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The HWJECT Auto-Disable Syringe is intended for aspiration of fluids. Additionally, it features autodisable feature (no sharp injury protection feature) that involves a design where the syringe automatically becomes inoperable by locking the plunger with clip after injection to prevent syringe reuse.

The auto-disable syringe is intended for aspiration and injection of fluids. The subject device is composed of needle cap, barrel, plunger, clip, plunger stopper, and needle tube. The clip cooperates with plunger and barrel to complete self-destruction of the device. It is nonpyrogenic and intended for single use. The auto-disable feature (no sharp injury) involves a design where the syringe automatically becomes inoperable by locking the plunger with the clip after injection to prevent syringe reuse. The capacity of the auto-disable syringe is available in 0.05 mL, 0.1 mL, 0.3 mL, 0.5 mL and 1 mL. The specification of needle tube ranges from 22G to 27G. The needle length ranges from 10 mm to 38 mm.

This document is a 510(k) premarket notification for a medical device called the "HWJECT Auto-disable syringe." The FDA's review concludes that the device is substantially equivalent to a legally marketed predicate device. This type of submission focuses on demonstrating equivalence to an existing device, rather than proving a novel device's safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval Application).

Therefore, the study conducted is primarily non-clinical performance testing and biocompatibility testing, aiming to show that the new device performs comparably to the predicate device and meets established safety standards. There is no information about AI/ML models or human reader studies in this document. The term "acceptance criteria" here refers to the performance standards and regulatory requirements the device must meet to demonstrate substantial equivalence, not statistical measures for an AI model's performance.

Here's an analysis based on the provided text, while explicitly noting that the request for information on AI/ML-specific criteria (like MRMC studies, expert adjudication for ground truth of an AI model, and training/test set sample sizes for AI) is not applicable to this document as it does not describe an AI/ML medical device.

Acceptance Criteria and Device Performance for HWJECT Auto-disable syringe

The acceptance criteria for this device are largely defined by adherence to recognized international and national standards for medical devices, particularly those for hypodermic syringes and needles. The "study" refers to a series of non-clinical tests performed to demonstrate compliance with these standards and substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

• Limits for extractable metals
• Lubricant
• Tolerance on nominal capacity
• Graduated scale
• Barrel
• Design
• Fit of the plunger stopper/plunger in the barrel
• Fiducial line
• Dead space
• Freedom from air and liquid leakage
• Auto-disable syringe feature | Performance testing results met the requirements of the standard, demonstrating substantial equivalence to the predicate device. Specific numerical results are not provided in this summary, but the conclusion is conformance. For the auto-disable feature, "Activation force: 2-4 N," and "Auto-disabled, prevents syringe re-use" are explicitly stated as characteristics matching the predicate device. |
  | ISO 9626:2016 (Stainless steel needle tubing for the manufacture of medical devices-Requirements and test methods) | - Stiffness
• Resistance to breakage
• Resistance to corrosion
• Needle O.D.
• Needle inner diameter | Performance testing results met the requirements of the standard. For the 22G needle gauge (a difference from the predicate), specific testing was conducted to verify that this difference does not raise new questions of safety and effectiveness, and it was found to be "in accordance with ISO 9626." |
  | ISO 7864:2016 (Sterile hypodermic needles for single use-Requirements and test methods) | - Needle point
• Bond between hub and needle tube
• Patency of lumen
• Cleanliness
• Needle length
• Testing for measuring the penetration force and drag force for needles | Performance testing results met the requirements of the standard. For needle bonding strength, a range of "62-100 N" is reported, conforming to ISO 7864:2016 requirements. For differences in needle length (extra specifications compared to predicate), non-clinical performance testing validated that these do not raise new safety/effectiveness questions. |
  | USP (Particulate matter in injections) | USP acceptance criteria for particulate matter. | Particulate testing results met the USP acceptance criteria. |
  | Biocompatibility Testing | Compliance with ISO 10993-1 for an Externally Communicating Device, Blood Path Indirect, Limited Contact (

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Insulin syringes are intended for subcutaneous injection of U-100 insulin

