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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 ENConnect 40 mm Screw Cap to ENPlus Adapter is intended to connect enteral giving sets, equipped with an ENPlus connector, to enteral nutrition crown cap bottles or wide neck reservoirs in order to deliver nutritional fluids.

The ENConnect 40 mm Screw Cap to ENPlus Adapter (the proposed device) is a non-sterile, single use device consisting of screw cap with a 40 mm thread, an ENPlus port, vent, and gasket. The proposed device is intended to connect enteral giving sets, equipped with an ENPlus connector, via the ENPlus port to wide neck reservoirs and/or crown cap bottles containing enteral nutrition.

This document, K190327, is a 510(k) Premarket Notification for a medical device called the "ENConnect 40 mm Screw Cap to ENPlus Adapter." It describes the device and its testing to demonstrate substantial equivalence to a predicate device.

However, the request asks for information about acceptance criteria and studies proving an AI/Software as a Medical Device (SaMD) meets those criteria. Specifically, it asks about:

• A table of acceptance criteria and reported device performance (typical for AI/SaMD metrics like sensitivity, specificity, F1-score, AUC).
• Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, and how training ground truth was established.

The provided document (K190327) is for a physical medical device (an adapter for enteral feeding), not an AI/SaMD. Therefore, it does not contain any of the information requested regarding AI/SaMD performance, ground truth establishment, or clinical study design specific to AI models.

The document focuses on demonstrating substantial equivalence for a physical device through:

• Non-clinical performance testing: This includes biocompatibility, flow rate, fluid leakage, ISO 18250-3 evaluations (dimensions, pressure leakage, stress cracking, resistance to separation), tensile testing, distribution simulation, and packaging tests. These are standard engineering and material science tests for physical devices to ensure safety and function, not AI performance metrics.
• Comparison to a predicate device: The document explicitly states that the designs are different but do not impact safety and effectiveness, and then lists various physical characteristics and operational aspects for comparison.

Therefore, it is impossible to extract the requested information from this document because it is not relevant to an AI/SaMD.

To illustrate, if this were an AI/SaMD document, the acceptance criteria table might look like this (hypothetical, as the document doesn't provide it):

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical for an AI/SaMD)

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The Cedic F 00126 ENFit to Reverse Luer Transition Connector is intended to connect an enteral female ENFit giving set to the "g" port of the AbbVie PEG-J enteral male Luer catheter.

The Cedic F 00128 Luer to ENFit Transition Connector is intended to connect the AbbVie Duopa Medication Cassette Reservoir delivery system to an enteral male ENFit catheter.

The Cedic Enteral ENFit Transition Connectors are designed to facilitate enteral specific connections between ISO 80369-3 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors. This submission describes the Cedic ENFit to Reverse Luer Transition Connector and the Cedic Luer to ENFit Transition Connector. These Cedic ENFit Transition Connectors are intended for prescription use only. The two transition connectors introduced by means of this submission are intended only for use with specific products commercialized in the US by Abbvie Inc., North Chicago, IL 60064-1802, USA, these being the AbbVie PEG-J enteral male Luer catheter (cleared under K142816) and the AbbVie Duopa Medication Cassette Reservoir (details available in DMF 26089) respectively.

The provided document describes Cedic Enteral ENFit Transition Connectors, which are medical devices designed to facilitate connections between new ISO 80369-3 compliant enteral connectors and older, non-compliant legacy enteral connectors. The document primarily focuses on demonstrating the substantial equivalence of these devices to a legally marketed predicate device (AMT Enteral Transition Adapters).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document refers to FDA-recognized standards for the design and testing of the connectors. The acceptance criteria are implicitly those defined by these standards, and the device performance is stated to be in compliance.

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

The document states, "Bench tests have been carried out on samples of the Cedic Transition Connectors." However, it does not specify the sample size used for these tests. The data provenance is from Cedic S.r.l. in Italy, and the tests appear to be prospective bench tests performed on the manufactured devices.

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

This information is not provided in the document. The "ground truth" for these types of devices typically relies on adherence to engineering standards and test specifications, rather than expert clinical consensus in the same way an imaging AI algorithm would.

4. Adjudication method for the test set

This information is not provided and is generally not applicable to bench testing against engineering standards. The tests are objective measurements against defined criteria.

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

An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that influence human interpretation. The Cedic device is a physical connector, not an AI algorithm.

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

A standalone algorithm performance study was not done. The device is a physical connector, not an algorithm.

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

The ground truth used for performance assessment is primarily engineering specifications and test methods defined by FDA-recognized international standards (ISO 80369-3, ISO 594-2, ISO 80369-20, ISO 10993). This is based on objective, quantitative measurements and adherence to design requirements for medical device connectors, rather than human interpretation or clinical outcomes data in the usual sense.

