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The device is intended for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by operators ranging from qualified medical practitioners to laypersons (under the supervision of a qualified medical practitioners) in all age groups.

The Oral/Enteral Syringe with ENFit connector is a disposable enteral feeding syringe provided in a variety of sizes from 0.5ml to 60ml. The Oral/Enteral Syringe with ENFit connector consists of plunger, gasket/piston, barrel with ENFit connector, and used to deliver fluids into the body orally or connected to an enteral access device with male ENFit connector. The proposed syringe is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

This document is a 510(k) premarket notification for an Oral/Enteral Syringe with ENFit connector, seeking substantial equivalence to a predicate device. As such, it does not describe a study to prove a device meets acceptance criteria in the way a clinical trial or performance study for a novel diagnostic algorithm might. Instead, it demonstrates substantial equivalence by showing that the device meets relevant performance standards and has similar technological characteristics to a predicate device.

Therefore, many of the requested categories (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth for test/training set, training set sample size) are not applicable in the context of this 510(k) submission for a non-active medical device like a syringe.

However, I can extract the acceptance criteria where applicable (i.e., performance standards and biocompatibility) and report the device's performance against those standards as described in the document.

Acceptance Criteria and Device Performance (Oral/Enteral Syringe with ENFit connector)

Device Under Review: Oral/Enteral Syringe with ENFit connector (K222772)
Predicate Device: Oral/Enteral Syringe with ENFit connector (K211025)

1. Table of Acceptance Criteria and Reported Device Performance

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The device is intended for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by operators ranging from qualified medical practitioners to laypersons (under the supervision of a qualified medical practitioners) in all age groups.

The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 0.5ml to 60ml. It consists of plunger, piston, barrel and tip cap, and used to deliver fluids into the body orally or connected to an enteral access device with male ENFit connector. The syringes (size 12ml, 35ml and 60ml) incorporate a female Standard ENFit connector; the syringes (size 0.5ml, 1ml, 3ml, 6ml) incorporate a female low dosing ENFit connector. There are 2 types of the syringe: Side connector ENFit syringe and central connector ENFit syringe. The sizes of the central connector tapered syringe range from 0.5ml and 1ml; and side connector ENFit syringe range from 3ml to 60ml. The proposed syringe is sterile or non-sterile. Sterile device was sterilized by Ethylene Oxide Gas to achieve a SAL of 10th and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

This document is a 510(k) Summary for the Oral/Enteral Syringe with ENFit connector (K211025). It does not contain information about a study proving the device meets acceptance criteria in the manner you describe for AI/imaging devices. Instead, it demonstrates substantial equivalence to a predicate device (K161039) through non-clinical testing.

Here's an analysis of the information provided in the context of your questions, explaining why certain sections are not applicable:

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

The document provides a list of standards the device complies with, which implicitly serve as acceptance criteria for different aspects of the device's performance. It also states that "dose accuracy testing is conducted to demonstrate the enteral syringes are accurate to ±10% when the syringe is filled with a minimum dose of 20% of the overall syringe capacity." This is a key performance metric and a stated acceptance criterion.

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

The document mentions "non clinical tests were conducted," but does not specify the sample sizes for these tests for each standard or the dose accuracy testing. It also does not mention data provenance in terms of country of origin or retrospective/prospective nature, as these types of details are typically associated with clinical studies involving patient data, not non-clinical device testing.

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 question is not applicable to this type of device submission. The "ground truth" concept, especially involving expert consensus and specific qualifications of medical professionals, is relevant for AI/imaging devices interpreting medical images or data. For this physical medical device (an enteral syringe), performance is assessed through objective engineering and biological tests against established international standards, not against expert human interpretations of data.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or reader studies where multiple experts evaluate ambiguous cases. For non-clinical tests on a physical device, the results are typically objectively measured and do not require expert adjudication in this manner.

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

This question is not applicable. MRMC studies are specifically designed for assessing the performance of diagnostic devices, particularly AI-powered ones, and their impact on human reader performance. This submission is for a physical medical device (a syringe), not a diagnostic AI tool.

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

This question is not applicable. This refers to the standalone performance of an algorithm. The device here is a physical syringe, not an algorithm.

