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The EnteraLite® Infinity® Enteral Feeding Pump is a rotary peristaltic pump designed to deliver programmed doses of enteral nutrition solutions at selectable rates.

The EnteraLite® Infinity® Enteral Feeding Pump as referred to as Infinity® with disposable set is a small, lightweight pump used to dispense liquid nutrients at a user controlled rate to patients. The device may be used in the hospital or at home by bedridden or ambulatory patients. The device is also designed for use with pediatric patients.

The device is software controlled, variable flow rate, peristaltic pump. It operates up to 24 hours (at a nominal flow rate of 125 ml/hr) from internal rechargeable batteries. The batteries are recharged by a wall mounted charger that plugs into a standard 100 to 240 volt alternating current wall socket. The charger is available in various input voltage and plug configurations to accommodate international requirements. The charger converts line voltage to a safe low voltage of 5 volts DC that is supplied from the charger to the pump. A "fuel gauge" type indicator on the pump's LCD display continuously shows the state of battery charge.

The pump motor runs at a single speed and is turned on and off at programmed intervals to obtain the desired flow rate. The motor drive circuit is controlled by a microcontroller that allows the motor to pause longer at lower flow rates with correspondingly shorter pauses at higher flow rates. The software embodied within the microcontroller is validated and verified as part of the design process.

The pump includes several safety features. An air-in-line sensor rapidly detects whenever nutrient flow is interrupted and alerts the user with both a visual and audible alarm. Two pressure sensors detect occlusions both on the nutrient bag (distal) side and the patient (proximal) side of the pump. The user is alerted to proximal or distal occlusions by both visual and audible alarms.

The disposable tubing set consists of a bag, or spike for nutrient bag, PVC connecting tubing, an integral cassette with a silicone pumping segment, and an enteral adapter. The set also contains a patented anti-free flow device within the cassette, which prevents free flow of fluids if the tubing set is inadvertently or purposely removed from the pump.

A backpack (convertible to a waistpack) is available for use under ambulatory conditions. The pump may be operated in any orientation.

The provided document describes a "Special 510(k): Device modification" for the EnteraLite® Infinity® Enteral Feeding Pump, focusing on a modification to the disposable tubing set's cassette. The study aimed to verify the contact of the door/top housing to the cassette after the addition of three bumps.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document refers to "testing including statistical and graphical analysis" for the two design verification reports (TR-49430 and TR-49071), but the number of units or tests performed is not provided.
• Data Provenance: Not explicitly stated. It's an internal verification study by ZEVEX, Inc. (now Moog Medical), so the data would be proprietary and likely generated within their testing facilities. The country of origin of the data is not mentioned, but the company is based in Salt Lake City, UT, USA. The study is prospective as it's a verification test for a design modification.

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

Not applicable. This study is a non-clinical performance test validating a design modification, not a diagnostic or clinical study requiring expert ground truth for interpretation. The "ground truth" here is successful mechanical function and adherence to design specifications as determined by engineering verification.

4. Adjudication Method for the Test Set

Not applicable, as this is a non-clinical engineering verification study.

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

No. This is a non-clinical engineering verification study to assess the impact of a physical design modification. It does not involve human readers or comparative effectiveness for diagnostic tasks.

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

Not applicable. This device is a mechanical pump with software control, but the study described is an engineering verification of a mechanical modification, not an algorithm's standalone performance in a diagnostic context.

7. The Type of Ground Truth Used

The ground truth used is the successful fulfillment of engineering design specifications and safety requirements for the modified cassette. This is based on internal verification tests and risk analysis (FMECA).

8. The Sample Size for the Training Set

Not applicable. This is a verification study for a physical modification, not a machine learning model that requires a training set.

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

Not applicable.

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