8. The sample size for the training set

This information is not applicable as the device is a physical connector and does not involve AI or machine learning models that require training sets.

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

This information is not applicable for the same reason as point 8.

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The Cedic Oral/Luer Enteral ENFit Transition Connector for is intended for connecting a male oral tip syringe or a male Luer slip tip syringe to an enteral giving set or enteral catheter with an ENFit medication port.

The Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port is a transition connector intended for connecting a male oral tip syringe or a male Luer slip tip syringe to an enteral giving set or enteral catheter with an ENFit medication port. This connector is available with and without end cap. It operates by providing a means of interconnecting incompatible enteral feeding device end fittings together. The PGLock end of the connector is designed in compliance with ISO 80369-1:2010 and ISO/IEC AAMI/CN3 (PS):2014. It is manufactured by injection molding from ABS HF 380.

The provided document describes a medical device, the "Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port," and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study data, sample sizes for test or training sets, information on ground truth establishment, or multi-reader multi-case study results.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed de novo device study.

Therefore, much of the requested information cannot be extracted from this document. I will provide what is available and indicate where information is missing.

Acceptance Criteria and Device Performance:

The document refers to FDA recommendations for enteral connectors and the associated mechanical testing. It states that the device was tested to demonstrate compliance with these recommendations. Specific quantitative acceptance criteria (e.g., minimum force for separation) and the exact reported device performance values are not explicitly provided in a table format within this document. The document primarily states what types of tests were conducted and that the device "is made of the appropriate rigid or semi-rigid materials" and that "Bench tests have been carried out."

Detailed Study Information:

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

   • Sample Size: The document states that "Bench tests have been carried out on samples" but does not specify the sample size used for these tests.
   • Data Provenance: The tests were conducted internally by the manufacturer (Cedic S.r.l. Biomedical Division, Italy) or a contracted lab on behalf of the manufacturer. The data is retrospective in the sense that the tests were performed before the 510(k) submission. There is no mention of country of origin of the data beyond the manufacturer's location.

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

   • This question is not applicable to this type of device and study. This is a mechanical device, and "ground truth" would be established by objective physical measurements according to specified standards, not expert consensus on interpretations.

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

   • This is not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation tasks (e.g., image reading) where consensus among experts establishes ground truth. For mechanical tests, results are typically objective measurements against a standard.

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

   • This is not applicable. This document describes a mechanical connector device, not an AI-assisted diagnostic tool or an imaging system that would involve human readers.

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

   • This is not applicable. This device is a passive mechanical connector, not an algorithm.

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

   • The "ground truth" for this device's performance is objective measurement of its physical properties and mechanical behavior against established engineering standards (e.g., ISO 80369-1, ISO 594-1, ASTM D747, ASTM D790) and the FDA's draft guidance recommendations for misconnection mitigation. It's essentially compliance with predefined technical specifications.

7. The sample size for the training set:

   • This is not applicable. This device is a mechanical product, not a machine learning model, so there is no "training set."

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

   • This is not applicable as there is no training set.

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The Cedic Enteral Distal End ENFit Transition Connector is intended for connecting an enteral giving set with an ENFit connector to an enteral catheter with funnel.

The Cedic Enteral ENFit Transition Connector for Medication Port is intended for connecting a male oral tip syringe to an enteral giving set or enteral catheter with an ENFit medication port.

The Cedic Enteral Funnel ENFit Transition Connector is intended for connecting an enteral giving set equipped with a stepped enteral distal end to an enteral catheter equipped with an ENFit connector.

Cedic Srl has designed three transition connectors that will allow specific connections between PGLock end connectors being used on new devices to some of the previously used end connectors that may still be in use in healthcare or home settings. The three transition connectors are:

• . Enteral Distal End ENFit Transition Connector, for connecting an enteral giving set with an ENFit connector to an enteral catheter with funnel. Available with and without end cap.
• . Enteral ENFit Transition Connector for Medication Port, for connecting a male oral tip syringe to an enteral giving set or enteral catheter with an ENFit medication port. Available with and without end cap.
• . Enteral Funnel ENFit Transition Connector, for connecting an enteral giving set equipped with a stepped enteral distal end to an enteral catheter equipped with an ENFit connector. Available with and without end cap.

All three Cedic ENFit Transition Connectors are intended for prescription use only.

The provided document is a 510(k) summary for Cedic ENFit Transition Connectors for Enteral Applications. It outlines the device's description, indications for use, and performance data to demonstrate substantial equivalence to legally marketed predicate devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document references FDA draft guidance for safety considerations for 510(k) submissions to mitigate misconnections with small-bore connectors for enteral applications. It discusses three key areas for performance data and how the Cedic ENFit Transition Connectors meet these recommendations.

