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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. 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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The DASH 3TM ENFit Syringe is a sugle use syninge indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids or nututional formula into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral synnges are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.

The DASH 3TM Eccentric ENFit Syringe is a single use syringe indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids or nutritional formula into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syninges are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.

The DASH 3TM Low Volume Tip ENFit Syringe is a sungle use syringe indicated for use as a dispenser, a measuning device, and a fluid transfer device. It is used to deliver fluids or nutritional formula into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syninges are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinicians, in all age groups.

The DASH 3M ENFit Syringe Cap allows the advance preparation and secure storage and transport of medication fluids or mutritional formula. The synnge cap will fit any size of the Single Use Synnges (DASH 3TM)

The DASH 3™ ENFit Syringe device family is a Single Use, in-hospital and home care (DASH 3TM ENFit Syringe, DASH 3TM Eccentric ENFit Syringe, DASH 3TM ENFit Low Dose Tip Syringe) device.

It is provided in sizes from 1 mL to 100 mL. The device incorporates a female ENFit connector for connection to an enteral access device with a male ENFit port specified in ISO 80369-3. The Low Dose Tip contains the low dose design feature specified in (Draft) ISO 20695.

The DASH 3TM ENFit accessories are designed to be compatible with ENFit connector devices. The DASH 3TM ENFit Syringe Caps fit any size of the Single Use ENFit Syringes (DASH 3™), which allows the advance preparation and secure storage and transport of medication/fluids or nutritional formula.

The provided text describes a medical device, the DASH 3™ ENFit Syringe family and its accessories, and outlines the testing conducted to demonstrate its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of diagnostic performance. Therefore, I cannot extract information related to sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these are not relevant to this type of device submission.

However, I can provide the acceptance criteria and confirmed performance based on the engineering and functional testing described in the document.

Acceptance Criteria and Reported Device Performance

The device performance is demonstrated through various tests designed to confirm compliance with ISO standards and other design specifications. The document states that the DASH 3™ Syringe device family and its accessories "met all acceptance criteria, as described in Section 17." The table below summarizes the listed tests, which serve as the acceptance criteria, and the reported outcome.

Details of the Study:

The studies conducted are primarily engineering and functional bench tests, and risk assessments.

• Sample sized used for the test set and the data provenance: The document does not specify exact sample sizes for each test. The data provenance is implied to be from internal testing conducted by the manufacturer, Intervene Group Limited, likely in the UK, given the address. The studies are prospective in the sense that they were conducted for the purpose of this 510(k) submission.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these types of engineering tests is typically defined by adherence to published international standards (e.g., ISO) and the device's design specifications, not by expert consensus on observational data.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Performance is measured against predefined objective standards and specifications.
• 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/diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/diagnostic device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for these tests is the adherence to the requirements outlined in the cited ISO standards (ISO 80369-3, ISO 80369-20, ISO 7886-1, Draft ISO 20695) and the internal design specifications of the device.
• The sample size for the training set: Not applicable. This is not a machine learning device; therefore, there is no "training set."
• How the ground truth for the training set was established: Not applicable.

In conclusion, the study supporting the device's substantial equivalence consists of a series of bench tests and assessments confirming that the DASH 3™ ENFit Syringe family and its accessories meet established engineering and performance standards, thereby demonstrating that they perform as intended and do not raise new questions of safety or effectiveness compared to predicate devices.

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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 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) for patients in all age groups.

The Enteral Syringe with ENFit Connector (10 ml to 60 ml) and the Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) are both sterile, standard piston style enteral syringes with an integrated female ENFit compatible connector compliant to the requirements of ISO DIS 80369-3, First Edition, Small-bore Connectors for Liquids and Gases in Healthcare Applications – Part 3: Connectors for Enteral Applications and designed to be compatible with male ENFit connectors.

The Enteral Syringe with ENFit Connector has capacities of 10, 20, 30 and 60 ml and is available in two different connector confiqurations: Centerline and Offset.

The Enteral Syringe with ENFit Low Dose Tip is a low dose syringe and has capacities of 1. 3 and 5 ml. The ENFit Lose Dose tip is a modification of the ENFit connector designed for the delivery of low doses of fluids for enteral feeding.

The document describes the VR Medical Technology's Enteral Syringe with ENFit® Connector and Enteral Syringe with ENFit® Low Dose Tip. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria in the context of an effectiveness study for an AI/ML device.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this type of device submission. This document focuses on demonstrating compliance with recognized standards and biocompatibility.

Here's an analysis based on the provided text:

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

The document does not present a formal table comparing acceptance criteria to device performance in the way typically seen for AI/ML device effectiveness studies. Instead, it lists various performance tests conducted according to international standards (ISO). The "acceptance criteria" are implied by compliance with these standards, and the "reported device performance" is indicated by the statement that these tests were "conducted" and supported a conclusion of substantial equivalence.

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

This information is not provided in the document. For physical device testing against standards, specific sample sizes are typically defined within the test protocols associated with the ISO standards, but these details are not presented here. Data provenance is also not relevant in the context of these physical performance tests.

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 information is not applicable as this is a physical device, not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth on patient data. The "ground truth" here is compliance with engineering and safety standards.

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

This information is not applicable as this is a physical device, not an AI/ML diagnostic or prognostic tool.

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 information is not applicable as this device is a physical enteral syringe, not an AI/ML system or a medical imaging device that would involve human readers.

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

This information is not applicable as this device is a physical enteral syringe, not an algorithm.

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

The "ground truth" in this context is the predefined requirements and specifications within the referenced ISO standards (ISO 10993-5, ISO 10993-10, ISO 7886-1, ISO DIS 80369-3, ISO 14971) and demonstrated through the physical performance and biocompatibility testing. In the case of the Usability Study, the "ground truth" would be the successful and safe use of the device by representative users.

8. The sample size for the training set

This information is not applicable as this is a physical device, not an AI/ML system that requires a "training set."

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

This information is not applicable as this is a physical device, not an AI/ML system.

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