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Entarik NI Feeding Tubes (FTs) are intended for the administration, fluids and medications by the nasoenteric or orogastric route for neonatal patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition.

The Entarik NI Feeding Tube System (Entarik NI System) is designed to aid, in conjunction with institutional protocols, qualified operators in the placement of the Entarik NI Feeding Tube (FT) into the stomach of neonatal patients requiring enteral feeding. The Entarik FTs are equipped with sensors designed to provide information about the tube tip relative to the stomach, thus assisting in reducing the incidence of misplacement during first positioning. The Entarik NI FTs are provided sterile.

The Entarik NI System also monitors the feeding tube position continuously during the course of feeding and automatically and in real time alerts of tube migration.

The Entarik NI System provides continuous monitoring of gastric and esophageal temperature. The Entarik device can be used solely for the purpose of monitoring gastric and esophageal temperature in situations where invasive monitoring is indicated.

The Entarik NI system is intended to record, store, view and analyze impedance in the pharynx and stomach.

The Entarik NI Feeding Tube System (Entarik NI System) consists of the Entarik NI Feeding Tube (disposable) and the Entarik NI Monitor (reusable) with Power Supply. The Entarik NI System is designed for enteral feeding and to aid in the placement of the Entarik NI Enteral Feeding Tube into the stomach of neonatal patients requiring enteral feeding. The Entarik NI System also continuously monitors feeding tube position, gastric and esophageal temperature, and gastrointestinal impedance and reflux. The feeding tubes are single use devices intended for prolonged use (less than 30 days). The Entarik NI Feeding Tubes are provided sterile.

The provided text describes the acceptance criteria and study proving the device meets those criteria for the Entarik NI Feeding Tube System.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it describes various tests performed and states that the device was found to be "safe and effective". We can infer the "acceptance criteria" from the fact that no issues were raised during these tests, indicating successful outcomes for all mentioned evaluations.

2. Sample Sizes and Data Provenance

• Training Set Sample Size: 16 subjects.
• Test Set Sample Size: 11 subjects for the validation study.
• Data Provenance: The document does not explicitly state the country of origin. The studies appear to be prospective clinical studies, as they involved the placement and monitoring of the device in new participates for the purpose of the study.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used or their specific qualifications (e.g., "radiologist with 10 years of experience") for establishing ground truth. It mentions that the validation study's placement confirmation was "per institutional standard of care," which implies reliance on qualified medical professionals within the clinical setting.

4. Adjudication Method

The document does not describe a specific adjudication method (e.g., 2+1, 3+1, none) for the test set. It mentions "placement was confirmed per institutional standard of care," suggesting that the medical institution's standard procedures were followed for verifying tube placement.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size of how much human readers improve with AI vs. without AI assistance. The study focuses on the device's ability to aid operators and monitor position, not on comparing human reader performance with and without AI.

6. Standalone (Algorithm Only) Performance

The document describes two clinical studies. The first (observational study) collected data silently for algorithm training and optimization without providing placement guidance. This suggests an initial phase where the algorithm was developed and refined, but standalone performance against a ground truth is not explicitly reported in terms of metrics like sensitivity/specificity for tube placement. The second (validation study) involved the device aiding qualified operators, indicating a human-in-the-loop scenario rather than a purely standalone algorithm evaluation of performance directly supporting a diagnostic claim.

7. Type of Ground Truth Used

• For the validation study's tube placement: "placement was confirmed per institutional standard of care." This likely refers to methods such as X-ray confirmation, pH testing of aspirate, or visual confirmation, as standard practice in clinical settings for feeding tube placement. While not explicitly stated, this would be a clinical ground truth established by medical professionals following established protocols.
• For continuous monitoring of tip location: The device itself automatically and in real time alerts of tube migration. The validation study confirmed this functionality was "safe and effective," implying these alerts were indeed accurate relative to actual tube migration conditions (though the specific ground truth for judging "tube migration" during continuous monitoring is not detailed).

8. Sample Size for the Training Set

The training set for the algorithm involved 16 subjects.