• Enteral connector misconnection assessment
• Human factors
• Fluid leakage
• Stress cracking
• Resistance to separation from axial load
• Resistance to separation from unscrewing
• Resistance to overriding
• Disconnection by unscrewing |
  | C. Enteral Connector Risk Assessment: Submit a risk assessment to demonstrate effective mitigation of misconnection risk, with objective evidence that risks have been reduced to acceptable levels according to ISO 14971:2007 or equivalent. (Quote from Section VI.C of FDA Draft Guidance) | Compliance: "In this respect, this 510(k) submission includes a copy of the risk analysis for the three subject transition connectors." |

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

The document states, "Bench tests have been carried out on samples of the Cedic ENFit Transition Connectors for Enteral Applications." It does not specify the exact sample size for these tests. The data provenance is implied to be laboratory testing conducted by the manufacturer, Cedic S.r.l., which is based in Italy. The tests appear to be prospective, specifically performed for this 510(k) submission to demonstrate compliance with the referenced FDA guidance.

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

This information is not provided in the document. The performance data described relates to mechanical and physical testing of the connectors, which typically does not involve expert readers or ground truth established by medical professionals in the same way, for example, an imaging diagnostic device would.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. Mechanical and physical tests do not typically involve adjudication by multiple experts in the manner of clinical or imaging studies. The results of the bench tests would likely be based on objective measurements against predefined pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not applicable to this type of device. The devices are transition connectors for enteral feeding, not diagnostic imaging or AI-assisted diagnostic tools.

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

This information is not applicable and therefore not provided in the document. The device is a physical connector, not an algorithm, so standalone algorithm performance is irrelevant.

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

The concept of "ground truth" as typically applied to diagnostic algorithms is not directly applicable here. For the mechanical and physical tests performed, the "ground truth" or reference standard would be the specified technical requirements and performance parameters outlined in the AAMI/ANSI/ISO 80369-1 standard and the FDA's draft guidance. For example, for fluid leakage, the ground truth would be a defined maximum allowable leakage rate. For resistance to separation, it would be a minimum force or torque the connection must withstand.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. The device is a physical medical connector, not a machine learning algorithm that requires a training set.

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

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

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For use in dispensing liquid nutrients (feeding solutions) by connecting an enteral feeding container to a patient's feeding tube.
For connecting a universal enteral spike set to a feeding container having a SpikeRight™ connection port.

Enteral Feeding Spike Adapter to be used for enteral administration. This device serves as a connection between the feeding container and the enteral set (gravity or pump fed).

The provided text is a 510(k) summary for the Cedic Enteral Feeding Spike Adapter. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, it does not contain information about acceptance criteria or specific study results proving the device meets acceptance criteria.

The document is a submission to the FDA for market clearance, where the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to present detailed performance studies against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given input. The document focuses on regulatory comparison, not performance testing against defined criteria.

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The Cedic srl Intravenous Gravity Set is used for IV fluid administration. This device serves as a connection between the IV fluid container and an indwelling catheter.

The Cedic srl Intravenous Gravity Set is a universal non-DEHP tubing set that allows IV solutions to be infused into the patient in conjunction with an indwelling catheter. The drip chamber fiker precludes passage of gross particle potentially generated during spiking of the IV solution container. The vent filter is 3u aerosol microbial barrier . The device consists of a spike, drip chamber with disk filter (15 um approx.), roller clamp, latex free flash bulb injection site, and male luer slip connector (Cedie product code: F 00010) or male luer lock connector (Cedic product code: F 00027).

This document pertains to the 510(k) premarket notification for a medical device, specifically an Intravenous Gravity Set, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for AI/ML performance evaluation is not applicable.

The document discusses the substantial equivalence of the Cedic srl Intravenous Gravity Set to legally marketed predicate devices. The "safety and effectiveness summary" in the original document outlines the following:

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

Note: The document broadly states "All testing of the Intravenous Gravity Set indicates that the device meets or exceeds the functional requirements for the device's intended use," without specific numerical values for acceptance criteria or detailed test results.

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

This information is not provided in the document. The filing focuses on substantial equivalence based on design, components, and manufacturing processes rather than a detailed clinical trial or performance study with a specified sample size.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This is not applicable as this is a medical device (intravenous gravity set) and not an AI/ML diagnostic tool requiring expert ground truth for image or data interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) 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.

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 concensus, pathology, outcomes data, etc):

Not applicable. The performance is assessed through various engineering and functional tests as listed above. The "ground truth" for this type of device is its ability to perform its intended mechanical and fluid delivery functions without issues like leaks, occlusions, or component failures.

8. The sample size for the training set:

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

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

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

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