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The Vesco Q™ Enteral Feeding Pump System is intended to be used by healthcare professionals, patients and caregivers for the intermittent and continuous delivery of enteral fluids for adult and pediatric (infant, child, and adolescent) feeding therapy in hospital and home care environments.

The Vesco Q™ Enteral Feeding Pump System is comprised of an enteral infusion pump and disposable enteral feed sets. The Vesco Q™ Pump is a rotary peristaltic pump engineered to deliver doses of enteral fluids at selectable rates programmed with a newly designed purpose- specific touchscreen interface. The pump body is designed to be ergonomic and portable. The Vesco Q™ Feed Sets are non-sterile, single patient use enteral feed sets that are designed to be anti-free flow until the pump is running. The feed sets are designed with cassettes for the simple loading of the feed set without a pump door. The feed sets incorporate a female ENFit connector which is compatible with devices that have male ENFit connectors. The ENFit connectors are being implemented within enteral feeding devices to eliminate misconnection with non-enteral feeding devices.

Vesco Q™ Feed Sets are available in three different feed set styles: Bag Feed Sets, ENPlus Feed Sets and Screw Cap Feed Sets. All of the feed sets are made of flexible PVC tubing, a silicone tube, a feed set to pump interface, and a plastic ENFit female connecting port. Bag Feed Sets are available in two different volumes, 500mL and 1000mL. The difference between each feed set is how the liquid nutrition is introduced to the set. The Bag Feed Set has a translucent film bag, the Safety Screw Spike Feed Set has a plastic spike connector, and the Screw Cap Feed Set has a plastic 40mm threaded opening to connect to feed containers.

The connectors on the proximal end of the extension sets are ENFit ISO 80369-3 compliant. The ENFit connector allows for connections of enteral specific applications while reducing the likelihood of misconnections to non-enteral devices.

This document is a 510(k) premarket notification for a medical device – specifically, the Vesco Q™ Enteral Feeding Pump System. It aims to demonstrate that the new device is "substantially equivalent" to an existing, legally marketed predicate device.

Crucially, this document focuses on establishing substantial equivalence for a physical medical device (an enteral feeding pump and its associated sets), not an AI/ML-driven diagnostic or assistive device that would require performance in terms of accuracy metrics like sensitivity, specificity, AUC, etc., or human-in-the-loop studies (MRMC).

Therefore, the specific acceptance criteria and study designs typically used for AI/ML devices (e.g., sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this submission. The "performance testing" section outlines tests for the physical device's mechanical, electrical, and biocompatibility properties, not AI/ML model performance.

Based on the provided text, I cannot provide information on the following as they are not relevant to this type of device submission:

• A table of acceptance criteria and reported device performance related to AI/ML metrics: The acceptance criteria are for physical and functional parameters (e.g., pumping accuracy, battery life, biocompatibility), not diagnostic or classification performance.
• Sample sizes used for the test set and data provenance: The "test set" in this context refers to physical units of the device, not a dataset for AI/ML evaluation.
• Number of experts used to establish the ground truth for the test set and qualifications: Ground truth for this device is based on engineering specifications and physical test results, not expert interpretation of data.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth is based on engineering standards and physical measurements.
• The sample size for the training set: Not applicable as there is no AI/ML model being trained.
• How the ground truth for the training set was established: Not applicable.

However, I can extract and describe the general "acceptance criteria" and "study" (performance testing) that proves the device meets them, as presented in the document for this physical medical device:

The acceptance criteria for the Vesco Q™ Enteral Feeding Pump System are based on establishing "substantial equivalence" to a predicate device (EnteraLite Infinity™ Enteral Feeding Pump) through a series of non-clinical performance and safety tests, and addressing any minor differences.

1. Acceptance Criteria and Reported Device Performance (Non-AI/ML):

The document defines acceptance implicitly through demonstration of adherence to design requirements, relevant ISO standards, and comparison to the predicate device. The performance is "proven" by stating that "It was found that the pump and feed sets are in compliance with all design and performance requirements based on the completed testing."

