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The Nutricair enteral ENFit adapter: ENFit male - stepped/Christmas tree connector is a disposable, sterile medical device intended to be used as an adapter between ENFit connections and funnel connections, used in enteral nutrition. A doctor, a nurse or the adult laypersons can do enteral feeding. The target population is adults.

The Nutricair™ enteral ENFit adapter: ENFit male – stepped/Christmas tree connector is sterile single use device. The adapter presents a ENFit connection in ABS at one extremity and a notched connection (in ABS) at the other extremity. The device has also a female ENFit cap in PEHD attached to the adapter with a link. This device incorporates a male ENFit connection to enteral access device with a female ENFit connector that is compliant to ISO 80369-3. It is provided with a sterility protector.

The provided text describes a medical device, the "Nutricair enteral ENFit adapter: ENFit male - stepped/Christmas tree connector," and its substantial equivalence to a predicate device. However, it does not include information about AI/ML device performance or a comparative effectiveness study with human readers. Therefore, I cannot provide details regarding:

• Sample size used for the test set and data provenance specific to an AI/ML study.
• Number of experts used to establish ground truth for an AI/ML test set.
• Adjudication method for an AI/ML test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
• Standalone AI algorithm performance.
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on non-clinical performance criteria and demonstrates compliance with established international standards for medical device connectors and biocompatibility.

Here's the information about the device's acceptance criteria and how it was shown to meet them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify general "test set" sample sizes or data provenance in terms of country of origin or retrospective/prospective for the non-clinical tests conducted. The tests refer to compliance with ISO standards, which typically specify the number of samples required for each test. The tests are non-clinical, involving physical and chemical properties of the device, not patient data.

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

Not applicable. The "ground truth" for the non-clinical performance tests is defined by the objective pass/fail criteria specified within the referenced ISO standards. Human expert interpretation of results is not described as part of establishing the 'truth' for these mechanical, chemical, and biological performance tests, though qualified personnel would be required to execute and analyze the tests according to the standards.

4. Adjudication method for the test set

Not applicable. The tests are objective and based on compliance with specific ISO standard criteria. No human adjudication process, such as 2+1 or 3+1, is mentioned or implied for determining the outcome of these physical and chemical 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 physical medical adapter, not an AI/ML software device for diagnostic imaging or similar applications requiring human reader studies.

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

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

7. The type of ground truth used

For the non-clinical performance tests, the "ground truth" is established by the specified pass/fail criteria and methodologies outlined in the referenced international standards (e.g., ISO 10993, ISO 20695, ISO 80369). These standards define acceptable limits for various physical, chemical, and biological properties.

8. The sample size for the training set

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

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The ENFit Adaptor is intended for connecting an enteral giving set with an ENFit connector to an enteral catheter with funnel.

To facilitate the interconnection between newly-released feeding sets, which are equipped with female ENFit connectors, and the funnel feeding ports of previously-designed enteral feeding tubes, the proposed device is designed with the mating component of an ENFit female connector, designed and tested in accordance with ISO 80369-3 and ISO 80369-20, at one of its ends, and the mating component of a non-ISO 80369-1 compliant funnel feeding port, a stepped tip connector, at its other end. It can prevent an interruption or delay in patient care by allowing fitment of enteral feeding sets with ISO 80369-3 compliant ENFit female connectors to existing enteral feeding tubes with non-ISO 80369-1 compliant end connectors, referred to as "funnel feeding ports" which are still available for use in healthcare setting.

The proposed device is sterile or non-sterile device is sterilized by ethylene oxide to achieve a SAL 10- and supplied in sterility maintenance package which maintain the sterility of the device during the shelf life 5 years.

No DEHP, BPA and Natural Rubber Latex are added in the device.

The provided text is a 510(k) summary for the ENFit Adaptor, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device. Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment relevant to an AI/ML device from this document.

The document discusses non-clinical tests to verify design specifications and compliance with various ISO standards for mechanical performance, biocompatibility, sterilization, shipping, and shelf-life of the physical adaptor. These tests are performed to demonstrate that the device itself is safe and effective as a physical connector, not as an AI-powered diagnostic or therapeutic tool.

For instance, the document mentions:

• Performance tests: Fluid Leakage, Stress Cracking, Resistance to Separation from Axial Load, Resistance to Separation from Unscrewing, Resistance to Overriding, Disconnection by Unscrewing, Connector Incompatibility Test, Materials Used for Small-bore Connectors, Dimensional analysis, Compatibility and Usability Test.
• Biocompatibility tests: Cytotoxicity, Irritation, Skin Sensitization.
• Sterilization, Shipping and Shelf-Life tests: Ethylene oxide sterilization residuals, seal leak detection, seal strength, seal integrity, Bacterial Endotoxins Test.

