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The Disposable Enteral Feeding Sets is intended to be used for enteral feeding nutrition into gastrointestinal tract by connecting with nasogastric tube by gravity. The devices may include a bag to contain the feeding nutrition and/or a spike to connect to a prefilled container. The device is used for children, adolescents, and adults.

The proposed device, Disposable Enteral Feeding Sets, is intended to be used for enteral feeding nutrition into gastrointestinal tract by connecting with nasogastric tube by gravity. The devices may include a bag to contain the feeding nutrition and/or a spike to connect to a prefilled container. The device is used for children, adolescents and adults. The proposed device is provided sterile or non-sterile and single use.

The provided text is a 510(k) Pre-market Notification for a medical device called "Disposable Enteral Feeding Sets". The document largely focuses on demonstrating substantial equivalence to a predicate device and does not contain the detailed information typically found in a study description for evaluation of AI/algorithm performance.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets acceptance criteria in an AI/algorithm context. The document describes standard performance testing for a physical medical device, not a software or AI device.

Here's why and what information can be extracted regarding general acceptance criteria and testing:

Why the requested information cannot be fully provided from this document:

• No AI/Algorithm Focus: The device is a "Disposable Enteral Feeding Set," which is a physical medical device for enteral nutrition. There is no indication that it incorporates any AI, machine learning, or complex algorithms that would require the kind of performance studies (e.g., standalone performance, MRMC studies, ground truth establishment by experts) typically associated with AI/ML-driven medical devices.
• "Acceptance Criteria" for Physical Device: The term "acceptance criteria" here refers to the performance specifications and safety standards for a physical product (e.g., leak integrity, flow rate, material biocompatibility, sterility), not diagnostic accuracy or clinical utility of an AI.
• "Study" for Physical Device: The "study" mentioned refers to non-clinical performance tests (chemical, physical, sterility, ENfit physical performance) conducted on the physical device to ensure it meets established safety and performance standards relevant to its physical function. It is not a clinical efficacy study or an AI performance study.

Information that can be extracted relevant to general performance and acceptance (for a non-AI physical device):

1. A table of acceptance criteria and the reported device performance:
   The document does not provide a specific table of acceptance criteria paired with reported device performance values. It states that "the test result showed that the aged proposed device met the acceptance criteria" for various tests. The specific acceptance criteria are implicitly those defined by the referenced international standards and internal procedures.

   Acceptance Criteria (Implied)	Reported Device Performance
   Compliance with ISO 20695:2020 Annex C & D	Met
   Compliance with ISO 8536-4:2022 Annex B	Met
   Compliance with ISO 8536-4:2020 Annex B.4	Met
   Compliance with ISO 80369-20:2015	Met
   Compliance with USP Sterility Tests	Met
   Final product inspection procedure specifications	Met
   Performance of bag part (e.g., integrity, capacity)	Met
   Performance of spike part (e.g., connection integrity)	Met
   Biocompatibility (for patient-contact material)	Met (no adverse effects)

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 specify the sample sizes for the non-clinical performance tests. The data provenance is implied to be from the manufacturer's testing in China, as the applicant is "Beijing L&Z Medical Technology Development Co., Ltd." These are non-clinical lab tests, not human data.

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):
   Not applicable. "Ground truth" in the context of expert consensus is relevant for AI/ML diagnostic or prognostic devices. For a physical device like an enteral feeding set, performance is evaluated against engineering specifications and international standards, not against expert human interpretations of data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable for a physical device's non-clinical performance testing.

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. The device is a physical feeding set, not an AI or imaging device that would involve human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable. There is no algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   Not applicable. Performance is measured against physical and chemical standards and specifications (e.g., sterility, dimensional accuracy, material integrity, flow rates), not a ground truth derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set:
   Not applicable. This is a physical medical device, not an AI/ML model that requires training data.

9. How the ground truth for the training set was established:
   Not applicable.

In summary, the provided FDA 510(k) clearance letter and summary pertain to a physical medical device and therefore do not contain the information requested regarding AI/algorithm performance studies.

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Enteral Feeding Sets are intended to dispense liquid nutrition (feeding solutions) at a user controlled rate. These enteral feeding sets interface with a patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The enteral feeding sets include a bag to contain the feeding solution and/or a EnPlus spike to connect to a pre-filled container. The device is used for infants, children, adolescents and adults.