Below is a summary of the broad categories of acceptance criteria and the statement of performance:

• Pumping accuracy
• Gear box life cycle
• Freefall
• Air-in-Line
• Button life cycle
• Power adapter life cycle
• Battery run time
• Noise level
• Pole clamp weight
• Occlusion
• Battery charge time
• Bolus accuracy (under various conditions)
• Cleanability and performance |
  | Feed Set Integrity | Compliance with EN ISO 20695:2020 for unaged and aged product for:
• Tensile test
• Pressure leak test
• Kink test (EN 13868:2002)
• Anti-free flow test (Vesco Medical's design requirement)
• Free flow rate test (Vesco Medical's design requirement) |
  | User Interface/Human Factors| Compliance with "Vesco Medical's design requirement" for Human Factors and Usability Validation. (Noted the touchscreen UI was "designed to be easy to read and intuitive to help mitigate user related hazards.") |
  | Electromagnetic Compatibility| Compliance with IEC 60601-1-2. |
  | Hardware, Software, Mechanical Safety| Compliance with IEC 60601-1. |
  | Software Verification & Validation| Compliance with FDA guidance document "Infusion Pump Total Product Life Cycle" recommendations. |
  | Risk Management | Compliance with ISO 14971:2007 (Risk Hazard Analysis) and Vesco Medical's design requirements (DFMEA). |
  | Material Compatibility | "Wipe and soak test for pump housing material selection" in accordance with Vesco Medical's design requirement. |

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

• Sample Size: The document does not specify the exact number of physical units (pumps and feed sets) tested for each performance criterion. It generally states that "Verification and validation testing were performed with the Vesco Q™ Enteral Feeding Pump and the Vesco Q™ Feed Sets." Typically, for such devices, a statistically appropriate number of units would be tested to ensure reliability, but the specific quantity is not disclosed in this summary.
• Data Provenance: Not applicable in the context of data for an AI/ML model. The "data" here are the test results from physical devices, which would have been generated in a laboratory or testing facility, likely in the US as the manufacturer (Vesco Medical LLC) is based in Ohio. The testing is non-clinical.

3. Number of Experts/Qualifications for Ground Truth:

• This concept is not relevant here as the "ground truth" for a physical pump's performance (e.g., flow rate accuracy, battery life) is determined by direct physical measurement against engineering specifications and industry standards, not by expert consensus on interpretations of data (like medical images).

4. Adjudication Method for the Test Set:

• Not applicable, as there is no human interpretation or ground truth adjudication process akin to those used for AI/ML diagnostic data.

5. MRMC Comparative Effectiveness Study:

• No MRMC study was done. This type of study (Multi-Reader Multi-Case) is specifically designed to assess how human reader performance changes when assisted by an AI system, typically in diagnostic imaging. The Vesco Q™ Enteral Feeding Pump is a physical medical device, not an AI diagnostic tool, so an MRMC study is not relevant or required.

6. Standalone Performance:

• Not applicable. The device is a functional pump, not a standalone algorithm. Its performance is inherent in its operation (e.g., "Pumping accuracy test" refers to the pump itself, not an algorithm's output).

7. Type of Ground Truth Used:

• The ground truth for this device's performance is based on engineering specifications, direct physical measurements, and compliance with industry standards (e.g., ISO, IEC, USP). This differs significantly from "expert consensus," "pathology," or "outcomes data" that would be used for AI/ML ground truth.

8. Sample Size for the Training Set:

• Not applicable, as there is no AI/ML model being trained. The "training" for this physical device refers to its design, manufacturing processes, and quality control.

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

• Not applicable, as there is no AI/ML model being trained. The "ground truth" here is the established design requirements and performance targets set by the manufacturer and relevant regulatory standards, which the device aims to meet through its engineering and manufacturing.

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Intended for delivery of enteral fluids, including nutritional fluids and/or water to the gastrointestinal system via nasogastric, orogastric, nasojejunal, gastrostomy, and jejunostomy tubes. Not for use with neonates. Intended for any patients ages infant, child/adolescent and adult who are physically unable to eat and swallow or who are unable to get sufficient nutrition through eating and swallowing. Intended to be used in hospital and acute care settings, as well as long term and home care settings by users ranging from clinicians to laypersons and patients. Some patients may need a caregiver to support using the device. It is intended to be used in both stationary and ambulatory conditions including ground and air transport while using backpack accessory.