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

In the observational study for algorithm training and optimization, the Entarik NI Monitor "did not provide any placement guidance or verification. It collected impedance and temperature data silently that was used to train and optimize the placement and monitoring algorithm." This implies that while the device collected its data, the true tube position (ground truth) during this training phase was independently established by standard clinical methods (e.g., X-ray) by the clinicians or institution, and this independent ground truth was then used to train the algorithm. The document doesn't explicitly state the method for ground truth establishment during the training phase, but it must have been an independent reference standard.

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This product is intended for use in neonatal and pediatric patients to provide nutrition via nasal or orogastric placement. The Polyurethane Feeding Tube is not intended for use beyond 30 days. The PVC Feeding Tube is not intended for use beyond 24 hours.

The Feeding Tube consists of the following main components: a feeding tube single lumen catheter and an enteral only connector hub with integral tethered connection closure plug. The catheter tubing is made of Polyurethane or PVC. The catheter tubing has an orange or purple radiopaque stripe of barium sulfate embedded in the tubing wall which can be visualized on x-ray, for exact placement of the tip. The single lumen catheter tubing has side holes for better flow and to provide multiple openings for aspiration. The proposed Feeding Tube is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

This document is a 510(k) premarket notification decision letter from the FDA to Anhui Tiankang Medical Technology Co., Ltd. regarding their "Feeding Tube" device. It primarily focuses on the device's substantial equivalence to a predicate device and outlines the non-clinical performance data provided to support this claim.

Based on the provided text, the device is a medical feeding tube, and the "acceptance criteria" and "proof" relate to demonstrating its safety and effectiveness through non-clinical performance testing and biocompatibility testing, rather than a study involving human subjects or an AI algorithm. Thus, many of the typical elements of AI/ML device acceptance criteria (e.g., sample size for test set, expert adjudication, MRMC studies, standalone algorithm performance, training set details) are not applicable here as this is a traditional medical device submission.

Here's an analysis of the acceptance criteria and the study (non-clinical testing) that proves the device meets them, based only on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to recognized international standards and successful completion of specific physical and biological tests. The "reported device performance" indicates that the subject device met these standards and test requirements.

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The Entarik Feeding Tube is intended for the administration of nutrition, fluids and medications by the nasoenteric route for patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition.

The Entarik Feeding Tube System is designed to aid, in conjunction with institutional protocols, qualified operators in the placement of the Entarik Feeding Tube (Entarik FT) into the stomach of patients requiring enteral feeding, The Entarik FT is equipped with sensors designed to provide information about the tube tip relative to the stomach, thus assisting in reducing the incidence of misplacement during first positioning. The Entarik Monitors the feeding tube position continuously during the course of feeding and in real-time alerts of tube migration.

The Entarik Feeding Tube System (Entarik System) consists of the Enteral Feeding Tube and the Entarik Monitor. The Entarik Feeding Tube is a nasogastric feeding tube with a single lumen for the administration of nutrition, fluids and medications. The Entarik Feeding Tube includes impedance and temperature sensors embedded within the tube, with wires located in the wall of the feeding tube. The Entarik Monitor is a portable electronic device that serves to measure and record impedance and temperature data from the sensors on the Feeding Tube and provides information to the operator to aid in initial placement and monitoring of feeding tube position.

The provided text describes the Entarik Feeding Tube System and its evaluation for FDA clearance. However, it does not contain specific acceptance criteria with performance metrics in a table format, nor does it detail a comparative effectiveness study (MRMC) comparing human readers with and without AI assistance. The document focuses on demonstrating substantial equivalence to a predicate device through various tests.

Based on the provided text, here is an analysis of the requested information:

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

The document does not provide a formal table of acceptance criteria with specific quantitative performance metrics. Instead, it describes various tests performed and states that the device "successfully completed" or "performed as intended."

Summary of Reported Device Performance (Qualitative):

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

• Human Factors Test Set: Fifteen (15) intended users.
• Animal Study Test Set: Eight (8) pigs (porcine model).
• Clinical Study Test Set: 10 healthy volunteers.
• Data Provenance: The document does not explicitly state the country of origin for the human or animal study data. The studies appear to be prospective in nature ("A feasibility validation study was conducted in 10 healthy volunteers," "A study was conducted to develop and validate the algorithm in a porcine model").

