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The proposed device is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syringes are intended to be used in clinical or home care setting by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.

The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 1ml~60ml. This device incorporates a female ENFit connection to an enteral access device with male ENFit connector.

The propsoed syringe is 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 five years.

This document describes the non-clinical testing performed to demonstrate that the ENFit Enteral Syringe meets its acceptance criteria and is substantially equivalent to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is demonstrated by compliance with several international standards. The specific acceptance criteria are defined within these standards. Below is a table summarizing the tests described and the reported outcome of compliance.

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

The document does not explicitly state the specific sample sizes (number of units tested) for each non-clinical test. However, it indicates that "Non clinical tests were conducted to verify that the proposed device met all design specifications" and that "Connector testing performed on the proposed device included the items listed below, in accordance with ISO 80369-3:2016... using the test methods provided in ISO 80369-20..." and similarly for syringe testing. These standards often specify minimum sample sizes for different tests.

The data provenance is from non-clinical (bench) testing performed on the proposed device. The device manufacturer is Jiangsu Caina Medical Co., Ltd. located in Jiangyin, Jiangsu, China. The report is a summary of these tests. This is retrospective in the sense that the tests were completed prior to this submission.

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

This section is not applicable as the information provided pertains to non-clinical (bench) testing of a medical device (enteral syringe). "Ground truth" and "experts" typically refer to human interpretation or pathology results in diagnostic or clinical studies. For physical device testing, the "ground truth" is defined by the technical specifications and requirements within the cited international standards (e.g., ISO, ASTM, USP).

4. Adjudication method for the test set

This section is not applicable as adjacency methods are used in clinical studies with human readers, not in non-clinical bench testing. The compliance is determined by whether the device's physical and performance characteristics meet the quantitative and qualitative requirements of the listed 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

This section is not applicable. An MRMC comparative effectiveness study is used for evaluating diagnostic or screening tools, often involving artificial intelligence. This document describes the non-clinical testing of a physical medical device (enteral syringe).

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

This section is not applicable. "Standalone performance" in this context refers to the performance of an algorithm without human intervention, typically in AI/software as a medical device. This document is about a physical medical device.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is compliance with established international and national standards and their specified test methods and acceptance criteria. This includes:

• Performance Specifications: Defined by standards like ISO 80369-3, ISO 7886-1 for connector and syringe function (e.g., fluid leakage, tolerance on graduated capacity).
• Biocompatibility Standards: Defined by ISO 10993 series for biological safety (e.g., cytotoxicity, irritation, sensitization).
• Sterilization and Packaging Standards: Defined by ISO 10993-7, ASTM F 88/F88M-09, ASTM F1140/F1140-13, USP37-NF32 <85>.

8. The sample size for the training set

This section is not applicable. "Training set" refers to data used to train machine learning models. This document describes the non-clinical testing of a physical medical device.

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

This section is not applicable.

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The Disposable blood collection sets are intended to be used with vacuum blood collection tube for venipuncture to collect blood specimens from patients.

The Safelock disposable blood collection sets are intended to be used with vacuum blood collection tube for venipuncture to collect blood specimens from patients, and the safety sheath is designed to aid in the reduction of accidental needlesticks.

The proposed devices are provided sterile, single use. The proposed devices are intended to be used with vacuum blood collection tube for venipuncture to collect blood specimens from patients. It has two models, Safelock disposable blood collection set and Disposable blood collection set.

For disposable blood collection set, they consist nine pieces components: (1) needle protect cover (2) patient-end tube needle (3) double wing needle handle (4)flexing tube (5) connect A (6) non-patient needle hub (7) puncture needle (8) rubber sleeve (9) puncture needle protective cover.

For Safelock disposable blood collection sets, they consist twelve components: (1) needle protect cover (2) patient-end tube needle (3) safety needle handle (4) double wing (5) safety sheath (6) Locking joint (7) flexing tube (8) connect A (9) non-patient needle hub(10) puncture needle (11) rubber sleeve (12) puncture needle protect cover.

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the way a new drug or high-risk device might.

Therefore, the information requested for a detailed study description such as sample sizes for test and training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and how ground truth was established for the training set, is not present in this document.

