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The CVC WAND™ Safety Introducer with Valved Peelable Sheath is indicated for use in percutaneous insertion of catheters into the venous system.

The CVC WAND™ Safety Introducer with Valved Peelable Sheath (hereafter CVC WAND™) is a catheter introducer device that is virtually identical to the predicate device. the PICC WAND® Peelable Safety Introducer (K111138). When assembled for use, it is an all-in-one preassembled intravascular catheter introducer, that provides the clinician with a safe, simple, and accelerated approach to the Seldinger Technique for placing in-dwelling intravascular catheters. The device is composed of the following key components:

• Introducer Needle
• Guidewire
• Dilator
• Valved Peelable Sheath Introducer
  Some of the components of the predicate device have been modified to facilitate the specific clinical requirements for peripheral access for the placement of a Central Venous Catheter (CVC). The primary modification to the predicate device is the addition of a valve within the body of the Peelable Sheath Introducer Hub. When the Guidewire, Needle and Dilator are removed from the Valved Peelable Sheath Introducer, as part of performing the Accelerated Seldinger Technique procedure, the valve in the hub is actuated (in the closed position) thus preventing air from entering into the venous circulatory system and conversely preventing blood from leaking out. The valve is designed to allow passage of the CVC through it into the central venous circulatory system. This valve provides a similar function as the Bard AirGuard™ Valved Introducer, the other predicate device (K042036). After confirmation of the proper CVC placement, the Valved Peelable Sheath Introducer is removed by breaking apart the Sheath Introducer hub and peeling the sheath off the CVC in the identical manner as the predicate PICC WAND® Peelable Sheath Introducer.
  The CVC WAND™ Safety Introducer is individually packaged in a PETG, glycol modified polyethylene terephthalate, plastic tray. The tray is heat sealed with a Tyvek® lid. The device is provided 'STERILE'(ethylene oxide gas) and is for 'single-use` only.

Here's a breakdown of the acceptance criteria and study information for the CVC WAND™ Safety Introducer with Valved Peelable Sheath, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text outlines the types of tests performed and states that the results "satisfied acceptance criteria as identified in applicable standards and the device design specification." However, it does not provide specific numerical acceptance criteria or the reported device performance metrics for these tests. It only lists the tests themselves.

Here's a table summarizing the tests, categorizing them implicitly based on the context:

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

The document does not explicitly state the sample sizes (number of units) used for the prospective bench testing (Table 5.3) or the biocompatibility testing (Table 5.1).

Data provenance is not mentioned beyond the fact that the tests were conducted. There's no indication of country of origin or whether the studies were retrospective or prospective, though the term "Prospective testing" is used for the performance testing in Table 5.3.

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

This information is not applicable to the provided document. The studies described are bench tests and biocompatibility tests, not clinical studies involving expert assessment of images or patient data to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed to establish ground truth for a test set, which is not the case here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The studies focus on device performance characteristics and biocompatibility, not on the comparative effectiveness of human readers with or without AI assistance.

6. Standalone (Algorithm Only) Performance

This information is not applicable. The device is a physical medical introducer, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the tests performed can be considered the established scientific/engineering principles, validated test methods (e.g., ISO standards), and the device design specifications. For example:

• For biocompatibility, the ground truth is that the device material should not elicit adverse biological reactions as defined by ISO 10993.
• For performance tests like "Valve Liquid Leakage," the ground truth would be that the valve should prevent leakage beyond a specified (but unstated) limit.

8. Sample Size for the Training Set

This information is not applicable. There is no AI component mentioned, and thus no "training set" in the context of machine learning. The studies described are physical device testing.

9. How Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for an AI/algorithm.

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