The Enteral Feeding Sets have four models, Enteral Feeding Pump bag Set, Enteral Feeding Pump EnPlus spike Set, Enteral Feeding Gravity bag Set, Enteral Feeding Gravity EnPlus spike Set. The Enteral Feeding Pump bag Set and Enteral Feeding Gravity bag Set both have a structure of a formula bag with 100ml graduations and a protective closure cap. The difference is the former is droved by pump and the latter is droved by gravity. Enteral Feeding Pump EnPlus spike Set and Enteral Feeding Gravity EnPlus spike Set feature a piercing spike (with or without screw cap) used to connect the set to a prefilled container of enteral feeding solution. It is a single-use, non-sterile device.

The provided document is a 510(k) Premarket Notification from the FDA for "Enteral Feeding Sets." It describes the device, its intended use, and a comparison to a predicate device, along with a summary of non-clinical testing.

However, the document does not contain any information about a study that proves the device meets the acceptance criteria for an AI/ML powered medical device. The acceptance criteria and testing detailed in the document are for traditional medical device performance, such as dimensions, material properties, leakage, tensile strength, and biocompatibility. There is no mention of AI models, test sets for AI performance, expert ground truth establishment, or MRMC studies.

Therefore, I cannot fulfill your request for information regarding AI/ML acceptance criteria and study details based on the provided text.

If you are looking for an example of how such a request would be answered for an AI/ML device, please provide a document that discusses an AI/ML powered medical device and its validation.

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Enteral feeding set is intended to use gravity to deliver liquid nutritional formulas or water to patient's enteral access device (feeding tube). The device includes a bag to contain the feeding solution.

The proposed device is provided non-sterile and single use. It has two types (Type A and Type B). Type A has more component (ENFit transition adapter) than Type B.

The Type A includes 5 models, ENF02G-1000R-T, ENF02G-1000B-T, ENF02G-1200R-T, ENF02G-1200B-T and ENF02-500R-T, which have the same components including 1) filling port, 2) bag, 3) tube, 4) drip chamber, 5) roller clamp, 6) ENFit female connector, 7) ENFit transition adaptor and 8) protecting cover. The difference between the 5 models is the specification of bag and tube.

The Type B includes 5 models, ENF02G-1000R, ENF02G-1000B, ENF02G-1200R, ENF02G-1200B and ENF02-500R, which have the same components including 1) filling port, 2) bag, 3) tube, 4) drip chamber, 5) roller clamp, 6) ENFit female connector and 7) protecting cover. The difference between the 5 models is the specification of bag and tube.

The provided document is a 510(k) summary for an Enteral Feeding Set. It describes non-clinical tests performed to demonstrate substantial equivalence to a predicate device, but it does not include any information about clinical studies or the performance of a device based on expert reviewer adjudication for a test set. This device is an "Enteral Feeding Set" which is a physical medical device, not a software-driven diagnostic or AI-powered system that would typically involve acceptance criteria related to diagnostic accuracy, sensitivity, or specificity, adjudicated by experts.

Therefore, many of the requested items (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the content of this document.

Here's an analysis of the provided information based on the request:

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

The document provides a summary of non-clinical test conclusions and a comparison to a predicate device (K142539). These demonstrate compliance with relevant standards rather than specific performance metrics against pre-defined acceptance criteria in the typical sense of a diagnostic device.

Study that proves the device meets the acceptance criteria:

The device meets its "acceptance criteria" through a series of non-clinical tests and compliance with recognized international standards for medical devices. The document explicitly states: "Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards." The study described is essentially a compilation of these non-clinical tests.

The following information is not available in the provided text as it pertains to clinical studies often associated with diagnostic or AI-powered devices, which is not the nature of this enteral feeding set's submission.

2. Sample size used for the test set and the data provenance: Not applicable; no clinical test set for diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no clinical test set requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable; no clinical test set requiring adjudication.
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 is a physical medical device, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable; the "ground truth" for this device is compliance with engineering specifications, material biocompatibility, and functional performance as per standards, rather than a diagnostic 'truth'.
8. The sample size for the training set: Not applicable; no training set mentioned, as this is a physical device, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

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The U Deliver Bolink ENFit Enteral Feeding Sets are intended for over-the-counter use to deliver liquid nutritional formulas or water to a patient's enteral access device (feeding tube).

