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The Enteral Drainage System is intended to allow the evacuation of excess gas and drainage of gastrointestinal fluids from patients utilizing an enteral device.
The Enteral Medicine Straw is intended for drawing and delivery of medicine to patients through an ENFit syringe.

The Enteral Drainage System and the Enteral Medicine straw are intended to be used during enteral nutrition treatments in combination with enteral feeding tubes, syringes and other compatible enteral medical devices.

The Enteral Drainage System is intended to allow the evacuation of excess gas and drainage of gastrointestinal fluids from patients utilizing an enteral device.
The device consists of:

• a bag in DEHP FREE PVC, equipped with a hydrophobic 3μm filter to allow gas escape;
• two short PVC tubes (5-6 cm) on top and bottom of the bag; the bottom one is equipped with a male enteral connector, and the top one with a female enteral connector that is capped off with an ENFit-compatible cap;
• a clamp to regulate the fluid flow, placed over the bottom tube.

It is available in five sizes, depending on the volume of the bag included in the device:

• MED50LU, Enteral drainage bag 50 ml;
• MED100LU, Enteral drainage bag 100 ml;
• MED250LU, Enteral drainage bag 250 ml;
• MED500LU, Enteral drainage bag 500;
• MED1000LU, Enteral drainage bag 1000 ml.

The device is connected to the nasogastric or naso-jejunal feeding tube between feeding sessions to allow the drainage of stomach or intestinal fluids and gasses in excess. The transparency of the materials allows for constant monitoring and visualization of drained fluids. The bag must be placed at a lower level than the patient's stomach and also acts as a venting device.

The Enteral Medicine straw, coded C005LU, is intended for drawing and delivery of medicine to patients through an ENFit enteral syringe. It consists of a male enteral connector (that allows the connection to a compatible enteral syringe) and a tubing in thermoplastic polyurethane.
Once the fluid is drawn up from the container into the syringe, the cannula must be disconnected, and the syringe can then be connected to another medical device (normally, a feeding tube or a gastrostomy tube) to administer its content to the patient.

All enteral connections of the subject devices are designed to avoid for inadvertent delivery of enteral feedings through the intravenous route. i.e., the devices cannot be connected to devices endowed with a luer connector.

The devices are sterilized with Ethylene Oxide (EtO).

These devices are targeted to neonatal, pediatric and adult patients, with compromised or limited gastric motility; they are for single patient use and can be reused multiple times within a twenty-four-hour period, after which they are to be replaced.

The provided text is a 510(k) clearance letter and an associated 510(k) Summary for the HMC Premedical S.p.a. Enteral Drainage System and Enteral Medicine Straw. This document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance and biocompatibility testing. It does not include information about human factor studies, clinical trials, or studies involving human readers or expert panels for ground truth determination.

Therefore, many of the requested criteria cannot be answered from the provided text.

Here's a breakdown of what can and cannot be answered:

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

The document broadly states that the device "met the pre-determined acceptance criteria" for performance tests and "comply with the applicable sections of the standards cited below." However, it does not explicitly list specific numerical acceptance criteria or the exact reported performance values for the tests mentioned (Misconnection testing, leak testing, tensile strength testing, dimensional requirements, integrity of device packaging).

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

• Sample Size: Not specified for any of the non-clinical tests.
• Data Provenance: Not specified. These are laboratory tests, not clinical data from specific countries.

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. No expert-based ground truth was established as these were non-clinical performance and biocompatibility tests, not clinical efficacy studies involving human interpretation.

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

Not applicable. No adjudication method was used as these were non-clinical performance and biocompatibility tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical accessory (drainage system, medicine straw), not an AI-powered diagnostic or assistive technology. No MRMC study was mentioned or would be relevant for this type of device.

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

Not applicable. This device is a medical accessory, not an algorithm or AI system.

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

For the non-clinical tests, the "ground truth" was defined by the requirements and specifications outlined in the referenced international standards (e.g., ISO 80369-3, ISO 80369-20, ISO 20695, ISO 10993 series, USP , ISO 11607-1, ASTM standards). Successful adherence to these standards constituted the "truth" for device performance and safety in a non-clinical setting.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable. This is a physical medical device, not an AI/ML model.

