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Winged Infusion Set is indicated for the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.

Safety Winged Infusion Set is indicated for the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury.

Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.

Blood Collection Set with Holder is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.

Safety Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury.

Safety Blood Collection set with Holder is indicated for venous blood collection. It is to be used by trained healthcare professionals in accordance with the instructions. The safety shield to aid in the protection agamst accidental needle stick injury.

Needle Holder is used for the collection of blood specimen into the blood collection tubes in routine venipuncture procedures. It is used with blood collection sets, needles and tubes. It is to be used by trained healthcare professional only.

The Blood Collection Set with Holder, Blood Collection Set, and Winged Infusion Set are single-use, sterile, winged needles bonded to flexible tubing with a Luer connector. The devices are individually wrapped and sterile with a luer port. The luer port can connect FDAcleared accessories like luer adapter, holder, etc.

The Safety Blood Collection Set with Holder, Safety Blood Collection Set, and Safety Winged Infusion Set are single-use, sterile, winged needles bonded to flexible tubing with a Luer connector and a safety mechanism. The winged needle is designed with a safety mechanism, which allows for activation and ensures the needle is covered immediately following venipuncture to protect against accidental needlestick injury. The Safety Blood Collection / Infusion Set (with/without needle holder) is individually wrapped sterile with a luer port. The luer port can connect FDA-cleared accessories like luer adapter, holder, etc.

The safety feature is operated by releasing a latch mechanism whereby the user slides a winged cover over the needle as it is removed from the patient. Once the needle is covered, the safety cover locks in place. There is no ability to clean and reuse these because the safety feature cannot be deactivated without bending the needle and rendering it unusable.

The devices are used for venous blood collection and/or the short-term infusion of intravenous fluids. The product is to be used by appropriately trained healthcare professionals only in accordance with the manufacturer's instructions. It can be used with an intravascular administration set, syringe, or other device to administer fluids.

The provided document is a 510(k) Premarket Notification from the U.S. FDA, which concerns the substantial equivalency of a medical device to legally marketed predicate devices. This type of submission focuses on demonstrating that a new device is "as safe and effective" as a predicate device and often relies on comparisons to known standards and existing devices rather than extensive clinical studies.

Therefore, the document does not describe a study that aims to prove that the device meets acceptance criteria related to AI/ML performance (e.g., sensitivity, specificity, F1-score for an AI algorithm, or human reader improvement with AI assistance).

Instead, the acceptance criteria and performance data provided in this document relate to the physical and functional performance, biocompatibility, sterilization, and packaging of a medical device (Winged Infusion Sets, Blood Collection Sets, and Needle Holders).

Here's an analysis of the provided information within the context of a medical device 510(k) submission, specifically addressing the points in your request where applicable, and noting where the information is not provided due to the nature of this type of submission (i.e., it's not an AI/ML device).

Analysis of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria:

This document describes the non-clinical performance testing conducted to support the substantial equivalence claim for physical medical devices (Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder). It does not pertain to an AI/ML device, and therefore, many of your specific questions related to AI/ML performance metrics, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable and are not found in this document.

The "acceptance criteria" here are compliance with recognized international and national standards for medical devices of this type. The "study" proving the device meets these criteria refers to the non-clinical performance testing conducted against these standards.

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

The document lists the standards that the device was tested against. The "reported device performance" is a blanket statement that "All the pre-determined acceptance criteria were met." There isn't a specific table with numerical performance metrics for each criterion; rather, it indicates compliance with the listed standards.