The insulin syringe consists of needle cap, barrel, plunger stopper, needle tube and plunger cap. It is sterile disposable, non-pyrogenic, easy to use and meets all of the required standards. The plunger cap is optional. The single insulin syringe in unit package lacks the plunger cap compared with the product in the multi-unit package. The needle cap is used to protect physical protection of the needle prior to use. The needle tube penetrates the patient's skin to inject fluid into the body. The plunger stopper is the sealing assembly that encloses mandrel component and is used to inject fluid into the body. The barrel is a tube-like and cylindrical structure that holds insulin before the injection. The plunger is the rod pushed down or up depending on clinical use. The plunger cap is used to protect plunger before use. The capacity of the insulin device is 0.3 mL, 0.5 mL and 1 mL. The specification of needle tube is 26G, 27G, 28G, 29G, 30G, 31G, 32G and 33G. The needle length is 5 mm, 6 mm, 8 mm and 10 mm.

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for an Insulin Syringe (K230061).

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

   The document lists the following performance tests and states that the proposed device was tested and demonstrated to be in conformance with the specified FDA recognized standards, and that the performance testing results met the standards' requirements to demonstrate the device's safety and effectiveness. No specific numerical performance values are provided, only conformance to standards.

   Acceptance Criteria (Standard)	Reported Device Performance
   ISO 8537-2016: Sterile single-use syringes, with or without needle, for insulin	Conforms to requirements for: Limits for acidity or alkalinity, Limits for extractable metals, Tolerance on the graduated capacity, Graduation lines, Numbering of scale, Scale interval units, Overall length of scale, Barrel and plunger stopper, Finger grips, Fit of plunger stopper in barrel, Dead space, Freedom from leakage past plunger stopper, Bond between hub and needle tube, Needle cap.
   ISO 7886:1-2017: Sterile hypodermic syringes for single use – Part 1: Syringes for manual use	Conforms to requirements for Lubricant of syringe.
   ISO 9626-2016: Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods	Conforms to requirements for: Stiffness, Resistance to Breakage, Resistance to Corrosion, Needle O.D., Needle inner diameter.
   ISO 7864-2016: Sterile hypodermic needles for single use - Requirements and test methods	Conforms to requirements for: Needle point, Patency of lumen, Cleanliness, Needle length, Lubricant of needle tube, Penetration force and drag force for needles.
   ISO 10993-1 (Biocompatibility)	Conforms to requirements for: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility, Pyrogen, Subacute/Subchronic Toxicity, Genotoxicity. (For Externally Communicating Device, Blood Path Indirect, prolonged Contact (>24hrs to 30 days)).
   USP and USP (Particulate testing)	Met USP acceptance criteria.
   ISO 11135 (Sterilization)	Sterilization process validated, EO and ECH residual does not exceed limit according to ISO 10993-7.
   ASTM F1980-16 (Shelf-Life)	Verified claimed shelf-life of 5 years under accelerated aging conditions.
   ASTM D4169-16 (Package integrity - shipping)	All packaging deemed acceptable for protection of product and sterility maintenance.
   ASTM D3078-02 (Vacuum Leak Test)	Conforms to requirements.
   ASTM F 1929-15 (Dye Penetration Test)	Conforms to requirements.
   DIN 58953-6: 2016 (Microbial Barrier Properties Test)	Conforms to requirements.
   ASTM F88/F88M-21 (Seal Strength Test)	Conforms to requirements.
   FDA Guidance for Medical Devices with Sharps Injury Prevention Features, August 9, 2005 (Simulated Clinical Use Testing)	Conducted and demonstrated conformance.

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 does not specify the exact sample sizes used for each test. For instance, for biocompatibility, it states testing was done in compliance with ISO 10993-1, but not the number of samples. The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature, but the manufacturer is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. in China.

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 information is not applicable and therefore not provided in the document. The device is a physical medical device (insulin syringe), not an AI/software device that requires expert adjudication for ground truth.

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

   This information is not applicable and therefore not provided in the document, as it pertains to AI/software device assessments.

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 done, as this is a physical medical device (insulin syringe) and not an AI-assisted diagnostic or imaging device.

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

   Not applicable, as this is a physical medical device.

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

   The "ground truth" for this device is conformance to established international and FDA-recognized standards for sterile single-use syringes and needles, verified through various physical, chemical, and biological tests. This includes mechanical properties, material safety, sterility, packaging integrity, and simulated use. There is no "ground truth" derived from expert consensus or pathology in the context of an AI/software device.