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The Extension Feeding Set with ENFit™ connectors is intended for use as an extension set for a Low-Profile Gastrostomy Replacement Tube (G. Button). It is intended to provide delivery of Enteral Nutrition from administration media with ENFit™ connector and or medication into a single patient, for a maximum of two weeks.

Feeding via an Extension Feeding Set is advocated when nutrition cannot be provided to the patient by mouth and therefore cannot consume an adequate number of calories because of an underlying condition.

The Extension Feeding Set with ENFit™ connectors (Extension Feeding Set), comprises a hollow tube with two different connectors at each end: an ENFit™ connector connecting to an administration media, the other is a secure lock connector for connecting to a gastric feeding device.

The Extension Feeding Set is sterile, single patient use device, consisting of a polyvinylchloride tube, ABS secure lock connector, Tritan ENFit™ connector. The connectors on the proximal end of the extension sets are ENFit™ ISO 80369-3 compliant. The ENFit™ connector allows for connections of enteral specific applications while reducing the likelihood of misconnections to non-enteral devices. Extension Feeding Sets are available in three lengths: 5 cm (2"), 30.5 cm (12") or 61 cm (24"). All Extension Feeding Sets are available with either a right-angle secure lock connector or a straight secure lock connector. Both connectors are compatible with G. Button.

The provided FDA 510(k) clearance letter and summary for the "Extension Feeding Set with ENFit™ connectors" (K250481) pertains to a physical medical device (gastrointestinal tube and accessories). Therefore, it does not include information on acceptance criteria, studies, or ground truth establishment relevant to an AI/ML-based medical device.

The questions you've asked (about acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, training set information) are all highly specific to the evaluation and validation of AI/ML-driven devices, particularly in image analysis or diagnostic support.

Since the provided document describes a physical Class II medical device (a tube with connectors), the clearance process for it focuses on:

• Substantial Equivalence: Comparing its design, materials, and technological characteristics to an existing legally marketed predicate device.
• Non-Clinical Testing: Laboratory tests to ensure physical performance (e.g., tensile strength, leakage, flow rate, biocompatibility) and safety based on relevant industry standards (e.g., ISO 80369-3 for ENFit connectors).
• Shelf Life Validation: Ensuring the device remains functional and sterile over its stated shelf life.

Therefore, I cannot extract the requested information (acceptance criteria, study details for AI/ML device validation) from the provided text because it describes a different type of medical device.

If you have a document describing an AI/ML-based medical device, I would be happy to analyze it for the specific details you've requested.

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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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Mobility+ is intended to deliver liquid nutrition formula to an enteral access device (feeding tube) in users aged 2 years and over.

The Mobility+ Enteral Feeding System OTC ("Mobility+ OTC" or the "System") is a portable, lightweight, non-electronic, disposable enteral feeding system intended to deliver liquid nutrition formula to an enteral access device (feeding tube) in users aged 2 years and over in clinical or home care settings. The device is for single patient use, disposable and intended for use over a 24-hour period.

The System has three primary components; food pouch, filling set and giving set.

Food Pouch: The Food Pouch serves as the Mobility+ Enteral Feeding System OTC system's combined reservoir and pump. The pouch consists of a foil container with an internal elastomeric pouch. The Food Pouch can hold up to 500 ml of feed.

Filling Set: The Filling Set is tubing that connects to the Mobility+ food pouch to deliver commercially available nutritional feed from its packaging to the Food Pouch using ENFit connectors. The Filling Set is used to transfer feed from the feed packaging into the Food Pouch, using a syringe.

Giving Set: The Giving Set is tubing that connects the Food Pouch to the implanted feeding tube's ENFit connector. The Giving Sets will be available in a variety of lengths to give a range of feed flow rates. All connectors in the Mobility+ Enteral Feeding System OTC comply with the FDA-recognized ENFit standard (ISO 80369-3 and ISO 18250-3).

The Mobility+ Enteral Feeding System OTC may be worn in a bag of choice that can fit the system without kinking the tubing and without squeezing the pouch. The instructions for use guide the user to place the spout of the pouch within 15cm (6 inches) above or below the stoma when feeding.