These are all physical and chemical property tests for a medical device connector, not performance metrics of an AI/ML algorithm.

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The enteral specific transition connectors are intended to facilitate enteral specific connections between ISO 80369-3 compliant connectors and non-ISO 80369-3 compliant legacy enteral connectors.

Not Found

The provided FDA document, K220165, describes a premarket notification for an Enteral Transition Adaptor. This device is a component of a medical system and not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study proving device meets acceptance criteria" as it relates to performance metrics for AI/ML algorithms, ground truth establishment, training/test sets, expert adjudication, or comparative effectiveness studies with human readers, does not apply to this regulatory submission.

The FDA 510(k) clearance process for devices like the Enteral Transition Adaptor focuses on establishing substantial equivalence to a predicate device. This typically involves demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or if there are different technological characteristics, that they do not raise different questions of safety and effectiveness.

The document states:

• Trade/Device Name: Enteral Transition Adaptor
• Regulation Number: 21 CFR 876.5980
• Regulation Name: Gastrointestinal tube and accessories
• Regulatory Class: Class II
• Product Code: PIO
• Indications for Use: The enteral specific transition connectors are intended to facilitate enteral specific connections between ISO 80369-3 compliant connectors and non-ISO 80369-3 compliant legacy enteral connectors.

Therefore, the standard questions related to acceptance criteria and studies for AI/ML performance (such as those outlined in your prompt) are not applicable here. The "study" proving the device meets acceptance criteria would be a demonstration of its compatibility and fit with the specified connectors, and its adherence to relevant standards for medical device accessories, rather than a performance study involving diagnostic accuracy.

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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 Nutrisafe 2 – ENFit adaptor is indicated for enteral use only. It enables the connection between an administration set equipped with a female ENFit connector at its distal end and a Nutrisafe 2 feeding tube equipped with a male Nutrisafe 2 connector at its proximal end.

The Nutrisafe 2 – ENFit adaptor is indicated for enteral use only. It enables the connection between an administration set equipped with a female ENFit connector at its distal end and a Nutrisafe 2 feeding tube equipped with a male Nutrisafe 2 connector at its proximal end. Vygon has not previously submitted any 510(k)s for the subject device.

The provided text is a 510(k) summary for the "Nutrisafe 2 - ENFit Adaptor" device. It describes the device's indications for use, technological characteristics, and non-clinical testing. However, it does not contain information about acceptance criteria or a study proving the device meets such criteria in the context of an AI/ML device.

The document refers to a "non-clinical verification" through "bench testing" that confirmed physical attributes and device performance meet "the requirements of standards performance." It lists several tests that were performed (dimensional analysis, fluid leakage, stress cracking, resistance to separation, resistance to overriding, disconnection by unscrewing, flow testing, and misconnection risk analysis). However, it does not specify the numerical acceptance criteria for each of these tests, nor does it provide the detailed results of these tests.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving an AI device's performance. The document describes a traditional medical device (an adaptor) and its regulatory submission, not an AI/ML powered device.

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The Medline ENFit Transition Connecting an enteral feeding set with an ENFit connector to a gastronomy tube with funnel.
The Medline ENFit G-Tube Connector is intended for connecting an enteral feeding set equipped with a stepped enteral distal end to a gastronomy tube equipped with an ENFit connector.

In an effort to mitigate the risk of misconnections associated with enteral feeding devices, manufacturers have recently began to adopt a uniform connector for enteral devices, called an ENFit connector, which is based upon the ISO 80369 series of standards and is in accordance with FDA Final Guidance for Industry: Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications (February 11, 2015). This uniform ENFit connector provides a locking feature that signals the appropriate connection to stay in place. In addition, the ENFit connector features a female mating component end for enteral feeding sets and a male mating component end for gastronomy feeding tubes, which allows for the interconnection of these devices.

However, it will take time for enteral devices with this uniform ENFit connector to become widely available and fully adopted across healthcare settings, as existing enteral devices with previouslydesigned "legacy" connectors, which are not compliant with ISO 80369-1, still remain in inventory. Therefore, to prevent an interruption or delay in patient care when an enteral device with an AAMI/CN3:2014 (PS) compliant ENFit connector must be connected to an existing enteral device with a non-AAMI/ANSI/ISO 80369-1 compliant connector, a temporary need has emerged for an adapter that can facilitate connection between enteral devices with these incompatible end connectors.