The Kangaroo OMNI™ Enteral Feeding Pump and Feeding Set are intended to be used together as a system. Kangaroo OMNI™ Enteral Feeding Sets for administration of standard formula are able to be connected to access devices of all sizes that are ENFit™ compatible. The Kangaroo OMNI™ Thick Formula Feeding Sets for administration of thick formula can be used with access devices 8 Fr size or greater that are ENFit™ compatible.

The Kangaroo OMNI™ Enteral Feeding Pump, Kangaroo OMNI™ Feeding Sets and Kangaroo™ Accessories consist of an enteral feeding pump and disposable enteral feeding sets along with accessories that deliver fluids via rotary peristaltic tension loop pumping to provide hydration and nutrition for those who do not have the ability to orally ingest food or drinks.

This document is a 510(k) Summary for the Kangaroo OMNI™ Enteral Feeding Pump and related accessories. It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence. However, this document does not contain information about a study that proves the device meets specific acceptance criteria based on AI/algorithm performance, multi-reader multi-case studies, or detailed ground truth establishment.

The "Performance Testing" section primarily focuses on engineering and regulatory compliance tests for the physical device, not software performance related to AI or diagnostic accuracy. It mentions software verification and validation but within the context of general medical device software guidance, not AI-specific performance metrics like sensitivity, specificity, or accuracy for a diagnostic task.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI-powered device using the provided text. The document describes a traditional medical device (an enteral feeding pump) and its associated accessories, and the testing outlined is typical for such a device (electrical safety, EMC, human factors, biocompatibility, battery testing, and essential performance requirements like flow rate accuracy and alarm detection).

Specifically, the document does not contain the following information relevant to AI device studies:

• A table of acceptance criteria and reported device performance (for an AI component): While there's a table comparing features, it lists physical and operational characteristics of the pump, not AI performance metrics.
• Sample size used for the test set and data provenance: Not applicable as it's not an AI test set.
• Number of experts used to establish ground truth and qualifications: Not applicable.
• Adjudication method for the test set: Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted or mentioned.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The document states "Clinical Testing: Not Applicable," further indicating that this submission does not involve clinical performance data for a diagnostic or AI-driven device.

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The AMSure® Enteral Feeding Pump is intended to work with the disposable enteral feeding sets to deliver nutritional formula to the gastrointestinal system of adult patients who are physically unable to eat and swallow or who are unable to get sufficient nutrition through eating and swallowing.

Only intended for adult patients, not for pediatric use.

The AMSure® Enteral feeding pump is intended to be used in healthcare facilities by licensed healthcare professional users only.

The AMSure® Enteral feeding pump is for use only with Amsino AMSure® feeding sets.

The AMSure® enteral feeding pump is intended to work with the disposable enteral feeding sets that deliver formula via rotary peristaltic pumping system to provide nutrition for those who do not have the ability to orally ingest food

The provided text does not contain information about an AI/ML-driven medical device, an acceptance criteria table with reported device performance for such a device, or a study that proves a device meets specific acceptance criteria using AI/ML technology.

The document is a 510(k) Premarket Notification for a non-AI/ML medical device, specifically an AMSure® Enteral Feeding Pump and Feeding Set. It details the device's indications for use, technological characteristics, and compares it to a predicate device (SENTINEL Enteral Feeding pump K011587) to demonstrate substantial equivalence.

While the document mentions "custom software designed to allow the user to set feed rates and volumes as well as other feeding options" and "2 separate MCUs, and each MCU embeds a specific software in order to secure the pump's running," this refers to basic embedded software for controlling the pump's mechanical functions and not an AI/ML algorithm that requires a test set, ground truth experts, or MRMC studies.

Therefore, I cannot extract the requested information (table of acceptance criteria and reported device performance for an AI/ML device, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, training set details, or ground truth establishment) because the document describes a traditional medical device without AI/ML components.

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The PUGGLE® Enteral Feeding Pump and Feeding Set are intended to deliver nutritional formula to the gastrointestinal system of a patient age infant and older who is physically unable to eat and swallow. Not for use with neonates. The PUGGLE® Enteral Feeding Pump and Feeding Set are intended to be used in clinical or home care settings by users ranging from laypersons to physicians. The PUGGLE® Enteral Feeding Pump and Feeding Set shall be used together only.