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

For this device, the "ground truth" is established by the requirements of the referenced international standards (e.g., ISO for sterility, biocompatibility, connector features, and ASTM for material properties) and specific performance specifications (e.g., dose accuracy ±10%). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for proving the performance of a syringe.

8. The sample size for the training set

This question is not applicable. This refers to the training data for an AI algorithm. This submission is for a physical medical device.

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

This question is not applicable. This refers to establishing ground truth for AI model training. This submission is for a physical medical device.

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The device is indicated for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by operators ranging from qualified medical practitioners to laypersons (under the supervision of a qualified medical practitioners) in all age groups.

The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 0.5ml to 60ml. The enteral feeding syringe consists of plunger, piston, barrel and tip cap, and used to deliver fluids into the body orally or connected to an enteral access device with male tapered connector. There are 2 types of the syringe: Side connector tapered syringe and central connector tapered syringe. The sizes of the central connector tapered syringe range from 0.5ml to 3ml; and side connector tapered syringe range from 6ml to 60ml. The proposed syringe is sterile or non-sterile. Sterile device was sterilized by Ethylene Oxide Gas to achieve a SAL of 10 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

The provided text is a 510(k) Summary for an Oral/Enteral Syringe, which is a medical device for dispensing and transferring fluids. It outlines the regulatory process for clearance and focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Crucially, this document describes physical, mechanical, chemical, and biocompatibility testing of a physical medical device (a syringe), not a software or AI-based device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they apply to software performance (e.g., sensitivity, specificity, F1 score for an AI model) are not relevant here.

The document discusses performance purely in terms of the physical characteristics of the syringe.

However, I can extract the information related to the physical device's "acceptance criteria" and the "study" (non-clinical tests) that proves it, as per the format you requested, but adapted for a physical device:

Acceptance Criteria and Study Proving Device Meets Criteria (for a Physical Medical Device)

The device in question is an Oral/Enteral Syringe. The acceptance criteria and the studies (non-clinical tests) proving the device meets these criteria are related to its physical properties, material safety, and functionality as a fluid delivery device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific "sample sizes" (i.e., number of syringes tested) for each non-clinical test. It broadly states that "Non clinical tests were conducted to verify that the proposed device met all design specifications."

• Data Provenance: The tests were conducted internally by or for Ningbo Tianyi Medical Appliance Co., Ltd. The data is from prospective non-clinical laboratory testing of the manufactured device. The country of origin of the data would be China, where the manufacturer is located.

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

This question is not applicable as the "ground truth" for a physical device like a syringe is established by objective engineering and laboratory measurements against internationally recognized standards (e.g., ISO, ASTM). There is no "expert consensus" in the sense of medical image interpretation for ground truth.

The "experts" involved would be qualified laboratory technicians and engineers with expertise in medical device testing and quality control.

4. Adjudication Method for the Test Set

Not applicable. As described above, the verification involves objective measurements against established technical standards, not subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This document pertains to a physical medical device.

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

Not applicable. This is a physical device, not an algorithm. The "standalone performance" is equivalent to the results of the non-clinical tests demonstrating compliance with physical, mechanical, and biocompatibility standards.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on established international and national standards (e.g., ISO 7886-1, ISO 80369 series, ISO 10993 series, ASTM F88/F88M, ASTM F1929) for medical device design, manufacturing, and safety. This involves objective measurements and assessments rather than clinical outcomes or expert consensus in an interpretative medical sense.

8. The Sample Size for the Training Set

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

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

Not applicable. There is no training set for a physical device.

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The device is indicated for use as a dispenser, a measuring device. It is used to deliver fluids into the body or enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups.

The proposed device is a disposable enteral feeding syringe provided two models, including Type A and Type B, the main difference is the piston of Type A is rubber stopper made of isoprene rubber, and the piston of Type B is rubber pad made of silicone rubber. The proposed device consists of a syringe barrel, syringe plunger and piston (rubber stopper or rubber pad). They are available in 1ml, 3ml, 5ml, 10ml, 20ml, and 60ml. The enteral syringes are sterilized by Ethylene Oxide to achieve a SAL of 10-6 and supplied maintenance package which could maintain the sterility of the device during the shelf life of five years.

