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The Avalon Elite™ Multi-Port Venous Femoral Catheter with Introducer is indicated to drain central venous blood via the femoral vein during extracorporeal procedures for up to six hours.

The Avalon Elite Multi-Port Venous Femoral Catheter is a one piece, wire reinforced cannula with multiple side hole drainage openings proximal to an open tip. The catheter is supplied with a dilator/introducer to facilitate placement into the vasculature by normal access techniques. The introducer/dilator is intended to follow a pre-positioned standard guidewire (not supplied.) The cannulae are available in 20 Fr, 22 Fr, 24 Fr, 26 Fr, and 28 Fr sizes. The insertable length is 24 inches [61cm]. The device is supplied sterile, non-pyrogenic and is intended for single use via prescription.

The provided document is a 510(k) Premarket Notification for a medical device called the Avalon Elite™ Multi-Port Venous Femoral Catheter. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. As such, it does not contain acceptance criteria for specific performance metrics in the same way a clinical trial for a novel device would. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence through comparative testing with the predicate device.

Here's an analysis based on the provided text, addressing your questions as much as possible given the nature of a 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" (e.g., "device must achieve X% accuracy") are not stated. The performance is reported in comparison to a predicate device, aiming to show similar or equivalent performance.

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

This document does not specify the exact sample sizes used for each performance test (e.g., number of catheters tested for pressure/burst). The tests are typically laboratory-based engineering and material performance assessments, not clinical studies with human participants. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" don't apply here.

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

Not applicable. The performance testing described (Pressure/Burst, Simulated Use, etc.) are engineering and material tests, not tests that require expert assessment of a "ground truth" derived from human interpretation.

4. Adjudication Method for the Test Set

Not applicable. This type of testing involves objective performance measurements rather than subjective expert interpretations requiring adjudication.

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 device is a physical medical catheter, not an AI/software device that assists human readers. Therefore, an MRMC study related to AI assistance is not relevant.

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

Not applicable. This device is a physical medical catheter, not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by objective engineering measurements and material science standards for parameters like pressure resistance, tensile strength, flow rates, and biocompatibility. The comparison is then made against the established performance characteristics of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

Not applicable. As there's no training set, there's no ground truth to be established for it.

Summary of the Study Proving Acceptance Criteria:

The "study" proving the device meets the (implicit) acceptance criteria is a series of "numerous tests and comparisons to the predicate device" conducted by Avalon Laboratories, LLC. These tests are listed as:

• Pressure/Burst
• Simulated Use
• Kink Resistance
• Tensile Strength
• Flow Characteristics
• Hemolysis
• Biocompatibility

The conclusion from these tests was that the Avalon Elite™ Multi-Port Venous Femoral Catheter is "substantially equivalent to the predicate device currently in commercial distribution," specifically the Bio-Medicus Multi-Stage Venous Femoral Cannula with Introducer (K052524). The equivalence was demonstrated across "similar design, size, and generic materials of construction," and the Avalon products were found "equivalent to the predicate products in all key areas of features and performance." The document also explicitly states that "Testing under simulated use conditions shows that the Avalon catheter maintains performance after 7 days."

The FDA's review and approval (K081933) indicate their agreement that the device demonstrates substantial equivalence based on the submitted data, allowing it to be marketed.

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