The Medline ENFit Transition Connector and the Medline ENFit G-Tube Connector address this temporary need and facilitate enteral-specific connections between AAMI/CN3:2014 (PS) compliant enteral connectors and non-AAMI/ANSI/ISO 80369-1 compliant connectors to ensure that patient enteral feeding is not impeded when an enteral feeding device with an AAMI/CN3:2014 (PS) compliant ENFit connector must be connected to a previously-designed, existing enteral feeding device with a non-AAMI/ANSI/ISO 80369-1 compliant end connector.

The Medline ENFit Transition Connector and the Medline ENFit G-Tube Connector, which are described in further detail below, allow specific connections between enteral feeding devices with AAMI/CN3:2014 (PS) compliant ENFit connectors (also known as "PGLock" connectors) and enteral feeding devices with non-AAMI/ANSI/ISO 80369-1 compliant, legacy connectors that are still available for use in healthcare settings. To facilitate this connection, the Medline ENFit Transition Connector and the Medline ENFit G-Tube Connector are both designed with the mating component of an AAMI/CN3:2014 (PS)-compliant ENFit connector at one end and the mating component of a previously-used, legacy connector at its other end.

Specifically, the two designs of ENFit transition adapters that are within the scope of this 510(k) Premarket Notification submission are:

1.) The Medline ENFit Transition Connector
The Medline ENFit Transition Connector allows fitment of newly-released enteral feeding sets with AAMI/ CN3:2014 (PS) compliant ENFit connectors to existing gastronomy tubes with non-AAMI/ ANSI/ISO 80369-1 compliant end connectors, referred to as "funnel feeding ports," which are still available for use in healthcare settings. Specifically, to facilitate the interconnection between newlyreleased feeding sets, which are equipped with female ENFit connectors, and the funnel feeding ports of previously-designed gastronomy tubes, this adapter provides the mating component of an ENFit female connector, designed and tested in accordance with AAMI/ CN3:2014 (PS) and AAMI/CN20:2014 (PS), at one of its ends, and the mating component of a non-AAMI/ANSV/ISO 80369-1 compliant funnel feeding port, a stepped Distal Tip connector, at its other end.

2.) The Medline ENFit G-Tube Connector
The Medline ENFit G-Tube Connector allows fitment of newly-released gastronomy tubes (or "Gtubes") with AAMI/CN3:2014 (PS) compliant ENFit connectors to previously-designed enteral feeding sets with non-AAMI/ANSI/ISO 80369-1 compliant connectors, which still may be available for use in healthcare settings. To facilitate the compatibility between gastronomy tubes with ENFit male connectors and the stepped Distal Tip connector of existing enteral feeding sets, the Medline ENFit G-Tube Connector provides the mating component of an ENFit male connector, designed and tested based upon AAMI/ CN3:2014 (PS) and AAMI/CN20:2014 (PS), at one of its ends, and the mating component of a stepped Distal Tip connector, a funnel feeding port, at its other end.

Here's a breakdown of the acceptance criteria and study information for the Medline ENFit G-Tube Connector and Medline ENFit Transition Connector, based on the provided FDA 510(k) summary:

This device is not an AI/ML powered device, so many of the requested fields are not applicable. The device is a physical medical connector.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details the testing performed to demonstrate substantial equivalence, focusing on the physical and functional properties of the connectors. The acceptance criteria are implicitly met by successful completion of these tests in accordance with relevant standards.

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

The document does not specify exact sample sizes for each test. It refers to "non-clinical verification" and successful completion of various studies and tests.

• Sample Size for Test Set: Not explicitly stated for individual tests.
• Data Provenance: The studies were conducted by Medline Industries, Inc. (the manufacturer). The data comes from non-clinical (laboratory/bench) testing of the devices themselves, rather than human or animal data. The country of origin of testing facilities is not specified, but the manufacturer is based in the USA. The data is prospective in the sense that the tests were conducted specifically for this 510(k) submission.

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

This section is Not Applicable (N/A) because the device is a physical connector, not an AI/ML algorithm that requires expert ground truth labeling of medical images or data. The "ground truth" for these tests refers to established engineering standards and safety requirements (e.g., ISO 80369-20, FDA guidance on misconnections). The tests themselves evaluate the device's adherence to these objective, measurable standards.

4. Adjudication Method for the Test Set

N/A. As the "truth" is based on objective engineering standards and observed performance in non-clinical tests, there's no need for expert adjudication in the context of this type of device submission. Test results are typically evaluated against predefined pass/fail criteria from the 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

N/A. This device is a physical medical connector, not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies are not relevant.

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

N/A. This is not an algorithm or AI system. The tests performed are standalone in the sense that they evaluate the device itself (its physical properties and function) without human interaction being a variable in determining "performance" in the way an AI algorithm's standalone performance might be measured.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of these connectors is based on:

• Established engineering standards: Primarily ISO 80369-20, and AAMI/CN3:2014 (PS), AAMI/CN20:2014 (PS).
• FDA guidance documents: Specifically, "Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications (February 11, 2015)."
• Objective physical and chemical test results: Measurements of leakage, strength, biocompatibility, dimensions, etc.