The PUGGLE® Enteral Feeding Pump and Feeding Set consists of an enteral feeding pump and disposable enteral feeding sets that deliver formula via rotary peristaltic pumping system to provide nutrition for those who do not have the ability to orally ingest food. The pump incorporates a graphical interface that walks the users through the PUGGLE® Enteral Feeding Pump and Feeding Set setup feed rates and volumes as well as other feeding options. The PUGGLE® Enteral Feeding Pump and Feeding Set come with three different connector types: standard, ENFit®, and ENFit® with Transition Connector.

The provided text is a 510(k) summary for the PUGGLE® Enteral Feeding Pump and Feeding Set. It outlines the device's technical characteristics and how it compares to a predicate device (Kangaroo™ Connect Enteral Feeding Pump and Set K143263). The document primarily focuses on demonstrating substantial equivalence to the predicate, rather than detailing a specific clinical study with acceptance criteria and device performance in the way a traditional clinical trial report would.

However, based on the Performance Testing section, we can extract information regarding acceptance criteria in the form of standards and general performance attributes, and the "reported device performance" is indicated by the statement that the device was verified and validated to meet these requirements.

Here's an attempt to structure the information based on your request, acknowledging that some fields may not be directly available in the provided document:

1. Table of Acceptance Criteria (based on standards and essential performance) and an indication of Device Performance

The study that proves the device meets the acceptance criteria is detailed under the "Performance Testing" section within the 510(k) summary. It describes a "safety assurance case" approach.

Detailed Information about the Study:

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

• Sample Size for Test Set: The document does not specify a numerical sample size for individual performance tests (e.g., how many pumps or feeding sets were tested). It refers to "performance testing of essential performance attributes" and "stability testing of feeding set" but doesn't give a number of units tested.
• Data Provenance: Not specified in the document. It does not mention country of origin or whether the data was retrospective or prospective, as these are typically not relevant for bench performance testing of this nature.

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)

• This question is Not Applicable (N/A) in this context. The testing described is primarily bench and engineering validation (e.g., electrical safety, EMC, flow rate accuracy). "Ground truth" established by experts, as in clinical image interpretation, is not relevant here. The "ground truth" for these tests would be the measured physical parameters against defined engineering specifications and regulatory standards.

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

• N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving expert interpretation of medical images. For engineering performance testing, the results are typically objectively measured against pre-defined specifications.

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

• N/A. This is an enteral feeding pump, not an AI-assisted diagnostic device. Therefore, MRMC studies or human reader improvement with AI are not applicable.

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

• This question is partially applicable in the sense that the device's technical functions (e.g., pump mechanism, sensors, alarms) were tested in isolation (standalone performance) against technical specifications. The "Performance Testing" section confirms that the "essential performance requirements of the device (including feeding sets) were verified through performance testing". This implies testing the device's inherent functionality. However, this is not "algorithm only" in the context of AI but rather the entire device's automated functions.

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

• The "ground truth" for these tests is based on established engineering specifications, national and international standards (e.g., IEC standards), and regulatory guidance documents (e.g., FDA guidance for Infusion Pumps). For example, flow rate accuracy is measured against a defined percentage deviation. Occlusion detection is measured against specified pressure thresholds and response times.

8. The sample size for the training set

• N/A. As an enteral feeding pump, there is no "training set" in the context of machine learning or AI that would require a data sample for training. The device operates based on programmed logic and hardware, not a learned model from a dataset.

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

• N/A. Since there is no training set, this question is not applicable.

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The Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets is intended to deliver nutritional formula to the gastrointestinal system of a patient age infant and older who is physically unable to eat and swallow. Not for use with neonates. The feeding pump and feeding sets are intended to be used in clinical or home care settings by users ranging from laypersons to physicians.

The Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets and Kangaroo™ Connect Portal consists of a wireless enabled enteral feeding pump and disposable enteral feeding sets that deliver formula via rotary peristaltic tension loop pumping to provide nutrition for those who do not have the ability to orally ingest food. The new Kangaroo™ Connect Enteral Feeding Pump wireless accessories include a communication hub and the Kangaroo™ Connect Portal. The communication hub collects short-range data from the pump through a Zigbee signal and sends the data through either WiFi or a cellular signal to the device cloud where the Kangaroo™ Connect Portal can access the data for monitoring. The wireless enabled pump, when used in conjunction with the wireless accessories, will provide a platform for remote data collection allowing clinicians to more efficiently monitor feeding rates and review actual history of nutritional delivery.

The provided document is a 510(k) summary for the Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets and Kangaroo™ Connect Portal (K153074). This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance statistics for each feature.

Therefore, the information requested in the prompt, especially specific numerical acceptance criteria, reported device performance for those criteria, and detailed study parameters (like sample sizes for test/training sets, data provenance, expert ground truth details, MRMC studies, standalone performance, and ground truth establishment methods), is not explicitly available within this 510(k) summary.

However, I can extract the general categories of performance testing that were conducted to support the device's safety and effectiveness. The document refers to a "safety assurance case" and "Performance Testing evidence."

1. Table of Acceptance Criteria and Reported Device Performance

As noted, specific numerical acceptance criteria and reported performance metrics are not provided in this summary. The summary describes categories of tests conducted.

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

• Sample size for test set: Not specified.
• Data provenance: Not specified. The studies mentioned (e.g., system verification and validation activities, performance testing) would typically be conducted by the manufacturer (Covidien/Medtronic) without specific country of origin or retrospective/prospective details being disclosed in this summary.

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

• This information is not provided. The assessment of device performance for general medical devices like enteral feeding pumps typically relies on objective physical measurements and engineering standards rather than expert-established ground truth in the way it's used for AI/diagnostic devices. Human factors testing involves users, but the specifics of expert qualifications are not within the scope of this type of summary.

4. Adjudication method for the test set

• This information is not provided and is generally not applicable to the type of performance testing (e.g., flow rate accuracy, electrical safety) described for an enteral feeding pump. Adjudication methods are more commonly associated with subjective assessments or diagnostic interpretability studies.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or interpretive devices involving human readers. The Kangaroo™ Connect Enteral Feeding Pump is a medical device for delivering nutritional formula, and its wireless accessories are for remote data collection and monitoring, not for diagnostic interpretation by human readers. The summary mentions human factors testing to evaluate usability, which is different from an MRMC study.

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

• Yes, implicitly. The performance testing described (e.g., "Flow Rate Accuracy," "Downstream Occlusion Detection," "Pump Alarms") would typically be conducted on the device (pump and software/firmware) independently of human interaction, to ensure the device itself performs according to its specifications. The "wireless enabled-disabled performance testing of essential performance attributes" refers to the inherent function of the device and its system. These tests assess the algorithm's performance in controlling the pump and detecting issues.

7. The type of ground truth used

• The "ground truth" for the performance testing of this device would be established by engineering standards and objective measurements. For example:
  • Flow Rate Accuracy: Measured flow rates would be compared against the programmed rates using calibrated instruments.
  • Occlusion Detection: Artificially induced occlusions would be tested for detection by the device's sensors.
  • Alarms: Specific conditions (e.g., empty bag, blocked tube) would be simulated or created to verify alarm functionality.
  • Electrical Safety/EMC: Compliance with relevant IEC standards would be assessed through standardized test procedures and equipment.
  • Software Verification/Validation: Code reviews, unit testing, integration testing, and system testing against design specifications.

8. The sample size for the training set

• This information is not provided and generally not applicable in the context of traditional medical device development where specific "training sets" are primarily associated with machine learning or AI algorithm development. While there are software elements (mentioned as "on board custom software"), the development process described is standard software verification and validation, not a machine learning model training process that would require a distinct "training set" in the AI sense.

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

• This information is not provided and generally not applicable (see point 8). The "ground truth" for ensuring the functionality of the device's software would be its design specifications and requirements.

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The Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets delivers nutritional formula to the gastrointestinal system of a patient age infant and older who is physically unable to eat and swallow. Not for use with neonates. The feeding pump and feeding sets are intended to be used in clinical or home care settings by users ranging from laypersons to clinicians.

