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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 .

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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Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient' s vascular system through the needle inserted into the vein.

Safelock Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein, and the safety sheath is designed to prevent accidental needlesticks.

The proposed devices are intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein. The device contains a conical fitting provides a standard female luer lock connector which may connect to an I.V. administration set with a male conical fitting. And the infusion needle is inserted patient's vein. Then the solution will be administered from the I.V. administration set through the infusion needle into patient vascular by gravity.

The provided document is a 510(k) summary for injection needles. Medical devices like this generally do not have specific "acceptance criteria" in the same way an AI/ML diagnostic device would for performance metrics such as sensitivity, specificity, or AUC. Instead, they are evaluated against established performance standards and guidelines for similar predicate devices.

However, I can extract information related to the device's testing and compliance, which serves a similar purpose to demonstrating that the device "meets acceptance criteria" for its type.

Here’s a summary based on the provided text, structured to align with your request as much as possible for a medical device of this nature:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of medical device (Disposable Infusion Needle), the "acceptance criteria" are mainly conformance to recognized international and industry standards, and demonstration of equivalency to predicate devices. Performance is reported through successful compliance with these standards and a simulated clinical study.

2. Sample Size for the Test Set and Data Provenance

• Sample Size (for simulated clinical study): Not explicitly stated. The document only mentions "A simulated clinical study was performed..." without specifying the number of devices or trials.
• Data Provenance: The study was a "simulated clinical study" performed by the manufacturer (Jiangyin Caina Technology Co., Ltd. in China) in accordance with FDA guidance. The data is retrospective in the sense that it was generated for the 510(k) submission, not as a prospective clinical trial on human subjects.

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

This information is not provided in the document. For a simulated clinical study evaluating a safety mechanism, "ground truth" would typically be established based on engineering specifications and successful activation/functionality of the safety feature as observed by study personnel, rather than expert consensus on medical imaging or diagnoses.

4. Adjudication Method for the Test Set

This information is not provided. Given it's a simulated clinical study for a mechanical safety feature, a formal adjudication panel as found in diagnostic studies is unlikely. Performance would be assessed objectively against pre-established pass/fail 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

There was no MRMC comparative effectiveness study done. This device is a physical medical instrument (infusion needle), not an AI/ML-based diagnostic or assistive technology for human readers.

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

There was no standalone algorithm performance study done. This device does not involve an algorithm.

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

For the simulated clinical study of the safety mechanism, the "ground truth" would be the functional performance of the safety sheath as designed and measured against predetermined engineering and safety specifications (e.g., successful locking, prevention of needlesticks in a simulated environment). This is based on objective, repeatable tests rather than clinical outcomes or diagnostic interpretations.

8. The sample size for the training set

There is no training set for this type of medical device. The device is not an AI/ML model that requires training data.

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

Not applicable, as there is no training set.

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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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Safelock Disposable Insulin Syringe is intended to inject U-100 insulin into the human body and aid in the prevention of accidental needle stick injuries.

Safelock Disposable Insulin Syringes are provided sterile, single use, which consist of five pieces components: (1) a syringe barrel calibrated in units of insulin (U-100) with a permanently attached single lumen needle on it, (2) a needle cap, (3) plunger and (4) protective end cap and (5) an additional safety mechanism installed at the needle end of the syringe. The devices are available in different combination of syringe volumes and needle sizes.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them, structured as requested:

Device: Safelock Disposable Insulin Syringe

1. Table of Acceptance Criteria and Reported Device Performance

The provided summary details various non-clinical tests performed according to recognized ISO and ASTM standards. The reported performance is generally stated as "met all design specifications" or "met the pre-established criteria." Specific quantitative acceptance criteria or performance metrics are largely absent from this summary but are implied by adherence to the referenced standards.

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

The provided text does not specify the sample size for any of the non-clinical tests (e.g., number of syringes tested for each ISO standard criterion, number of packages for ASTM, number of devices for safety feature testing).

The provenance of the data is that it was generated through non-clinical bench testing performed by the manufacturer, Jiangyin Caina Technology Co., Ltd. (located in China). The summary reports on tests performed on the "proposed device." It does not indicate retrospective or prospective in the typical sense of clinical studies, as these are lab-based evaluations.

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 evaluation relies on direct measurement and adherence to objective standards (ISO, ASTM, USP) rather than expert interpretation of a ground truth in a clinical or image-based context. The "ground truth" is defined by the parameters and limits set forth in the referenced standards.

4. Adjudication Method for the Test Set

This section is not applicable. The tests are objective measurements against established standard criteria, not subjective assessments requiring adjudication among multiple reviewers.

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 is not applicable as the device is a medical syringe with a safety feature, not an AI-powered diagnostic or assistive technology for human readers. There is no mention of AI in this submission.

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

This is not applicable for the same reason as point 5. The device does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth for most tests is based on objective, internationally recognized performance standards (ISO, ASTM, USP) which define acceptable limits for physical, mechanical, chemical, and sterility properties. For the simulated clinical study and safety feature testing, the "ground truth" was derived from "pre-established criteria" and FDA guidance for sharps injury prevention devices, which likely includes defined force thresholds or functional performance checks.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device and does not involve AI or machine learning models that require a training set.

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

This is not applicable for the same reason as point 8.

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Syringes with or without needle are intended to inject fluids into or withdraw fluids from the body. Needles are intended to be used with a legally marketed syringe intended to inject fluids into or withdraw fluids from the body.

