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The ENvizion Medical ENvue System is designed to aid qualified operators in the ENvizion Medical Enteral Feeding Tube from 8 Fr to 12 Fr into the stomach or small intestine of adult patients requiring enteral feeding. The ENvizion Medical ENvue System is intended as an adjunct to current practices for assisting clinical practitioners who place feeding tubes.

The ENvizion Medical Enteral Feeding Tube (EFT) has been specifically designed for use with the ENvue System and is intended for placement in the stomach or small intestine. It is intended for use in adult patients who require intermittent or continuous feeding via the oro/nasoenteric route. The EFT is intended only to be used with a feeding pump and is not compatible with gravity-based feeding bags.

The ENvizion Medical ENvue System is an electro-mechanical device with embedded software designed to aid in the placement of the ENvizion Medical Enteral Feeding Tube (with or without stylet), which is an enteral feeding tube placed into the stomach or small intestine of patients requiring enteral feeding. The ENvue System tracks the Enteral Feeding Tube (EFT) as it progresses through the oro/nasoenteric route down the esophagus, into the stomach and to the small intestine anatomy and displays the placement pathway in real time during placement. Once the placement is completed, the user disconnects the ENvue from the EFT. The EFT connects to a feeding pump using ENFit connections.

This 510(k) notification adds an 8 Fr EFT with a stainless-steel stylet and changes the input source for patient posture from using the plate sensor to the marking stylus. The plate sensor has been removed from the system.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it relies on demonstrating substantial equivalence to a predicate device and confirming safety and effectiveness through various tests and a retrospective clinical evaluation. The primary performance metric reported for the clinical evaluation is agreement with X-ray confirmation.

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

• Sample Size: 50 placements across 48 randomly selected patients (2 of the subjects had 2 placements each).
• Data Provenance: Retrospective, pseudonymized clinical evaluation. The country of origin is not specified in the provided text.

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

The document does not explicitly state the number of experts or their qualifications for establishing the ground truth (X-ray confirmation). It simply refers to "x-ray position confirmation." In a clinical setting, X-ray interpretation would typically be performed by qualified radiologists or other medical professionals with expertise in imaging diagnostics.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. It states "100% agreement between the system display and the x-ray position confirmation," implying a direct comparison without a need for resolving discrepancies between multiple expert readings or a specific adjudication protocol.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study focused on the agreement between the device's display and X-ray confirmation, not on comparing human readers with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance evaluation of sorts was conducted, as the study explicitly measured the "agreement between the system display and the x-ray position confirmation." This directly assesses the device's ability to accurately indicate tube position on its own, independent of a human operator's judgment beyond the initial setup and interpretation of the X-ray for ground truth. The device is designed to aid qualified operators, suggesting a human-in-the-loop context for its overall use, but the reported study specifically focuses on the accuracy of the system's output.

7. The Type of Ground Truth Used

The ground truth used was X-ray position confirmation.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size for a training set. This is a 510(k) submission for a modification to a previously cleared device, and the focus is on performance validation of the modified device rather than a de novo software development process.

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

Since information about a training set is not provided, the method for establishing its ground truth is also not available in this document.

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The McLean-Ring Nasojejunal Feeding Tube Set is intended for enteral feeding and medication in adult and pediatric populations. The device is intended to be used in the treatment of the following pediatric subgroups: children and adolescents.

The McLean-Ring Nasojejunal Feeding Tube Set is composed of a feeding tube and wire guide. The feeding tube is made of a 9.5 French polyurethane tube. The feeding tube is available in 130 centimeters only, measured from the distal tip to the proximal hub. The distal end of the feeding tube features six sideports. The distal tip of the feeding tube is open with a smooth round finish. A 0.650-inch long stainless steel weight is fit outside the distal end of the feeding tube and is completely covered with a shrink tube, forming 0.180-inch outer diameter over the weight. The proximal end of the feeding tube features a hub with a cap that is made of polyurethane. The wire guide is made of stainless steel in a 0.038-inch diameter. The wire guide is 275 centimeters long. In addition, the entire length of the wire guide is coated with PTFE. The distal end of the wire guide is straight but flexible. The subject device, McLean-Ring Nasojejunal Feeding Tube Set, may be introduced directly when there is adequate peristalsis and no gastric outlet obstruction. Alternatively, the feeding tube may be passed over a wire guide. The feeding tube is intended to be indwelling up to 30 days and is for one-time use.