• ISO 9626 Second edition 2016-08-01: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
• ISO 7864 Fourth edition 2016-08-01: Sterile hypodermic needles for single use -Requirements and test methods
• ISO 80369-7 First edition 2016-10-15: Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
• ISO 80369-20 First edition 2015-05-15: Small-bore connectors for liquids and gases in healthcare applications part 20: common test methods.
• ISO 23908 First edition 2011-06-11: Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters, and needles used for blood sampling | "All the pre-determined acceptance criteria were met." |
  | Biocompatibility | - ISO10993-5: 2009: In Vitro Cytotoxicity
• ISO10993-10: 2021: Skin Sensitization
• ISO10993-23: 2021: Intracutaneous Reactivity Test
• ISO10993-11: 2017: Acute Systemic Toxicity
• ISO10993-4:2017: Coagulation test
• ISO10993-4: 2017: Complement activity (SC5b-9) Test
• ISO10993-4: 2017: Hemolytic Properties Test
• ISO10993-3: Ames Test
• ISO10993-3: Mammalian Chromosome Aberration Test | "All the pre-determined acceptance criteria were met." |
  | Sterilization | - ISO11135-1: Sterilization of health care products ethylene oxide part 1
• ISO11737-1: Sterilization of medical devices-Microbiological Methods-Part 1
• ISO11737-2: Sterilization of medical devices -- Microbiological methods - Part 2
• ISO10993-7: Biological evaluation of medical devices - Part 7: Test of Ethylene Oxide Residuals.
• ANSI/AAMI ST72: Bacterial endotoxins - Test methods | "All the pre-determined acceptance criteria were met." |
  | Packaging &
  Shelf Life | - ISO 11607-1:2006/(R) 2010: Packaging for terminally sterilized medical devices
• ASTM F1929-15: Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
• ASTM F1980-16: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
• ASTM D3078-02 (2021): Standard Test Method for Determination of Leaks in - Flexible Packaging by Bubble Emission.
• ASTM F88/F88M-15: Standard Test Method for Seal Strength of Flexible Barrier Materials | "All the pre-determined acceptance criteria were met." |

Specific tests performed for Packaging and Shelf Life: Accelerated Aging Test, Simulated shipping distribution testing, Visual inspection, Performance Inspection (Chemical performance and Physical performance), Sterile Test, Vacuum Leak Test, Dye penetration test, Tensile Seal Strength Test.

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

The document does not specify the sample sizes for each test mentioned (e.g., how many devices were tested for tensile strength, biocompatibility, etc.). The data provenance is not explicitly stated in terms of country of origin but is implied to be from the manufacturer's testing (Jiangsu Kangbao Medical Equipment Co., Ltd, China). The testing is non-clinical, likely conducted retrospectively for the purpose of the 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 question is not applicable. This is not an AI/ML device that requires expert-established ground truth from, for example, medical images. The "ground truth" here is adherence to specified engineering, material, and biological standards.

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

Not applicable, as this is not an AI/ML device requiring human review/adjudication of outputs.

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 not an AI/ML device. "Clinical Data: 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 consensus, pathology, outcomes data, etc)

The "ground truth" for this device is physical and material science standards (e.g., ISO, ASTM standards for materials, performance, sterilization, and packaging). Compliance with these established industry standards constitutes the "ground truth" for device safety and effectiveness in this context.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in the AI sense. The manufacturing processes and designs would be "trained" in an engineering sense over time and through quality control, but this is not data for an algorithm.

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

Not applicable, as there is no AI/ML training set. The "ground truth" for manufacturing and design would be engineering specifications and quality control parameters.

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The Sterile Disposable Syringe with Safety Needle is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Disposable Syringe with Needle is intended for use in the aspiration of fluids for medical purpose.

The Sterile Disposable Safety Needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Disposable Needle is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose.

The Sterile Disposable Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of needle tube, needle hub and safety mechanism. The proposed device is available in variety of needle gauges and lengths. The safety needle is compatible for use with a luer slip and luer lock syringe. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. Needle specification is same as the needle size of Sterile Disposable Syringe with Safety Needle.

Compared with Sterile Disposable Safety Needle, Sterile Disposable Needle has the same components and specifications except without safety mechanism.

The Sterile Disposable Syringe with Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose. There are two kinds of sterile disposable syringe with safety needle: syringe with fixed needles and syringe without fixed needles. Sterile disposable syringe with safety needle of 0.5ml and 1ml are available syringe with fixed needles. Syringe without fixing needle are consists of syringe (piston, barrel, plunger) and hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size.

Compared with Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle has the same components and specifications except without safety mechanism. The Sterile Disposable Syringe with Needle do not have a type of the syringe with fixed needle.

The proposed devices are 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 5 years.

The provided document describes the 510(k) premarket notification for "Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle" (K221247) by Jiangsu Kangbao Medical Equipment Co., Ltd. The submission aims to demonstrate substantial equivalence to a predicate device (K170651) based on non-clinical testing.

Here's a breakdown of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various international and ASTM standards that the device was tested against. The acceptance criterion for each standard is implicit within the standard itself (e.g., "complies with the requirements of related standards," "no cytotoxicity," "no hemolysis"). The reported performance consistently states that the proposed device met these criteria.

