performance Tests: The device "met the pre-determined acceptance criteria applicable to the safety and efficacy of the device." The specific numerical or qualitative acceptance criteria for each test (e.g., maximum air leak rate, minimum tensile strength) are not explicitly detailed in the provided text, but it is stated that the device successfully met them.

Acceptance Criteria for Biocompatibility Tests: These tests are based on the requirements of ISO 10993 series and ASTM F756-08.

Overall Conclusion: The results of the testing demonstrated that the subject 6 French Concierge Guiding Catheter met the pre-determined acceptance criteria applicable to the safety and efficacy of the device, leading to a determination of substantial equivalence to the predicate device.

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

The provided text does not explicitly state the sample sizes used for each of the performance or biocompatibility tests. It only lists the types of tests conducted.

The data provenance (e.g., country of origin, retrospective/prospective) is not mentioned in the provided text. The tests appear to be laboratory verification tests rather than clinical studies with patient data.

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

This information is not applicable to the type of testing described. The tests performed are engineering design verification and biocompatibility tests, not studies requiring expert interpretation of clinical data or images to establish a 'ground truth'.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" is not applicable to the type of testing described (design verification and biocompatibility). These tests involve objective measurements and analyses against established standards and criteria, not subjective expert reviews that would require adjudication.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document describes engineering performance tests and biocompatibility evaluations, not clinical studies involving human readers or AI assistance.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical medical catheter, not a software algorithm or AI-driven system.

7. The Type of Ground Truth Used

The "ground truth" for the tests described is the pre-determined acceptance criteria based on established industry standards and regulatory guidance documents. These include:

• ISO 10555-1:1995 (Sterile, single-use intravascular catheters - Part 1: General requirements)
• ISO 10555-2:1996 (Sterile, single-use intravascular catheters - Part 2: Angiographic catheters)
• ANSI/AAMI/ISO 11135-1:2007 (Sterilization of health care products - Ethylene oxide)
• ISO 10993-1:2009 (Biological Evaluation of Medical Devices Part-1) and FDA Modified ISO 10993 Test Profile
• ASTM F756-08 (Assessment of Hemolytic Properties of Materials)
• ISO 10993-3 :2003 (Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity)
• ISO 10993-4:2002 (Selection of tests for interaction with blood)
• ISO 10993-5:2009 (Tests for in vitro cytotoxicity)
• ISO 10993-10:2010 (Tests for irritation and skin sensitization)
• ISO 10993-11:2006 (Tests for systemic toxicity)
• ISO 2233:2000 (Packaging - conditioning and testing)
• ASTM D4169-08 (Performance testing of shipping containers and systems)

The ground truth is these standards and the criteria derived from them, which the device must meet to be considered safe and effective.

8. The Sample Size for the Training Set

Not applicable. This document describes the testing of a physical medical device (catheter), not the development or training of a machine learning algorithm.

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

Not applicable. As stated above, this is not a study involving machine learning or algorithms with training sets.

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