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ASC High Pressure Braided Tubes are accessory devices to angiographic catheters intended to provide an extended luminal connection between an angiographic injector and an angiographic catheter for the purpose of delivering radiopaque contrast medium to selected sites in the vascular system.

The HPBT are sterile, single use, disposable devices, that are delivered non-toxic and non-pyrogenic. The HPBT consists of braided polymeric tubing terminated at both ends with luer connectors. The luer connector may be one of three types: male rotating, or female. A typical HPBT is shown below. Cross-sectional views of the three luer connectors are shown on the next page. The tubing has three sub-components: extrusion base coat, reinforcement nylon braid, and extrusion top coat.

The description you've provided is for a 510(k) premarket notification for a medical device called "ASC High Pressure Braided Tubing" (HPBT), aiming to demonstrate substantial equivalence to a predicate device. This type of regulatory submission typically focuses on functional and safety performance rather than clinical efficacy studies often found with novel devices.

Given this context, the document doesn't describe a clinical study in the way a diagnostic AI device's performance would be evaluated. Instead, it describes bench testing to ensure the device meets engineering specifications and safety standards. Therefore, many of your requested points (sample size of test set, data provenance, ground truth, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable in this context.

Here's how to interpret and answer your questions based on the provided document:

Acceptance Criteria and Reported Device Performance

The document describes several performance characteristics and standards the HPBT must meet. The "reported device performance" is integrated into the descriptions of compliance with these standards and the bench testing results, which aim to demonstrate equivalence or superiority to the predicate device.

Study Details (as applicable to a 510(k) bench testing submission)

1. Sample size used for the test set and the data provenance:
   The document states "extensive bench testing of both devices" was performed. It does not specify the exact sample sizes (number of units tested) for individual tests like tensile strength, burst strength, or luer compatibility.
   Data Provenance: The testing was conducted internally by Adam Spence Corporation, implying the data is from in-house lab testing, not clinical data from a specific country. This is a prospective set of tests designed specifically for this submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This question is not applicable in the context of this type of submission. "Ground truth" established by human experts is relevant for diagnostic AI devices where human interpretation is the benchmark. For this device (HPBT), ground truth is established by engineering specifications, validated test methods (e.g., ISO standards), and physical measurements. No human experts were used to establish a "ground truth" for the performance characteristics of the tubing itself.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This question is not applicable. Adjudication methods are used in studies involving human interpretation or clinical endpoints. For bench testing, results are objective measurements against predefined criteria/standards.

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:
   This question is not applicable. MRMC studies are specific to evaluating diagnostic systems, especially those involving human interpretation (e.g., radiologists reading images with or without AI assistance). This document describes a medical device (tubing) for fluid delivery, not a diagnostic AI system.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This question is not applicable. This device is not an algorithm or an AI system. Its performance is entirely mechanical/physical.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the bench testing, the "ground truth" is defined by engineering specifications, regulatory standards (e.g., ISO for luer fittings, AAMI for sterilization), and physical measurement thresholds. For example, the "ground truth" for rated pressure is 1200 PSI, which is a design specification and a quantifiable test outcome. The "ground truth" for biocompatibility is compliance with ISO-10993-1.

7. The sample size for the training set:
   This question is not applicable. There is no "training set" as this is not an AI/machine learning device. The device is manufactured based on design specifications and then tested against those specifications and relevant standards.

8. How the ground truth for the training set was established:
   This question is not applicable as there is no training set.

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