The U Deliver Bolink ENFit Enteral Feeding Sets consist of two configurations:

• U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector (ref. BK-2085) .
• U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector (ref: BK-2405)
  The U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a safety screw connection meeting the requirements of clauses 4 "General requirement" and 5 "Dimensional requirements for enteral feed reservoir connectors" of ISO18250-3, "Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral applications', to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3, 'Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications'.
  The U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a screw cap with a 40 mm thread, to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3
  Both sets are constructed from medical grade, biocompatible materials, and are supplied non-sterile for single patient use only.

The provided document is an FDA 510(k) clearance letter for a medical device: "U Deliver Bolink ENFit Enteral Feeding Sets." It describes the device, its intended use, and the basis for its substantial equivalence to a predicate device.

However, the document does not contain any information about an AI/ML-driven medical device. Specifically, it does not describe:

• An AI algorithm or its performance.
• Acceptance criteria for an AI model.
• A study that proves an AI device meets acceptance criteria, including details on sample size, data provenance, expert ground truth establishment, adjudication, MRMC studies, standalone performance, or training set details.

The "Performance Data" section explicitly states: "No new device testing was necessary as no changes have been been made to the device design, materials or packaging. The testing necessary for this submission was usability testing to demonstrate that both laypersons with no prior tube feeding experience and caregivers/tubefeeders were able to perform the essential tasks using only the proposed instructions for use. The results of usability testing demonstrate that the subject device(s) are appropriate for over-the-counter use." This confirms that the critical study mentioned was a usability test for a physical device, not an AI performance study.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI device based on this document.

The document pertains to the clearance of a physical medical device (enteral feeding sets) and its change in indications for use from prescription-only to over-the-counter, based on usability testing and substantial equivalence to a cleared predicate device.

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CONOD Enteral Feeding Sets are intended to dispense liquid nutrition (feeding solutions) at a user controlled rate. These enteral feeding sets interface with a patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The enteral feeding sets include a bag to contain the feeding solution and/or a piercing spike to connect to a pre-filled container. The device is used for infants, children, adolescents and adults.

The CONOD Enteral Feeding Sets have three models, CONOD safety spike plus pump set, CONOD gravity feeding set and CONOD feeding pump set. The CONOD Feeding Pump Set (1200ml) and gravity feeding set both have a structure of a 1200ml formula bag with 100ml graduations and a protective closure cap. The difference is the former is droved by pump and the latter is droved by gravity. CONOD Safety spike plus Pump Set features a piercing spike used to connect the set to a prefilled container of enteral feeding solution. It is a single-use, non-sterile device.

I am sorry, but based on the provided text, there is no information about acceptance criteria and a study proving a device meets those criteria in the context of AI/ML performance.

The document is a 510(k) premarket notification for "CONOD Enteral Feeding Sets," which is a medical device for dispensing liquid nutrition. The provided sections detail:

• Submission Information: Company, contact, device name, regulation, product code.
• Device Description: Models (pump set, gravity set, safety spike plus pump set), single-use, non-sterile.
• Indications for Use: Dispensing liquid nutrition at a user-controlled rate, interfacing with a feeding tube, for infants, children, adolescents, and adults.
• Comparison to Predicate Device (K150286, Medline Enteral Feeding Sets): Highlights similarities in intended use, product code, classification, design features (non-DEHP material, ISO 80369-3:2016 connector), materials, prescription use, disposability, intended use time (no longer than 24 hours), non-sterility, shelf-life, and available tube lengths.
• Performance Data: This section describes biocompatibility testing (cytotoxicity, sensitization, skin irritation, 10993-1, 10993-5, 10993-10 standards) and performance testing (fluid leakage, stress cracking, resistance to separation (axial load, unscrewing), resistance to overriding, disconnection by unscrewing, tensile properties, liquid leakage, flow rate, bioburden, usability), all conducted according to various ISO/EN/IEC standards.
• Animal Study/Clinical Study: States that neither was required.
• Conclusion: The device is substantially equivalent to the predicate based on non-clinical data and performance testing.