The provided document is a 510(k) Premarket Notification from Cook Incorporated for the McLean-Ring Nasojejunal Feeding Tube Set. It describes the device, its intended use, and its comparison to a predicate device (Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube).

Critically, this document describes a medical device, specifically a feeding tube, not an AI/ML-based medical device. Therefore, the concepts of "acceptance criteria for an AI/ML device," "study proving the device meets acceptance criteria for an AI/ML device," "sample size used for the test set," "data provenance," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "training set," and "how ground truth for training set was established" are not applicable to the information provided.

The document focuses on the substantial equivalence of a physical medical device. The "studies" mentioned are bench testing to assure reliable design and performance (e.g., dimensional, flow rate, kink resistance, MRI compatibility) and biocompatibility testing. Additionally, clinical evidence is provided through a review of published literature on the use of similar feeding tubes in pediatric patients. This literature review is used to support the safety and performance for the device's intended use in children and adolescents, not to prove the performance of an AI algorithm.

Since the request is about an AI/ML device and the provided text describes a physical medical device, I cannot extract the requested information.

If you have a document describing an AI/ML medical device, please provide it, and I will be able to answer your questions accordingly.

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The ENvizion Medical ENvue System is designed to aid qualified operators in the placement of the ENvizion Medical Enteral Feeding Tube of 10 Fr and 12 Fr into the stomach or small intestine of adult patients requiring enteral feeding. The ENvizion Medical ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes.

The ENvizion Medical Enteral Feeding Tube (EFT) has been specifically designed for use with the ENvue System and is intended for placement in the stomach or small intestine. It is intended for use in adult patients who require intermittent or continuous feeding via the oro/nasoenteric route. The EFT is intended only to be used with a feeding pump and is not compatible with gravity-based feeding bags.

The ENvizion Medical ENvue System is an electro-mechanical device with embedded software designed to aid in the placement of the ENvizion Medical Enteral Feeding Tube (with or without stylet), which is an enteral feeding tube placed into the stomach or small intestine of patients requiring enteral feeding. The ENvue System tracks the Enteral Feeding Tube (EFT) as it progresses through the oro/nasoenteric route down the esophagus, into the stomach and to the small intestine anatomy and displays the placement pathway in real time during placement. Once the placement is completed, the user disconnects the ENvue from the EFT. The EFT connects to a feeding pump using ENFit connections.

This Special 510(k) notification adds 4 new models of EFTs, that include a stainless-steel stylet.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics that would typically be evaluated in a clinical study. Instead, it focuses on demonstrating substantial equivalence to a predicate device and reference devices by ensuring that the differences do not raise new questions of safety or effectiveness. The performance data section describes tests completed to demonstrate substantial equivalence, rather than defining strict numerical acceptance criteria for a new feature's performance.

However, based on the performance data listed, we can infer some criteria and the reported outcome:

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

The document describes non-clinical performance testing (biocompatibility, mechanical testing, simulated use, shelf life) rather than a clinical study with a "test set" of patients. Therefore, specific sample sizes for a clinical test set are not applicable here.

The data provenance is from laboratory and engineering testing conducted by the manufacturer, ENvizion Medical Ltd., to demonstrate compliance with standards and equivalence to predicate devices. No information about country of origin for data is provided beyond the manufacturer's location (Israel), as these are internal product verification and validation tests. The tests were performed to address the addition of a new feature (stylet) to an already cleared device, not for initial market clearance based on extensive clinical data.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This submission focuses on non-clinical performance data and equivalence for an incremental change to a medical device, not a diagnostic AI device requiring expert consensus for ground truth. The "ground truth" here is established by engineering and biological testing standards and comparison to a known predicate.

