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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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NUTRICAIR™ enteral feeding syringes with ENFit® are disposable, sterile medical devices that are intended for the measurement, the preparation and enteral administration of solutions (hydration, feeding) or medications for neonatal, pediatric and adult patient populations. These devices are intended to be used in clinics and home care settings by: - health care professionals - adult laypersons (instructed by/or under the supervision of health care professionals).

The Nutricair™ enteral syringe with ENFit is sterile, single use device. It is provided in size 10 ml. It consists in a body with ENfit connector in polypropylene, a plunger in polypropylene and a piston seal in isoprene. This device incorporates a female ENFit connection to enteral access device with a male ENFit connector that is compliant to ISO 80369-3. Graduations from 1 to 10 ml are printed on the body. The 10 mL syringe model number is NCE10SE.

The provided text describes a 510(k) premarket notification for a medical device called "Nutricair Enteral Syringe with ENFit," which functions as an enteral feeding syringe. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness or conducting clinical trials.

As such, the information you're requesting regarding acceptance criteria and studies demonstrating a device meets acceptance criteria, an AI-driven system, ground truth establishment, sample sizes for training/test sets, expert adjudication, MRMC studies, or standalone algorithm performance, is not applicable to this document.

This submission focuses on engineering and performance criteria to show the new device performs as safely and effectively as an existing one, usually through non-clinical bench testing and comparative analysis of design features.

Here's a breakdown of why your specific questions generally don't apply to a 510(k) for a physical medical device like a syringe, based on the provided text:

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

  • The document largely relies on meeting established international standards (e.g., ISO) for medical devices, particularly those related to syringes and enteral connectors. The "acceptance criteria" are these standard requirements, and the "reported device performance" is that the device met these standards.
  • The table on pages 6-7 ("Table 5-1: Device comparison table") highlights comparisons to the predicate device and states "Equivalent" or "Similar" and "No impact on safety or performance" as the outcome, indicating that existing standards and comparative performance are the basis for acceptance.
  • Section VIII, "Performance Testing," lists the types of tests performed (biocompatibility, visual inspections, enteral device performance tests, enteral connector performance tests, risk analysis, usability analysis) and the standards they comply with (e.g., ISO 10993, ISO 20695, ISO 7886-1, ISO 80369-20, ISO 80369-3, ISO 14971, ISO 62366-1). The acceptance criteria for each of these would be the specific quantitative or qualitative limits defined within those ISO standards. The document states that the device "met updated standard ISO 20695:2020" or "met the standards of 80369-3." However, specific numeric performance results are not typically included in these public 510(k) summaries unless a deviation from a standard is justified or an equivalence needs quantitative proof for a specific parameter.

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

  • For physical product testing as described (e.g., fluid leakage, stress cracking, barrel dimensions), sample sizes are typically defined by the test protocols within the relevant ISO standards (e.g., a certain number of syringes tested per batch). This information is generally not included in the 510(k) summary itself, as it's part of the detailed test reports provided to the FDA.
  • Data provenance for such physical device testing is typically the manufacturer's internal testing labs or third-party accredited labs. Country of origin for testing is not specified, but the manufacturer is based in France. The testing is retrospective in the sense that it was completed before the submission to demonstrate compliance.

• 3. Number of experts used to establish the ground truth... and their qualifications:

  • This is not applicable. There is no "ground truth" in the diagnostic AI or clinical outcome sense for a basic physical device like a syringe. The "truth" is whether it meets engineering specifications and safety standards defined by regulatory bodies and consensus standards. These are established through engineering principles, laboratory testing, and risk assessment by qualified engineers and scientists.

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

  • Not applicable. This concept pertains to human review of diagnostic imaging or clinical findings for establishing ground truth, which is not relevant here.

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

  • Not applicable. This is not an AI/software device that would involve human readers or diagnostic interpretation.

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

  • Not applicable. This is not an AI/software device.

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

  • As explained in #3, "ground truth" in the diagnostic sense is not applicable. The "truth" is whether the physical device meets its specified engineering performance parameters and safety requirements, as verified through standard laboratory tests and adherence to ISO standards.

• 8. The sample size for the training set:

  • Not applicable. This device does not involve machine learning or a "training set."

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

  • Not applicable. No training set is involved.

In summary: The provided document is an FDA 510(k) clearance summary for a disposable medical syringe. The "acceptance criteria" are the relevant ISO standards for medical device safety and performance, and the "study" is a series of non-clinical, bench-top engineering tests demonstrating compliance with these standards and substantial equivalence to a predicate device. Concepts related to AI/ML performance, diagnostic ground truth, or multi-reader studies are entirely outside the scope of this particular device and its regulatory submission.

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

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

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

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

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

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

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

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

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

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI diagnostic device. The "tests" here are physical and chemical evaluations against predefined criteria in international standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-powered device or an imaging device requiring human reader interpretation. No MRMC study was conducted.

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

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

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

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

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

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

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

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

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

Specifically:

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

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

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Carefusion NeutraClear™ Needle-free connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration sets for the administration or withdrawal of fluids from a patient through a cannula placed in the vein or for withdraw of fluids through the artery. Carefusion NeutraClear™ Needle-free connector may be used with low-pressure power injectors with a flow at 10ml/s, in state of connection.

Carefusion NeutraClear™ Needle-free connector is a bidirectional needleless injection valve. The Carefusion NeutraClear™ Needle-free connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration sets for the administration or withdrawal of fluids from a patient through a cannula placed in the vein or for withdraw of fluids through the artery. Carefusion NeutraClear™ Needle-free connector may be used with low-pressure power injectors with a flow at 10 ml/s, in state of connection.