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

The document does not specify the number or qualifications of experts used to establish ground truth for the human factors, animal, or clinical studies.

• For the clinical study, "Correct placement of the tube was verified via X-Ray." This suggests radiologists or other qualified medical personnel interpreted the X-rays, but details are not provided.

4. Adjudication method for the test set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test sets. For the clinical study, it simply states that X-ray was used for confirmation of tube placement.

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, the document explicitly states that the predicate device (smARTrack) automatically stops feeding using a motorized mechanism in the event of tube dislodgement, whereas the Entarik device does not have that feature. The Entarik system has an alert. This implies the Entarik system is primarily an aid to operators, but the study described is not an MRMC comparative effectiveness study with human readers assisted by AI vs. unassisted human readers. The clinical study's focus was on initial placement guidance and the system's ability to identify tube movement, not on measuring improvements in human reader performance.

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

Yes, implicitly.

• Animal Study: The animal study appears to be a standalone (algorithm only) validation for detecting respiratory tract placement: "A study was conducted to develop and validate the algorithm in a porcine model... the algorithm was successful in detecting respirations in all eight pigs and at all depths of insertion." This suggests the algorithm's performance was evaluated directly without human intervention during the detection process.
• Clinical Study (Monitoring): The statement "The Entarik Monitors the feeding tube position continuously during the course of feeding and in real-time alerts of tube migration... The system also correctly identifies tube movement" suggests standalone algorithm performance in detecting migration, though the exact metrics are not provided.

7. The type of ground truth used

• Animal Study (Respiratory Tract Detection): Ground truth was established by intentional placement of the feeding tube in the respiratory tract at various depths.
• Clinical Study (Initial Placement): Ground truth for correct tube placement in the stomach was established using X-Ray ("gold standard" placement verification).
• Clinical Study (Tube Migration): The text states "The system also correctly identifies tube movement," but it doesn't specify how the ground truth for "tube movement" was independently established (e.g., another imaging modality, direct observation, or a different sensor).

8. The sample size for the training set

The document does not explicitly state the sample size used for the training set for any of the algorithms. It mentions that clinical studies were conducted "to develop an algorithm to guide feeding tube placement into the stomach" but does not separate development/training data from validation data. The animal study was also for "developing and validating" the respiratory tract algorithm.

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

The document combines the description of algorithm development and validation. For the development of the algorithm to guide feeding tube placement, it states that "clinical studies were conducted to develop an algorithm to guide feeding tube placement into the stomach." It implies that data collected during these "development" studies (potentially similar to the 10 healthy volunteers study) with X-ray confirmation would have served as the ground truth for training.

For the respiratory tract detection algorithm, it was developed in a porcine model, and ground truth would have been established by known, intentional placement of the tube into the respiratory tract.

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The Nasogastric Feeding Tubes – ENFit Port - PVC are intended for hydration, feeding and administration of oral medications for patients who require enteral feeding. This product is single use for no longer than 24 hours.

The Nasogastric Feeding Tubes – ENFit Port - PVC are sterile, single use devices. The feeding tubes consist of a graduated polyvinyl chloride tube, with radiopaque edge. The tubes have a closed tip and two lateral eyes for Fr sizes 5 to 10 and three lateral eyes for Fr sizes 12 to 16. The tubes have at the other end an ENFit male connector in ABS with its Polypropylene cap. A tether in thermoplastic polyurethane connects the ENFit connector to its cap. The ENFit connector allows the device to be connected to female enteral devices that have an ISO 80369-3 compliant connector. The feeding tubes are available in 50cm and 90cm lengths and in French sizes from 5 to 16.

The provided text describes the regulatory clearance of a medical device, the "Nasogastric Feeding Tubes - ENFit Port - PVC," through a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's de novo clinical efficacy through comparative studies. As such, the information you've requested regarding AI device performance metrics, expert adjudication, and training/test set specifics for an AI algorithm is largely not applicable to this document.

The document discusses non-clinical performance testing to demonstrate that the new device meets established standards and performs comparably to the predicate device.