4. Adjudication Method for the Test Set:

Not applicable, as this was not a clinical study requiring adjudication of expert interpretations for a test set.

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

No. An MRMC study was not done. The device is not an AI-assisted diagnostic tool that would typically undergo such a study to evaluate human reader improvement. The ENvizion Medical ENvue System aids in the physical placement of feeding tubes.

6. Standalone (Algorithm Only) Performance:

Not applicable. The device is an electro-mechanical system with embedded software designed to assist a qualified operator in a physical procedure (feeding tube placement), not a standalone algorithm providing diagnostic or predictive outputs without human intervention. The "performance data" presented relates to the physical and mechanical properties and safety of the device components.

7. Type of Ground Truth Used:

The "ground truth" in this context is established through:

• Engineering specifications and test standards: For dimensional inspection, bond strength, tubing stiffness, and simulated use.
• Biological safety standards: ISO 10993-1 for biocompatibility.
• Comparison to predicate and reference devices: To demonstrate that the modified device performs "as well or better" and that differences do not raise new safety or effectiveness concerns.

8. Sample Size for the Training Set:

Not applicable. This submission is for an electro-mechanical device with embedded control software, not a machine learning or AI algorithm that requires a "training set" of data.

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

Not applicable, as there is no "training set" in the context of this device and submission type.

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The Cediflo Enteral Feeding Tubes are intended for the administration of enteral nutrition, fluids, and/or medications by the nasoenteric route into the stomach or small intestine. Indicated for patients 2 years and above which require nutritional support, are not able to meet their nutritional requirements by oral intake and have functioning and accessible gastrointestinal tract. Maximum duration of use: 42 days.

The Cediflo Junior Enteral Feeding Tubes are intended for the administration of enteral nutrition, fluids, and/or medications by the nasoenteric route into the stomach or small intestine. Indicated for neonatal and pediatric patients which require nutritional support, are not able to meet their nutritional requirements by oral intake and have functioning and accessible gastrointestinal tract.

The Cediflo and Cediflo Junior Enteral Feeding Tubes are sterile, single use devices intended for use in acute care facilities, long-term care facilities, and home. They are made from radiopaque polyurethane tubing printed with centimeter markings and bonded at the proximal end to a rigid male ENFit connector with a tethered cap. The proposed device is offered in lengths of 50 cm to 120 cm and diameters of 5 Fr (1.66 mm) to 16 Fr (5.33 mm). These tubes are supplied with or without a guidewire. The distal tip of the polyurethane tubing is closed and rounded with four side holes to allow for fluid flow.

The male ENFit connector of the proposed device is designed to comply with ISO 80369-3:2016 and allows for connection to enteral feeding specific sets and syringes while reducing the likelihood of misconnections to devices that are not intended for enteral administration. A twist on cap is tethered to the male ENFit connect via a strap.

The guidewire, when provided, of the proposed device is a stainless-steel braided wire with a rounded distal tip which is pre-loaded into the polyurethane feeding tube. The guidewire stiffens the polyurethane tubing to aide in insertion of the device. The guidewire has a lubricious coating that aids in removal of the guidewire from the feeding tube in situ. A flow through guidewire connector is attached to the proximal end of the guidewire which provides the connection between the wire and feeding tube.

The provided document (K181787) is a 510(k) premarket notification for Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes. This type of medical device is a physical tube used for nutritional support, not a software-based AI/ML device. Therefore, the questions related to AI/ML acceptance criteria, ground truth establishment, expert adjudication, MRMC studies, and training/test set data are not applicable to this document.

The document primarily relies on non-clinical performance testing to demonstrate substantial equivalence to predicate devices, as well as biocompatibility testing. No clinical performance testing, animal testing, or AI/ML specific studies were conducted or required for this device.

Here's a breakdown of the relevant information provided in the document regarding how the device meets acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of "acceptance criteria" in the way one would for an AI/ML device with specific metrics like sensitivity or specificity. Instead, it demonstrates compliance with relevant international standards and performs specific mechanical and material tests.