The "performance data" discussed refers to engineering and material safety tests for the medical equipment itself, not the performance of an AI/ML algorithm. Therefore, I cannot extract the information requested about AI/ML acceptance criteria, study details, sample sizes, expert involvement, or ground truth for an AI/ML device.

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The U Deliver Bolink ENFit Enteral Feeding Sets are intended to deliver liquid nutritional formulas or water to a patient's enteral access device (feeding tube).

The U Deliver Bolink ENFit Enteral Feeding Sets consist of two configurations:

• U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector (ref. . BK-1085)
• U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector (ref: BK-1405) .
  The U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a safety screw connection meeting the requirements of clauses 4 "General requirement" and 5 "Dimensional requirements for enteral feed reservoir connectors" of ISO/DIS 18250-3. 'Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral applications', to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3, 'Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications'.
  The U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a screw cap with a 40 mm thread, to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3
  Both sets are constructed from medical grade, biocompatible materials, and are supplied non-sterile for single patient use only.

This document is a 510(k) premarket notification for the U Deliver Bolink ENFit Enteral Feeding Sets, establishing substantial equivalence to a predicate device. As such, it does not contain a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial or a performance study with human subjects or medical imaging analysis.

Instead, the document focuses on bench testing to demonstrate physical and functional equivalence of the U Deliver Bolink ENFit Enteral Feeding Sets to the predicate device and compliance with recognized standards.

Here's an analysis of the information provided, addressing the requested points where applicable, and noting where the information is not present in this type of submission:

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

The document does not provide a formal table of acceptance criteria with reported performance in a quantitative manner for specific benchmarks. Instead, it lists the types of bench tests conducted, implying that the acceptance criteria for these tests are met by conforming to recognized standards (ISO 80369-3, ISO 80369-20, ISO/DIS 18250-3, ISO 10993) or by demonstrating equivalence to the predicate device.

Bench Tests Performed (Implied performance met as per standards/equivalence):

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 the exact sample sizes used for each bench test. It generally states that "Bench tests have been carried out on samples of the U Deliver Bolink ENFit Enteral Feeding Sets."
• Data Provenance: The document implies that the testing was performed by or for the manufacturer (Cedic S.r.l., Italy, a contract manufacturer). The submission itself is from U Deliver Medical, LLC (USA). The testing is prospective (conducted specifically for this submission).

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 to this type of device and submission. This is a medical device for delivering nutritional formulas, not an imaging or diagnostic device that requires expert interpretation to establish a 'ground truth'. The "ground truth" here is compliance with technical standards and functional performance metrics, verified through engineering bench tests.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation (e.g., radiology reads) to resolve discrepancies in expert opinions. This submission relies on objective engineering measurements and compliance with recognized standards.

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 is not a software device, an AI-powered diagnostic tool, or a device that involves "human readers." It's a physical enteral feeding set.

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

Not applicable. This device does not involve algorithms or AI. It is a physical medical device.

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

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

• Technical Standards: Compliance with FDA-recognized international standards such as ISO 80369-3, ISO 80369-20, ISO/DIS 18250-3, and ISO 10993. These standards define the required physical dimensions, mechanical properties, and biocompatibility.
• Predicate Device Equivalence: Demonstrating that the subject device performs similarly to or better than the legally marketed predicate device (Metrixcare Enteral Feeding Sets, K132424) in relevant functional aspects (e.g., flow rate).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

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

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Medline Enteral Feeding Sets are intended to dispense liquid nutrition (feeding solutions) at a user controlled rate. These enteral feeding sets interface with a patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The enteral feeding sets may include a bag to contain the feeding solution and/or spike to connect to a pre-filled container.

Medline Enteral Feeding Sets consist of the following three configurations:

• 1.) Medline Enteral Feeding Pump Bag Set (1000ml)
• 2.) Medline Enteral Feeding Pump Spike Set
• 3.) Medline Enteral Feeding Gravity Bag Set (1000ml)

The Medline Enteral Feeding Pump Bag Set (1000ml) is designed for use with Alcor Sentinel® and Nestle Compat® enteral feeding pump systems and features a 1000ml formula bag with 100ml graduations and a protective closure cap.

The Medline Enteral Feeding Gravity Bag Set (1000ml) uses the free flow of gravity to dispense enteral feeding solutions and features a 1000ml formula bag with 100ml graduations and a protective closure cap.

