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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

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

• Sample Size: Not explicitly stated for each test, but standard test methods were followed. The number of devices required for each standard (e.g., ISO 7886-1, ISO 80369-3) would dictate the sample sizes.
• Data Provenance: The tests are non-clinical (bench testing, material testing, biocompatibility testing) performed on the manufactured device. The location of testing labs is not specified, but the applicant is based in China. The data is prospective for the purpose of this submission (i.e., new tests performed on the specific device for this 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 non-clinical device submission. "Ground truth" in the diagnostic/AI sense is not relevant. Performance is measured against established international and harmonized standards.

4. Adjudication method for the test set:

• Not Applicable. This refers to clinical assessments or expert review, which is not part of this type of submission. Testing involves laboratory measurements against predefined criteria in standards.

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 a non-clinical syringe, not an AI-enabled diagnostic device.

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

• Not Applicable. This is a non-clinical syringe, not an AI-enabled diagnostic device.

7. The type of ground truth used:

• Not Applicable. For this type of device, performance is evaluated against objective, measurable criteria defined in international scientific and engineering standards (e.g., ISO, ASTM). There isn't a "ground truth" derived from expert consensus, pathology, or outcomes data in the context of a diagnostic product.

8. The sample size for the training set:

• Not Applicable. This is a non-AI device submission; there is no "training set."

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

• Not Applicable. This is a non-AI device submission; there is no "training set" or ground truth for it.

Summary of Study (Based on Submitted Information):

The "study" in this context is a collection of non-clinical performance evaluations and testing conducted to demonstrate that the Anhui Tiankang Medical Technology Co., Ltd. Oral/Enteral Syringe with ENFit connector is substantially equivalent to its predicate device. This involves:

• Biocompatibility Testing: Evaluating the device's materials for cytotoxicity, irritation, and sensitization according to ISO 10993 series. The device reported "No Cytotoxicity; No Irritation; No Sensitization."
• Sterilization Validation: Confirming the Ethylene Oxide (EO) sterilization process meets ISO 11135 standards and an SAL of 10-6, along with EO and ECH residue testing per ISO 10993-7. The device was found to comply.
• Shelf Life Determination: Performing accelerated aging tests according to ASTM F1980-16 to support a 3-year shelf life.
• Package Integrity Testing: Conducting tests like seal strength (ASTM F88/F88M-15), blue dye penetration (ASTM F1929-2015), and visual inspection (ASTM F1886/F1886M-16) to ensure packaging maintains sterility. All packaging was deemed acceptable.
• Product Performance Testing: Evaluating the syringe against specific functional standards:
  • Dose accuracy according to ISO 7886-1:2017.
  • Enteral connector compatibility and performance according to ISO 80369-3:2016.
  • General connector requirements and common test methods from ISO 80369-1:2018 and ISO 80369-20:2015.
  • Material properties referenced by ASTM D638-22 and ASTM D790-17.

The submission concludes that the non-clinical testing demonstrates the device's safety, effectiveness, and performance are comparable to the legally marketed predicate device, thereby establishing substantial equivalence. No clinical studies were included or deemed necessary for this type of device.

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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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