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The Aveir™ Introducer is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.

The Aveir™ Introducer is designed to perform as a guiding sheath for introduction of diagnostic or interventional devices. It is intended to provide a conduit into the venous system for insertion of diagnostic or interventional devices. The Aveir™ Introducer has a 25 French (Fr) inner diameter and comes in two lengths - Model LSN25301, 30 cm. and Model LSN25501, 50 cm. The only difference between the two models is the length.

The Aveir™ Introducer comprises the following two components:

1. Introducer sheath with a flush port and a three-way stopcock
2. Dilator

The introducer sheath is coated with a hydrophilic coating and is fitted with a suture loop, a sideport with a three-way stopcock, and a hemostasis valve, which minimizes air introduced and maintains hemostasis during insertion and/or exchange. The sheath contains a radiopaque tip marker incorporated within the sheath material to identify the location of the distal tip sheath. The dilator contains a locking mechanism that locks the dilator into the introducer sheath.

The introducer sheath and dilator are supplied sterile (via ethylene oxide) in one package and are intended for single procedure.

This document is a 510(k) Premarket Notification from the FDA regarding the "Aveir Introducer," a medical device manufactured by Abbott Medical. It focuses on demonstrating the substantial equivalence of the Aveir Introducer to previously marketed predicate devices.

Based on the provided text, the document describes performance testing for a medical device (Aveir Introducer) used as an introducer sheath. However, it does not detail acceptance criteria or specific study results in a format typically seen for algorithms or AI/ML-based device performance evaluations (e.g., accuracy, sensitivity, specificity, AUC).

Instead, the "Performance Data" section discusses:

• Biocompatibility Testing: According to ISO 10993-1 and FDA Guidance, including tests like cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, hemocompatibility (hemolysis, complement activation, thrombogenicity), and particulate matter.
• Bench Testing: Including design verification (physical, dimensional, functional characteristics, hydrophilic coating lubricity and durability) and packaging/shelf life testing.
• Animal Testing: An acute GLP study for usability validation related to implanting or retrieving a leadless pacemaker via the femoral vein.

Therefore, many parts of your request for information about acceptance criteria for an AI/ML system and the detailed study proving its performance cannot be answered from the provided text. The document describes a traditional medical device (catheter introducer) and its non-AI related performance evaluation.

However, I can extract what is implied about "acceptance" in the context of this device's testing:

Acceptance Criteria and Device Performance (Based on available information, not AI/ML specific):

The document states:
"Based on the results of usability validation testing, the Aveir™ Introducer possesses acceptable usability and acceptable residual usability risk based on the observed difficulties and use errors of the participants. All acceptance criteria were met under the conditions of the study. There were no observed use errors that could result in serious patient harm."

And for the overall performance:
"The resulting evidence obtained from the design verification and validation testing demonstrated that the subject device is substantially equivalent to the predicate devices."

While the specific quantitative acceptance criteria for each test (biocompatibility, bench, and animal) are not explicitly stated in a table, the overall conclusion is that the device met its design specifications and criteria.

Table of Acceptance Criteria and Reported Device Performance (Inferred from text):

Since this document pertains to a traditional medical device and not an AI/ML system, the following points cannot be addressed or are not applicable from the provided text:

2. Sample size used for the test set and the data provenance: Not applicable in the AI/ML sense. For animal testing, it was an "acute GLP study." For biocompatibility and bench testing, sample sizes are usually defined by the specific test standards, but not specified here. Data provenance (country, retrospective/prospective) is not mentioned for quantitative data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device testing. Usability in animal models involves observing procedures by trained personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, ground truth largely relates to meeting engineering specifications, biological safety standards, and successful performance in animal models (e.g., successful insertion, no observed harm, expected physical properties).
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

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