This is a non-AI medical device; therefore, sections 1-9 are not applicable.

The provided document describes the Mobility+ Enteral Feeding System OTC, a non-electronic, disposable enteral feeding system intended to deliver liquid nutrition formula. As a physical medical device (a pump and tubing system) rather than an AI/software device, the concepts of acceptance criteria related to AI performance, ground truth establishment by experts, training/test sets, or MRMC studies are not applicable in this context.

The document states:

• "Non-Clinical Information: The Mobility+ System OTC is the identical device as the predicate. Therefore, all technological characteristics (e.g., design, material, functionality) are identical and non-clinical performance data tests were not repeated."
• "Clinical Information: Clinical studies were not deemed necessary for The Mobility+ Enteral Feeding System OTC as bench testing was sufficient to demonstrate substantial equivalence by way of comparison to a legally marketed predicate device."

The acceptance criteria for this device are demonstrated through design verification and validation tests, which focus on the physical and functional aspects of the system.

Here's the relevant information about the "acceptance criteria" through the lens of device testing:

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

The document lists "Design Verification Tests" and "Design Validation Tests". These tests represent the acceptance criteria for the device's functionality and safety. The reported device performance is that the device met these requirements.

The document states: "The test results (K222678 – Volume 0007 Bench Testing) demonstrate that the Mobility+ Enteral Feeding System OTC, being identical to the predicate device, meets the requirements in the applicable standards."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable as this is a physical device and the primary evidence is bench testing, not data from a test set. The testing was done on the predicate device (K222678) and deemed identical, meaning the provenance would be tied to the predicate's testing. Specific sample sizes for each bench test are not provided in this summary.

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 for a physical device is established by physical measurement, performance specifications, and safety standards, not expert consensus on interpretations as would be the case for an AI diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or subjective assessment that would require 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 device is not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical, non-electronic enteral feeding system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this medical device is established by adherence to design specifications, functional requirements, and recognized standards (e.g., ISO 10993-1 for biocompatibility, ISO 80369-3 and ISO 18250-3 for ENFit connectors), as demonstrated through bench testing.

8. The sample size for the training set
Not applicable. This is a physical device, not an AI model.

9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI model.

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The ENFit to ENFit Extension Sets are intended for enteral feeding, on the order of a physician, to provide a means of delivering enteral nutrition, fluids and medications from an enteral feeding syringe or set through to an ENFit feeding tube connector for enteral applications.

The device is single use for patients who require enteral feeding.

The ENFit to ENFit Extension Sets are sterile, single use devices. The extension sets are single and bifurcated port tubing sets with ENFit input port(s) and tethered caps, extension set tubing and clamp(s), and a single ENFit connector on the patient end. The ENFit connectors allow the extension set to be connected to other enteral devices that also have ISO 80369-3 compliant connectors. The extension sets are available in the listed lengths from 50 to 150 cm.

This document is a 510(k) Premarket Notification from the FDA for a medical device called "ENFit to ENFit Extension Sets." It details the device's characteristics, intended use, and a comparison to a predicate device to establish substantial equivalence.

Based on the provided text, the device in question is a physical medical device (extension sets for enteral feeding), not a software or AI-driven diagnostic tool. Therefore, the questions regarding acceptance criteria for a "study that proves the device meets the acceptance criteria" in the context of AI/software performance (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment for training data) are not applicable to this type of device submission.

The "acceptance criteria" for this device are related to its physical performance, safety, and functional equivalence to a legally marketed predicate device, as demonstrated through non-clinical testing and comparison. The "study that proves the device meets the acceptance criteria" refers to the verification and validation testing performed.

Here's the information as requested, adapted to the context of a physical medical device:

Acceptance Criteria and Device Performance (adapted for a physical medical device)

The acceptance criteria for this device are established by demonstrating compliance with recognized international standards for medical devices and particularly for enteral feeding connectors, and by showing substantial equivalence to a predicate device in terms of design, intended use, and performance.

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

The document primarily demonstrates acceptance by adherence to specific ISO standards and by direct comparison to a predicate device. The "reported device performance" is the confirmation that the device met the requirements of these standards.