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

• Sample Size: Not explicitly stated as "sample size" in the context of a "test set" for an algorithm. Instead, the tests refer to a sufficient number of manufactured units or materials to validate the design and manufacturing claims (e.g., "accelerated aging conditioning" implies a batch of devices).
• Data Provenance: The testing was conducted by or for Cedic s.r.l., located in Peschiera Borromeo (MI), Italy. This is a manufacturer's internal testing or contracted testing to demonstrate compliance with standards. It is retrospective in the sense that it's done on manufactured products for regulatory submission, but not in the clinical data sense.

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

• Not applicable. This is a physical device, not an AI/ML algorithm that requires expert-established ground truth from medical images/data. The "ground truth" for this device's performance is objective measurement against engineering standards and material properties.

4. Adjudication Method for the Test Set:

• Not applicable. No human adjudication of clinical data is involved. Performance is determined by whether the device meets quantitative and qualitative engineering and material standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This is not a study type relevant to an enteral feeding tube.

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

• Not applicable. This is not an algorithm. The "standalone" performance here refers to the device's ability to meet its specifications independently, which is what the non-clinical tests demonstrate (e.g., flow rate, tensile strength).

7. The Type of Ground Truth Used:

• The "ground truth" for this device's performance is based on established engineering standards (ISO, EN), material specifications, and physical measurements (e.g., flow rate, tensile strength, leakage). It's objective, quantitative data derived from laboratory testing, not medical consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" for a traditional medical device like an enteral feeding tube.

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

• Not applicable. No training set exists.

In summary, this 510(k) clearance relied on demonstrating that the Cediflo Enteral Feeding Tubes meet established performance standards and are substantially equivalent to existing predicate devices through comprehensive non-clinical (laboratory and engineering) testing, rather than clinical trials or AI/ML performance studies.

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The ENvizion Medical ENvue System is designed to aid qualified operators in the placement of the ENvizion Medical Enteral Feeding Tube of 10 Fr and 12 Fr into the stomach or small intestine of adult patients requiring enteral feeding. The ENvizion Medical ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes.

The ENvizion Medical Enteral Feeding Tube (EFT) has been specifically designed for use with the ENvue System and is intended for placement in the stomach or small intestine. It is intended for use in adult patients who require intermittent or continuous feeding via the oro/nasoenteric route. The EFT is intended only to be used with a feeding pump and is not compatible with gravity-based feeding bags.

The ENvizion Medical ENvue System is an electro-mechanical device with embedded software designed to aid in the placement of the ENvizion Medical Enteral Feeding Tube, which is an enteral feeding tube placed into the stomach or small intestine of patients requiring enteral feeding. The ENvue System tracks the Enteral Feeding Tube (EFT) as it progresses through the oro/nasoenteric route down the esophagus, into the stomach and to the small intestine anatomy and displays the placement pathway in real time during placement is completed, the user disconnects the ENvue from the EFT. The EFT connects to a feeding pump using ENFit connections.

Here's a breakdown of the acceptance criteria and study information for the ENvizion Medical ENvue System and Enteral Feeding Tube, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy thresholds) for the device's performance in terms of aiding tube placement. Instead, it focuses on the successful completion of various tests to demonstrate safety and effectiveness and states that "the device successfully passed all of the testing and the results demonstrate the device is safe, effective, and performs as well or better than the predicate device."

Here's a table summarizing the tests performed, which indirectly serve as acceptance criteria:

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

The "test set" for the human clinical study consisted of:

• Sample Size: Data pooled from 58 subjects.
• Data Provenance: The study was a prospective, single-center clinical trial. The country of origin is not explicitly stated in this summary, but the manufacturer is based in Israel.

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

The document does not specify the number of experts or their qualifications for establishing ground truth in the clinical study. It mentions the system "is designed to aid qualified operators," but doesn't detail how the correctness of tube placement (ground truth) was definitively determined independent of the device. Given the nature of feeding tube placement, ground truth often relies on imaging (like X-ray) or pH testing by medical professionals, but this isn't detailed here.

