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1. The Paragon Infusion System with Bolus is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, subcutaneous, intramuscular and epidural.
2. The Paragon Infusion System with Bolus is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous.

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The provided document is a 510(k) clearance letter from the FDA for the Paragon Infusion System with Bolus. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to devices already on the market prior to May 28, 1976, or reclassified. This substantial equivalence determination is based on a review of the company's premarket notification, which would have included data and information to support this claim. However, the details of that data and the specific performance criteria used for testing are not included in this FDA clearance letter.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method for the test set: This information is not present.
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: This device is an infusion system, not an AI-assisted diagnostic tool, so an MRMC study is not applicable and is not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This device is an infusion system, not an algorithm.
7. The type of ground truth used: This information is not present.
8. The sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

The document primarily focuses on the regulatory clearance process, outlining the device's classification, product code, and indications for use. It also provides contact information for further inquiries regarding FDA regulations.

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• 1. The Paragon Infusion System is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain medications for general, subcutaneous, intramuscular and epidural.
• 2. The Paragon Infusion System is also intended for continuous and/or intermittent infusion of medication (such as local anesthetics or narcotics) to surgical wound sites for postoperative pain relief via percutaneous or indwelling catheter.

The Paragon Infusion System consists of a reusable mechanical infusion pump and various types of single use administration sets. This special 510(k) proposes a new line of administration sets that incorporates a variable flow rate mechanism.

This document is a 510(k) premarket notification for a medical device (Paragon Infusion System) and does not contain the detailed study information required to populate the acceptance criteria table and answer the specific questions.

The provided text is a summary of safety and effectiveness, focused on demonstrating substantial equivalence to existing devices for regulatory approval, not a scientific study report with performance metrics.

Therefore, I cannot provide the requested information from the given input. To answer these questions, a document detailing the actual performance testing, clinical study results, and ground truth establishment would be needed.

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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 Infusion 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.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Flow Rate Performance Data:

Other Specifications:

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

• Sample Sizes:
  • For 100 ml x 0.5 ml/hr, 1.0 ml/hr, 2.0 ml/hr, and 4.0 ml/hr models: N = 5 pieces each.
  • For 100 ml x 10.0 ml/hr model: N = 10 pieces.
• Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission, this would be prospective testing conducted by the manufacturer for regulatory approval. The country of origin is I-Flow Corporation, based in Lake Forest, CA, USA.

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

• Not Applicable. This study is a performance evaluation of a mechanical device (infusion pump and administration set) against physical specifications (flow rate accuracy). It does not involve human interpretation or subjective assessment that would require expert ground truth establishment in a medical imaging or diagnostic context.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is a performance test for a mechanical device against objective, quantitative metrics (flow rate, standard deviation), there is no human adjudication process involved. The results are directly measured.

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

• No. An MRMC study is not relevant for this type of device and performance testing. MRMC studies are typically used to evaluate the impact of a diagnostic tool or AI algorithm on human reader performance in interpreting medical images or data.

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

• Not Applicable. This device is a mechanical infusion pump, not an algorithm or AI system. The performance testing is inherently "standalone" in the sense that it measures the device's physical output (flow rate) directly.

7. The Type of Ground Truth Used:

• The "ground truth" for this study is the predefined design specification of ±10% accuracy for the flow rate of the infusion pump across its various models. The device's measured flow rates are compared directly against these quantitative specifications. The measurements are taken under "standard operating conditions" (e.g., operating temperature, test solution, operating pressure, head height).

8. The Sample Size for the Training Set:

• Not Applicable. This is a mechanical device, not a machine learning model. Therefore, there is no "training set."

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

• Not Applicable. As there is no training set, this question is irrelevant.

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