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The devices in this product family are used to dispense liquid nutrients (feeding solution) at a preprogrammed pump or user controlled rate. These enteral feeding sets interface with the patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a prefilled container.

These enteral feeding sets are designed to be used with or without an enteral feeding pump, (pump is not in scope for this 510k) model specific. Refer to diagrams below for explanation of components. The enteral sets terminate in a bonded conical connector, the ENFit connector; that is designed to be incompatible with ISO 594-1/2 and other non-enteral feeding connections. The ENFit connector is a new connector and it is anticipated that not all patient feeding tubes will be compatible with it, so the administration sets include an adapter that connects to the ENFit connector on one end while providing the traditional "Christmas Tree" shaped transitional stepped connector on the other.

This document appears to be a 510(k) summary for an enteral feeding set, which is a medical device. Based on the provided text, the device is not an AI/ML device. Therefore, the specific criteria for AI/ML device studies (such as sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, or standalone performance) are not applicable or detailed in this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) submissions. This is achieved through non-clinical performance data.

Here's an analysis of the acceptance criteria and supporting study information, focusing on the available details from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various non-clinical tests performed to support substantial equivalence. While specific quantitative acceptance criteria are not explicitly stated in a table format in the provided text, the performance is reported as "Passed" or "Acceptable" for each test.

2. Sample size used for the test set and the data provenance

Not applicable for an AI/ML device. For this physical medical device, specific sample sizes for tests like bond strength or leak testing are not provided in the summary. The provenance would be the manufacturing facility where the tests were performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a physical device, and its performance is evaluated against engineering specifications and industry standards, not through expert-labeled ground truth in the context of an AI/ML model.

4. Adjudication method for the test set

Not applicable. This is a physical device.

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

No. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for this device is defined by:

• Engineering specifications: The device's design inputs and required performance characteristics.
• Industry standards: Notably ISO 80369-3 for small-bore connectors.
• Predicate device performance: The new device is compared to a legally marketed predicate device (K012147) to demonstrate similar safety and effectiveness.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Summary for the provided document:

The document describes an enteral feeding set, which is a physical medical device, not an AI/ML device. Therefore, most of the requested information pertaining to AI/ML device studies (such as test/training set sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) is not relevant or available in this submission.

The device's conformity is established through non-clinical performance data, showing that it "Passed" or was "Acceptable" for a series of tests related to its physical integrity, biocompatibility, connection safety (especially ISO 80369-3 compliance), human factors, and risk management. The "ground truth" here refers to the device meeting its design specifications and applicable industry standards. The submission asserts substantial equivalence to a predicate device based on these non-clinical tests, without requiring clinical testing.

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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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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 a 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 extensively 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, DEHP free 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, a version of which is used in the stationary pumps manufactured by ZEVEX, 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 text is a 510(k) summary for the EnteraLite® Infinity™ Enteral Feeding Pump. This document is a regulatory submission to the FDA, primarily focusing on establishing substantial equivalence to a predicate device.

It does not contain information about acceptance criteria or a study proving device performance against those criteria in the context of many of the requested categories. This type of information is typically found in detailed design validation reports, risk analysis documents, and specific performance testing protocols, which are usually part of the full 510(k) submission but are not included in this publicly available summary.

Specifically, the document discusses the device's technical characteristics, intended use, and its similarities to a predicate device (K954735). It mentions software validation and verification as part of the design process and highlights safety features like air-in-line and pressure sensors. However, it does not provide quantitative data, sample sizes, expert qualifications, or details on ground truth establishment as would be present in a study report.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be addressed based on the provided text, alongside an explanation of why other points cannot be answered:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document does not list specific acceptance criteria for performance metrics (e.g., flow rate accuracy, alarm response time) nor does it present reported device performance against such criteria in a quantitative format. It generally states that the software is "extensively validated and verified" and describes safety features, but no numerical performance data is given.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The document does not mention any specific "test set" or sample sizes used for performance testing. It focuses on the device's design and features, not the methodology or results of extensive testing with a defined test set. Data provenance is also not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be provided. This question pertains to studies involving expert review for establishing ground truth, typically in AI/ML performance evaluation (e.g., image interpretation). This document describes a medical device (an enteral feeding pump), which does not involve establishing ground truth through expert review in this manner. The "ground truth" for a pump would be established by physical measurements and engineering specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided. Similar to point 3, adjudication methods are relevant for expert consensus in classification or diagnostic tasks, which is not applicable to the description of an enteral feeding pump in this document.

