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The PICC WAND™ Peelable Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.

The PICC WAND™ Peelable Safety Introducer is an all-in-one preassembled intravascular catheter introducer that consists of the following basic introducer components: Introducer Needle, Nitinol Guidewire, Dilator and a peelable Sheath Introducer. It is intended to provide the clinician with a safe, simple and accelerated approach, using the Accelerated Seldinger Technique, to place an in-dwelling intravascular catheter through the skin into the circulatory system. The peelable Sheath Introducer allows for the placement of peripherally inserted central catheters (PICC) and midline catheters. The device includes a Fast-flash™ feature that provides the clinician with feedback that the introducer needle is in the intraluminal position within the blood vessel. The device also incorporates a safety mechanism to guard against accidental needle stick.

The provided text describes a 510(k) premarket notification for a medical device, the PICC WAND™ Peelable Safety Introducer. The document focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria for a novel AI or diagnostic device. Therefore, much of the requested information (e.g., sample size for test set, data provenance, ground truth establishment, MRMC study, training set details) is not applicable or cannot be extracted from this type of regulatory submission.

However, I can extract information related to the device performance and the study conducted to demonstrate equivalence.

Here's a summary based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail form for a new device's performance. Instead, it focuses on demonstrating equivalence to a predicate device. The "performance characteristics" and "requirements of the product design specification" serve as the de facto acceptance criteria, implying that the modified device must perform at least as well as, or be equivalent to, the predicate and meet established design requirements.

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

• Sample Size for Test Set: Not specified in the document. The testing was "in vitro bench testing," implying laboratory-based testing rather than patient data.
• Data Provenance: Not applicable in the context of patient data, as the tests were in vitro bench tests.

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

Not applicable. The "ground truth" for this device's performance is determined by physical measurements and functional tests in a laboratory setting, not by expert interpretation of data or images.

4. Adjudication Method for the Test Set

Not applicable. This device's performance is assessed through objective physical and functional tests, not by human adjudication of ambiguous results.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results, often with AI assistance. The PICC WAND™ is a medical instrument, and its performance is evaluated through engineering and functional bench tests.

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

Not applicable. The PICC WAND™ is a physical medical device, not an algorithm, so the concept of "standalone performance" in this context does not apply.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this product is derived from engineering specifications, established physical testing methodologies, and performance standards for such introducer devices. For instance, "columnar strength" would be determined by a force gauge, and "Fast-flash function and timing" would be measured with a stopwatch or similar timing device under controlled conditions.

8. The Sample Size for the Training Set

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

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

Not applicable, as there is no training set for this device.

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The PICC WAND® Peelable Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.

The PICC WAND® Peelable Safety Introducer is an integrated sterile, single-use intravascular catheter introducer. It is designed to incorporate a combination of devices into an all-in-one device that provides the clinician with a safe and simple approach to the Modified Seldinger technique, and thereby accelerate the procedure required to place indwelling intravascular catheters. The device includes an Introducer Needle, Guidewire, Dilator, and a Peelable Sheath Introducer in a single integrated device, and incorporates a safety mechanism to guard against accidental needlestick.

The provided document describes the 510(k) premarket notification for the PICC WAND® Peelable Safety Introducer. The information primarily focuses on establishing substantial equivalence to a predicate device through biocompatibility and performance testing. There is no information regarding AI-based devices or studies that would involve AI models. Therefore, many of the requested categories are not applicable to this submission.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

Study Details (Focus on Safety and Performance, Not AI)

1. Sample size used for the test set and the data provenance:
   The document does not specify the sample sizes for the biocompatibility or in vitro bench testing. The data provenance is not explicitly mentioned (e.g., country of origin), but it is implied to be from studies conducted by Access Scientific, Inc. for regulatory submission in the USA. These tests are prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not applicable. The studies described are laboratory/bench tests and biocompatibility assessments, not clinical studies requiring expert ground truth for interpretation of medical images or data.

3. Adjudication method for the test set:
   This information is not applicable as the studies are not clinical trials that would require adjudication for outcomes.

4. 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 a medical device (catheter introducer), not an AI-powered diagnostic or assistive tool. No MRMC study was performed.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable. This device does not involve an algorithm or AI.

6. The type of ground truth used:
   For biocompatibility, the ground truth would be established by validated test methods adhering to ISO standards (e.g., ISO 10993 series) for biological safety, with results compared against predetermined safety thresholds. For biomechanical performance, the ground truth would be established by engineering specifications and performance requirements derived from the predicate device and intended use, measured through in vitro bench testing.

7. The sample size for the training set:
   Not applicable. This device does not involve a training set as it is not an AI/ML product.

8. How the ground truth for the training set was established:
   Not applicable (no training set).

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