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for the test set in terms of determining ground truth for tube placement outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No, an MRMC comparative effectiveness study, as typically described for AI systems evaluating images, was not explicitly mentioned. The clinical study focused on the device's safety and effectiveness as an adjunct to current practices and its ability to guide placement, rather than comparing human performance with and without the device. The device itself aids in the placement process, not in interpreting diagnostic information where an MRMC reader study would be more common.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. The device, the ENvue System, is "designed to aid qualified operators" in the placement of the feeding tube. It is inherently a human-in-the-loop device, displaying the placement pathway in real-time for the user. Therefore, a standalone (algorithm only) performance assessment would not be relevant to its intended use.

7. The Type of Ground Truth Used

The type of ground truth used in the clinical study for verifying tube placement is not explicitly detailed. However, for feeding tube placement systems, common methods for confirming correct placement (i.e., ground truth) typically involve:

• X-ray imaging (radiography)
• pH testing of aspirate
• Auscultation (listening for air insufflation)

The document notes that the feeding tube itself is "radiopaque...for X-ray visualization," suggesting that X-ray confirmation would be a standard part of practice. The predicate device's indications also mention "confirmation or correct tube placement by acceptable hospital protocol is required."

8. The Sample Size for the Training Set

The document does not provide information on a "training set" sample size. The ENvizion Medical ENvue system is a device that utilizes electromagnetic sensing technology to guide tube placement. While it contains embedded software ("Software Validation" is listed as a test), this is not an AI/Machine Learning diagnostic device in the traditional sense that would require a large training dataset for model development. The software likely controls the electromagnetic tracking and display, and its validation would involve functional testing rather than a training dataset from patient cases.

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

Since there is no mention of a training set in the context of an AI/ML algorithm that learns from data, the concept of establishing ground truth for a training set is not applicable here. The system relies on physical electromagnetic principles to track the tube.

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The Kangaroo™ Feeding Tube Extension Sets with ENFit small bore connectors are intended for enteral feeding, on the order of a physician, to provide a means of delivering enteral nutrition or medication from an enteral feeding syringe through to any feeding tube which will accept a connector for enteral applications.

The device is intended for neonates and infants who require enteral feeding.

The Kangaroo™ Feeding Tube Extension Sets with ENFit small bore connectors are sterile, disposable medical devices designed to deliver nutrition to patients who cannot obtain nutrition or liquid by mouth, are unable to swallow safely, or need nutritional supplementation. The proposed set is intended as a conduit between the enteral feeding formula container (mostly enteral feeding syringe) and feeding tube. The device is designed with a single lumen microbore PVC tube with ENFit small bore connectors at both ends. During enteral feeding therapy, mainly for neonates and infants, there are situations when the feeding tube extension set is required to connect the syringe to patient feeding tube when the distance between the patient and the source of enteral feeding demands additional length of tube.

This document is a 510(k) Summary for a medical device called "Kangaroo™ Feeding Tube Extension Sets with ENFit Small Bore Connectors." As such, it focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria in the way generally understood for AI/ML device performance studies (e.g., diagnostic accuracy, sensitivity, specificity against a clinical ground truth).

The information provided describes non-clinical testing performed to show that the new device (with ENFit connectors) is functionally equivalent and safe compared to the predicate device and compliant with relevant ISO standards for small-bore connectors.

Therefore, the requested information elements (especially those related to AI/ML performance, ground truth, expert adjudication, MRMC studies, and training sets) are not directly applicable or available in this type of FDA submission. I will extract the closest available information based on the context of this document.

Here's an attempt to answer your questions based on the provided text, reinterpreting "acceptance criteria" as compliance with ISO standards and functional performance metrics for a hardware device:

Acceptance Criteria and Study for Kangaroo™ Feeding Tube Extension Sets

This document describes the non-clinical testing performed to demonstrate that the Kangaroo™ Feeding Tube Extension Sets with ENFit Small Bore Connectors are substantially equivalent to a legally marketed predicate device (Covidien Kangaroo™ Enteral Feeding Extension Sets, K9733409) and meet relevant international standards for safety and performance.

