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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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The Oral/Enteral Syringes is intended for the delivery of liquid medication, formula, and breast milk.

The Oral/Enteral Syringes are intended for the delivery of liquid medication, formula, and breast milk. The syringes incorporate safety connectors that mate with the Respironics Enteral Only Extension Set, but will not mate with Luer lock or Luer slip fittings. The safety connectors prevent inadvertent connection of the enteral system to an IV system or an IV system to the enteral system. The Oral/Enteral Syringe barrels, plungers and end caps are comprised of Polypropylene, and the pistons are comprised of Silicone.

The provided text describes a 510(k) premarket notification for "Oral/Enteral Syringes." However, it is a submission for a medical device (syringes), not an AI/ML powered device. As such, the information you requested regarding acceptance criteria and studies that apply to AI/ML powered devices, such as sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, and standalone performance, are not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices through design verification tests related to the physical and functional properties of the syringes.

Here's the information that is available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (as much as can be extracted):

2. Sample size used for the test set and the data provenance: Not applicable (this is a physical device, not an AI/ML model evaluated on a test set of data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device would be its physical properties and functional performance as described by engineering and regulatory standards, not expert consensus on data interpretation.

8. The sample size for the training set: Not applicable.

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

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