This document is a 510(k) premarket notification for an Oral/Enteral Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a performance study of an AI/ML powered device. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria and study proving an AI/ML device meets those criteria.

The document states:

• "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."
• "No clinical study is included in this submission."

Therefore, I cannot extract the requested information as it pertains to a medical device (syringe), not an AI/ML powered device.

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ENFit Oral/Enteral Syringe is indicated for use as a dispenser, a measuring device, and an oral/enteral fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups.

The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 0.5ml to 100ml. It consists of plunger, piston, barrel and tip cap, and used to deliver fluids into the body orally or connected to an enteral access device with male ENFit connector. The syringes (size 5ml, 6ml, 12ml, 20ml, 30ml, 35ml, 50ml, 60ml and 100ml) incorporate a female Standard ENFit connector; the syringes (size 0.5ml, 1ml, 3ml, 5ml and 6ml) incorporate a female low dosing ENFit connector. There are 2 types of the syringe: Side connector ENFit syringe and central connector ENFit syringe. The sizes of the Side connector ENFit syringe range from 10ml to 100ml; and central connector ENFit syringe range from 0.5ml to 100ml. The proposed syringe is sterile or non-sterile. Sterile device was sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years. The sterile syringes are provided with transparent barrel, and the non-sterile syringes are provided with transparent/ amber color barrel.

This document describes the premarket notification (510(k)) for the ENFit Oral/Enteral Syringe manufactured by Jiangsu Caina Medical Co., Ltd. The submission aims to demonstrate substantial equivalence to a predicate device (K161039).

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by compliance with recognized international standards for medical devices and specific tests. The reported device performance is indicated by the statement of compliance with these standards.

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

The document does not explicitly state the sample sizes used for each non-clinical test. The testing was conducted to verify compliance with international standards, which typically involve specific sample size requirements. The data provenance is from non-clinical tests conducted by the manufacturer, Jiangsu Caina Medical Co., Ltd., based in China. The data is retrospective in the sense that the tests were performed on finished devices to support the 510(k) submission.

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

Not applicable. This is a submission for a physical medical device (syringe) and does not involve the use of AI, image analysis, or diagnostic interpretation requiring expert ground truth establishment in the traditional sense. The "ground truth" here is compliance with engineering and biological safety standards, which are evaluated by accredited laboratories and regulatory bodies, not by "experts" establishing a diagnostic truth.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not a study requiring adjudication of expert opinions. Device performance is determined by objective physical and chemical testing.

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

No MRMC study was done. This device is an ENFit Oral/Enteral Syringe, a physical device, and not an AI-powered diagnostic tool. Therefore, human readers or AI assistance are not relevant.

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

No standalone algorithm performance study was done. This is a physical device, not an algorithm.

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

For this device, the "ground truth" is defined by adherence to established international and national standards for medical devices, specifically:

• Engineering and Performance Standards: ISO 80369-3, ISO 7886-1, ISO 80369-20, ASTM F88/F88M-15, ASTM F1929-15.
• Biological Safety Standards: ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation and Skin Sensitization), ISO 10993-7 (EO sterilization residuals).
• Quality Management Standards: ISO 14971 (Risk Management).

Compliance with these standards, demonstrated through non-clinical laboratory testing, serves as the "ground truth" for the device's safety and effectiveness for its intended use.

8. The Sample Size for the Training Set

Not applicable, as this is a physical medical device and not an AI algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device submission.

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Single Use Oral/Enteral Syringes with ENFit Connector (provided sterile and non-sterile):

The device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used in clinical and non-clinical settings by users ranging from clinicians to laypersons in all age groups.

Reusable Oral/Enteral Syringes with ENFit Connector (provided non-sterile):

The device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used multiple times in non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use only.

NeoMed Oral/Enteral Syringes with ENFit® connector (12 mL to 60 mL) are standard piston style syringes consisting of a syringe barrel with integral ENFit syringe tip, syringe plunger, syringe gasket, and supplied sterile or non-sterile, and single use or multiuse. They are provided in varying colors and sizes ranging from 12 mL to 60 mL nominal capacity. The integral syringe tip is a female ENFit connector which is compatible only with enteral access devices or accessories having ENFit compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids.

