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The Upstream Needle Holder is intended to facilitate the placement of guidewires into the vascular system.

The Upstream Needle Holder is a sterile, single lumen rigid polymer tube having male luer connector at the distal end to provide connection to standard needle, and female luer connectors at the proximal end for guidewire access. The Upstream Needle Holder with shut-off connector includes a standard shut-off connector. The shut-off connector includes a sliding element that opens and closes the connector lumen.
The Upstream Needle Holder is intended for use with guidewires of up to 0.0315" diameter. The Upstream Needle Holder is provided in a 23 cm length. The hub at distal end of the Upstream Needle Holder interfaces with a standard needle connection. The hub at the proximal end of the Upstream Needle Holder allows guidewire access, or connection of shut-off connector through which a guidewire is inserted and may be locked in position using the connector lock position.

Here's an analysis of the provided 510(k) summary regarding the Upstream Peripheral Technologies Needle Holder, structured according to your requested information.

It's important to note that this document is a 510(k) summary for a medical device and not a study report for an AI algorithm. Therefore, many of the requested points, particularly those related to AI algorithm performance, ground truth establishment for AI, and MRMC studies, will not be applicable. This device is a physical medical instrument, not a software algorithm.

Acceptance Criteria and Device Performance (Upstream Needle Holder)

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary lists the types of tests performed but generally does not provide specific numerical acceptance criteria or detailed quantitative results for each test. It states a general conclusion for each category of testing.

General Conclusion from Document: "All of these tests demonstrated that the Upstream Needle Holder meets its intended performance specifications." And "In vitro verification testing demonstrates that the Upstream Needle Holder performs as intended and meets all design specifications with respect to their mechanical and handling characteristics, and that its materials are biocompatible."

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

This document describes the testing of a physical medical device, not an AI algorithm. Therefore, the concept of "test set" and "data provenance" (in the context of country of origin of data or retrospective/prospective studies) as typically applied to AI performance evaluation does not apply.

• Sample Size: The document does not specify the exact number of units tested for each in-vitro bench test or biocompatibility assessment. Standard practice for such device testing would involve a statistically relevant number of samples to ensure reproducibility and reliability, but specific numbers are not provided in this summary.
• Data Provenance: Not applicable in the context of an AI test set. The tests were performed in vitro (bench testing) and in vivo (biocompatibility animal testing, though specific to material interaction, not clinical data) as part of the device's development and regulatory submission.

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

Not applicable. This is not an AI algorithm requiring expert-established ground truth from diagnostic images or clinical data. The "ground truth" for the device's performance is established by direct physical measurements according to engineering specifications and biological assessments against established safety standards.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI algorithm requiring adjudication of diagnostic outputs. The "adjudication" of device performance is through direct measurement, observation, and adherence to predefined test methods and acceptance criteria.

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 algorithm, and therefore, an MRMC study comparing human performance with and without AI assistance is irrelevant.

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

Not applicable. This is not an AI algorithm. Its performance is inherent in its physical and mechanical properties.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on well-established engineering principles, material science standards (e.g., ISO 10993 for biocompatibility), and functional requirements for medical devices of its type.

• For Biocompatibility: Ground truth is established by standardized biological tests demonstrating the absence of harmful biological reactions.
• For In Vitro Bench Testing: Ground truth refers to the device meeting its predefined design specifications and functional requirements (e.g., tensile strength values, leak tightness, dimensional accuracy, smooth guidewire passage). These specifications are engineering-driven and based on the intended use and safety profile required for an Introducer Catheter.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm that requires a "training set."

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

Not applicable. This is not an AI algorithm; there is no "training set" or corresponding ground truth to establish in this context.

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