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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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