8. The sample size for the training set

   Not applicable, as this is a physical medical device, not an AI/software device that requires a training set.

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

   Not applicable, as this is a physical medical device.

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The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. The intended user population of insulin pen needle is for "Adult Use Only" (ages 21yrs old and above).

The proposed device, Insulin pen needle and insulin injection pen are use cooperatively to inject insulin into the human body. The Insulin Pen Needle is composed of a needle container, a needle shield, a needle hub, a needle tube. The insulin pen needle for single use is offered in various gauge sized and length. The proposed device is available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 106.

The provided document is a 510(k) summary for an Insulin Pen Needle. It details the device, its intended use, comparison with a predicate device, and performance data from non-clinical tests.

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

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

The document lists standards that the device conforms to, and states that testing results were in conformance or met acceptance criteria. Specific quantitative acceptance criteria or reported performance values are generally not provided in this 510(k) summary format, which often focuses on demonstrating compliance with recognized standards rather than presenting raw data or detailed performance metrics.

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 does not specify sample sizes for any of the tests conducted. It also does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. It only mentions that the manufacturer is in Anhui, China, and the correspondent is in Shanghai, China, implying the tests were likely performed or managed from China.

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 information is not applicable and not provided in the document. The device is an Insulin Pen Needle, which is a physical medical device. Its performance is evaluated through bench testing against recognized standards (e.g., ISO, ASTM, USP) and biocompatibility testing, not through expert-reviewed diagnostic outputs that require a "ground truth" derived from human experts.

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

This information is not applicable and not provided. As explained above, the device's performance is determined by objective physical and chemical tests, not by human interpretation or clinical adjudication.

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 and not provided. MRMC studies are relevant for diagnostic imaging devices or AI-assisted diagnostic tools, not for a physical device like an Insulin Pen Needle. The document explicitly states "Clinical testing: Not Applicable."

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

This information is not applicable and not provided. This question pertains to AI/algorithm performance. The device is a physical medical device, not an algorithm.

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

This information is not applicable for this device. Ground truth is generally used in diagnostic studies or AI performance evaluations against a known correct answer. For an Insulin Pen Needle, performance is assessed against established engineering and biological standards.

8. The sample size for the training set

This information is not applicable and not provided. A training set is used for machine learning algorithms. The device is a physical medical device.

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

This information is not applicable and not provided. This question pertains to machine learning.

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The Blood Collection Needle (with/without Needle Holder) is intended to be used with a vacuum blood collection tube for the collection of venous blood.

The subject devices are blood collection devices used in routine venipuncture procedures, which form a channel between the patient's vein and the evacuated blood collection tube intended to collect blood.

The Blood Collection Needle (with/without Needle Holder) is intended for single use only and consists of a bottom sheath or needle holder, needle tube, rubber cap, upper sheath, and hub. They are available in different configurations.

The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.

It is manufactured from tubular stainless steel sharpened at both ends and is attached to the hub:

• -The subject devices are available with a pre-attached needle holder or without a needle holder; 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 needle's end is shorter and fitted with a protective rubber cap and a needle holder.
• The opposite end of the needle is longer for withdrawing blood and is fitted with a needle sheath.

The subject devices are available in different specifications of needle gauge (25G-18G) and length (3/4"-1 1/2").

The proposed devices are only packaged as sterile, disposable, and single-patient use.

The devices are packaged for sterile, single-use, and single-patient use only.

There is no information in the provided text about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a blood collection needle, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and supporting studies in the way you've described.

Specifically, the document states:

• "To establish substantial equivalence to the identified predicate devices, we performed the tests noted below on the subject devices. The testing results proved that the device complies with the applicable standards requirement and is substantially equivalent to the predicate devices." (Page 8)
• "No clinical data was submitted in this submission." (Page 10)

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth establishment, expert adjudication, or MRMC studies, as this information is not present in the provided text for this specific device. The document primarily references compliance with various ISO and ASTM standards for performance, biocompatibility, sterilization, and packaging, rather than a specific study with defined acceptance criteria and detailed results.

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Sterile Hypodermic Syringe with/without needle: The Sterile Hypodermic Syringe with/without needle is intended for use in the aspiration and injection of fluids for medical purposes.
Sterile Hypodermic Needle: The Sterile Hypodermic Needle is intended to be used with a syringe for fluids aspiration and injection for medical purposes.