Enteral feeding pump and disposable enteral feeding sets

I am sorry, but the provided text does not contain the specific information required to generate a table of acceptance criteria and reported device performance for a medical device that meets the requested parameters related to AI/algorithm studies (standalone, MRMC, sample sizes, ground truth establishment, expert qualifications, etc.).

The document is a 510(k) summary for the Kangaroo™ Connect Enteral Feeding Pump and Kangaroo™ Connect Feeding Sets. It details the device's intended use, technological characteristics, and nonclinical testing performed to demonstrate substantial equivalence to a predicate device.

While it mentions software verification and validation, and studies on infusion delivery accuracy, it does not describe:

• Specific acceptance criteria with numerical targets for performance metrics.
• A study explicitly designed to prove the device meets acceptance criteria in the context of an AI/algorithm.
• Any AI or algorithm-driven components in the way typically discussed for image analysis or diagnostic support systems. The software mentioned is for operating the pump and setting feed rates, not for making diagnostic or interpretive decisions.
• Sample sizes for test sets (in the context of AI/algorithm evaluation).
• Data provenance for test sets.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size for a training set (as no AI training appears to be the focus here).
• How ground truth for a training set was established.

The studies described are typical for an infusion pump, focusing on biocompatibility, stability, human factors, electrical safety, software verification, battery evaluation, infusion accuracy, fluid ingress protection, and sensor performance. These are functional and safety performance tests for a physical medical device, not evaluative studies for an AI/ML algorithm's diagnostic or predictive performance.

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The Kangaroo™ Enteral Feeding Set with ENFit connectors delivers nutritional formula to the gastrointestinal system of a patient age Infant and older who is physically unable to eat and swallow. Not for use with neonates. The feeding sets are intended to be used in clinical or home care settings by users ranging from laypersons to clinicians.

Enteral Feeding sets for use with Kangaroo Feeding pumps. The pump set incorporates 5 basic segments: Fluid reservoir(s), which may be an attached bag (500ml or 1000ml) or a spike for connection to a formula container; Tubing from fluid reservoir to pump (9 or 24 inch); Pump interface module (peristaltic tubing); Tubing from pump to patient connector (66 inches); Patient connector (ENFit connector compliant to ISO 80369-3).

I am sorry, but based on the provided document, I cannot fulfill your request. This document is a 510(k) premarket notification for a medical device (Kangaroo™ Enteral Feeding Sets with ENFit connectors) and does not contain information about a study with acceptance criteria and reported device performance in the context of an AI/algorithm-driven device.

The document primarily focuses on:

• Substantial equivalence to a predicate device.
• Device description and intended use.
• Comparison of technological characteristics between the proposed and predicate devices, highlighting the change to an ENFit connector compliant with ISO 80369-3.
• Nonclinical testing (biocompatibility, stability, usability/human factors related to the ENFit connector).
• Explicitly stating that clinical testing was not relied upon for evidence of safety, effectiveness, or substantial equivalence.

Therefore, there is no information regarding:

• A table of acceptance criteria and reported device performance for an algorithm.
• Sample sizes for test or training sets, data provenance, ground truth establishment, or expert involvement for an AI study.
• MRMC comparative effectiveness studies or standalone algorithm performance.

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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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1.0 The Medi-SIS Syringe Infusion System is indicated for the delivery of enteral fluids through clinically accepted routes of administration.
2.0 The Medi-SIS Administration Extension Set is intended for single patient use only.
3.0 The Medi-SIS Syringe Driver can be reused up to 5,000 times

The Medi-SIS Syringe Infusion System consists of a Syringe Driver (mechanical syringe pump), proprietary administration extension set, and compatible syringe.

The Medi-SIS Syringe Driver consists of a mechanical syringe pump assembly that is manufactured from plastic housings and end caps, and steel spring (mechanical force from the spring presses against the syringe plunger), and holds a 30mL or 60mL Becton Dickinson syringe (preamendment device) or a 30mL or 60mL Acacia syringe (K092986). The Medi-SIS Syringe Driver must be used in conjunction with a Medi-SIS Administration Extension Set, which controls the time the infusion will occur (by flow restrictor) for the entire volume of the filled syringe. The Medi-SIS Syringe Infusion System infuses fluids in a continuously decreasing rate and the user can calculate the average flow rate based from volume and time infused.

