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For use with a vascular access device for the administration of drugs and solutions. The Padi-Lock Medical Tubing Length Reducing Apparatus can be connected to the administration set by snaking through the device to shorten the length of the tubing. The device is intended to be used in hospitals and home patient care worere IV tubing is used.

The Padi-Lock was designed to control the excess length in IV tubing. This patented device efficiently reduces the slack in tubing that can get tangled or tripped on causing additional patient injury or discomfort. The Padi-Lock hangs freely on the IV tubing. The Padi-lock efficiently reduces up to 32 inches of excess IV tubing. The Padi-Lock is made of polystyrene. The device dimensions are 7.5'' x 4.42'' x 0.28" (L x W x H) with a tube channel designed to fit the outer dimension of IV tubing (0.14"). The tubing is snaked through the device so that it securely sits in the channel for unobstructed flow of the fluid through the tubing.

This document describes the Padi-Lock Medical Tubing Length Reducing Apparatus and its substantial equivalence to a predicate device. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that "The devices met the requirements of the predetermined acceptance criteria" and "All devices passed the test" for a functionality bench test. However, it does not explicitly list the quantitative or qualitative acceptance criteria nor the detailed reported device performance against those criteria. It only states that the device successfully met them.

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

• Sample Size: The document states "All devices passed the test," implying that all test devices that underwent the "User/Performance Testing Protocols" passed. However, the absolute number of devices tested (the sample size used for the test set) is not specified.
• Data Provenance: The testing was "Bench testing," indicating it was conducted under controlled laboratory conditions, likely in the US by the manufacturer (Padi-Lock, LLC). It was a retrospective analysis of the device's performance against pre-defined protocols.

3. Number of Experts and Qualifications for Establishing Ground Truth for the Test Set:

• Number of Experts: This information is not provided.

• Qualifications of Experts: This information is not provided.

  Note: Given this was bench testing for a physical apparatus that does not directly interact with patient physiology or diagnostic imaging, the concept of "ground truth established by experts" in the traditional sense of clinical or diagnostic studies may not directly apply. The 'ground truth' in this context would likely be defined by engineering specifications and functional requirements.

4. Adjudication Method for the Test Set:

• Adjudication method: This information is not provided. Given the nature of bench testing, it's more likely that direct measurement and observation against specified criteria were used, rather than an adjudication process between multiple human evaluators.

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

• MRMC study: No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not performed." This type of study typically involves human readers (e.g., radiologists) evaluating cases with and without AI assistance to measure a difference in diagnostic performance. The Padi-Lock device is a physical apparatus, not an AI or diagnostic tool.

• Effect size of human reader improvement: Not applicable, as no MRMC study was conducted.

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

• Standalone study: Yes, in a sense. The "Bench testing... to assess functionality of the Padi-Lock" can be considered a standalone performance evaluation of the device itself, without human intervention in its operation beyond setting up the test. This is not an "algorithm" standalone study as typically understood for AI devices, but rather a functional performance test of the physical device. The device's performance was evaluated based on whether it met pre-determined acceptance criteria for its physical function.

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

• Type of Ground Truth: The ground truth for the bench testing was based on predetermined engineering specifications and functional requirements defined by the manufacturer and relevant standards (though specific standards are not listed). It's essentially the device's ability to perform its stated function (reducing tubing length effectively, maintaining flow) according to design parameters. This is not clinical ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: This information is not applicable as the Padi-Lock is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

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

• Ground Truth for Training Set: This information is not applicable as the Padi-Lock is a physical medical device, not an AI/machine learning algorithm that requires a "training set" or corresponding ground truth for training.

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