The Sterile Hypodermic Syringe with/without needle is intended for use in the aspiration and injection of fluids for medical purposes. The Sterile Hypodermic Needle is intended to be used with a syringe for fluids aspiration and injection for medical purposes. It is intended for the patient population, including adults, transitional adolescents, adolescents, and children. The device is intended for use in a professional healthcare facility. The device is a disposable syringe made of the following components: Needle cap, Needle tube, Needle hub, Barrel, Plunger, Plunger stopper.

The provided submission describes a medical device, a Sterile Hypodermic Syringe with/without Needle and a Sterile Hypodermic Needle, and does not involve AI/ML. Therefore, the requested information regarding acceptance criteria and studies that prove the device meets these criteria in the context of AI/ML, human readers, ground truth, and sample sizes for training/test sets is not applicable to this document.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing, biocompatibility testing, sterilization validation, and package/shelf-life testing. No clinical data was submitted.

However, based on the non-clinical performance testing sections, I can extract the acceptance criteria and the studies performed to meet them as they relate to the physical device properties.

1. Table of Acceptance Criteria and Reported Device Performance

The remaining requested information is not applicable to this document as it pertains to AI/ML device studies, which this submission is not.

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

• Not applicable as this is a traditional medical device (syringe/needle) and not an AI/ML device. Performance testing for traditional devices typically involves testing physical samples defined by the relevant standards, not a "test set" of data in the AI/ML sense. No specific country of origin or retrospective/prospective nature of data for these tests is mentioned beyond the manufacturing location (China).

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)

• Not applicable as this is not an AI/ML device study. Ground truth in this context would refer to the validated methods and accepted performance limits defined by the referenced international standards, rather than expert consensus on data interpretation.

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

• Not applicable as this is not an AI/ML device study.

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 as this is not an AI/ML device study. No human reader studies are mentioned.

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

• Not applicable as this is not an AI/ML device study.

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

• For the non-clinical performance, biocompatibility, sterilization, and packaging tests, the "ground truth" is defined by the objective pass/fail criteria and methodologies outlined in the referenced international and national consensus standards (e.g., ISO, ASTM, AAMI/ANSI). These standards represent established scientific and engineering principles for evaluating medical device safety and performance.

8. The sample size for the training set

• Not applicable as this is not an AI/ML device study.

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

• Not applicable as this is not an AI/ML device study.

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The safety blood collection needle without a needle holder is intended to be used with a vacuum blood collection tube to collect venous blood. The safety shield is intended to protect against accidental needle stick injury.

The proposed device is a blood collection device to form a channel between the patient's vein and the evacuated blood collection tube intended for blood collection. The Pipe pluq piercing needle is designed with a rubber cap, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needle stick injury. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions. The Safety blood collection needles without needle holders are manufactured from tubular stainless steel sharpened at both ends that are attached as follows:

• -The threaded hub has one side that is to connect with the needle holder, which is used to guide the needle into a vacuum blood collection tube. This end of the needle is shorter and fitted with a rubber cap and a needle hub.
• -The opposite end of the needle tube is 3/4"-1 1/2" for blood collection and is fitted with a protective sleeve.
  The needle hub and protective cap protect the needle tube.
  The safety feature is easily operated through the release of a latch mechanism whereby the user slides a safety shield over the needle as it is removed from the patient. Once the needle is covered, the safety shield locks in place. This mechanism is substantially equivalent to that of the predicate device.
  The devices are packaged as sterile, single-use, and single-patient use only.
  The proposed device is comprised of the components listed below:
• 1. Bottom sheath
• 2. Rubber cap
• 3. Needle hub
• 4. Connecting base
• 5. Safety shield
• 6. Needle tube
• 7. Upper sheath

The provided text describes a 510(k) premarket notification for a medical device called "Safety Blood Collection Needle (Without Needle Holder)". This notification primarily focuses on establishing "substantial equivalence" to a predicate device, rather than providing detailed acceptance criteria and a comprehensive study report in the way scientific literature or a clinical trial would. Therefore, some of the requested information, particularly regarding specific numerical performance metrics, sample sizes for test/training sets, expert qualifications, and effect sizes for AI, is either not applicable or not explicitly stated in the document.

