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The S.P.A.R. " Sterile Ambulatory Reservoir is intended for use with the Sims Deltec CADD-PCA® Model 5800 and CADD-Prizm® Model 6100 Ambulatory Infusion Pumps, manufactured and distributed by Sims Deltec Inc., St. Paul, Minnesota. The S.P.A.R. Ambulatory Reservoir is intended for use as an accessory to the Sims Deltec CADD-PCA® Model 5800 and CADD-Prizm® Model 6100 infusion pumps by replacing the Deltec Medication Cassette ™, Model 2050 - 50 mL and 2100 - 100 mL with S.P.A.R. ™ Sterile Ambulatory Reservoir.

The S.P.A.R.TM Sterile Ambulatory Reservoir is a sterile, disposable, nonpyrogenic, tamper proof (evident), ambulatory, reservoir system designed for use with the SIMS Deltec CADD-PCA® Model 5800 and CADD-Prizm® Model 6100 infusion pumps.

This document describes the 510(k) summary for the S.P.A.R.™ Sterile Ambulatory Reservoir. The primary purpose of the submission is to demonstrate the substantial equivalence of the S.P.A.R.™ reservoir to the predicate device (SIMS Deltec Medication Cassette™) when used with the SIMS Deltec CADD-Prizm® Model 6100 infusion pump.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds in the provided text. Instead, the study's goal was to demonstrate "equivalence" by showing that both reservoirs are affected by various factors in a "similar manner." The reported performance demonstrates this similarity in response.

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

• Sample Size for Test Set: Not explicitly stated in the provided text. The document refers to "measured stroke displacement data" without detailing the number of test runs, reservoirs, or conditions.
• Data Provenance: The study was carried out by the manufacturer (Faulding Pharmaceutical Company) to compare their S.P.A.R.™ reservoir to the predicate SIMS Deltec Medication Cassette™. This suggests prospective, in-house laboratory testing rather than data from real-world patients or clinical settings. The country of origin for the data is implicitly the country where Faulding Pharmaceutical Company conducted its research, which appears to be the USA (Cranford, New Jersey is listed as the address).

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

Not applicable. This device is an accessory to an infusion pump, and the study focuses on the physical performance characteristics (stroke displacement) of the reservoir under various conditions. The "ground truth" here is the physical measurement of stroke displacement, not a clinical diagnosis or interpretation requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" is measured physical performance. There's no human interpretation or adjudication involved in determining stroke displacement.

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

Not applicable. This is not an AI/imaging device, and no human reader study or MRMC comparative effectiveness study was performed.

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

Not applicable. This device is a passive mechanical component (a reservoir) and does not involve algorithms or AI.

7. The Type of Ground Truth Used

The ground truth used was measured physical performance data: specifically, stroke displacement measurements under various controlled environmental and operational conditions (temperature, back pressure, fluid viscosity, flow rate).

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI, and 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 for this device.

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