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

The document does not specify the exact sample sizes for each non-clinical test performed on the test set. It mentions "non clinical tests were conducted to verify that the proposed device met all design specifications" and that "Physical, Mechanical, Chemical testing listed in following table were performed on the proposed device." Similarly, for biocompatibility and packaging tests, it states "The proposed device was evaluated for the following tests" and "Sterile barrier packaging testing were performed on the proposed device."

The data provenance is not explicitly stated in terms of country of origin, but the submitting company is Jiangsu Kangbao Medical Equipment Co., Ltd. from China. The studies are non-clinical, meaning they are lab-based and not involving human subjects. They are inherently prospective in nature as they test the new device against established standards.

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

This information is not applicable to this submission. The "ground truth" for non-clinical performance and biocompatibility is established by adherence to recognized international and national standards (e.g., ISO, ASTM, USP). These standards define the test methods and acceptance criteria, and the device's performance is measured against these objective criteria rather than expert consensus on a clinical outcome.

4. Adjudication Method for the Test Set:

This information is not applicable. Since the tests are against objective engineering and biological standards, there is no need for an adjudication method typically used in clinical studies involving human interpretation or subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." The submission focuses on non-clinical performance, biocompatibility, and substantial equivalence to a predicate device based on these non-clinical tests. Therefore, there is no effect size reported for human readers with or without AI assistance.

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

This question is not applicable as the device is a physical medical instrument (syringe and needle), not an algorithm or AI-powered system. No standalone "algorithm only" performance was evaluated.

7. The type of ground truth used:

The type of "ground truth" used for this submission is based on established international and national standards and their defined acceptance criteria. For example:

• Biocompatibility: Absence of cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, pyrogenicity, complement activation, and thrombogenicity as defined by the respective ISO and USP standards.
• Physical/Mechanical/Chemical Performance: Compliance with the specifications and performance requirements outlined in ISO 7886-1, ISO 7864, ISO 9626, ISO 80369-7, and USP .
• Packaging Integrity: Maintenance of sterility barrier as per ASTM F1886/F1886M-16, ASTM F88/F88M-15, and ASTM F1929-15.
• Sterilization: EO/ECH residue within limits (ISO 10993-7), endotoxin limit (USP ), and sterile assurance level (SAL) of 10-6.
• Safety Feature: Meeting pre-established criteria as per FDA Guidance and ISO 23908:2011.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical instrument, not a machine learning or AI model. Therefore, there is no "training set" to establish.

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

This information is not applicable as there is no training set for this type of device.

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The Sterile Disposable Syringe with Safety Needle is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Disposable Syringe with Needle is intended for use in the aspiration of fluids for medical purpose.

The Sterile Disposable Syringe is a sterile luer slip or luer lock syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.

The Sterile Disposable Safety Needle is intended to be used with a luer slip or lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Disposable Needle is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose.

The Sterile Disposable Syringe is intended for manual and single use only, which consists of piston, barrel, and plunger. The proposed device is available in a variety syringe volume. The syringe is available in luer lock and luer slip configurations, which are intended to be connected with a hypodermic needle.

The Sterile Disposable Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of needle tube, needle hub and safety mechanism. The proposed device is available in variety of needle length. The proposed device is compatible for use with a luer slip or luer lock syringe. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.

Compared with The Sterile Disposable Safety Needle, The Sterile Disposable Needle has the same components and specifications except without safety mechanism.

The Sterile Disposable Syringe with Safety Needle for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of syringe (piston, barrel, plunger) and hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size.

Compared with The Sterile Disposable Syringe with Safety Needle, The Sterile Disposable Syringe with Needle has the same components and specifications except without safety mechanism.

The proposed devices are sterilized by Ethylene Oxide a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.

The provided text describes a 510(k) premarket notification for several sterile disposable syringe and needle devices, comparing them to a predicate device (K193526). This submission focuses on establishing substantial equivalence through non-clinical testing and comparison of characteristics, rather than a clinical study evaluating diagnostic performance. Therefore, many of the requested elements for acceptance criteria and study design (like ground truth, expert qualifications, effect size for AI assistance, MRMC studies, and training set details) are not applicable to this type of submission.

The acceptance criteria for each device are defined by their compliance with relevant international and national standards, and the non-clinical tests performed to verify these compliances. The "reported device performance" is essentially that the devices met these acceptance criteria as demonstrated by the test results.

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the devices are primarily established by the relevant ISO and ASTM standards. The reported device performance is that it met the requirements of these standards.