Based on the provided text, here's an analysis of the acceptance criteria and supporting information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by compliance with applicable international standards (ISO, AAMI, ASTM) and demonstrating performance equivalent to the predicate device. The reported performance is generally stated as "Complies with" or "Identical," implying that the device met the requirements of these standards. Exact numerical values for performance are not typically included in a 510(k) summary unless there's a specific, quantifiable, and comparative requirement to highlight.

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

• Sample Size: The document does not specify the exact sample sizes used for each performance test. It refers to compliance with standards like ISO and ASTM, which typically outline specific testing methodologies and required sample quantities. For instance, ISO 2859-1 (Sampling procedures for inspection by attributes) is mentioned, indicating statistically derived sample sizes for lot-by-lot inspection, but the actual number of units tested is not reported.
• Data Provenance: The testing was non-clinical ("Non-Clinical Performance Testing"). The origin of the data is the manufacturer's testing, conducted to demonstrate compliance with international standards. There is no mention of country of origin for the data itself, only the manufacturer's location (Anhui, China). The data is implicitly "retrospective" in the sense that it was generated for this specific submission to demonstrate compliance.

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 the context presented. The document describes a medical device (a blood collection needle), not an AI/ML-based diagnostic system that requires expert interpretation for ground truth establishment. The "ground truth" for this device's performance is objective measurements against established engineering and biological standards.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or AI/ML evaluations where there might be disagreement among human annotators or evaluators. For the engineering and biological tests described (e.g., tensile strength, sterility, biocompatibility), the results are objective measurements against defined criteria, not subjective interpretations requiring adjudication.

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 is not an AI-assisted diagnostic or interpretation tool. It is a physical medical device (blood collection needle). Therefore, an MRMC study and AI-related effect sizes are irrelevant to this submission.

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

This information is not applicable. The device is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective measurements defined by nationally and internationally recognized standards. These include:

• Engineering Specifications: Standards like ISO 9626 (stainless steel needle tubing), ISO 7864 (hypodermic needles), ISO 80369 series (small-bore connectors), ISO 23908 (sharps injury protection), ASTM F88/F88M (seal strength), etc., which define measurable physical and chemical properties and test methods.
• Biological Standards: ISO 10993 series (biocompatibility) provides established methods for assessing biological safety (e.g., cytotoxicity, sensitization, systemic toxicity).
• Microbiological Standards: ISO 11135-1 (sterilization), ISO 11737-1/2 (microbiological methods) define criteria for sterility and validation of sterilization processes.
• Clinical Outcomes/Pathology: This type of ground truth is not used here, as no clinical data or pathology results are reported for the device itself.

8. The Sample Size for the Training Set

This information is not applicable. The device is not an AI/ML system that requires a "training set."

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

This information is not applicable. As the device is not an AI/ML system, there is no training set and therefore no ground truth established for it in that context.

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Safety blood collection needles with/without needle holder are intended to be used with vacuum blood collection tubes for multiple collections of venous blood. The safety shield is intended to aid in the protection against, accidental needle stick injuries.

The Safety blood collection needles with/without needle holder is used in routine venipuncture procedures. That is composed of a bottom sheath, rubber cap, needle hub, connecting base, safety shield, needle tube, upper sheath, and optional needle holder, which are made from PP, PE, ABS, rubber, and SUS materials. The proposed device has various configurations and sizes, differing in various colors for easy recognition by use. The threaded hub is one side that connects with the needle holder, which is used to quide the needle into a vacuum blood collection tube. This end of the needle is shorter and is fitted with a rubber cap and a needle hub. The Safety blood collection needles with /without needle holder are manufactured from tubular stainless steel sharpened at both ends that are attached: - The opposite end of the needle tube is ¾" ~ 1 ½″ for blood collection and is fitted with a protective sleeve. - The needle hub and protective cap protect the needle tube. The self-locking mechanism is positioned within the center and the proximal end of the sheath. The hinge structure could let clinical personnel flexibly adjust the sheath to the designed position for use. The safety feature is easily operated by releasing a latch mechanism whereby the user slides a safety shield over the needle as it is removed from the patient. Once the needle is covered, the safety shield locks in place.