NeoMed Low Dose Tip Oral/Enteral Syringes with ENFit® connector (1 mL to 6 mL) are standard piston style syringes consisting of a syringe barrel with integral ENFit syringe tip that has the additional low dose tip design feature, syringe plunger, syringe gasket, and supplied sterile or non-sterile, and single use or multiuse. They are provided in varying colors and sizes ranging from 1 mL to 6 mL nominal capacity. The integral syringe tip is a female ENFit connector with the additional low dose tip design feature which is compatible only with enteral access devices or accessories having ENFit compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids.

Reusable Standard ENFit Syringes (12 mL to 60 mL) and reusable Low Dose Tip ENFit Svringes (1 mL to 6 mL) are supplied non-sterile and are intended for single patient use. They are provided in varying colors and sizes ranging from 1 mL to 60 mL nominal capacity.

The provided text describes a medical device, NeoMed Oral/Enteral Syringes with ENFit® connector, and its substantial equivalence to a predicate device. However, the document does not contain information typically found in studies that prove a device meets acceptance criteria for an AI/ML product. The questions raised in the prompt are more relevant to AI/ML device performance evaluation than to the type of medical device described (syringes).

Therefore, I cannot provide a direct answer to the acceptance criteria and study details for an AI/ML device based on the given input, as the input focuses on a physical medical device (syringes) and its substantial equivalence determination.

The document does list "PERFORMANCE DATA (BENCH)" for the syringes, which includes various tests to ensure the physical device's functionality, safety, and compliance with standards. These are benchmarks for the syringes, not for an AI/ML algorithm.

If the prompt were intended for a different type of medical device where AI/ML is involved, the information required would typically be found in clinical study reports, performance evaluation sections, or specific FDA guidance documents for AI/ML-based medical devices.

Summary of what can be extracted from the provided text regarding device performance (for the syringes, not an AI/ML device):

The device is NeoMed Oral/Enteral Syringes with ENFit® connector (12 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringes with ENFit® connector (1 mL to 6 mL).

The document details various performance tests (bench) conducted to demonstrate the device's substantial equivalence to a predicate device (K161039). These tests assess the physical and functional attributes of the syringes.

Here's a breakdown of the performance data provided for the syringes:

• Finished Device Testing:

  • Risk Analysis (design, use, and process FMEA in accordance with ISO 14971:2007)
  • Human Factors and Usability Validation
  • Biocompatibility (ISO 10993-5: Cytotoxicity, ISO 10993-10: Irritation and sensitization, ISO 10993-11: Acute Toxicity)
  • Chemical Testing (Extractables and Leachables)
  • Reusability (Cleaning Instructions Validation, Use Cycle Parameters Study)
  • Finished Device Verification Testing (Critical Dimension verification, Ink Adhesion, ISO 7886)
  • Capacity Tolerance
  • Graduated Scale
  • Piston Fit in Barrel
  • Air and Liquid Leakage Testing
  • Direct Oral Administration Dosing Accuracy Testing

• Syringe Tip (ISO 80369-3 (ENFit) connector) Testing:

  • Enteral Connector Misconnection Assessment
  • Human Factors Validation Study (Standard ENFit)
  • Dimensional verification to ISO 80369-3
  • Liquid leakage testing
  • Resistance to stress cracking
  • Resistance to separation from axial load
  • Resistance to separation from unscrewing
  • Resistance to overriding
  • Disconnection by unscrewing

• Syringe Tip (ISO 80369-3 (ENFit) connector with Low Dose Tip Design Feature) Testing:

  • Low Dose Tip Misconnection Risk Management Report
  • Usability Study for Low Dose Syringe Tip Design Feature
  • Low Dose Tip Oral/Enteral Syringe Design Dosing Accuracy Testing
  • Dimensional verification to ISO 80369-3
  • Liquid leakage testing
  • Resistance to stress cracking
  • Resistance to separation from axial load
  • Resistance to separation from unscrewing
  • Resistance to overriding
  • Disconnection by unscrewing

