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The Micro Ace™ Advanced Micro Access System is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guidewire into the vascular system.

The Merit Micro Ace™ Advanced Micro Access System (hereafter referred to as Micro Ace™) provides access to the vascular system and facilitates the placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wire. The system is available in 4 French and 5 French sizes – and includes the coaxial introducer-dilator pair, a 21 gauge needle and a 0.018" (0.46mm) guide wire.

The introducer-dilator assembly that is included in each kit is 10 cm effective length. The system will be offered with optional guidewires:
• Some catalog codes will include a nitinol wire with platinum guide wire tips;
• Some catalog codes will be offered with a stainless steel wire with platinum guidewire tips.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Micro Ace™ Advanced Micro Access System." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on human-in-the-loop or standalone AI performance.

Therefore, the following information cannot be extracted from the provided text:

• No AI/Machine Learning Component: The prompt's questions (e.g., about AI assistance, standalone algorithm performance, training/test set ground truth, expert adjudication) are relevant to a medical device that incorporates AI or machine learning. The Micro Ace™ Advanced Micro Access System is a physical medical device (a vessel dilator for percutaneous catheterization) and does not appear to have any software or AI component described in this document. The term "algorithm" is not mentioned in the context of device performance.
• No "Acceptance Criteria" for AI/Software Performance: The document outlines the performance testing conducted to ensure the device functions as intended and is safe, but these are typical engineering and biocompatibility tests for a physical device, not performance metrics for an AI algorithm.
• No Human Reader Study: Since there's no AI component, there's no multi-reader multi-case (MRMC) comparative effectiveness study with human readers assisting with AI.
• No Training or Test Sets for AI: The concepts of training and test sets and ground truth establishment (expert consensus, pathology, outcome data) are specific to AI/ML model development and evaluation. These do not apply to the physical device described.

Instead, the document details the following for a physical medical device:

1. Acceptance Criteria and Reported Device Performance (Summary):

The document states that "All tested samples met pre-established performance criteria and were deemed acceptable." Specific numeric acceptance criteria are not provided in the text, nor are the detailed reported performance metrics for each test. The document lists the types of tests performed:

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

The document mentions that both 4F and 5F Micro Ace™ products were tested, and testing included sterile devices (following ethylene oxide processing) and aged devices. The exact numerical sample size for each test is not specified.
The data provenance is from Merit Medical Systems, Inc., the manufacturer. It is internal device testing, not patient data from a specific country or retrospective/prospective study in a clinical setting.

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

This question is not applicable as the studies relate to physical device performance testing (e.g., mechanical properties, biocompatibility), not the establishment of ground truth for diagnostic imaging or similar applications requiring expert consensus. "Clinician feedback" was part of design validation, but the number and qualifications of these clinicians are not detailed.

4. Adjudication Method for the Test Set:

Not applicable. This refers to consensus building among experts for tasks like image labeling, which isn't relevant to the described device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This type of study is for evaluating diagnostic performance (often with AI assistance). The Micro Ace™ is a physical medical access system, not a diagnostic device.

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

No. This refers to AI algorithm performance.

7. The Type of Ground Truth Used:

Not applicable in the context of diagnostic AI. The "ground truth" for this device's performance is determined by meeting pre-specified engineering and biocompatibility test standards (e.g., a specific tensile strength value, absence of cytotoxic effects).

8. The Sample Size for the Training Set:

Not applicable. There is no AI model or "training set" for this physical device.

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

Not applicable.

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