Here's an analysis based on the provided text, where applicable:

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

The document refers to a "Substantial Equivalence Discussion" (Table 5-2) comparing the new device to a predicate. The "acceptance criteria" are effectively the performance characteristics and safety profiles of the predicate device, and the "reported device performance" is the new device's compliance with these or relevant standards.

2. Sample size used for the test set and the data provenance
The document does not detail specific sample sizes for each non-clinical test. The tests were conducted according to various ISO standards (e.g., ISO 10993 series for biocompatibility, ISO 20695:2020 for enteral device performance, ISO 80369-20:2019 linked to ISO 80369-3:2016 for connector performance). These standards typically specify sample sizes or methods for determining them. No information on data provenance (country of origin, retrospective/prospective) is provided, as these are physical product tests, not data-driven AI evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical medical tube, not an AI device that produces diagnostic interpretations requiring expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI diagnostic device. The "tests" here are physical and chemical evaluations against predefined criteria in international 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 an AI-powered device or an imaging device requiring human reader interpretation. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by the criteria defined in the referenced international standards (e.g., ISO 10993, ISO 20695, ISO 80369 series). For example, passing biocompatibility tests means the materials meet the safety requirements outlined in ISO 10993.

8. The sample size for the training set
Not applicable. This is not an AI/machine learning device. No training set was used.

9. How the ground truth for the training set was established
Not applicable. No training set was used.

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The Pediatric Nasogastric Feeding Tubes - Single ENFit Port are intended for enteral feeding to deliver nutrition, fluids, and medications to the patient from an enteral feeding syringe or feeding set designed with ENFit connectors for enteral applications. This product is single use for no longer than 29 days.

The Pediatric Nasogastric Feeding Tubes – Single ENFit Ports are intended for hydration, feeding and administration of oral medications for pediatric patients who require enteral feeding. This product is single use for no longer than 29 days.

The Pediatric Nasogastric Feeding Tubes – Single ENFit Port are sterile, single use devices. The feeding tubes consist of a graduated Polyurethane tube, with radiopaque edge. The tubes have a closed tip and 2 lateral eyes. The tubes have at the other end an ENFit male connector in ABS with its Polypropylene cap. A tether in thermoplastic polyurethane connects the ENFit connector to its cap. The ENFit connector allows the device to be connected to female enteral devices that have an ISO 80369-3 compliant connector. The feeding tubes are available in 40mm, 60mm and 90mm lengths and in French sizes from 4 to 12.

The provided text is a 510(k) summary for the Pediatric Nasogastric Feeding Tubes - Single ENFit Port. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study of an AI-powered diagnostic device.

Therefore, the information required to answer the questions about acceptance criteria and the study that proves the device meets the acceptance criteria for an AI diagnostic device is not present in the provided text. The document details performance testing for a physical medical device (nasogastric feeding tubes), not an AI algorithm.

Specifically:

• There is no AI device described.
• There are no acceptance criteria for AI performance (e.g., accuracy, sensitivity, specificity).
• There is no mention of a test set, training set, ground truth acquisition involving experts, MRMC studies, or standalone algorithm performance.

The "Performance Testing" section (pages 9-10) describes non-clinical tests performed on the physical feeding tubes, such as biocompatibility, pressure leak testing, tensile testing, and connector performance tests against various ISO standards. It explicitly states, "Clinical tests were not required to demonstrate performance... Product functionality has been adequately assessed by non-clinical tests." and "Animal tests were not required... Product functionality has been adequately assessed by non-animal tests."

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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 NutriGlide™ Nasal Feeding Tube is indicated for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.

The Nutriglide™ Nasal Feeding Tube is a nasal feeding tube available in both sterile and non-sterile ENFit® and legacy configurations featuring a y-port, widening lumen diameter, dissolvable tube tip, and optional stylet with water activated lubricous coating. The device is identical between the ENFit® and legacy configurations but for the y-port which will feature either ENFit® adapters or the legacy ports. Both configurations feature tubing with a unique taper design where the lumen gradually increases from the proximal end (external) to the distal opening (indwelling). This design creates a tube that is smaller near the external y-port and gradually increases to its largest diameter at the distal tip opening where the nutrition/medication exists into the patient's stomach or small intestine. The lubricious dissolvable tip offers increased comfort during placement on the various configurations of both the ENFit® and legacy devices, and then once dissolved it reveals the entire rounded distal opening of the tube, allowing for maximum flow during feeding.

