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The Homepump C-Series is intended for continuous infusion of medications for general infusion use, including chemotherapy and pain management. Routes of administration include intravenous, subcutaneous, intramuscular and epidural.
The KVO model of the Homepump C-Series is intended for general purpose drug and/or diluent delivery at a sufficient flow rate to maintain a patient IV line open (i.e. keep vein open). The Y-site at the distal end of the administration set allows piggy back infusions. The routes of administration include intravenous, subcutaneous and intramuscular.

Device Description

The Homepump C-Series is an elastomeric infusion pump with an integrated administration set. The elastomeric membranes function as the fluid reservoir and the pressure source. The pressure that pumps the fluid comes from the strain energy of the elastomeric membranes which are forced to expand when the pump is filled. The incorporation of fixed diameter flow control tubing or glass orifice combined with the elastomeric pressure source produces the desired flow rate. Homepump C-Series models are available in fill volumes from 50 to 500 ml and flow rates from 0.5 to 10 ml/hr. The One•Step KVO models of the Homepump C-Series have an optional Y-site and optional check valve attached to the distal end of the administration set. The following accessories are available: carry case, E-clip and power ring.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the I-Flow Homepump C-Series device based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Priming/Residual Volume:
<= 10 ml for 500 ml volume pump	Not explicitly stated but assumed met by "Testing occurred at standard operating conditions"
<= 9 ml for 270 ml volume pump	Not explicitly stated but assumed met by "Testing occurred at standard operating conditions"
<= 4 ml for 125 ml volume pump	Not explicitly stated but assumed met by "Testing occurred at standard operating conditions"
<= 3 ml for 65 ml volume pump	Not explicitly stated but assumed met by "Testing occurred at standard operating conditions"
Operating Temperature:
31°C skin temperature (88°F)	Testing occurred at standard operating conditions (which includes this temperature)
Test Solution:
0.9% NaCl	Testing occurred with 0.9% NaCl
Pressure Source:
6.0 psi	Testing occurred with a 6.0 psi pressure source
Head Height:
0"	Testing occurred at 0" head height
Flow Rate Accuracy:
±10% at 95% confidence interval	"All models produced an average flow rate and pressure within the ±10% accuracy claim."

Study Details

Based on the provided document, the submission is a 510(k) for an elastomeric infusion pump. The information focuses on demonstrating substantial equivalence to a predicate device, and the "study" described is primarily focused on performance testing of the device's physical specifications.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of devices or test runs. The document states "All models produced an average flow rate and pressure within the ±10% accuracy claim," implying that multiple units of each model (various fill volumes and flow rates) were tested.
- Data Provenance: The data appears to be from internal testing conducted by I-Flow Corporation. There is no mention of external validation, clinical trials, or specific countries of origin for the data beyond being generated by the manufacturer. The testing described is retrospective in the sense that it was conducted as part of the device development and regulatory submission process.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this submission. The "ground truth" for this device's performance is objective measurement against specified engineering and performance criteria (e.g., flow rate accuracy, pressure, temperature). It does not involve human interpretation or expert consensus in the way a diagnostic imaging study would.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in studies where human interpretation (e.g., of medical images) is involved and discrepancies need to be resolved. This document describes objective performance testing.
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 comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices involving human readers. The Homepump C-Series is a medical device for infusion, not an AI or diagnostic imaging tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance test was done. The described testing ("All models produced an average flow rate and pressure within the ±10% accuracy claim") is a standalone performance evaluation of the device itself, without a human operator's influence on the core performance metrics being evaluated. It measures the device's ability to maintain a flow rate and pressure according to its design specifications. There is no "algorithm" in the sense of a software-based AI algorithm for this device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this device's performance is based on pre-defined engineering specifications and direct physical measurement. For instance, flow rate is measured against a target rate, and accuracy is determined by how close the measured rate is to the target.
The sample size for the training set:
- This question is not applicable. The Homepump C-Series is a mechanical/elastomeric infusion pump, not a learning algorithm or AI model that requires a "training set" of data.
How the ground truth for the training set was established:
- This question is not applicable for the same reasons as above.

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