• Cytotoxicity per ISO 10993-5:2009
• Guinea Pig Maximization Sensitization per ISO 10993-10:2010
• Irritation per ISO 10993-10:2010
• Acute Systemic Toxicity per ISO 10993-11:2017
• Material-mediated Pyrogenicity per 10993-11:2017 | Compliant with Use of International Standard ISO 10993-1: "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." |
  | Visual Inspections:
• Verification of bonding. | Visual inspection for verification of bonding was performed and met requirements. |
  | Enteral Device Performance (per ISO 20695:2020):
• Pressure leak testing
• Tensile testing
• Flow rate testing | Found to be in compliance with design and performance requirements when tested according to ISO 20695:2020. |
  | ENFit Connector Performance (per ISO 80369-20:2019 & ISO 80369-3:2016):
• Fluid leakage
• Stress cracking
• Resistance to separation from axial load
• Resistance to separation from unscrewing
• Resistance to overriding
• Disconnection by unscrewing
• ENFit dimensional verification | Tested per ISO 80369-20 and met the standards of 80369-3 for all specified connector performance aspects. Evaluated per ISO 80369-3 for ENFit dimensional verification and met requirements. Device is compliant with ISO 80369-3. |
  | Risk Analysis (per ISO 14971:2019):
• Design Failure Modes and Effects Analysis (DFMEA). | Risk analysis per ISO 14971:2019 was performed, including DFMEA. |
  | Usability Analysis (per ISO 62366-1:2015): | Usability analysis per ISO 62366-1:2015 was performed. |
  | Substantial Equivalence to Predicate Device (K143018) for:
• Indications for Use
• Intended Use
• Environment of Use
• Intended Users
• Patient Population (differences acknowledged but deemed acceptable)
• No Reuse
• Sterility Condition
• ENFit Connector
• Lengths (differences acknowledged but deemed acceptable) | All aspects were deemed "Substantially Equivalent?", with "Yes" indicated for each. Differences in patient population (pediatric and adult vs. neonates and pediatric) and lengths were justified as not impacting safety or performance. |

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

For this type of device, "sample size" is typically not referred to in the context of data points for an algorithm's performance, but rather the number of physical devices or batches tested in laboratory settings. The document states "Verification and validation testing was performed with the ENFit Extension Sets" but does not specify the exact number of units tested for each non-clinical test. The data provenance is from non-clinical (laboratory) testing conducted by the manufacturer, Vesco Medical, to assess the device's compliance with ISO standards. This is prospective testing carried out specifically for regulatory submission. The country of origin of the data is implicitly the country where Vesco Medical conducted its testing (Westerville, Ohio, USA).

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

This concept is not applicable. For physical medical devices, "ground truth" is established by adherence to recognized international standards and performance specifications, not through expert consensus on diagnostic images or similar. The "experts" would be the engineers and quality assurance professionals performing and evaluating the non-clinical tests according to the established protocols. Their qualifications would involve expertise in materials science, mechanical engineering, and quality systems for medical devices.

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

This concept is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiologists reviewing images) to establish a consensus ground truth. For physical device testing, results are typically quantitative and compared against predefined pass/fail criteria from 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:

This is not applicable. MRMC studies are used for evaluating diagnostic performance of AI or imaging systems. This submission is for a physical enteral feeding extension set, not a diagnostic imaging device or AI software. There are no "human readers" interpreting data with or without AI assistance.

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

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

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

The "ground truth" for this device is based on objective performance measurements against established international standards (e.g., ISO 80369-3, ISO 80369-20, ISO 20695, ISO 10993, ISO 14971, ISO 62366-1) and demonstrated functional equivalence to a legally marketed predicate device. There is no "pathology" or "outcomes data" in the typical sense used for diagnostic devices; rather, the device is tested for physical and material integrity, fluid dynamics, and biocompatibility.

8. The sample size for the training set:

This is not applicable. There is no "training set" as this is not an AI/machine learning device. The design and manufacturing processes are iterative and informed by industry standards and best practices, but there isn't a "training set" of data in the AI sense.