Table of Acceptance Criteria and Reported Device Performance (Summary derived from Sections 6 and 8):

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

• Sample Size:
  • For most non-clinical tests (biocompatibility, physical, mechanical, chemical, packaging, sterilization, shelf-life), specific sample sizes are not explicitly stated in the provided document. The document usually states "tests were performed" or "test results show."
  • For the "Simulated Clinical Study" and "Safety Feature Test," the sample size is also not explicitly stated, only that "a simulated clinical study was performed" and "the safety feature test was performed on both proposed device and predicate device."
• Data Provenance: The document does not specify the country of origin for the test data. All studies described are non-clinical bench tests and simulated studies, not involving human subjects.

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

• This is not applicable as the evaluation relies entirely on non-clinical, bench testing against established international and national standards. There is no "ground truth" established by experts in the context of clinical interpretation, but rather adherence to engineering and material science specifications.

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

• This is not applicable. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish ground truth for subjective interpretations (e.g., image reading). The tests performed here are objective measurements against defined 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 is not applicable. No MRMC study was conducted. This product is a physical medical device (syringes and needles), not an AI/software device intended for diagnostic assistance to human readers.

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

• This is not applicable. This product is a physical medical device, not an algorithm, so a standalone algorithm performance evaluation is not relevant.

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

• The "ground truth" in this context is implicitly defined by the requirements and methodologies outlined in the referenced ISO and ASTM standards. For example, the "ground truth" for injectability might be defined by the force required to depress the plunger as per ISO 7886-1, or for biocompatibility, the absence of cytotoxicity as per ISO 10993-5. There is no clinical or expert consensus ground truth involved in this type of submission.

8. The sample size for the training set:

• This is not applicable. There is no "training set" as this is not a machine learning or AI device. The document describes pre-market non-clinical validation testing.

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

• This is not applicable for the reasons stated above.

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Vein set is intended for vein puncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adapter from the blood collection set connector and attaching a syringe, or other compatible/appropriate device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy

Safety vein set is intended for vein puncture to collect blood specimens. It is also indicated for intravenous administration of fluids after removing the attached luer adapter from the blood collection set connector and attaching a syringe, or other compatible/appropriate device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. Additionally, after withdraw of the needle from the patient's vein, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.

Blood collection needle (vein set type) is intended for use in the blood collection or short-term infusion (up to 2 hours) of intravenous fluids.

Blood collection needle (needle holder type) is intended for use in the blood collection or short-term infusion (up to 2 hours) of intravenous fluids.

Safety blood collection needle (vein set type) is intended for use in the blood collection or short-term influsion (up to 2 hours) of intravenous fluids. The device is designed with a safety mechanism to help reduce the risk injury.

Safety blood collection needle (needle holder type) is intended for use in the blood collection or short-term infusion (up to 2 hours) of intravenous fluids. The device is designed with a safety mechanism to help reduce stick injury

The proposed device is a blood collection device that forms a passage between the patient's vein and a vacuum blood collection tube for collecting blood. The proposed device can also be used for short-term infusion. The proposed devices are divided into several types, some have safety devices and some do not have safety devices, and the safety mechanism helps to reduce the risk of needle stick injuries. The proposed devices are provided sterile, single use. The propose device can be used for vein collect blood/infusion as well as peripheral vein collect blood/infusion, but not central vein collect blood/infusion.

The provided text details the 510(k) submission for several blood collection and intravenous administration devices. It focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria for a new, innovative device with a complex algorithm. Therefore, many of the questions about acceptance criteria, specific performance metrics, expert qualifications, and study designs for algorithmic performance (like MRMC studies) are not directly applicable or available in this document.

However, I can extract information related to the device's performance as demonstrated by the non-clinical tests conducted to support its substantial equivalence. The "acceptance criteria" here are largely defined by the requirements of the referenced ISO standards and general safety/effectiveness considerations for medical devices of this type.

Here's an attempt to answer your questions based on the provided text, while acknowledging its limitations for certain aspects:

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

The document doesn't explicitly state "acceptance criteria" as singular numerical targets for a new algorithm. Instead, it refers to conformity with established international standards for medical devices and safety features. The "reported device performance" is essentially the outcome of these tests, demonstrating compliance.

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 generally refers to "non clinical tests" and "simulated clinical study" without specifying the exact sample sizes (e.g., number of devices tested) for each specific test mentioned (e.g., cytotoxicity, seal strength). The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated, but the submission is from Jiangsu Kangbao Medical Equipment Co., Ltd. in China, implying testing was likely conducted in China or by labs contracted by them. The studies described are non-clinical and simulated clinical, not human clinical trials.