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are primarily defined by compliance with ISO 80369-3 (Small-bore connectors for liquids and gases in healthcare applications – Part 3: Connectors for enteral applications) and ISO 80369-20 (Common test methods), as well as biocompatibility, stability, and functional equivalence (flow testing). The document states the device conforms to these requirements.

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

The document does not explicitly state the sample sizes for each specific test (e.g., number of extension sets tested for fluid leakage, stress cracking, etc.). It generally refers to "the proposed extension sets" or "the proposed devices" being tested.

• Data Provenance: The data comes from non-clinical laboratory testing performed by the manufacturer (Covidien). The country of origin of the data is not specified, but the manufacturer is based in Mansfield, MA, USA. The studies are prospective in the sense that they were designed and executed to test the new device's compliance.

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

This question is not applicable to this submission. For a hardware device, "ground truth" is typically defined by adherence to objective engineering and chemical standards (e.g., ISO dimensional tolerances, flow rates, material composition, breakage forces) rather than expert consensus on a subjective outcome like image interpretation. The testing was performed in accordance with established international standards (ISO).

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., by radiologists) to reach a consensus ground truth. For the described tests (fluid leakage, dimensions, etc.), the results are objectively measured against defined criteria within the ISO standards; there is no subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers' performance with an AI device compares to their performance without one. This device is a physical medical device (feeding tube extension set), not an AI algorithm.

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

No, a standalone algorithm performance study was not done. This device is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• International Standards: Specifically, the requirements and test methods defined in ISO 80369-3 (for enteral connectors) and ISO 80369-20 (common test methods for small-bore connectors).
• Biocompatibility Standards: General standards for material safety in contact with biological systems.
• Functional Equivalence: Direct comparison of key performance characteristics (like flow) to the predicate device, which is already legally marketed and established as safe and effective.

8. The Sample Size for the Training Set

This question is not applicable. This device is a physical medical device, not an AI algorithm developed through machine learning. Therefore, there is no "training set" in the context of an AI/ML model.

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

This question is not applicable, as there is no training set for an AI/ML model.

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The Veritract Enteral Feeding Tube System is intended for use in those patients who require intermittent or continuous tube feeding via the nasogastric route. The vision and steering provided by the Veritract System is intended as an adjunct to current practices to aid qualified clinicians with experience in placing naso-enteric feeding tubes into the stomach or small bowel of patients requiring enteral feeding. Placement of the tip of the device into the small bowel should only be attempted by clinicians with expertise in small bowel placement. Confirmation of correct tube placement by X-ray or acceptable hospital protocol is required prior to commencing administration. The Veritract Enteral Feeding Tube has not been tested for use longer than shortterm use (

Not Found

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the "Veritract Enteral Feeding Tube System," which indicates that the device has been found substantially equivalent to a legally marketed predicate device.

The letter discusses:

• The device name, regulation number, and product code.
• The FDA's determination of substantial equivalence.
• General controls provisions and other regulations applicable to the device.
• Contact information for various FDA offices.
• The Indications for Use Statement (Section 4), which describes how the device is intended to be used, but not performance metrics or acceptance criteria from a study.

Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample sizes, ground truth establishment, MRMC studies, or standalone performance, as these details are not present in the provided document.

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The Syncro-Blue Tube™ functions as a conduit to facilitate enteral feeding, and may be used in the pediatric, adult or elderly patient who cannot consume an adequate diet orally. Small bowel feeding may be indicated for patients with functioning gut who require short- to moderate-term feeding support, such as posttrauma patients, post-surgical patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exists, or may result, secondary to an underlying disease or condition.

The Syncro-Blue Tube serves as a conduit through which enteral feeding solutions are directly infused into the patient's small bowel. The modified device will be marketed in one length (23.6" [60cm]) and one French size (8 Fr). During placement of the tube, an external magnet is used to assist the physician in placing the tube into the small bowel. The Syncro-Blue Tube has a stylet with a reed switch positioned near its distal tip. The reed switch is connected by wires to an external LED/battery pack that lights in response to the presence of the external steering magnet. The reed switch is located at the distal end of the stylet. The distal tip of the stylet contain magnets which are attracted to the steering magnet. When the tube is positioned, the stylet is removed from the device, making the Syncro-Blue Tube MRI Safe.