The provided text is a 510(k) Premarket Notification for the Nutriglide™ Nasal Feeding Tube. It describes the device's characteristics, intended use, and comparison to predicate devices, along with performance data. However, this document does NOT contain information about a study proving the device meets acceptance criteria related to an AI/ML algorithm or a multi-reader, multi-case study.

The performance data section (Section VII) focuses on biocompatibility, sterilization, shelf life, and bench testing for the physical device itself. It explicitly states:

• C. Animal Study: Animal testing was NOT performed.
• D. Clinical Study: Clinical testing was NOT performed.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets these criteria in the context of an AI/ML algorithm, as no such study is described in this document.

The document covers the following for the physical medical device:

1. A table of acceptance criteria and the reported device performance:
The document references that the device met "all the acceptance criteria" for various bench tests. However, it does not provide a specific table detailing these acceptance criteria alongside the quantitative reported performance for each. It mentions conformance to recognized standards and "reliable design and performance under the specified testing parameters according to predetermined criteria."

• Bench Testing Acceptance Criteria (General Statement): The subject device met all the acceptance criteria and does not raise new questions of safety or effectiveness when compared to the predicates.
• Bench Testing Categories Performed (without specific numeric criteria or results):
  • Testing per ASTM F2528 (Enteral Feeding Devices with a Retention Balloon)
  • Testing per EN 1618:1997 (Catheters other than intravascular catheters - Test methods for common properties)
  • Testing per EN1615:2000 (Enteral Feeding catheters and Enteral Giving Sets for Single Use and their Connectors - Design and Testing)
  • Testing per ISO 80369-3 (Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications)
  • Bench testing according to AMT specifications for:
    • Kink Distance
    • Clog Formation
    • Clog Removal
    • Tip Dissolution
    • Lubricious Coating
    • Component Attachment strength
    • Component integrity testing

Regarding the other requested information (which would typically be relevant for an AI/ML device approval but are not present here):

• 2. Sample sized used for the test set and the data provenance: Not applicable, no AI/ML test set described.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no AI/ML ground truth establishment described.
• 4. Adjudication method for the test set: Not applicable.
• 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, no MRMC study described.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no AI/ML algorithm described.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable, no training set described.
• 9. How the ground truth for the training set was established: Not applicable.

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The Nutricare Clear feeding tube is intented for insertion into the alimentary canal of pediatric subgroups; Newborn (Neonate), Infant, Child, Adolescent) through either the nasal or oral cavity for the purpose of supplying fluids, medication or nutrition, for up to 30 days.

Not Found

I apologize, but the provided text from the FDA 510(k) clearance letter for the Nutricare Clear-ISOSAF Nasogastric Feeding Tube does not contain information about an AI/ML medical device, its acceptance criteria, or the study proving its performance.

The document is a standard FDA clearance letter for a physical medical device (nasogastric feeding tube), outlining:

• The device name and its intended use.
• The regulatory classification and product code.
• Confirmation of substantial equivalence to a predicate device.
• General controls and other regulatory requirements applicable to the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is not present in the provided text.

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This device is intended to provide short-term enteral access for delivery of nutrition and/or medications to small bowel. This device is indicated for adult use only.

The subject device is packaged with: a nasal feeding tube, a nasal transfer tube, a wire guide, and two feeding adapters. The single lumen nasal feeding tube is composed of radiopaque polyvinyl chloride with ink markings that are endoscopically visible and assist with tube placement. The nasal feeding tube is available in two diameters, 8 Fr and 10 Fr. with a length of 240 cm and 10 feeding ports. The nasal transfer tube has a diameter of 14 Fr, is composed of clear PVC and is 20 inches in length. The wire guide is stainless steel coated with polytetrafluoroethylene (PTFE) and is 250 cm in length. Two feeding adapters are provided; one as a friction fit version and one ENFit compatible.