The provided text describes a 510(k) premarket notification for a medical device: "Safety Blood Collection Needles with/without Needle Holder." This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing. It does not contain information about a clinical study involving human-in-the-loop performance, expert ground truth establishment for a test set in a diagnostic AI context, or MRMC studies.

Therefore, many of the requested details about acceptance criteria, study design, and expert involvement (points 2-5, 7-9) are not applicable or cannot be extracted from this specific document, as it pertains to a physical medical device (blood collection needles) rather than a diagnostic AI or imaging device requiring extensive validation with human readers and expert-adjudicated ground truth.

However, I can extract the acceptance criteria and performance data for the non-clinical tests that were performed.

Acceptance Criteria and Reported Device Performance (Non-Clinical)

The device, "Safety Blood Collection Needles with/without Needle Holder," was evaluated through non-clinical performance testing against various international standards to demonstrate its safety and effectiveness.

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The LDV (Low Dead Volume) Syringe is intended to be used for medical purpose to inject fluid into or withdraw fluid from body.

The LDV (Low Dead Volume) Syringe is consistent with the calibrated syringe and permanent needle intended to be used for injection or withdrawal of fluids to or from the human body. The needle is fixed that cannot be removed. The needle cap is colored to differentiate the different types of needle models. The syringe plunger is well-designed to reduce the fluid waste, called low dead volume or low dead space. The LDV (Low Dead Volume) Syringe has various colors, syringe volumes, needle gauge sizes, and needle length sizes, which could be applied in different clinic-use scenarios. Meanwhile, the device is sterilized with ethylene oxide and without any pyrogen. Therefore, this is a single-use device that should be immediately discarded after use.

The provided text is a 510(k) summary for the LDV (Low Dead Volume) Syringe, a medical device. It details the device's characteristics, comparison to predicate devices, and non-clinical performance testing.

However, the information requested in your prompt (acceptance criteria, study details, expert involvement, and ground truth for an AI/algorithm-driven device) is not present in this document. The LDV Syringe is a physical medical device (syringe with a fixed needle), not an AI/algorithm-based diagnostic or therapeutic tool. Therefore, the concepts of acceptance criteria for algorithm performance, test sets, training sets, human reader studies, and expert ground truth establishment for algorithm output do not apply to this specific device submission.

The document discusses "acceptance criteria" and "performance testing" in the context of physical device standards (e.g., ISO standards for sterility, needle performance, dead space volume, biocompatibility). These are mechanical, material, and sterilization performance criteria, not related to the performance of an algorithm.

Therefore, I cannot provide the requested information from the given text because the text describes a physical medical device, not an AI/algorithm-driven one.

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The Safety Blood Collection / Infusion Set (with/without needle holder) is indicated for venous blood collection and/or 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.

The Blood Collection / Infusion Set (with/without needle holder) is indicated for venous blood collection and/or 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 Blood Collection / Infusion Set (with/without needle holder) is a single-use, sterile, winged needle bonded to flexible tubing with a Luer connector. The Blood Collection / Infusion Set (with/without a needle holder) is individually wrapped and sterile with a luer port. The luer port can connect FDA cleared accessories like luer adapter, holder, etc.

The Safety Blood Collection / Infusion Set (with/without needle holder) is a single-use, sterile, winged needle 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, ensuring the needle is covered immediately following venipuncture to protect against accidental needlestick injury. The Safety Blood Collection / Infusion Set (with/without a needle holder) is individually wrapped and sterile with a luer port. The luer port can connect FDA cleared accessories like luer adapter, holder, etc.

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

The Blood Collection / Infusion Set (with/without needle holder) and Safety Blood Collection / Infusion Set (with/without needle holder) are used for venous blood collection and/or the short-term infusion of intravenous fluids. It can be used with an intravascular administration set or a syringe or other device to administer fluids. The product is to be used by appropriately trained healthcare professionals only in accordance with the manufacturer's instructions.

This document is a 510(k) Summary for a medical device called "Safety Blood Collection / Infusion Set (with/without needle holder) and Blood Collection / Infusion Set (with/without needle holder)". It is a submission to the FDA for market clearance, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets acceptance criteria in the sense of a clinical trial for an AI/ML product.

Therefore, many of the requested items (sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, etc.) are not applicable to this type of regulatory submission for this class of device.

