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Prepare™ Administration Set is intended for the administration of various medical solutions from an IV container to the patient's access catheter and is used only with Deltec CADD®-1, CADD®-Plus, and CADD®-PCA pumps. Intended for intravenous, intra-arterial, subcutaneous, epidural, and subarachnoid administration.

Prepare™ Administration Set is indicated for use in acute and alternate site settings. Alternate sites include, but are not limited to, infusion clinics, nursing homes, and home healthcare.

Prepare™ Administration Set is designed for use with Deltec CADD®-1, CADD®-Plus, and CADD®-PCA pumps. The device provides the interface with the pump and a sterile fluid path from an infusion fluid container to a patient's access catheter.

Here's a breakdown of the acceptance criteria and study information for the Prepare™ Administration Set based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study conducted was a bench test comparison between the Prepare™ Administration Set and the predicate device, the CADD® Administration Set, along with biocompatibility and sterility testing.

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

• Sample Size: The document does not specify the exact sample size for the bench tests. It only states that "the device and the predicate were subjected to various bench tests."
• Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing by APPRO Healthcare, Inc. (the manufacturer). This would be prospective data generation for premarket submission. No country of origin for the data is mentioned other than the manufacturer being in the US.

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

• Not Applicable. This type of device (administration set) does not typically involve expert review for its performance evaluation in the way, for instance, a diagnostic image analysis AI would. The "ground truth" for the performance criteria (e.g., accuracy of delivery) would be established by calibrated measurement instruments and engineering specifications.

4. Adjudication Method for the Test Set

• Not Applicable. As no expert review or human interpretation was involved for determining the device's functional performance during bench testing, no adjudication method was necessary or performed.

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

• No. An MRMC study is not relevant for this type of medical device (an administration set). These studies are typically conducted for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance to measure performance improvement.

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

• No. This device is a passive administration set and does not involve an algorithm or AI. Its function is mechanical/fluidic, not computational.

7. The Type of Ground Truth Used

• The ground truth for the performance criteria (accuracy of delivery, volume delivered, fit to pump) would have been objective measurements obtained from calibrated testing equipment and engineering specifications, compared against the predicate device's established performance.
• For biocompatibility, the ground truth was based on standardized biological assays as recommended by ISO-10993-1.
• For sterility, the ground truth was based on validated sterilization process criteria (e.g., Sterility Assurance Level - SAL).

8. The Sample Size for the Training Set

• Not Applicable. This device does not use machine learning or AI, and therefore does not have a "training set."

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

• Not Applicable. As there is no training set for this type of device, this question is irrelevant.

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