8. The Sample Size for the Training Set

N/A. This device is a physical connector, not an AI/ML algorithm that requires a training set. The "training" for the device's design is implicitly the engineering design process guided by the standards and predicate device.

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

N/A. As there is no AI/ML training set, this question is not applicable. The design "ground truth" would be established by the engineering and regulatory requirements for safe and effective medical device connectors. The predicate device (Cedic ENFit Transition Connectors for Enteral Applications, K140581) also serves as a benchmark for established safety and effectiveness.

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The AMT Enteral Transition Adapters are intended to facilitate enteral specific connections between AAMI/CN3(PS) compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.

New standard ISO-80369-1 is pushing feeding tube manufacturers to transition current extension set designs to incorporate enteral only connectors. Most enteral feeding devices currently on the market utilize luer slip or catheter tip connectors to connect enteral giving sets and syringes to enteral receiving sets. Standard luer slip and catheter tip connectors raise risk levels for patients as devices outside of the enteral market use similar connections, including IVs. Therefore, the ISO/IEC 80369 series was developed to help reduce the possibility of misconnections across different medical fields.

The FDA recently cleared an updated AMT enteral extension set in 510(k) K142989. This extension set remains identical to our previously marketed device, but includes Enfit connectors. However, launching a enteral extension sets with Enfit connectors will not be simultaneous across all manufacturers and distributors. Therefore, transition adapters are necessary for a limited time.

As the new Enfit connectors are not backwards compatible with current luer and bolus connections currently used for enteral products, AMT has designed several transition adapter configurations to help users make the switch to the new connections. AMT estimates that there will be a time of at least a year and possibly up to three years where users and distributors will still have access to enteral devices with luer / bolus connectors. The transition adapters AMT has designed in this 510(k) will allow users to use their old giving/receiving sets until the market is flushed of old inventory.

The AMT Enteral Transition Adapters come in 5 configurations and are made up of 5 separate components. The five configurations include:
• Male Enfit to Male Luer Adapter
• Female Enfit to Female Luer Adapter
• Female Enfit to Y-Port (Bolus/Luer) Adapter
• Female Enfit to Bolus Adapter
• Male Enfit to Christmas-tree Adapter

These 5 transition adapter configurations will allow AMT to offer users with options for all of the common enteral connectors currently on the market. All components and materials have been previously cleared in 510(k)s for similar use. It is planned to include these transition adapters kitted with enteral devices previously cleared through the 510(k) process, as well as selling the adapters as stand-alone items.

This document is a 510(k) summary for the AMT Enteral Transition Adapters, which is a medical device subject to FDA review. The focus of this document is on establishing substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific performance acceptance criteria in a clinical or AI-based context.

Therefore, much of the requested information regarding acceptance criteria, study design for performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details (which are typically relevant for AI/algorithm-driven devices or clinical trials) is not applicable to this type of regulatory submission for a physical medical device.

However, I can extract the relevant performance testing information and present it in the requested format where possible, noting the limitations of the document's scope.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding device performance values for each criterion. Instead, it lists the types of performance tests conducted. The "Conclusions" section states that the device is "substantially equivalent ... in testing criteria," implying that the device met the criteria for these tests, likely aligned with the predicate device or relevant standards.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "various performance tests on all components," but does not provide specific sample quantities for each test.
• Data Provenance: Not specified, but given it's a 510(k) submission for a physical device, testing would typically be conducted in a laboratory setting by the manufacturer (Applied Medical Technology, Inc.) in the USA (Brecksville, OH). The tests would be prospective in nature, performed on newly manufactured devices.

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 adapter, not an AI or diagnostic imaging device that requires expert-established ground truth for its performance evaluation (e.g., diagnosis, abnormality detection). The performance tests listed are engineering and mechanical evaluations.

4. Adjudication method for the test set

• Not Applicable. As per point 3, this is not a clinical or AI performance study requiring adjudication of expert interpretations.

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

• Not Applicable. This is a physical medical device, not an AI system.

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

• Not Applicable. This is a physical medical device, not an AI algorithm.

7. The type of ground truth used

• For the performance tests listed (tensile strength, fluid leakage, etc.), the "ground truth" would be established by engineering specifications, material science standards, and mechanical test methods defined by ISO or other relevant industry standards (e.g., ISO 80369-1 for connector incompatibility). Test results are compared against predefined pass/fail criteria from these standards.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI system 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 system.

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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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