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 the provided document. The device is a physical medical instrument (vein set, blood collection needle), not an AI/algorithmic device that requires expert review to establish "ground truth" for interpretations of data like images or clinical signals. The "truth" here is determined by objective physical and biological measurements against established standards.

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 typically used in clinical studies or performance evaluations where human experts are making subjective assessments and a consensus is needed. For physical medical devices tested against standards, the "ground truth" is determined by the test methodology itself (e.g., a tensile strength test yields a numerical result, a cytotoxicity test yields a "yes/no" result based on cellular response).

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 used to evaluate the performance of diagnostic imaging aids or similar AI-powered tools that assist human readers. The submitted device is a physical sterile device for blood collection and IV administration, not an AI diagnostic tool.

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

This question is not applicable. The device described does not involve an algorithm.

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

For this type of device, the "ground truth" is based on:

• Compliance with international standards: ISO standards (e.g., ISO 10993 for biocompatibility, ISO 594 for Luer fittings, ISO 7864 for needles) and US Pharmacopeia (USP ) for particulate matter.
• Physical and chemical tests: Measuring attributes like seal strength, leak detection, mechanical properties, and material composition.
• Biological tests: Assays for cytotoxicity, sensitization, systemic toxicity, pyrogenicity, hemolysis, etc.
• Safety mechanism evaluation: Verification that the safety feature (for applicable models) functions as intended to prevent needle stick injuries, as evaluated in a "simulated clinical study" and "safety feature test".

8. The sample size for the training set

This question is not applicable, as there is no mention of an algorithm or training set for this physical medical device.

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

This question is not applicable, as there is no mention of an algorithm or training set for this physical medical device.

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Enteral Feeding Syringe with ENFit Connector 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 settings by users ranging from laypersons (under the supervision of a clinician) to clinicians in all age groups.

The proposed device, Enteral Feeding Syringes with ENfit Connectors, is provided sterile, single use. It has 3 components: (1) barrel, (2) plunger, and (3) piston. The Enteral Feeding Syringes with ENfit Connectors is available in various size, including 1ml, 2.5ml, 5ml, 10ml, 20ml, 60ml and 100ml. In addition, it contains low dose enteral specific connectors. The Enteral Feeding Syringes with ENfit Connectors 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 5 years.

The provided text describes a 510(k) summary for Enteral Feeding Syringes with ENFit Connectors, which are medical devices, not AI/ML-driven software. Therefore, the questions regarding acceptance criteria, study details, expert involvement, and ground truth for an AI device are not applicable to this document. The document details the substantial equivalence of the proposed device to a predicate device based on non-clinical tests and conformance to established standards.

Here's an analysis of the provided information, focusing on the device's conformity to standards rather than AI-specific criteria.

Device: Enteral Feeding Syringes with ENFit Connectors

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria for this medical device are based on compliance with several ISO standards and specific performance tests. The device's reported performance demonstrates compliance with these standards.

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

The document does not specify the exact sample sizes for each non-clinical test conducted. It states that "Non clinical tests were conducted to verify that the proposed device met all design specifications" and that the "test results demonstrated that the proposed device complies with the following standards." The provenance of the data is from in-house non-clinical testing performed by Jiangsu Kangbao Medical Equipment Co., Ltd.

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

This question is not applicable as the device is not an AI/ML system requiring expert-established ground truth for a test set. The validation relies on technical specifications and international standards, which are evaluated by engineers and quality control personnel.

4. Adjudication method for the test set

This question is not applicable as there is no mention of a human-based adjudication process for the non-clinical tests described. Compliance is determined by adherence to established measurement and testing protocols defined by the ISO 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 question is not applicable as the device is not an AI/ML system, and no human readership studies are referenced.

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

This question is not applicable as the device is a physical medical instrument, not an algorithm.

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

For this physical device, the "ground truth" for non-clinical performance and safety is defined by the established international standards (ISO standards) and engineering specifications. For biocompatibility, this is determined by laboratory tests for cytotoxicity, irritation, and sensitization as per ISO 10993. For sterilization, it's about achieving a specific SAL.

8. The sample size for the training set

This question is not applicable as the device is not an AI/ML system and does not involve a training set.

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

This question is not applicable as the device is not an AI/ML system and does not involve a training set.

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