The Medline Enteral Feeding Pump Spike Set features a piercing spike used to connect the set to a prefilled container of enteral feeding solution. It is designed for use with Alcor Sentinel® and Nestle Compat® enteral feeding pump systems.

Medline Enteral Feeding Sets are single-use, non-sterile and disposable enteral feeding sets consiting of an enteral feeding bag, tubing, drip chamber, piercing spike, roller clamp and Distal Tip ENFit connectors.

The provided text describes a 510(k) premarket notification for Medline Enteral Feeding Sets, comparing them to a predicate device. The core of the submission is the replacement of a 4-step Distal Tip Connector with an ENFit connector, aiming to improve safety by mitigating misconnections.

Here's an analysis of the acceptance criteria and the study information, focusing on what is explicitly stated and what cannot be determined from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific quantitative thresholds. Instead, it lists various performance tests conducted and generally states that the results demonstrated the device's function and performance were not altered, and that it met requirements.

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

• Sample Size: Not specified for any of the performance tests. The document only lists the types of tests performed (e.g., "Enteral Connector Misconnection Assessment Study," "Human Factors Validation Study").
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be conducted by Medline Industries, Inc. or their contracted labs.
• Retrospective or Prospective: Not specified. Performance testing is typically prospective, but the document does not confirm this.

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

This information is not provided. The document details engineering and performance testing, not a study requiring expert clinical assessment for ground truth. The "Human Factors Validation Study" might involve user evaluation, but the number or qualifications of "experts" are not mentioned.

4. Adjudication Method for the Test Set

This is not applicable as the studies described are performance and engineering tests, not clinical evaluations requiring adjudication of subjective assessments.

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

This is not applicable. This document describes a medical device (enteral feeding sets), not an AI/imaging diagnostic device that would typically undergo an MRMC study.

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

This is not applicable as the device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests would be established by the physical and chemical properties of the materials and component designs, and their adherence to engineering standards (e.g., ISO 80369-1 for ENFit connectors) and device specifications. For biocompatibility, it's defined by the pass/fail criteria of ISO 10993 standards.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device. There is no "training set" in the context of an algorithm or AI model development described here.

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

This is not applicable (see point 8).

In summary, the provided text is a 510(k) summary for a physical medical device. It focuses on engineering performance, biocompatibility, and functional compatibility testing to demonstrate substantial equivalence to a predicate device, particularly concerning a design change to incorporate an ENFit connector. It does not contain information typically found in studies for AI/software as a medical device (SaMD) or clinical diagnostic studies that would involve "test sets," "training sets," "experts," or "adjudication."

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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 CORFLO Anti-IV Enteral Feeding Extension Set is intended to be used to deliver enteral formula from the nutritional source to any enteral feeding device accepting standard enteral step connectors. The CORFLO Anti-IV Enteral Feeding Extension Set is for pediatric and neonatal use only.

CORFLO Anti-I.V. Enteral Feeding Extension Set Model# 20-1030AIV-LB-S

The provided document is a 510(k) clearance letter from the FDA for a medical device: CORFLO Anti-I.V. Enteral Feeding Extension Set Model# 20-1030AIV-LB-S.

**This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or training set details.

The letter is a regulatory document confirming that the FDA has found the device to be "substantially equivalent" to legally marketed predicate devices, meaning it does not require a new premarket approval application (PMA). This determination is based on the safety and effectiveness information submitted in the 510(k) premarket notification, but the letter itself does not describe the specific studies or data generated to support that substantial equivalence. These details would typically be found in the original 510(k) submission itself if it were publicly available.

Therefore, I cannot provide the requested table and information based on the text provided.

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The CORFLO Anti-I.V. Enteral Feeding Extension Set is intended to be used to deliver enteral formula from the nutritional source to any enteral feeding device acccepting a standard enteral step connector. The CORFLO Anti-IV Enteral Feeding Extension Set is for pediatric and neonatal use only.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called "CORFLO Anti-I.V. Enteral Feeding Extension Set Model # 20-1060AIV-S." This document describes the FDA's determination of substantial equivalence to a predicate device, allowing the product to be marketed.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.

The letter is a regulatory approval document, not a scientific study report. Therefore, I cannot extract the requested information from the provided text.

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