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

This is not applicable. Since there is no training set for an AI model, there is no "ground truth" established for it. The design specifications and performance requirements are informed by engineering principles, regulatory standards, and the performance of existing predicate devices.

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The feeding tube is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication, or decompression through an established gastrointestinal stoma tract.

The Kangaroo Skin Level Gastrostomy Device Feed Set Kit with ENFit® Connection is indicated for use in adult and pediatic patients that require enteral feeding, medication administration, or decompression through a Kangaroo Skin Level Device.

The Kangaroo ™ Skin Level Balloon Gastrostomy Kit will be comprised of one Kangaroo™ Skin Level Device and one of each of the feed sets. The feed sets, continuous and bolus, are also available in Feed Set Kits packaged individually and then boxed as a 10-pack.

The Kangaroo™ SLD is constructed primarily of silicone and consists of a hub which is overmolded on to a previously extruded bi-lumen shaft. The tip of the shaft is filled with radiopaque barium RTV. At the distal end, a silicone subsumed tip balloon is reverse bonded to the shaft using a silicone RTV. This subsumed tip balloon accomplishes patient comfort by not exposing the tip of the shaft to the patient as well as being in line with the shaft. In use, the balloon end of the catheter is inserted through a gastrointestinal stoma tract and into the stomach. The balloon is then inflated with sterile or distilled water (per the recommended volume for the specific device size) to secure the device in place. To confirm placement of the device in the stomach, fluoroscopic procedures are typically used since the catheter shaft tip has radiopaque barium stripe present. Accessories for the Kangaroo™ SLD include two feed extension set confiqurations (ENFit bolus and continuous), an inflation syringe, a feeding syringe (ENFit), and gauzes.

The hub has two ports. The top (center) port contains a reflux valve assembly which is keyed to accept the feed set valve connectors. Leaks are prevented by the reflux valve assembly (with cross-slit valve design). The second port is the inflation port and contains the inflation valve.

The device is available in the configurations per determined market needs shown below in Table 5.5-2.

The feed extension sets have a valve connector end that inserts into the Kangaroo™ SLD reflux valve. For these ENFit Feed Sets, the opposite end has an ENFit-compatible connector complying with ISO 80369-3 (for prevention of misconnections with nonenteral feeding devices). The extension set can then connect to any ENFit-compatible enteral giving sets or ENFit-compatible syringes. Finally, both the Kangaroo™ Skin Level Device and the Kangaroo™ Feed Sets are compatible with competitor devices currently on the market.

This document is a 510(k) summary for the Kangaroo Skin Level Balloon Gastrostomy Kit and associated feed sets. It does not describe a study involving an AI/ML device, but rather a traditional medical device (gastrostomy kit). Therefore, many of the requested categories related to AI/ML device studies, such as the use of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable.

However, I can extract information regarding the device's acceptance criteria and how its performance was demonstrated through non-clinical testing.

Here's the summary of the acceptance criteria and study information that is applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with numerical performance results directly in the format requested. Instead, it states that results from all tests "met the acceptance criteria for each test."

However, it lists the types of performance tests conducted based on relevant standards. The "acceptance criteria" can be inferred as the requirements set by these standards:

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

The document does not explicitly state the sample sizes (number of devices) used for each specific test mentioned under "Performance Testing Bench." It only indicates that "all the above tests met the acceptance criteria," implying that sufficient units were tested to demonstrate compliance.

The data provenance is from non-clinical bench testing conducted by the manufacturer, Xeridiem Medical Devices, on the proposed devices, or leveraged from previously conducted tests on the identified predicate and reference devices. There is no mention of country of origin for data; it is assumed to be from the manufacturer's internal testing. The data is prospective in the sense that the tests were conducted specifically to support this 510(k) submission.

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

Not applicable, as this is for a traditional medical device and not an AI/ML diagnostic or interpretive device. The "ground truth" here is the performance of the device against engineering and safety standards, directly measured through physical tests.

4. Adjudication Method for the Test Set

Not applicable. Device performance was assessed against predefined engineering and safety standards, not through human interpretation requiring adjudication.

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

No. This is not an AI/ML device, and therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.

