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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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The Vesco Medical Extension Feeding Sets are intended for use as an extension set to other gastric feeding devices, incorporating safety connectors which may reduce the risk of accidental connection of an IV system, or the enteral system to the IV system.

The Vesco Medical Extension Feeding Set product line is comprised of a group of enteral tubes that will be used by trained caregivers for the delivery of nutrition and water. The Extension Sets will be used in a hospital or home environment. The Extension Sets will be provided non-sterile and are for single patient use. The Extension Sets will incorporate a male ENFit connector which is compatible with syringes and other devices that have female ENFit connectors. The ENFit connectors are being implemented within enteral feeding devices to eliminate misconnection with non-enteral feeding devices.

The Vesco Medical Extension Feeding Sets are non-sterile, single patient use devices consisting of a polyvinylchloride tube, ABS G-button connector, ENFit connector, cap and clamp. 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. The G-button connectors are to allow compatibility to the Mic-key and Mini low profile devices.

This document describes the FDA's 510(k) clearance for the Vesco Medical Extension Feeding Sets. The clearance is based on proving substantial equivalence to a predicate device (Aquarius Extension Feeding Sets cleared under K141631). Therefore, the "acceptance criteria" and "device performance" are primarily demonstrated through comparison to the predicate and confirmation that the proposed device meets relevant standards and internal design requirements.

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

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

The document states that the proposed device (Vesco Medical Extension Feeding Sets) is identical to its predicate device (Aquarius Extension Feeding Sets). Therefore, the "acceptance criteria" are implied to be the performance characteristics of the predicate device, and the "reported device performance" is that the Vesco Medical device matches these.

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

The document does not explicitly state the sample sizes for the specific tests (e.g., how many units were tested for flow rate, tensile strength, or leakage). It lists the types of tests performed.
The data provenance is not specified in terms of country of origin or retrospective/prospective. The tests were performed by Vesco Medical, as indicated by "Vesco Medical's design requirement."

• 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 is not applicable in this context. The "ground truth" for this device, a physical extension set, is established through compliance with recognized international standards (ISO, EN, ASTM) and the manufacturer's own design specifications, rather than expert consensus on interpretive data (like medical images).

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

Not applicable, as this refers to adjudication of expert interpretations for ground truth, which is not relevant for this type of device submission.

• 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 device is a physical medical component, not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.

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

Not applicable, as this device is not an algorithm or AI system. Its performance is evaluated through physical and chemical testing.

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

The "ground truth" for the performance of the Vesco Medical Extension Feeding Sets is primarily established by:
* International Standards: Compliance with standards like ISO 10993 (biocompatibility), EN 1615, EN 1618 (tensile, leakage), ISO 80369 (connector compatibility), ASTM F1980 (accelerated aging).
* Manufacturer Design Requirements: Internal specifications set by Vesco Medical for flow rate and DFMEA.
* Predicate Device Performance: The primary claim of substantial equivalence is based on the new device being identical in form, function, and materials to the already cleared predicate device, which itself met similar standards.

• 8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "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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The Vesco Medical Nasoenteric Feeding Tubes), with and without flow-through stylet, are for the administration of nutrition, fluids, and medications to the stomach or small bowel by the nasoenteric route in pediatric, adult or elderly patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition. The Vesco Medical Nasoenteric Feeding Tubes have not been tested for use longer than short-term use (

The Vesco Medical Nasoenteric Feeding Tubes (NE Tubes) are non-sterile, single use devices consisting of flexible, radiopaque, polyurethane tubing adhered to a plastic male ENFit single-port connector with a tethered, twist-on cap. The plastic ENFit port allows for connection to enteral feeding sets and enteral-specific syringes while reducing the likelihood of misconnections to non-enteral devices. The cap allows for port coverage when enteral devices are not in use. The distal tip of the tubing is open and has four (4) evenly spaced, alternating eyelet openings to allow for first three inches of the distal tip are coated with a hydrophilic lubricant to aid in friction reduction during tube insertion. The tubing is printed with graduated markings in centimeters, the length from the distal tip in order to provide users with approximate insertion depth information. Certain models of the Vesco Medical Nasoenteric Feeding tube are provided with a stylet wire attached to a flow-through, ENFit hub. The stylet wire is intended to stiffen the tube during insertion and be removed after insertion is complete. The proposed device will be offered in sizes ranging between 8 French and 14 French.