The proposed devices contain syringes and needles with various models. All the models for syringes and needles follow same design principle respectively; the differences are the size of the devices. The proposed devices are intended to inject fluids into or withdraw fluids from the body. The proposed devices would be available in two different configurations: Syringe with needle and Syringe without needle. Proposed devices are provided radiation (Co60) sterilized with a hard pack package which could maintain the sterility of the devices for five years. They are for single use only.

This document is a 510(k) Pre-market Notification for a medical device (syringes and needles). The purpose of this type of submission is to demonstrate that the new device is "substantially equivalent" to a predicate device already on the market. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of demonstrating substantial equivalence, primarily by conforming to recognized standards and showing comparable performance to the predicate device.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are the international standards the device aims to comply with, and the reported performance is the confirmation that the device does comply with these standards.

Note: The document only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device, [and] The test results demonstrated that the proposed device complies with the following standards." It does not provide specific numerical performance metrics for the device against each standard's criteria, but rather a blanket statement of compliance.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "non clinical tests" but does not detail the number of units tested for each standard.
• Data Provenance: The manufacturing company is Jiangyin Caina Technology Co., Ltd. in Jiangsu, China, and the submission correspondent is also based in Shanghai, China. The testing was conducted by the manufacturer, or a facility contracted by them. The data is retrospective in the sense that the tests were performed on finished products.

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

This section is not applicable to this type of device and submission. This document pertains to the regulatory clearance of basic medical devices (syringes and needles) based on engineering performance and biocompatibility standards, not on expert interpretation of complex diagnostic data. There is no "ground truth" to be established by experts in the context of diagnostic accuracy for this product.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers interpret data (e.g., medical images) and their decisions need to be reconciled to establish a ground truth. For this submission, the "ground truth" is defined by compliance with established international performance and safety standards, as measured by objective 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

This section is not applicable. This submission is for a physical medical product (syringes and needles), not an AI-powered diagnostic device or software. Therefore, there are no human readers or AI assistance involved in its intended use or evaluation.

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

This section is not applicable. As mentioned above, this is not an AI algorithm or software device.

7. The Type of Ground Truth Used

The "ground truth" for this device's validation is compliance with established performance and safety standards (ISO standards) for sterile hypodermic syringes, needles, and their components, as well as biocompatibility standards. The standards themselves define the acceptable parameters for mechanical performance, material properties, sterility, and safety.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" in the context of a physical medical device like a syringe and needle. Training sets are relevant for machine learning algorithms.

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

This section is not applicable for the same reason as point 8.

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Syringes with or without needle are intended to inject fluids into or withdraw fluids from the body.
Needles are intended to be used with a legally marketed syringe intend to inject fluids into or withdraw fluids from the body.

The proposed devices include: a standard piston syringes consisting of the proposed syringes consist of three components: (1) barrel, (2) piston and (3) plunger rod, and a needle consists of (1) needle tube, (2) needle hub and (3) needle sheath. They would be available in three different configurations respectively as follows:
Configuration 1 Syringes with Needle
Proposed syringes will be provided along with a proposed needle in one single package. The combinations of sizes are various upon the request of the users.
Configuration 2 Syringes without Needle
Proposed syringes will be provided without a needle. The combination of sizes are various upon the It could be used together with any other U.S. legally marketed request of the users. a) hypodermic needle with luer slip female connector complied with ISO594-1:1988 or 'iver lock female connector complied with ISO 594-2:1996.
Configuration 3 Needles
Proposed needles will be provided alone, which could be used together with any other U.S. legally marketed syringes with luer slip male connector complied with ISO594-1:1988 or luer lock male connector complied with ISO 594-2:1996 to complete its intended use.

This document describes the safety and effectiveness of the proposed device, "Syringes, With or without Needles" and "Needles", as substantially equivalent to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly states that the acceptance criterion is compliance with specific international standards. The reported device performance is that the proposed device met all design specifications and complied with these standards.

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

The document describes "Bench tests" being conducted. However, it does not specify the sample size used for these tests. The provenance of the data is not explicitly stated in terms of country of origin but implies the tests were conducted by the manufacturer, Jiangyin Caina Technology Co., Ltd. in China, or by a contract lab working for them. The nature of "Bench tests" typically suggests prospective testing to verify design specifications.

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

This information is not applicable in this context. The "ground truth" for medical devices like syringes and needles is established by adherence to recognized international performance standards (e.g., ISO standards) and regulatory requirements, not by expert consensus on specific cases. The tests are objective measurements against predefined specifications.

4. Adjudication Method for the Test Set:

This information is not applicable. As the tests are objective measurements against standards, there is no need for an adjudication method by human experts. The results are either compliant or non-compliant with the specified 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. The device (syringes and needles) is a physical medical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or evaluation of human improvement with AI is irrelevant.

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

This information is not applicable. The device is a physical medical instrument, not an algorithm. Standalone performance refers to AI software.

7. The Type of Ground Truth Used:

The "ground truth" used for this device is based on established international performance standards and design specifications (e.g., ISO standards for dimensions, material properties, sterility, fluid tightness, etc.). These standards define the expected objective performance for such devices.

8. The Sample Size for the Training Set:

This information is not applicable. The development and testing of a physical medical device like a syringe or needle do not typically involve a "training set" in the context of machine learning or AI. Performance is evaluated against established engineering specifications and standards.

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

This information is not applicable for the same reason as point 8.

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