Regarding the specific questions in the prompt (relevant to an AI/ML device, not these syringes):

1. A table of acceptance criteria and the reported device performance: This information is not provided in a format relevant to AI/ML performance metrics (e.g., sensitivity, specificity, AUC). The performance data listed are for the physical properties and functionality of syringes.
2. Sample size used for the test set and the data provenance: Not applicable to this type of device. The "test set" here refers to the samples of syringes subjected to various bench tests, not a dataset for an AI/ML model.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for AI/ML refers to expert labels or pathology results. For these syringes, "ground truth" would be engineering specifications and international standards.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is for assessing human performance with/without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
7. The type of ground truth used: For these syringes, the "ground truth" for the tests would be established by engineering specifications, validated test methods, and adherence to international standards like ISO 14971, ISO 10993, ISO 7886, and ISO 80369-3.
8. The sample size for the training set: Not applicable; this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

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The subject device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups.

Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) are basically enteral syringes that can also be used for oral uses. There are two different types of models of the syringes, which are Type A and Type B. The Type A syringes of a polypropylene barrel and plunger rod and a synthetic rubber gasket stopper manufactured from polyisoprene. The Type B syringes consist of a polypropylene barrel and plunger rod and a silicone O-ring. The 10 to 60 mL syringes come with the standard female ENFit connector and the 1 to 5 mL syringes come with a female ENFit connector incorporating a low dose tip design.

The provided text focuses on establishing substantial equivalence for an Oral/Enteral Syringe, primarily through comparison to a predicate device and adherence to recognized standards. It does not contain information about an AI/ML powered medical device, or the kind of acceptance criteria and study designs that would be typical for such a device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, including specifics like sample size for test and training sets, expert ground truth establishment, MRMC studies, or standalone performance, as this information is not present in the provided document for this particular medical device.

The document discusses non-clinical tests performed to ensure the device's effectiveness and safety, primarily focusing on:

• Biocompatibility: Adherence to ISO 10993 series standards (in vitro cytotoxicity, irritation, skin sensitization, systemic toxicity).
• Performance safety and effectiveness (according to ISO 7886-1): Cleanliness, lubricant, limits of extractable metals, limits for acidity/alkalinity, tolerance on graduated capacity, graduated scale, dead space, barrel configuration, nozzle design verification, piston/plunger assembly, freedom from air and liquid leakage, force to operate the piston.
• Performance safety and effectiveness (according to ISO 80369-3 for connectors): Fluid leakage, stress cracking, resistance to separation from axial load, resistance to unscrewing, resistance to overriding, disconnection by unscrewing.
• Additional Performance tests: Dimensional verification (to ISO 80369-3, low dose tips, syringes), risk management report, dosing accuracy testing (for low dose tips and oral administration).

The conclusion states that the "subject device will be as safe and effective for usage as the listed predicate device," based on these non-clinical tests and the comparison of technological characteristics. No clinical tests were performed for this submission.

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The device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups.

NeoMed Oral/Enteral Syringes with ENFit® connector (12 mL to 100 mL) are standard piston style syringes consisting of a syringe barrel (vented or non-vented) with integral ENFit® syringe tip, syringe plunger, and syringe gasket. They are supplied in sizes ranging from 12 mL to 100 mL nominal capacity, sterile or non-sterile, with or without a syringe tip cap, and in varying colors. The integral syringe tip is a female ENFit® connector designed to be compatible only with enteral access devices or accessories having ENFit® compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids.

NeoMed Low Dose Tip Oral/Enteral Syringes with ENFit® connector (0.5 mL to 6 mL) are standard piston style syringes consisting of a syringe barrel with integral ENFit® syringe tip that has the additional low dose tip design feature, syringe plunger, and syringe gasket, They are supplied in sizes ranging from 0.5 mL to 6 mL nominal capacity, sterile or nonsterile, with or without a syringe tip cap, and in varying colors. The integral syringe tip is a female ENFit® connector with the additional low dose tip design feature designed to be compatible only with enteral access devices or accessories having ENFit® compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids.