The document primarily details non-clinical tests conducted to ensure the device meets design specifications and is safe and effective for its intended use, comparable to predicate devices.

Here's what information can be extracted or inferred:

1. Table of Acceptance Criteria (Inferred from non-clinical tests) and Reported Device Performance:

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

• Sample Size: Not specified in the document for any of the non-clinical tests.
• Data Provenance: The tests were conducted internally or by contracted labs. The document does not specify country of origin for the data, but the manufacturer is based in China. The tests are non-clinical (laboratory/bench tests), not human subject trials, so "retrospective or prospective" is not directly applicable in the typical sense.

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

• Not applicable as no human-read test set requiring expert ground truth is described. The acceptance criteria are based on recognized international and national standards for device performance, materials, and safety.

4. Adjudication method for the test set:

• Not applicable. No adjudication is described for the non-clinical 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 MRMC study was conducted or mentioned, as 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, as this is not an algorithm-based device.

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

• The "ground truth" for the non-clinical tests is adherence to the specified technical standards (e.g., ISO, ASTM, USP) and the FDA's guidance document for sharps injury prevention.

8. The sample size for the training set:

• Not applicable. No training set for an algorithm is mentioned.

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

• Not applicable. No training set for an algorithm is mentioned.

Summary of what the document focuses on:

This 510(k) submission primarily relies on non-clinical bench testing and adherence to established standards to demonstrate the safety and effectiveness of the "Safelock Disposable Blood Collection Set" and "Disposable Blood Collection Set". The key finding is that these devices are "Substantially Equivalent (SE)" to existing predicate devices (EXEL Vaculet Blood Collection Set K020533 and SURSHIELD™ Safety Winged Blood Collection Set K031279), meaning they share similar intended use, technology, and performance characteristics, and do not raise new questions of safety or effectiveness. No clinical studies were included in this submission.

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The disposable insulin syringe is intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.

The Disposable Insulin Syringes are provided sterile, single use.

For the Disposable Insulin Syringes, they consist of six components: (1) orange needle cap (2) needle (3) piston (4) plunger (5) barrel (6) orange protective end cap. The materials for all components are listed in Table 1 Component material list.

The Disposable Insulin Syringes are available in different combination of syringe volumes and needle sizes. The range of syringe volume, needle gauge and needle length are listed in Table 2 syringe and needle specification.

This document describes the premarket notification for a Disposable Insulin Syringe (K151949). It does not contain information about an AI/ML powered device. Instead, it details the substantial equivalence to a predicate device, focusing on non-clinical performance and biocompatibility.

Therefore, many of the requested categories for AI/ML device studies are not applicable. I will extract the relevant information for the device's acceptance criteria and the studies conducted to meet them.

Here's the breakdown of the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test. The document generally refers to "non clinical tests" being conducted.
• Data Provenance: The device manufacturer is Jiangyin Caina Technology Company Incorporated, located in Jiangyin, Jiangsu, China. The testing was conducted as part of their submission without specifying the exact location of the testing laboratories, but it would presumably be in China or by accredited labs. The data is retrospective in the sense that it's submitted to demonstrate compliance for a device manufactured by the company.

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

• Not Applicable: This is a submission for a non-AI/ML medical device. "Ground truth" in the context of expert consensus is not relevant here. Compliance is assessed against established international and ASTM standards for physical, chemical, and biological properties.

4. Adjudication Method for the Test Set

• Not Applicable: As this is not an AI/ML diagnostic or image interpretation device, adjudication methods by experts are not relevant. Compliance is measured against objective 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 device is a disposable insulin syringe, not an AI/ML powered diagnostic or clinical support tool.

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

• Standards-based Compliance: The "ground truth" for this device's performance is adherence to recognized international and national standards (ISO, ASTM, USP) for medical devices. For biocompatibility, reliance was also placed on prior clearance (K113091) for materials with the same intended use.

8. The Sample Size for the Training Set

• Not Applicable: This device does not involve a "training set" in the context of AI/ML. Manufacturing processes are validated through established quality control and testing protocols.

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

• Not Applicable: Not an AI/ML device.

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