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

• Cannot be provided. MRMC studies are specific to evaluating diagnostic technologies (like AI in radiology). This document describes a mechanical/electrical medical device (an infusion pump) and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described. The device itself is not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Cannot be provided. This question is also typically relevant for AI algorithms. While the pump is "software controlled," the "standalone performance" refers to the entire device's operation, not an isolated algorithm in the context of AI evaluation. The document implies the pump's performance is tested as a complete system, but it doesn't detail standalone algorithm testing in the way this question implies for AI.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Cannot be provided as requested. For a device like an enteral feeding pump, "ground truth" would be established by:
  • Engineering specifications and calibration standards: for flow rate accuracy, pressure limits, alarm thresholds, battery life.
  • Simulated usage conditions: testing air-in-line detection, occlusion detection with known conditions.
  • Pre-defined pass/fail criteria: based on regulatory standards and user needs.
    However, the document does not explicitly state the types of "ground truth" or how they were established. It only mentions the features.

8. The sample size for the training set

• Cannot be provided. The concept of a "training set" is relevant for AI/ML models that learn from data. While the pump has software, it's not described as an AI/ML device that requires a training set in the typical sense. The software is validated through traditional software engineering verification and validation processes, not machine learning training.

9. How the ground truth for the training set was established

• Cannot be provided. As explained in point 8, the concept of a "training set" for AI/ML does not apply to the device described in this document in the traditional sense. Therefore, ground truth establishment for a training set is not pertinent here.

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The Enteral ite enteral feeding pump 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 bed-ridden or ambulatory patients.

The Enteral ite enteral feeding pump 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 bed-ridden or ambulatory patients. The device is also designed for use with pediatric patients.

The device is a 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 120 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 12 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 was extensively 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.

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

The ZEVEX disposable nutrient administration set is comprised of nine components. All components of the set remain extracorporeal. The ZEVEX set interfaces with the in vivo apparatus via an industry standard non-I.V. compatible stepped adapter. The disposable set includes a short length of silicone tubing that is stretched around the three feeding purno rollers. As the rollers turn, they occlude the tubing forcing the nutrient solution through the silicone pump tube. The set also includes a unique fail safe device that precludes free-flow when the set is not correctly installed in the pump with the door closed. Pull tests were done to assure that the set would not be easy to inadvertently disconnect when in use.

The provided text is a Summary of Safety and Effectiveness Information for the EnteraLite™ Enteral Feeding Pump, submitted to the FDA on October 6, 1995.

This document describes the device and claims substantial equivalence to a predicate device (Kangaroo® PET® Enteral Feeding Pump), rather than presenting a study to prove acceptance criteria. Therefore, most of the requested information regarding study details (sample size, experts, adjudication, MRMC, standalone performance, training set) is not available in this document.

However, we can infer the acceptance criteria from the comparison tables and the claim of substantial equivalence. The "reported device performance" would be the characteristics and alarms listed for the EnteraLite™ device.

Here's an attempt to answer the questions based on the provided text:

1. A table of acceptance criteria and the reported device performance

Based on the "SUBSTANTIAL EQUIVALENCE COMPARISON" and "ALARM COMPARISON" tables, the acceptance criteria are implicitly the performance characteristics and alarm functions of the predicate device, the Kangaroo® PET® Enteral Feeding Pump. The reported device performance is that of the EnteraLite™ pump.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified.
• Data Provenance: Not specified. The document states a "summary was prepared," implying it's based on internal testing and comparison to the predicate device, but no specific study data or provenance is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The document does not describe a clinical study involving expert interpretation or ground truth establishment in this manner.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. The document does not describe a clinical study with an adjudication process.

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:

• No. This device is an enteral feeding pump, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• The device itself is a standalone system. The document states: "The software embodied within the microcontroller was extensively validated and verified as part of the design process." However, details of this "validation and verification" are not provided. The performance criteria (e.g., flow accuracy, occlusion pressures, battery life) are intrinsic to the device's function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for the device's performance characteristics (e.g., flow accuracy, battery life, alarm thresholds) would have been established through design specifications, engineering testing, and adherence to relevant industry standards like ANSI/AAMI ID26-1992 and UL2601-1 (as mentioned in the references). For safety features like occlusion pressure and air-in-line, the ground truth is the physical conditions detectable by the device's sensors and its ability to respond as designed.

8. The sample size for the training set:

• Not applicable. This is not a machine learning model document.

9. How the ground truth for the training set was established:

• Not applicable. This is not a machine learning model document.

Summary of the document's approach:

The document establishes safety and effectiveness through a substantial equivalence claim to a legally marketed predicate device. This involves:

• Detailed comparison of features, performance specifications, and safety mechanisms (alarms).
• Highlighting where the new device meets or exceeds the predicate's performance (e.g., better flow accuracy, longer battery life, additional safety features like air-in-line sensor).
• Citing adherence to relevant FDA guidance documents and industry standards for infusion pumps.

The "study" or evidence provided is primarily this detailed comparative analysis and the implicit assumption that if a device is "substantially equivalent" to one already approved, and addresses any potential concerns outlined in guidance documents, its safety and effectiveness are established. Specific engineering test results (e.g., for flow accuracy) are typically part of the full 510(k) submission but are only summarized in terms like "± 5% including high viscosity solutions" in this summary.

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