The provided text is a 510(k) summary for NeoMed Oral/Enteral Syringes with ENFit® connectors. It describes performance testing conducted but does not present specific acceptance criteria or quantitative performance data that would allow for a detailed table with reported device performance against those criteria. It lists the types of tests performed.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, expert qualifications, or adjudication methods for a test set regarding specific performance metrics.

However, I can extract the information that is present regarding the studies:

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

• Not explicitly provided in the document. The document lists the types of performance tests conducted (e.g., Capacity Tolerance, Graduated Scale, Air and Liquid Leakage Testing, Dosing Accuracy Testing, various ENFit® connector resistance tests) but does not state the numerical acceptance criteria or the specific performance results achieved by the device against these criteria.

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

• Sample size: Not specified for any of the performance tests.
• Data provenance: Not specified. The testing was conducted by the manufacturer, NeoMed, Inc., which is based in Woodstock, GA, USA. The document implies these were bench tests performed during device development.

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/Not specified. The tests mentioned are primarily bench tests (e.g., dimensional verification, leakage, resistance, dosing accuracy) that rely on objective measurements rather than expert interpretation or ground truth establishment in a clinical sense. Human Factors Validation Studies and Usability Studies involved human participants, but the number or qualifications of "experts" to establish ground truth is not relevant in the context you've described.

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

• Not applicable/Not specified. This pertains to clinical studies often involving expert interpretation of medical images or patient outcomes. The listed tests are bench performance 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

• No. An MRMC comparative effectiveness study is not mentioned. This type of study is relevant for AI/CAD systems that assist human readers in image interpretation, which is not the function of these oral/enteral syringes.

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

• No. This device is a medical syringe, not an algorithm or AI system.

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

• Objective measurement/Standards compliance. For tests like dimensional verification, capacity tolerance, leakage testing, and resistance tests, the "ground truth" is defined by the physical or engineering specifications (e.g., ISO standards, internal design specifications) against which the device performance is measured. For dosing accuracy, it would be the actual volume dispensed versus the intended volume.

8. The sample size for the training set

• Not applicable. This device is a physical product, not a machine learning model that requires a training set.

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

• Not applicable. As above, it's not a machine learning model.

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The MED-RX® Oral/Enteral Syringes are to be used by a healthcare professional to measure and administer oral medication and enteral nutrition. The MED-RX® Oral/Enteral Syringes are sterile, single use, and for pediatric use only.

The MED-RX® Oral/Enteral Syringe is available in two configurations, an enteral tip syringe and an overmolded enteral tip syringe. Both configurations of the MED-RX® Oral/Enteral Syringe are available in various volumes, from 1 to 60mL. All MED-RX® Oral/Enteral Syringe feature graduation markings along the barrel of the syringe, are provided with a tip cap, and are incompatible with standard luer devices. The MED-RX® Oral/Enteral Syringes are provided sterile, and are single use and disposable.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Benlan™ MED-RX® Oral/Enteral Syringes:

The provided text is a 510(k) Summary for a medical device and therefore describes a regulatory submission for substantial equivalence, not a clinical study proving device performance against specific acceptance criteria in the context of diagnostic accuracy or clinical outcomes.

The "acceptance criteria" and "device performance" in this document refer to various functional, material, and safety tests to demonstrate that the device is as safe and effective as a legally marketed predicate device. The document does not describe a study evaluating the device's clinical performance with human readers, AI, or diagnostic accuracy metrics.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of document.

Here's how the provided information maps to your request:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Study Details (As applicable to this type of regulatory submission)

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

• Sample Size (for functional and biocompatibility tests): The document states "All bench testing was successfully completed on both configurations of the MED-RX® Oral/Enteral Syringe: the overmold enteral tip syringe and the enteral tip syringe." It also states "Both configurations of the MED-RX® Oral/Enteral Syringe were tested for biocompatibility." Specific numerical sample sizes for each test are not provided.
• Data Provenance: The tests were conducted by the manufacturer, Benlan™ (located in Oakville, ON, Canada, as per the submission contact information). These are laboratory/bench tests, not clinical data from patients.