Carefusion NeutraClear™ Needle-free connector is intended for single patient use in intravenous and blood administration sets without need for needles, thus eliminating the potential for needle-stick injuries during use. The subject device is not intended to treat existing infections. The device is not intended to have any effect on contaminated infusion solutions.

This document describes the regulatory submission (510k) for the Carefusion NeutraClear™ Needle-free connector. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing extensive independent clinical effectiveness studies typical for novel devices.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the testing performed to demonstrate that the modified device (with minor changes compared to the predicate) performs as intended and is as safe and effective as the predicate. The document doesn't detail a traditional clinical study but rather a series of performance and safety tests.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly list "acceptance criteria" alongside "reported device performance" in a quantitative table for each test. Instead, it states that various tests were performed and that the device met the acceptance criteria for all of them. The "reported device performance" is summarized as having met these criteria.

(Note: The specific quantitative results or acceptance thresholds for each test are not detailed in this summary.)

2. Sample sizes 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 used for the individual performance tests (microbial ingress, hemolysis, priming volume/flow rate, etc.). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) summary for minor device modifications, these details are often kept in the full submission, not the 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)

This type of information (experts, ground truth for test sets) is typically relevant for studies evaluating diagnostic or AI-driven devices, where human expertise is used to define a "correct" answer against which the device is measured. For a medical device like a needle-free connector, which undergoes performance and safety testing, "ground truth" is established by adherence to recognized standards and objective measurements performed in a laboratory setting, not by human expert interpretation. Therefore, this information is not applicable and not provided in the document.

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

Similar to point 3, adjudication methods are relevant for subjective assessments or when discrepancies arise in human interpretation (e.g., in reading medical images). Performance testing of a physical medical device against predefined standards does not involve an adjudication method by human experts. Therefore, this information is not applicable and not provided in the document.

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

MRMC studies and the concept of "human readers improving with AI assistance" are specific to AI/CAD devices. The Carefusion NeutraClear™ Needle-free connector is a physical medical device, not an AI or diagnostic tool. Therefore, an MRMC comparative effectiveness study was not performed, and this information is not applicable.

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

This question is also specific to AI/algorithm performance. The device in question is a physical needle-free connector. Therefore, a standalone algorithm performance study was not performed, and this information is not applicable.

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

The "ground truth" for evaluating the performance of this device is based on objective measurements and adherence to recognized performance standards and guidance, such as ISO 8536-4:2010, ISO 594-2:1998, ISO 8536-10:2004, ISO 10993-1:2009, ISO 11135-1:2007, and ISO 10993-7:2008. These standards define the acceptable physical, mechanical, and biological properties and performance characteristics of such devices. For example, for microbial ingress, the ground truth is whether microorganisms can penetrate the device under specific test conditions, as defined and measured by the test method.

8. The sample size for the training set

The concept of a "training set" is relevant for machine learning or AI models. This device is a physical product, not an AI system. Therefore, there is no training set, and this information is not applicable.

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

As there is no training set for this type of device, this question is not applicable.

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Bidirectional needleless injection valve is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration sets for the administration or withdrawal of fluids from a patient through a cannula placed in the vein or for withdraw of fluids through the artery. Bidirectional needleless injection valve may be used with low-pressure power injectors with a flow at 10 ml/s, in state of connection.

The CAIR LGL valves features include a smooth swappable septum surface, septum seal integrity with no gaps or openings, a microbial physical barrier, straight through fluid pathway, zero dead space, zero fluid displacement low priming volume, saline-only flush option and no clamping sequence or positive pressure syringe technique required.
The Cair bidirectional needleless injection valve may be used with low pressure power injectors having a pressure of 7 bars with a luer lock connection.
The subject device is composed of materials (polycarbonate, silicone) that have been successfully and safely used in medical devices including the predicate device. The materials used in the subject device have been subjected to and passed biocompatibility testing.

This document describes the 510(k) summary for the Cair bidirectional needleless injection valve (Cair Drive and Neutraclear). It does not contain information about a study proving that the device meets acceptance criteria via performance metrics as would typically be found for AI/ML-enabled devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and conformity to various standards.

Therefore, many of the requested sections related to AI/ML device studies, such as sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, and training set details, are not applicable or cannot be extracted from this document.

Here's the information that can be extracted or inferred from the provided text, primarily regarding non-clinical testing for substantial equivalence:

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

The document states: "Testing conducted, that reference the design verification and validation testing of the Cair bidirectional needleless injection valve (Cair Drive and Neutraclear), meets predetermined acceptance criteria for the device." However, the specific acceptance criteria and the quantitative performance results are not detailed in this summary section beyond general statements of meeting criteria. The types of tests performed are listed, implying that the device "meets predetermined acceptance criteria" for each of these:

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 traditional medical device (not AI/ML) and the document describes non-clinical engineering and biological tests rather than studies with patient data. No sample sizes are specified for the non-clinical tests conducted. The submitter is CAIR L.G.L. from France.

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. The "ground truth" here would be established by validated test methods and standards for the non-clinical tests (e.g., ISO standards for sterility, biocompatibility, leak rates), not by expert consensus on clinical data.

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

Not applicable. Adjudication methods are relevant for expert review of clinical cases. For non-clinical tests, conformance to specified test protocols and standards dictates success or failure.

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/ML diagnostic or assistive tool, so MRMC studies are irrelevant.

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

Not applicable. This device is a passive mechanical component, not an algorithm.

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

For the non-clinical tests, the "ground truth" is defined by established international standards (e.g., ISO, 21 CFR) and their specific pass/fail criteria for each test (e.g., sterility, leak rates, biocompatibility).

8. The sample size for the training set

Not applicable. This device does not involve machine learning and therefore has no "training set."

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

Not applicable.

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