This document is a 510(k) Premarket Notification from the FDA regarding the Vesco Medical Nasoenteric Feeding Tubes. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not describe a study involving an AI/ML device or its performance criteria in the way requested.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of an AI/ML device from this document. The document pertains to a traditional medical device (nasoenteric feeding tubes) and its regulatory clearance based on substantial equivalence and non-clinical performance testing.

However, I can extract information about the non-clinical performance testing that was done for this specific device, which serves as its "acceptance criteria" and "study" for regulatory clearance.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

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

This document describes non-clinical laboratory testing of physical samples of the device. It does not refer to a "test set" in the context of an AI/ML algorithm or patient data. The provenance of the testing data is not explicitly stated in terms of country of origin, but it is implied to be laboratory testing conducted for regulatory submission in the U.S. There is no concept of "retrospective or prospective" testing for these types of physical bench tests.

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

This is not applicable to the non-clinical physical device testing described. Ground truth for the performance of a physical device against a standard is established by the specifications of the standard itself and measurable physical properties, not expert consensus.

4. Adjudication method for the test set

Not applicable to non-clinical physical device testing. The "adjudication method" for these tests is whether the device passed or failed the specified criteria of the international standards and Vesco Medical's design requirements.

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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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

The "ground truth" for the non-clinical tests described is defined by:

• International Standards: ISO 80369-3, EN1615:2000, EN1618:1997, EN 13868:2002, ISO 10993-1, ISO 10993-5, ISO 14971:2012.
• Vesco Medical Design Requirements: For visual inspections, patency, and stylet removal force.
• Predicate Device Performance: Used as a benchmark for patency/flow rate and resistance to kinking, demonstrating "as well as or better than" performance.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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The Vesco Medical NRFit™ Tip Syringes are intended to inject fluids into or withdraw fluids from the body.

The Vesco Medical NRFit Tip Syringes are sterile, single use devices consisting of rigid polypropylene barrels and plungers with a synthetic rubber gasket. The tips of the syringe barrels are NRFit ISO 80369-6 compliant. The NRFit tip allows for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe barrel is printed with graduated markings indicating, in milliliters, the volume of liquid inside the syringe barrel.

The document provides information on the non-clinical testing conducted for the Vesco Medical NRFit™ Tip Syringes to demonstrate substantial equivalence to predicate devices. Here's a breakdown based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (number of units tested) for each non-clinical test. It only states that "Verification and validation Testing was performed with the Vesco Medical NRFit Tip Syringes."

The data provenance is from non-clinical tests performed by Jiangyin Caina Technology Co., Ltd and Vesco Medical. No country of origin is explicitly stated for the testing facilities within this document, though Jiangyin Caina Technology Co., Ltd is likely a Chinese company based on its name. These tests are non-clinical verification and validation studies.

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

This information is not applicable as the study described is a series of non-clinical, laboratory-based performance tests against international standards (ISO). There are no "experts" establishing ground truth in the context of clinical or diagnostic performance; instead, the ground truth is defined by the technical specifications and criteria set forth in the ISO standards themselves.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods are typically employed in studies where human interpretation or subjective assessment of data is involved (e.g., medical image interpretation). For objective physical and mechanical tests against ISO standards, the results are directly measured and compared to predefined pass/fail criteria.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic aid devices, particularly those involving AI in image interpretation. The device in question, Vesco Medical NRFit™ Tip Syringes, is a physical medical device (syringe) and does not involve AI or human "readers" in its function or evaluation in the context of this submission.

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

No, a standalone (algorithm only) performance study was not done. This concept is specific to AI/software as a medical device. The Vesco Medical NRFit™ Tip Syringes is a physical device subject to physical and mechanical testing.

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

The ground truth for these non-clinical tests is based on international standards and specifications (e.g., ISO 80369-6:2016, ISO 80369-20:2016, BS EN ISO 7886-1:1997). The device's performance is measured against the specific requirements and pass/fail criteria outlined in these standards.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of non-clinical performance testing for a physical medical device like a syringe. Training sets are relevant for machine learning algorithms.

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

This information is not applicable as there is no training set for this type of device and study.

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