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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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