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The device is indicated for use as a dispenser, measuring device, and 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) to in all age groups.

The device is an enteral feeding syringe for single use. The devices are piston-style syringes consisting of a syringe barrel, syringe plunger, syringe gasket, and syringe cap. The device incorporates a female ENFit connector designed to be compatible only with enteral access devices or accessories. It has ENFit compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids.

The device is a disposable syringe made of the following components:

1. Plunger: The Plunger is a piston having a longitudinal shaft that is mechanically received into the proximal syringe barrel aperture. It is made of polypropylene and uncoated. The proximal end of the plunger is flat to allow the device user to apply uniform pressure to the plunger shaft, thereby initiating the plunger into the syringe barrel.
2. Barrel: The Barrel is a single, clear molded plastic hollow barrel made of polypropylene. This is the identical material used to manufacture the barrel of the predicate device. The distal end of the barrel possesses an integrally molded syringe tip. The barrel is marked on the exterior with non-toxic, biocompatible ink to create gradient volume graduation markings. The barrel is translucent to allow visualization of fluid contents and volume. The barrel is designed at an appropriate length to accommodate the nominal volume of each syringe size as labeled.
3. Gasket: The gasket is attached to the distal end of the syringe plunger in an o-ring orientation. It is attached to the plunger via a mechanical interference fit. The purpose of the gasket is to engage the syringe barrel to form a low-pressure seal, which is impervious to fluids.
4. Tip cap: The tip cap is an ENFit compatible closure cap for the syringe. The syringe tip cap is designed to be compatible with the ENFit female syringe tip of the syringe. The syringe tip cap is made of polypropylene and purple colorant.

This document primarily discusses the substantial equivalence of a medical device (Enteral Feeding Syringes with ENFit connector) to a predicate device, focusing on non-clinical performance testing, biocompatibility, and sterility. It does not present a study proving a device meets acceptance criteria in the context of an AI/ML medical device, clinical efficacy, or human reader performance. The document explicitly states "No clinical study is included in this submission."

Therefore, based on the provided text, I cannot answer the questions related to clinical studies, human readers, AI assistance, ground truth establishment for AI/ML models, or sample sizes for training sets.

However, I can extract the acceptance criteria and performance data for the non-clinical aspects of the device.

Here's the information gleaned from the document regarding the acceptance criteria and device performance for the physical device itself:

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

The document defines acceptance criteria by referencing compliance with specific international standards and then states that the device "met all requirements" or that "All of the pre-determined acceptance criteria were met." Specific numerical performance data is provided for sterility residuals and bioburden.

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

The document does not explicitly state the sample sizes for the performance, biocompatibility, sterility, or packaging tests. It describes "bench testing" and "verification tests" which are typically done on a defined number of units, but the specific count is not provided. The data provenance is not specified in terms of country of origin, but it is implied to be from the manufacturer's testing facilities (Jiangsu Shenli Medical Production Co., Ltd in China). These tests are typically prospective for regulatory submission.

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 is not applicable as the document describes non-clinical performance and safety testing of a physical device, not an AI/ML system requiring expert interpretation of medical images or data.

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

Not applicable for tests of a physical medical device.

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. The document explicitly states: "No clinical study is included in this submission."

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

Not applicable. This is not an AI/ML device.

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

For the physical device testing:

• Performance: Ground truth is defined by the technical specifications and requirements outlined in the referenced ISO standards (e.g., specific force required, leak integrity, volume accuracy).
• Biocompatibility: Ground truth is adherence to the toxicological and biological safety requirements in ISO 10993 series.
• Sterility: Ground truth is 10^-6 SAL, absence of growth in sterility tests, compliance with residual limits, and pyrogenicity/endotoxin limits.
• Packaging & Shelf Life: Ground truth is maintaining integrity and sterility over the claimed shelf life as per referenced ASTM and ISO packing standards.

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. This is not an AI/ML device.

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This device is intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

The submitted device is a sterile hypodermic needle for single use. The device is a single lumen hypodermic needle offered in a 22 gauge x 1 ½ " length. The device is constructed of the material noted in the table below:

The device is classified for patient contact as externally communicating circulating blood in a limited contact duration (<24h).

This document is a 510(k) premarket notification for a medical device called "Sterile Hypodermic Needle for Single Use" by Jiangsu Shenli Medical Production Co., Ltd. The purpose of this notification is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (IMC Hypodermic Needle, K102584).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device, a "Sterile Hypodermic Needle for Single Use," the acceptance criteria are based on compliance with various international standards for medical devices, particularly those related to hypodermic needles, biocompatibility, and sterility. The reported device performance is that it meets all these standards.