This document is a 510(k) Premarket Notification from the FDA for the Entuit Nasal Jejunal Feeding Tube. It focuses on establishing substantial equivalence to a predicate device, primarily due to the addition of an ENFit connector. The document does not provide information about clinical studies with acceptance criteria for device performance in the context of diagnostic accuracy, AI assistance, or human reader performance.

Therefore, I cannot populate the requested tables and information segments because they are related to clinical performance studies, often seen with AI/ML-based devices or diagnostic tools, which are not applicable to the information provided in this 510(k) summary for a medical device like a feeding tube.

The "Performance Data" section explicitly states: "Performance testing consisting of non-clinical bench testing demonstrates the subject device meets the performance requirements to fulfill the intended use." and "The following non-clinical testing was conducted to demonstrate the performance of the subject device and confirms that the subject device performs as intended: ENFit Connector Testing per ISO 80369-3: 2016 and Design Verification of Feeding Adapters."

This indicates that the evaluation was based on bench testing for physical and mechanical properties, not clinical trials impacting accuracy or human performance.

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The Gabriel® Feeding Tube with Balloon functions as a conduit to facilitate enteral feeding, and may be used in adult or elderly patients 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 post-trauma patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exist, or may result, secondary to an underlying disease or condition.

The Gabriel Feeding Tube with Balloon serves as conduit through which enteral feeding solutions are directly infused into patients small bowel. The tube has two distal end openings, one distal end balloon, one proximal end pilot balloon that indicates the status of the inflation of the distal end balloon and a proximal end EnFit connector that replaced our Y shaped catheter tip connector of the predicate device. The tube shaft is lined by a monofilament spiral wire to prevent occlusion from kinking. A braided 7 strands stainless steel stiffening central stylet prevents coiling in the mouth during insertion and provides column strength to facilitate placement into the stomach.The tube patient contacting material is made from DEHP-free PVC. Size 12 Fr tube is 130 cm long.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Gabriel® Feeding Tube with Balloon, and EnFit Connector." This document focuses on demonstrating substantial equivalence to a predicate device (K160787) rather than providing detailed acceptance criteria and study results for a novel AI/software-as-a-medical-device (SaMD) product.

Therefore, the information required to answer the specific questions about acceptance criteria, study design, sample sizes, expert involvement, and ground truth for an AI device is not present in the provided text. The document describes a traditional medical device (a feeding tube) and its physical and functional characteristics, along with non-clinical tests for its performance and safety compared to its predicate.

Here's what can be extracted from the document regarding the device and its testing, but it does not fulfill the prompt's request for AI device study details:

Device Description and Purpose:
The Gabriel® Feeding Tube with Balloon, and EnFit Connector is a nasoenteral feeding tube designed to facilitate enteral feeding in adult or elderly patients who cannot orally consume an adequate diet. It's intended for bedside insertion and use in patients requiring short to moderate-term feeding support. Key features include a distal end balloon for peristaltic advancement and airway misplacement detection, a flexible shaft with a spiral wire to prevent kinking, and a central stainless steel stylet for insertion. The primary changes from the predicate device are the replacement of a Y-shaped catheter tip connector with a rigid male EnFit connector to mitigate misconnection risk, a change from MR unsafe to MR conditional, and the addition of certain items to a convenience kit.

Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Testing for Substantial Equivalence):

As this is a physical medical device and not an AI/SaMD, the "acceptance criteria" are implied by successful completion of mechanical, functional, and safety tests to demonstrate equivalence to a predicate device. The reported performance is that the device "passed" these tests.

Information NOT available in the provided text (as it pertains to AI/SaMD studies):

The prompt specifically asks for details related to AI/SaMD acceptance criteria and studies which are not relevant to this 510(k) submission for a non-AI medical device. Therefore, the following points cannot be addressed from the given document:

2. Sample size used for the test set and the data provenance: Not applicable to this type of device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as this is not an AI device relying on interpreted data.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Clinical Testing:
The document explicitly states: "No clinical testing was performed in association with this submission." This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical testing and comparison to an existing predicate device.

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