The Syncro-Blue Tube, The Magnetically Guided Enteral Feed Tube, as described in the provided document, underwent several performance tests to demonstrate substantial equivalence to a legally marketed predicate device (Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube cleared under K072787). The document, however, does not provide specific acceptance criteria values or detailed performance results against those criteria. It also does not involve an AI algorithm, so many of the requested criteria related to AI/ML device studies are not applicable.

Here's a breakdown of the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document lists the types of performance tests conducted but does not specify the numerical acceptance criteria for each test or the precise quantitative results achieved by the Syncro-Blue Tube. It generally states that "The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate device."

Study Information:

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

   • The document does not specify the sample sizes used for each of the performance tests.
   • The data provenance is not explicitly mentioned, but the tests were "laboratory tests," implying they were conducted in a controlled environment, likely in the US or a similar regulatory setting. It is a retrospective summary of bench testing.

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

   • This question is not applicable as the device is a physical medical device (feeding tube) and the performance tests are engineering and biological evaluations, not diagnostic interpretations requiring expert ground truth in the context of image or data analysis.

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

   • This question is not applicable for the type of device and tests described. Adjudication is typically for resolving discrepancies in expert interpretations, which is not relevant here.

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 question is not applicable as the device is a physical medical device and does not involve AI or human readers for interpretation.

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

   • This question is not applicable as the device does not involve an algorithm.

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

   • The "ground truth" for these performance tests would be defined by established engineering and biological standards and specifications for tensile strength, flow rates, magnetic responsiveness, flexibility, biocompatibility, radiopacity, etc. The document implies compliance with these standards by stating substantial equivalence to a predicate device.

8. The sample size for the training set:

   • This question is not applicable as the device does not involve a training set for an AI/ML algorithm.

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

   • This question is not applicable as the device does not involve a training set for an AI/ML algorithm.

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MEDICINA enteral feeding tubes and their accessories are dedicated to the nasogastric and orogastric administration of liquid nutritional media, through the gastro intestinal tract of neonatal and pediatric patients.

MEDICINA feeding tubes is a complete range of devices intended to the gastro-intestinal feeding of patients, with liquid nutritional media. These feeding tubes are available in several sizes (diameter and length), and two materials: PolyUrethan (PUR) and silicon (SIL). They are equipped with connecting elements that does not incorporate a Luer, and thus eliminates the risk of inadvertently connecting the system to an Intra Veinous system. The MEDICINA feeding tube features a locking connection which eliminates the risk of involuntary disconnection; voluntary disconnection is achieved by simply unscrewing the hub connections. Another benefit of the MEDICINA system is that it does not change the technique of the end-user, and therefore it does not require any special training

The provided text describes a medical device, MEDICINA enteral feeding tubes and accessories, but does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, expert qualifications, or adjudication methods in the context of a study. The document primarily focuses on establishing substantial equivalence to predicate devices and addressing the risk of misconnection.

Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance, or details about the study design, as this information is not present in the provided text.

The document states:

• "The bench testing has demonstrated that MEDICINA feeding tubes are functionally equivalent to Nutrisafe2 and Neomed Enteral feeding tubes."
• "Verification tests performed during the design process have shown that MEDICINA feeding tubes meets performance and safety requirements, and are substantially equivalent to the predicate devices."
• "Risk of misconnection between the enteral feeding tube with a 6% luer taper connector used in intravascular device" was addressed by designing connectors that are "bigger by approximately 1 mm compared to a standard IV 6% luer taper female connector." This was "demonstrated in our report RAES10042009 rev 02 attachment III EN1615 section 4.2.1. (copy attached)."

These statements indicate that testing was performed, but they do not provide the detailed parameters (acceptance criteria, specific performance metrics, sample sizes, expert involvement, etc.) you've requested. The focus is on demonstrating "functional equivalence" and "substantial equivalence" through bench testing and compliance with standards (e.g., EN 1615), rather than a specific clinical or performance study with detailed acceptance criteria and reported metrics typically seen in AI/algorithm-focused evaluations.