The Medi-SIS Syringe Driver is reusable and provided non-sterile.

The Medi-SIS Administration Set consists of various lengths of flexible non-DEHP PVC tubing. on/off clamp, flow restrictor, and male and female connectors. The male and female connectors meet Acacia's internal specifications for enteral applications to ensure cross connections do not occur between IV and Enteral infusions. Additional componentry may be added and configurations modified based on the needs of clinicians.

The following Administration Extension Sets will be available:

60mL Syringe Size, 1.0mL per minute delivery rate 60mL Syringe Size, 2.0mL per minute delivery rate 30mL Syringe Size, 0.5mL per minute delivery rate 30mL Syringe Size, 1.0mL per minute delivery rate 30mL Syringe Size. 2.0mL per minute delivery rate

The approximate residual volume for the syringe/administration set combination is approximately 2.20mL for all configurations. The Medi-SIS Administration Extension Set is provided sterile, single use, and non-pyrogenic.

The provided 510(k) summary (K111381) describes performance testing for the Medi-SIS Syringe Infusion System, specifically for the addition of enteral fluid delivery to its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size (e.g., number of tests, number of devices) used for the non-clinical tests assessing enteral fluid delivery time and residual volume. It also does not specify the provenance of the data (country of origin, retrospective or prospective). It simply states that "non-clinical tests were performed."

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

Not applicable. The tests performed were non-clinical, evaluating device performance (fluid delivery and residual volume) against specifications, not requiring expert human interpretation or ground truth establishment in a medical context.

4. Adjudication Method for the Test Set

Not applicable. As the tests were non-clinical performance evaluations, no adjudication method (like 2+1 or 3+1 used for expert consensus in medical image analysis) was required.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on non-clinical performance, not human reader performance with or without AI assistance. The device is an infusion pump, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in a sense, a "standalone" performance study was done for the device itself, as the tests focused on the physical device's ability to deliver enteral fluids as specified. However, this isn't in the context of an "algorithm" or AI. The device's performance was evaluated independently of human interaction during the test, purely on its mechanical and fluid delivery capabilities.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests was based on predicate device specifications and internal Acacia specifications for performance. For example, enteral fluid delivery was verified against the specified time and the residual volume had a specific measurable value.

8. Sample Size for the Training Set

Not applicable. This device is an infusion pump, not an AI/machine learning device that requires a training set. The performance evaluation was based on non-clinical engineering tests.

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

Not applicable. There was no training set for this device.

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The Compat GOTM feeding pump with the administration sets are intended exclusively for enteral feeding. The purpose of this administration system is the delivery of Enteral nutrition at controlled rates (pump assisted) to patients gastrointestinal system. Intended for us for patient with any condition requiring Enteral feeding and Enteral hydration. The Compat GOTM Enteral Feeding Pump and the Compat GOTM Enteral Administration Sets are intended to use by adults or paediatric in hospital and home care environments, both in stationary and ambulatory ways.

The Compat GOTM Enteral Feeding Pump ( a Class II device) and Enteral Administration Sets are designed to deliver formulas and Enteral hydration liquids via linear peristaltic pumping to provide nutrition for patients which are not able to ingest food orally. The Compat GOTM Enteral Feeding_System is working with the Compat GO™ Enteral Feeding Pump and the Compat GOTM Enteral Administration Sets only caused by its adapted safety and effectiveness concept. The Compat GOTM Enteral Administration Sets are compatible with the standard prefilled formula containers presently available on the market. The Compat GO™ Enteral Administration Sets are designed to compatible with present market Enteral access devices and accessories.

The provided text is a 510(k) Premarket Notification for the Fresenius Applix Smart/Compat GO enteral feeding pump and administration sets. It does not contain information about studies proving the device meets acceptance criteria. The document is primarily focused on demonstrating substantial equivalence to legally marketed predicate devices, outlining the device description, intended use, and product comparison to predicate devices.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details because it is not present in the provided text. The document is a regulatory submission for market clearance, not a clinical study report.

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