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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 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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NeoConnectTM Enteral Syringe with ENFit™ Connector:
The device is indicated for use as a dispenser, a measuring device. It is used to deliver fluids into the body 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.

NeoConnect™ NeoSecure™ Tip Cap:
A NeoConnect™ Enteral Syringe with ENFit™ connector accessory used to prevent fluid loss and contamination of syringe contents until ready for use.

The NeoMed NeoConnect™ Enteral Syringes with ENFit™ connector are standard piston style syringes consisting of a syringe barrel with an integral ENFit™ syringe tip, syringe plunger, syringe gasket, and supplied with or without a syringe tip cap. They are provided in varying sizes ranging from 0.5 mL to 100 mL nominal capacity. The integral syringe tip is a female ENFit™ connector which is compatible only with enteral access devices having ENFit™ male connectors to form a dedicated system that prevents wrong-route administration of fluids. They possess translucent barrels to provide visualization of fluid contents and volume.

The NeoConnect™ NeoSecure™ Tip Cap is supplied with the NeoConnect™ Enteral Syringe with ENFit™ connector or sold separately (sterile or non-sterile). It is an ENFit™ compatible closure cap for the tip of the syringe.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) premarket notification letter and a summary for an enteral syringe and tip caps. It discusses substantial equivalence to predicate devices and lists various performance tests conducted. However, it does not provide acceptance criteria, reported device performance in a comparative table, details about specific study designs (like sample sizes for test/training sets, data provenance, expert qualifications, or adjudication methods), or information about MRMC comparative effectiveness studies or standalone algorithm performance.

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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 via extension sets and feeding tubes in neonatal and small pediatric patients.

The NeoMed NeoConnect™ Enteral Syringes are standard piston style syringes consisting of a syringe barrel with integral ENFit syringe tip, syringe plunger, syringe gasket, and supplied with a syringe tip cap. They are provided in varying sizes ranging from 0.5ml to 100ml nominal capacity. The integral syringe tip is a female ENFit connector which is compatible only with feeding tubes and extension sets that have ENFit male connectors to form a dedicated system that prevents wrong-route administration of fluids. They possess translucent barrels to provide visualization of fluid contents and volume.

The provided document is a 510(k) premarket notification for a medical device (NeoMed NeoConnect™ Enteral Syringes with ENFit Connector). It does not contain information about a study proving device performance against acceptance criteria in the context of an AI/ML powered device, which typically involves metrics like sensitivity, specificity, AUC, or reader performance.

The document describes bench testing for the physical properties and safety of the syringe. These are acceptance criteria for a physical medical device, not an AI algorithm.

Therefore, many of the requested categories (e.g., sample size for test set, ground truth experts, MRMC study, standalone performance) are not applicable to the information provided in this regulatory submission.

However, I can extract the acceptance criteria and related "performance" from the document based on the provided bench testing section.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the document. The document refers to "Finished Device Verification Testing" and various specific tests but does not disclose the number of units tested.
• Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission, this would be prospective bench testing conducted by the manufacturer, NeoMed, Inc. The document implies the tests were performed as part of the device's design validation prior to market submission.

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

• Not Applicable. This document describes testing for a physical medical device (syringe), not an AI/ML algorithm that requires expert-established ground truth for diagnostic or prognostic performance. The "ground truth" for these tests would be the measured physical properties or compliance with engineering standards.

4. Adjudication method for the test set:

• Not Applicable. As above, this is not an AI/ML diagnostic or prognostic test. Adjudication methods like 2+1 or 3+1 are used for expert consensus in image interpretation or similar tasks, which are 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 for a physical medical device; no AI component is mentioned, and therefore, no MRMC study involving AI assistance would have been performed or reported here.

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

• Not Applicable. There is no algorithm or software component described in this device submission.

7. The type of ground truth used:

• Direct Measurement / Standard Compliance. The ground truth for this device's performance is established by direct physical measurements against defined engineering standards (e.g., critical dimensions, leakage rates, strength of connections, biocompatibility testing against ISO standards). This is typical for traditional hardware medical devices.

8. The sample size for the training set:

• Not Applicable. This device does not have a "training set" as it is not an AI/ML product. The design and manufacturing processes are developed based on engineering principles and regulatory standards, not trained on data.

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

• Not Applicable. As there is no training set, there is no ground truth for a training set.