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 syringe, and the testing involves functional, material, and biological safety evaluations, not diagnostic image interpretation or complex clinical decision-making requiring "experts" to establish ground truth in the traditional sense of a clinical study. The "ground truth" for these tests are objective measurements (e.g., cytotoxicity, leakage, material properties) as defined by the relevant ISO standards.

4. Adjudication method for the test set:

• Not Applicable. See point 3.

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

• No. This is a physical medical device (syringe) and not an AI or diagnostic imaging device. An MRMC study is not relevant to its regulatory approval in this context.

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

• No. This is a physical medical device (syringe) and not an AI or algorithm-based device.

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

• For functional performance tests, the ground truth is derived from whether the device met pre-defined engineering specifications and performed as expected (e.g., no leakage, proper functionality, incompatibility with luer devices). These are objective criteria.
• For biocompatibility tests, the ground truth is established by the accepted scientific standards and methodologies outlined in the ISO standards (e.g., ISO 10993-5 for cytotoxicity, ISO 10993-10 for sensitization and intracutaneous reactivity). The "truth" is whether the biological response meets the criteria for non-toxicity, non-sensitization, etc., as per the standard.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.

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

• Not Applicable. See point 8.

In summary: The provided document is a 510(k) summary for a non-active, non-diagnostic medical device. The "acceptance criteria" and "study" refer to engineering, functional, and biological safety testing designed to demonstrate substantial equivalence to a predicate device, rather than a clinical trial evaluating diagnostic or treatment efficacy that would typically involve human readers, AI, or complex outcome measures.

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The device is indicated for use as a dispenser, a measuring device and an oral fluid transfer device. It is used to inject fluids into the body via extension sets and feeding tubes in neonatal and small pediatric patients.

The NeoMed Oral / Enteral Syringe is specifically designed for administration of enteral liquids to neonatal and small pediatric patients. The NeoMed Oral / Enteral Syringe is a standard piston syringe which is incompatible with luer-lock and intravenous devices. The NeoMed Oral / Enteral Syringes are compatible with NeoMed enteral-only connectors, the NeoMed extension sets and NeoMed feeding tubes to form a dedicated system that prevents wrong-route administration of non-IV fluids and other competitive enteral/feeding tube, extension set type products that do not utilize a luer-lock system. They possess translucent barrels to provide visualization of fluid contents and volume, and patented orange lettering/gradient markings which coordinate with NeoMed orange extension sets and feeding tubes. NeoMed Oral / Enteral Syringes are manufactured as a single piece molded barrel that does not rely on adapters to create an oral tip. The NeoMed Oral / Enteral Syringes possess design features that prevent connectivity to luer type devices and hence prevents the chance that a feeding tube could be infused into the IV line.

The NeoMed Oral / Enteral Syringe device consists of the following components:

• Syringe Barrel
• Syringe Plunger
• Syringe Gasket
• Syringe Tip
• Syringe Cap

Here's an analysis of the provided text regarding the NeoMed Oral / Enteral Syringe, focusing on the acceptance criteria and the study proving it meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific "sample size" for the test set in terms of a number of units tested. It refers broadly to "Design Verification testing" and "test results." The data provenance is implied to be from internal testing conducted by NeoMed, Inc. and is therefore prospective for the device being submitted. There is no information regarding country of origin of the data beyond the manufacturer's location in the USA.

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

This information is not provided in the document. The document refers to "Design Verification testing" and "risk analysis," which implies engineering and technical testing against established standards, rather than clinical ground truth established by medical experts for a diagnostic or treatment outcome.

4. Adjudication Method for the Test Set

This information is not provided as the "test set" appears to refer to engineering and performance testing against standards, not a clinical study requiring expert adjudication of results.

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 conducted. This is a medical device (syringe) and the submission focuses on its physical and functional performance, biocompatibility, and sterility, not on diagnostic or AI-assisted clinical interpretation.

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

This is not applicable as the device is a physical syringe, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" used for this device is based on engineering and performance standards (e.g., ISO 7886-1, ISO 7886-2, ISO 10993-1, ISO 80369-1) and the established performance of the predicate device (K092908). The testing verifies that the physical properties, functionality, and biocompatibility meet these predefined benchmarks, rather than clinical outcomes or expert diagnoses.

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

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