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Prepare™ Cartridge is used as a drug reservoir and fluid path for administering intravenous, intra-arterial, subcutaneous, epidural, and subarachnoid drugs to a patient's access site using specified infusion pumps and extension sets.

For intravenous, intra-arterial, subcutaneous, epidural and subarachnoid administration

Prepare™ Cartridge must be used only with SIMS Deltec CADD®-1, CADD®-Plus, and CADD®-PCA pumps for the infusion of various medicinal solutions. Prepare™ Cartridge is indicated for use in acute and alternate care settings. Alternate care includes, but is not limited to, infusion clinics, nursing homes, and home healthcare.

Prepare™ Cartridge is designed for use with Deltec CADD®-1, CADD®-Plus, and CADD®-PCA pumps. The device provides a reservoir for holding up to 100ml of prepared drug and interfaces with various models of SIMS Deltec infusion pumps to provide a pathway from the reservoir to the patient's access site.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Prepare™ Cartridge:

This 510(k) summary describes a device that is an accessory to an infusion pump, not an AI/ML powered medical device. Therefore, many of the requested categories related to AI performance, ground truth, and expert review are not applicable. The device is a physical cartridge that holds medication, and its evaluation focuses on physical characteristics, biocompatibility, and sterilization.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the provided text for the bench tests. The description only states "The device and the predicate were subjected to various bench tests."
• Data Provenance: Not explicitly stated beyond being "bench tests." It can be inferred that these were laboratory tests conducted by the manufacturer, APPRO Healthcare, Inc. There is no mention of country of origin of data in a clinical sense, nor is it a retrospective or prospective clinical study. These are engineering and laboratory tests.

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

• Not applicable. This device is hardware for drug delivery, not an interpretative medical device (like imaging or diagnostics). Therefore, "ground truth" established by human experts in the context of diagnostic accuracy is not relevant here. The "truth" for physical/technical performance, biocompatibility, and sterility is determined by validated test methods and established scientific principles, not expert consensus interpretation of data.

4. Adjudication Method for the Test Set

• Not applicable. See point 3. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes, not for bench testing of a physical medical device accessory.

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

• No. This is a physical device accessory, not an AI/ML diagnostic or interpretive tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are not applicable.

6. If a Standalone (Algorithm Only) Performance Study Was Done

• Not applicable. This is a physical non-AI device. There is no "algorithm only" performance to evaluate. The performance described is of the physical cartridge itself in conjunction with the specified infusion pumps.

7. The Type of Ground Truth Used

• Engineering/Laboratory Test Standards and Specifications: The "ground truth" for the performance criteria (capacity, accuracy of delivery, volume, fit) would be derived from the design specifications of the device and established test methods, likely involving measurements against a standard for the predicate device. For biocompatibility, the ground truth is the absence of adverse biological responses as defined by ISO-10993 standards and validated assays. For sterility, it's the successful completion of a validated sterilization process to achieve a specific Sterility Assurance Level (SAL), typically 10^-6.

8. The Sample Size for the Training Set

• Not applicable. This is a physical non-AI device. There is no "training set" in the context of machine learning or AI.

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

• Not applicable. See point 8.

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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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