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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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This product is intended for short-term use

The NeoMed Gastrointestinal Tube and Accessories is a PVC single lumen catheter that is used to deliver liquid nutritional media. This NeoMed PVC feeding tube is designed to connect with other NeoMed accessories such as the NeoMed Extension tubing under FDA clearance K100288 and NeoMed oral syringe under FDA clearance K092908.

The device consists of the following main components: a feeding tube single lumen catheter and a one-piece molded enteral only connector hub with integral tethered connection closure plug. The catheter tubing has an orange radiopaque stripe of barium sulfate embedded in the tubing wall which can be visualized on x-ray, for exact placement of the tip. The tip is closed. The single lumen catheter tubing has side holes for better flow and to provide multiple openings for aspiration.

The provided text describes a 510(k) submission for the NeoMed Gastrointestinal Tube and Accessories, which seeks substantial equivalence to existing predicate devices. The study conducted to demonstrate this equivalence is primarily an engineering bench test study rather than a clinical study involving human patients or complex AI algorithms.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes "bench testing" and "design verification functional test results." It does not specify a "test set" in the context of patient data or algorithm performance. The testing involved physical tubes and components. No information is provided regarding the specific number of units tested for each functional test (tensile strength, dimensions, etc.), nor is there any mention of data provenance (e.g., country of origin) as the tests are laboratory-based engineering evaluations.

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

Not applicable. The study is a bench test, and there is no mention of experts establishing a "ground truth" for a test set in the context of clinical or image-based evaluations. The "ground truth" for these engineering tests would be the established engineering specifications and performance standards.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of adjudication, as this study does not involve human interpretation or subjective assessments that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This study is an engineering bench test for physical device characteristics and does not involve human readers, AI assistance, or comparative effectiveness in a clinical setting.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No. This device is a physical medical tube, not an AI algorithm. Therefore, no standalone algorithm performance study was conducted.

7. Type of Ground Truth Used

The ground truth used for this study is based on engineering specifications, material properties, and functional performance standards derived from the intended use and comparison with predicate devices. For example, for dimensions, the ground truth would be the specified dimensions in the design; for tensile strength, it would be the minimum required strength; for biocompatibility, it would be successful compliance with ISO 10993-1.

8. Sample Size for the Training Set

Not applicable. This study does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. This study does not involve a "training set" for which ground truth would need to be established.

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The NeoMed Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the risk of accidental misconnection with an I.V. system to the enteral system or the enteral system to an I.V. system.

The NeoMed Enteral Only Extension Set is a sterile disposable for single patient use only device designed to help minimize the potential for inadvertent delivery of enteral feedings through the intravenous route. The device consists of flexible PVC tubing designed to connect existing feeding tubes (nasogastric, oralgastric, etc) to various delivery systems in including pumps and syringes. The set consists of tubing with an enteral connector (catheter tip) and an oral syringe connector not compatible with IV tubing or stopcocks. The NeoMed Enteral Only Extension Set provides an orange stripe for easy quick identification of enteral feeding lines as well as an "Enteral Only" tag and slide clamp to provide the additional safety assurance for connection errors.

The provided text describes the NeoMed Enteral Only Extension Set, a Class II medical device. However, it does not contain the information needed to fill out a table of acceptance criteria, detailed device performance, or a comprehensive study description as requested.

The document is a 510(k) summary, which focuses on establishing substantial equivalence to a predicate device rather than presenting detailed clinical study results or specific performance criteria with numerical targets.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Table: The document states that "Design verification functional test results demonstrate that the NeoMed Enteral Only Extension Set performs its intended use." It then lists the types of tests conducted: "mechanical: tensile, strain, elongation and physical/properties testing comprised of dimensional verification, flow rate, and hub compatibility. Packaging challenges for package integrity and product stability were conducted with aging studies. All materials have been evaluated in accordance with ISO 10993-1: Biological Evaluation of Medical Devices – part 1: Evaluation and Testing and the three tests conducted - cytotoxicity, sensitization, and irritation pass."

*Crucially, the specific quantitative acceptance criteria (e.g., "tensile strength > X N") and the numerical results (e.g., "tensile strength = Y N") for these tests are NOT provided in this document. The document only states that the tests were conducted and "pass" or "demonstrate that the device performs its intended use."