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

Not applicable. This is for a traditional medical device.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of this traditional medical device is based on established engineering and safety standards (e.g., ISO 80369-3, EN1615, ISO 20695, ASTM F2528-06, ISO 10993-1). The device's physical and functional characteristics are directly measured and compared against the requirements specified in these standards.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. As there is no training set.

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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 Vonco Products EnteraLoc Flow spouted pouch with ENFit® Connector is indicated for use as a dispenser of enteral nutrition by way of direct connection to a feeding tube or extension set. It is intended to deliver nutrition into the gastrointestinal system of a patient. The pouch, once filled, is intended to be used in clinical or home care settings by users ranging from laypersons to clinicians, in all age groups.

The Vonco Products EnteraLoc Flow spouted pouch with ENFit® Connector consists of a foil pouch with an integrated female ENFit® connector at one end. The EnteraLoc Flow pouch is provided with a tamper evident cap. The pouch is designed to be pre-filled with liquid nutrition formula for tube feeding. EnteraLoc Flow is a single use device.

EnteraLoc Flow spouted pouch with ENFit® Connector is designed as a single use, over-the-counter device. The pouches will be available in a range of sizes, with a range of nutritional values (based upon the formula which the pouch is filled). Based upon the required nutritional intake requirements, the user will select the proper size pouch and quantity for feeding.

The provided document is a 510(k) premarket notification decision letter from the FDA regarding the "EnteraLoc Flow" device, which is an enteral nutrition dispensing pouch. The document details the device's indications for use, comparison to predicate devices, and a list of performance tests conducted.

However, the document does not contain the level of detail requested for the acceptance criteria and study that proves the device meets those criteria, particularly within the context of an AI/ML-based medical device. Specifically, it lacks information on:

1. A table of acceptance criteria and reported device performance with specific quantitative metrics. The document lists types of tests (e.g., Flow Rate Analysis, Biocompatibility Testing, Performance Testing per ISO standards) but does not provide the pass/fail criteria or the actual results obtained.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. Whether a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, or the effect size of human readers' improvement with AI vs. without AI assistance. This is explicitly an AI/ML-specific question, and the device described is a physical medical device, not an AI/ML diagnostic tool.
6. Whether a standalone performance study was done (algorithm only without human-in-the-loop performance). Again, this is an AI/ML-specific question.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, intended use, and various physical and biological performance tests relevant to a non-AI/ML medical device.

Therefore, it is impossible to extract the requested information from the provided text as it pertains to an AI/ML product's acceptance criteria and study details. The device in question, the "EnteraLoc Flow" spouted pouch with ENFit® Connector, is a physical device for dispensing enteral nutrition, not an AI/ML diagnostic or assistive tool. The questions are tailored for evaluating an AI/ML-based medical device.

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Mobility+ is intended to deliver liquid nutrition formula, to an enteral access device (feeding tube) in users aged 2 years and over.

The Mobility+ Enteral Feeding System ("Mobility+" or the "System") is a portable, lightweight, nonelectronic, disposable enteral feeding system intended to deliver liquid nutrition formula to an enteral access device (feeding tube) in users aged 2 years and over in the clinical or home care settings. The device is for single patient use, disposable and intended for use over a 24 hour period. The System has three primary components; food pouch, filling set and giving set.

The provided text describes the regulatory submission for the Mobility+ Enteral Feeding System, a medical device. It does not contain information about an AI/ML-driven device or a study involving acceptance criteria for an AI algorithm's performance. The document focuses on demonstrating substantial equivalence to a predicate device using bench testing and non-clinical data, not on the performance of a software algorithm.

Therefore, I cannot extract the information required to populate the fields related to AI/ML device performance, ground truth, expert adjudication, or MRMC studies, as these concepts are not applicable to the descriptions within your input.

The document explicitly states:
"Clinical studies were not deemed necessary for The Mobility+ Enteral Feeding Set as bench testing was sufficient to demonstrate substantial equivalence by way of comparison to a legally marketed predicate device."

This indicates that the study performed was a non-clinical bench testing and design verification/validation study to demonstrate that the physical device performs as intended and is equivalent to existing devices, not a study evaluating an AI algorithm's diagnostic or therapeutic capabilities.

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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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