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The Paragon Infusion Kit is intended to provide continuous infusion a local anesthetic directly into an intraoperative (soft tissue / body cavity) site for general surgery for postoperative pain management. Additional routes of administration include percutaneous, subcutaneous, intramuscular and epidural infusion. The Paragon pump is re-usable. The disposable Paragon administration set is single patient use only. No testing has been conducted to determine the efficacy of the Paragon for the delivery of blood, blood products, lipids or fat emulsions. The Paragon is not intended for the delivery of blood, blood products, lipids or fat emulsions. The Paragon is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.

The Paragon Infusion Kit is identical to the I-Flow PainBuster Infusion Kit with the exception of the Paragon pump and administration set replacing the PainBuster pump. The kit is comprised of a Paragon pump and administration set (K923875) and various kit components such as catheter, needle, syringe, Y adapter, dressing, tape, gauze and carry case. The Paragon administration set is intended to attach to the kit catheter at the distal end of the set to provide continuous infusion of a local anesthetic directly into the intraoperative site for general surgery for postoperative pain management. The Paragon administration set is a disposable device intended for single patient use. The Paragon pump is reusable. The Paragon is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.

The provided text describes the "Paragon Infusion Kit" and includes a summary of safety and effectiveness, as well as operational specifications and performance data. The device is an infusion pump kit intended for continuous infusion of local anesthetics for postoperative pain management.

Based on the document, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Flow Rate Accuracy: ±10% at 95% confidence interval (as stated in Section 3.1)

Additional Acceptance Criteria / Operational Specifications (Section 3.1):

• Priming/Residual Volume: < 5 ml
• Operating Temperature: 31°C skin temperature (90°F)
• Test Solution: 0.9% NaCl
• Operating Pressure: 6.0 psi pressure source
• Head Height: 0"

The document states: "All models produced an average flow rate within the ±10% accuracy claim." (Section 3.2)

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

• Sample Size:
  • For 100 ml x 0.5 ml/hr models: 5 pieces
  • For 100 ml x 1.0 ml/hr models: 5 pieces
  • For 100 ml x 2.0 ml/hr models: 5 pieces
  • For 100 ml x 4.0 ml/hr models: 5 pieces
  • For 100 ml x 10.0 ml/hr models: 10 pieces
• Data Provenance: The document does not specify the country of origin for the data or whether the study was retrospective or prospective. It appears to be an internal laboratory performance test conducted under specified "standard operating conditions" (Section 3.1).

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

• Not applicable. The "ground truth" for this performance study is a physical measurement of flow rate against a specified target. This is a laboratory test, not an assessment requiring expert consensus on clinical data.

4. Adjudication Method for the Test Set

• Not applicable. This was a direct measurement of physical performance (flow rate), not a judgment-based assessment requiring adjudication.

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

• No. An MRMC study is relevant for diagnostic or clinical interpretation devices where human readers assess cases, often with and without AI assistance, to determine changes in diagnostic accuracy or efficiency. This document describes a medical device (infusion pump) and its physical performance, not a diagnostic algorithm.

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

• Yes, in spirit. The testing presented is entirely standalone performance for the device (infusion pump). There is no "algorithm" in the sense of AI or software interpreting data for diagnosis, but rather the mechanical performance of the pump itself. The measurements are taken directly from the device's output.

7. The Type of Ground Truth Used

• Physical Measurement/Engineered Specification: The ground truth is the targeted flow rate (e.g., 0.5 ml/hr, 1.0 ml/hr), and the device's performance is measured against this specification under controlled laboratory conditions. The "Test Solution" was 0.9% NaCl, and "Operating Pressure" was 6.0 psi, along with other specified conditions (Section 3.1).

8. The Sample Size for the Training Set

• Not applicable. The Paragon Infusion Kit is a mechanical device, not an AI or machine learning model. Therefore, there is no "training set" in the context of data-driven model development. The design and engineering of the pump and administration set are based on physical principles (e.g., Poiseuille's equation - Section 2.3.3.1).

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

• Not applicable. As explained above, this is a mechanical device and does not have a training set or ground truth established in the typical sense of AI/ML. Its performance is designed and validated through engineering principles and physical testing.

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