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

• Sample Size for Test Set: Not specified. The document refers to "functional tests conducted" but does not give the number of units tested for each type of performance test.
• Data Provenance: Not specified (e.g., country of origin of data). The testing appears to be internal validation by the manufacturer, NeoMed, Inc., or its contracted labs.
• Retrospective or Prospective: N/A for this type of bench/functional testing.

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

• Not Applicable. This document describes bench and biocompatibility testing for a medical device (an extension set), not a diagnostic or prognostic device that requires expert-established ground truth from patient data. The "ground truth" for these tests would be the established engineering standards or regulatory requirements.

4. Adjudication method for the test set

• Not Applicable. As above, this is laboratory and bench testing, not a clinical study involving human readers or subjective interpretations requiring adjudication.

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

• No such study was done. This device is an enteral extension set, a physical medical device, not an AI-powered diagnostic or decision support 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 algorithm.

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

• Engineering Standards and Regulatory Guidelines. For the functional and biocompatibility tests, the "ground truth" is adherence to established industry standards (e.g., ISO 10993-1 for biocompatibility) and the device's design specifications.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this device does not involve machine learning or AI.

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

• Not Applicable. As above, no training set.

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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 Sterile Syringe is specifically designed for administration of enteral liquids to neonatal patients. The NeoMed Sterile Syringe is a standard piston syringe which is incompatible with luer-lock and intravenous devices. The NeoMed Sterile Syringes are compatible with NeoMed enteral-only connectors, the NeoMed orange extension sets and feeding tubes to form a dedicated system that prevents wrong-route administration of non-IV fluids and other competitive enteralfeeding 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 Sterile Syringes are manufactured as a single piece molded barrel that does not rely on adapters to create an oral tip. The NeoMed Sterile 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 Sterile Syringes will be available in 1ml, 3ml, 6ml, 35ml, and 60ml individual packs.

The NeoMed Sterile Syringe device consists of the following components:

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

This document describes the NeoMed Sterile Syringe and its substantial equivalence to a predicate device. However, it does not contain the specific detailed information typically found in an acceptance criteria study report for an AI/ML medical device.

Therefore, I cannot populate the table and answer all the questions as requested based on the provided text. The document focuses on performance testing to demonstrate functional equivalence to a predicate device rather than on specific clinical study results with acceptance criteria in the context of an AI/ML algorithm.

Here's what can be extracted and what cannot:

Information that CANNOT be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: No specific acceptance criteria are defined in terms of metrics (e.g., sensitivity, specificity, accuracy) for a study. The performance is described as "functionally equivalent" and performing its "intended use."
• Sample sized used for the test set and the data provenance: No information on specific test sets, sample sizes, or data provenance (country, retrospective/prospective).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a clinical study using expert ground truth.
• Adjudication method: Not applicable.
• 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/ML device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no external ground truth beyond standard device testing is mentioned.
• The sample size for the training set: Not applicable, as this is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Information that CAN be extracted and inferred:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions "Bench testing" and "Design verification performance test results." However, it does not specify sample sizes for these tests, data provenance, or whether the study was retrospective or prospective. It refers to standard laboratory testing rather than real-world patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This is a medical device, not an AI/ML algorithm that relies on expert ground truth for performance evaluation in a clinical setting. The "ground truth" for this device would be defined by engineering specifications and objective performance measurements for fluid delivery, measurement accuracy, and material properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this is not a study involving human interpretation or subjective assessments requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No. This is a physical medical device (syringe), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or reported here.

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 (expert consensus, pathology, outcomes data, etc):
For this device, the "ground truth" for performance would be based on engineering specifications, established standards, and objective physical measurements during bench testing. For example, volume accuracy, force required for operation, material integrity, and secure connection with intended enteral devices.

8. The sample size for the training set:
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:
Not applicable.

In summary, the provided text describes a 510(k) submission for a traditional medical device (syringe) that relies on bench testing and material biocompatibility to demonstrate substantial equivalence, not an AI/ML device that would require the specified types of studies and acceptance criteria.

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The NeoMed Polyurethane Feeding Tube is intended for nasogastric or orogastric delivery of various types of liquid nutritional media through the gastro intestinal tract of neonatal and small pediatric patients, and is not intended for use beyond 30 days.

The NeoMed Polyurethane Feeding Tube is a polyurethane single lumen catheter that is used to deliver liquid nutritional media. The device consists of the following main components: a feeding tube single lumen catheter, a hub with tethered connection closure plug, and a connector.