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The Pediation Enteral Feeding tubes are intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. They are intended for nasogastric or orogastric placement, limited to

The proposed modification to the Pediatric Enteral Feeding Tubes and accessories is to add additional materials that the feeding tube may be made from, i.e., PVC, silicone, and polyurethane. In addition, we offer accessories: an enteral feeding extension set and syringe with non-IV connector. These may be sold with the Enteral Feeding tubes or separately. There is an option of the connectors to be provided as standard IV luer lock or a non-IV connector. In all cases the feeding tube and accessories are marked "For enteral feeding only".

The enteral feeding tubes are provided in various diameters (4, 5, 6.5, 8, 10 Fr) and various lengths. They have an integral female fitting. There are 2 eyelets near the tip of the tube. They have markings along the shaft of the tubing and an integral radiopaque line. They are provided sterile.

The Enteral extension sets are provided in various lengths and various configurations of components.

The provided text describes a 510(k) premarket notification for a Pediatric Enteral Feeding Tube and Accessories. This document focuses on demonstrating substantial equivalence to predicate devices through design comparisons and performance testing based on industry standards, rather than a clinical study comparing the device's performance against specific acceptance criteria in a user setting.

Therefore, many of the requested details, such as specific acceptance criteria for diagnostic performance, sample sizes for test sets, expert qualifications for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details, are not applicable to this type of submission. The submission is primarily about demonstrating that the device meets safety and basic performance standards through bench testing and material comparisons.

Here's a breakdown of the information that can be extracted or inferred from the provided text, with an explanation for the N/A answers:

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

   This document does not present acceptance criteria in a typical quantitative performance metric format for a diagnostic device. Instead, it lists performance testing performed in accordance with industry standards. The "reported device performance" is the statement that the device "met the requirements of the industry standards."

   Acceptance Criteria (Industry Standard Requirement)	Reported Device Performance
   ISO 594/1 (Gauging of 6% luer conical fittings)	Met the requirements
   BS EN 1615:2000 (Gauging of non-luer conical fittings)	Met the requirements
   BS EN 1615:2000 (Tensile strength and properties of tubing and connectors)	Met the requirements
   BS EN 1615:2000 (Air leakage test of tubing and connectors)	Met the requirements
   BS EN 1615:2000 (Liquid leakage test of tubing and connectors)	Met the requirements
   BS EN 1618:1997 (Separation force)	Met the requirements
   BS EN 1618:1997 (Stress cracking)	Met the requirements
   BS EN 1618:1997 (Unscrewing torque of fitting assembly)	Met the requirements
   BS EN 1618:1997 (Ease of assembly)	Met the requirements
   BS EN 1618:1997 (Resistance to overriding the threads of lugs of the fitting)	Met the requirements

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

   • Sample Size: Not specified. The testing described is bench testing of physical attributes of the device components, not a clinical test set with patient data.
   • Data Provenance: Not applicable, as it's not clinical data. The tests were performed in accordance with industry standards.

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

   • Number of Experts: Not applicable. Ground truth, in the context of device design and materials, is established by adherence to engineering specifications and industry standards for material properties and connector compatibility. It's not a clinical judgment requiring experts to establish diagnostic ground truth.
   • Qualifications of Experts: Not applicable.

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

   • Adjudication Method: None. Adjudication is not relevant for bench testing against engineering standards. The compliance with standards is typically verified by qualified engineers or technicians and documented in test reports.

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

   • MRMC Study: No. This device is a medical tube and accessories, not an AI-powered diagnostic tool.
   • Effect Size: Not applicable.

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

   • Standalone Performance: No. This device does not involve an algorithm.

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

   • Type of Ground Truth: The "ground truth" for this device's performance is compliance with published industry standards (ISO, BS EN) for physical and functional properties of medical tubing and connectors. This involves objective measurements against predefined limits set by those standards.

8. The sample size for the training set

   • Sample Size for Training Set: Not applicable. This device does not use machine learning or AI, so there is no training set in that context.

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

   • Ground Truth Establishment for Training Set: Not applicable.

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