This document focuses on non-clinical performance testing and biocompatibility to show that the new device performs as intended and is as safe and effective as the predicate device.

Here's the information that can be extracted and a breakdown of why some questions are not directly answerable from this document:

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

The document states that "All of the pre-determined acceptance criteria were met" for various categories of non-clinical testing. While it lists the standards to which the device was tested, it does not provide the specific numerical acceptance criteria within those standards or the exact reported performance values (e.g., a specific tensile strength value that passed the ISO 7864 requirement).

However, it does implicitly describe acceptance criteria as compliance with established international standards for similar devices.

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

• Sample Size: Not explicitly stated for specific tests beyond general adherence to standards (e.g., ISO 2859-1 for sampling procedures). For medical device clearances like this, testing typically involves a sufficient number of units to demonstrate compliance with the relevant standards for the device type, rather than statistical sampling for clinical performance.
• Data Provenance: The manufacturer is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. in Anhui Province, China. The testing would have been conducted by or for this manufacturer. The document doesn't specify if the underlying data for the standard compliance comes from prospective or retrospective studies, but given it's non-clinical testing, it would be prospective testing of newly manufactured devices.

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)

• N/A. This is a non-clinical device clearance. Ground truth in the context of expert review for medical imaging or AI performance is not relevant here. The "ground truth" for the device's acceptable performance is defined by its adherence to established international engineering, materials, and sterility standards.

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

• N/A. Adjudication methods are relevant for subjective interpretations, typically in clinical studies or expert reviews. Non-clinical performance tests have objective, measurable endpoints defined by 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

• N/A. This is a physical medical device (blood collection/infusion set), not an AI/ML product. MRMC studies are not relevant.

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

• N/A. This is a physical medical device, not an AI algorithm.

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

• The "ground truth" for this device's safety and effectiveness is its compliance with internationally recognized consensus standards (e.g., ISO, ASTM, USP) for the performance, materials, sterility, and biocompatibility of hypodermic needles and infusion sets. These standards define the acceptable physical, chemical, and biological properties.

8. The sample size for the training set

• N/A. This is a physical device, not an AI/ML product that undergoes "training."

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

• N/A. Not applicable, as it's not an AI/ML product.

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Hypodermic Safety Needle with Syringe: The Hypodermic Safety Needle with Syringe is intended for use in the 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.

Hypodermic Safety Needle: The Hypodermic Safety Needle is intended to be used with a luer 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 needlestick.

The device is used for subcutaneous injection, intramuscular injection, intravenous injection of blood, and preparation of liquid medicine. The needle tube will be pushed into the safety cap after use. It is designed to aid in the prevention of needlestick injuries.

The device is a disposable anti-needle stick syringe made of the following components: Needle cap, Needle tube, Safety shield, Needle hub, Barrel, Plunger, Plunger stopper.

This document describes the premarket notification (510(k)) for the Hypodermic Safety Needle and Hypodermic Safety Needle with Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria in the way an AI/ML device would.

However, I can extract the information you've requested based on the regulatory submission's approach to performance and safety, interpreting the "acceptance criteria" as compliance with relevant international standards and the "study" as the non-clinical performance testing.

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

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 does not explicitly state the sample sizes for the performance testing. The "data provenance" for non-clinical performance testing would typically be from in-house or contracted laboratory testing conducted by the manufacturer (Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. in China). These are prospective tests designed to show compliance with the standards.

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 to this type of device submission. The "ground truth" for these tests are the objective technical requirements and measurement methods defined by the international ISO standards. Compliance is determined by whether the device's measured performance falls within the specified limits of these standards, not by expert consensus on clinical interpretation.

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

Not applicable. This type of device performance testing does not involve human adjudication in the way clinical diagnostic studies do. Compliance against standards is an objective measurement.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a conventional medical device (safety needle/syringe), not an AI/ML diagnostic or assistive device. No MRMC study was performed.

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

Not applicable. This is a conventional physical medical device, not an algorithm or software. No standalone performance testing in this context was performed.

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

The "ground truth" for this submission are the objective technical requirements and test methods defined by recognized international standards (ISO standards). Device performance is measured against these established, quantitative benchmarks.

8. The sample size for the training set

Not applicable. This is a conventional medical device, not an AI/ML device that requires a training set.

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

Not applicable. This is a conventional medical device, not an AI/ML device.

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