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

The document does not specify a distinct "test set" in the context of AI/ML, but rather refers to various "performance testing" conducted to meet specific standards. For each of these tests (e.g., biocompatibility tests, physical performance tests), the sample sizes used are not explicitly stated in this summary document. The document states that the data is from "Jiangsu Shenli Medical Production Co., Ltd." in Changzhou City, Jiangsu Province, China, indicating the country of origin of the data. The studies are prospective in nature, as they involve testing the newly developed device against established standards.

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

This submission is for a traditional medical device (hypodermic needle) and does not involve AI/ML. Therefore, the concept of "ground truth established by experts" in the context of interpretation of results (like in image analysis) is not directly applicable here. The "ground truth" for this device's performance is objective compliance with pre-defined international standards and physical/chemical test parameters. These standards are developed and overseen by international bodies and qualified experts in the field of medical device manufacturing and safety. The expertise lies in the development of these standards and the execution and interpretation of the tests by qualified testing laboratories.

4. Adjudication Method for the Test Set

Not applicable, as this is a traditional medical device submission, not an AI/ML algorithm requiring expert adjudication of results. The "adjudication" is essentially the determination of whether the device's performance metrics meet the specified quantitative and qualitative requirements of the applicable international standards. This is typically done by qualified laboratory personnel and regulatory reviewers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This submission is for a physical medical device (hypodermic needle), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI assistance improvement are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective adherence to internationally recognized consensus standards and validated test methods. This includes:

• Quantitative measurements: e.g., bond strength, dimensions, chemical residue levels (Ethylene Oxide).
• Qualitative biological responses: e.g., absence of cytotoxicity, sensitization, hemolysis.
• Sterility levels: Demonstrated by achieving a specific Sterility Assurance Level (SAL).

The ground truth is not subjective expert consensus on interpretations but rather the objective compliance with predefined, measurable criteria.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML algorithm that requires a "training set."

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

Not applicable. This is not an AI/ML algorithm.

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The Safety Blood Collection Set and blood collection tube/syringe are used together for the collection of venous blood. The winged needle is designed with a safety shield which can be activated to cover the needle immediately following blood collection to aid in the protection against accidental needlestick injury.

The Safety Blood Collection Set is used in routine venipuncture procedures. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. The product is to be used by appropriately trained healthcare professionals.

The Blood Collection Needle is manufactured from tubular stainless steel sharpened at both ends that is attached to the hub. The hub is threaded on one side to connect with the needle holder which is used to guide the needle into an evacuated blood collection tube. This end of the needle is the shorter end and is fitted with a protective rubber sleeve and a hard plastic needle cap. The opposite end of the needle is ¾" for withdrawing blood and is fitted with a color coded hard plastic needle cap. The two needle caps protect the needle and maintain the sterility. The seal between the two needle caps is covered with a perforated paper label that permits identification and acts as a seal integrity.

The Safety Blood Collection Set is delivered sterile and is intended for single use only.

This document describes the premarket notification (510(k)) for the Jiangsu Shenli Medical Production Co., Ltd.'s Safety Blood Collection Set (K163093). The document primarily focuses on establishing substantial equivalence to a predicate device, the Improsafe Blood Collection Set (K123987), rather than a detailed study proving the device meets specific acceptance criteria through a clinical or performance study with human readers or AI.

Therefore, much of the requested information (e.g., sample size for test set, number of experts, adjudication methods, MRMC study, standalone performance, training set details) is not applicable to this type of submission, which relies on demonstrating equivalence through technical characteristics and compliance with standards.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All of the pre-determined acceptance criteria were met," but it does not provide a table with specific quantitative acceptance criteria alongside corresponding test results. It lists the types of performance tests conducted.

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

• Sample Size: This document does not specify the sample sizes used for each of the performance tests listed. For typical device clearance, these would be engineering tests, not clinical studies with human participants.
• Data Provenance: The tests were performed to demonstrate substantial equivalence for a device manufactured by Jiangsu Shenli Medical Production Co., Ltd. (China). The data would therefore originate from testing conducted by or for this company, likely in China or by contracted laboratories. The nature of these tests is retrospective in the sense that they were conducted on already manufactured devices to demonstrate compliance.

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

This information is not applicable to this type of device submission. The "ground truth" here is compliance with established engineering standards and design specifications, verified through laboratory testing, not expert interpretation of medical images or conditions.

4. Adjudication method for the test set

This information is not applicable. Adjudication typically refers to the resolution of conflicting expert opinions in clinical studies. For engineering performance tests, results are usually compared against predefined objective criteria.

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. This submission is for a physical medical device (blood collection set), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI effect sizes are irrelevant.

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

This information is not applicable, as the device is not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for the device's performance is adherence to established national and international standards for medical devices (e.g., ISO 7864 for needles, ISO 10993-1 for biocompatibility) and its own design specifications. This is confirmed through laboratory and engineering testing.

8. The sample size for the training set

This information is not applicable, as this is not an AI/machine learning device.

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

This information is not applicable, as this is not an AI/machine learning device.

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