The provided text describes the submission for a 510(k) premarket notification for the "NeoMed Polyurethane Feeding Tube". This document focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria through a clinical study or detailed standalone algorithm performance.

Here's a breakdown of why many of your requested points cannot be answered from this document:

• This is not an AI/ML device. The device is a physical medical device (a feeding tube). Therefore, concepts like AI assistance, human readers, effect size, training sets, and sophisticated ground truth establishment are not applicable.
• The approval is based on substantial equivalence, not a new clinical study with acceptance criteria. The document explicitly states that "Bench testing has demonstrated that the NeoMed Polyurethane Feeding Tube is functionally equivalent to predicate NeoMed Silicone Enteral Feeding Tube, and that any minor differences do not affect safety or effectiveness."

Therefore, I cannot provide a detailed answer to many of your questions in the format you requested, as the information is not present in the provided text, and the nature of the device and approval pathway does not align with your questions.

However, I can extract the relevant information regarding the "performance data" mentioned:

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

The document does not specify formal, quantitative "acceptance criteria" with numerical targets in the context of a clinical study or software performance metrics. Instead, "performance data" refers to design verification testing to demonstrate equivalence.

2. Sample size used for the test set and the data provenance
This information is not provided. The document mentions "bench testing" and "design verification performance test results," but does not specify sample sizes or data provenance for these tests. It is likely referring to laboratory-based engineering tests rather than patient data.

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/ML-based diagnostic or imaging device requiring expert ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, for the same reasons as above.

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-assisted device.

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 (expert consensus, pathology, outcomes data, etc.)
For a device relying on bench testing for substantial equivalence, the "ground truth" would be engineering specifications, material standards (like ISO 10993 for biocompatibility), and functional performance metrics compared against the predicate device, rather than clinical outcomes or expert consensus on disease states.

8. The sample size for the training set
Not applicable; this is not an AI/ML device that uses a training set.

9. How the ground truth for the training set was established
Not applicable.

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The NeoMed Dual Lumen Umbilical Catheter is intended for use in neonatal and pediatric patients to sample blood, monitor blood pressure, or administer fluids intravenously.

The NeoMed Dual Lumen Umbilical Catheter is a silicone dual lumen catheter with natural white barium sulfate included for radiopacity. The device consists of the following main components: a dual lumen umbilical catheter, a hub, and two extension legs, one with a three-way stopcock and the other with an injection site.

This document describes the NeoMed Dual Lumen Umbilical Catheter and its substantial equivalence to a predicate device. It does not contain information about an AI device, therefore, the requested information about acceptance criteria, study details, ground truth establishment, or sample sizes related to AI performance cannot be provided.

The document focuses on the regulatory clearance of a medical device based on its similarity to an existing device (predicate device). The "performance data" mentioned refers to design verification tests demonstrating that the new catheter performs its intended use and is equivalent to the predicate device, not performance against specific acceptance criteria for an AI algorithm.

To explicitly address the numbered points:

1. A table of acceptance criteria and the reported device performance
   • Not applicable as this document is not about an AI device or a study with specific performance metrics against acceptance criteria. The document states, "Bench testing has demonstrated that the NeoMed Dual Lumen Umbilical Catheter is functionally equivalent to predicate NeoMed Single Lumen Umbilical Catheter and that any minor differences do not affect safety or effectiveness." and "Design verification performance test results demonstrate that the NeoMed Dual Lumen Umbilical Catheter performs its intended use and is equivalent to the predicate device."
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. The document refers to "bench testing" and "design verification performance test results," which implies laboratory testing of the physical device rather than a study using a test set of data. No information on sample size or data provenance is provided.
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. There is no mention of experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   • Not applicable. There is no mention of a test set or adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
   • Not applicable. This is not an AI device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
   • Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   • Not applicable. Ground truth for an AI algorithm is not relevant to this submission. The "ground truth" equivalent for this device would be its functional performance in laboratory tests, confirming it meets design specifications and operates as intended, similar to the predicate.
8. The sample size for the training set
   • Not applicable. This is not an AI device, so there is no training set.
9. How the ground truth for the training set was established
   • Not applicable. This is not an AI device, so there is no training set or ground truth establishment relevant to AI.

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