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The Sterile Hypodermic Needles for Single Use are intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

The proposed device, Sterile Hypodermic Needles For Single Use, consists of a needle tube, needle hub and protective cap. The needle tube is made from stainless steel (SUS 304), the needle hub made of Polypropylene material (abb. PP) and the color complies with ISO 6009.The protective cap is made of PP and does not contact the patient. The conical fitting of Sterile Hypodermic Needles For Single Use is a luer that can be used with other medical devices which have 6% conical fitting. It is provided sterile with EO sterilization, and the sterilization assurance level (SAL) is 10-6. Additionally, each component is made from properly tested raw materials. And the Hypodermic Needles For Single Use are individually packaged in a sterile Sterile barrier.

This document is a 510(k) summary for a medical device (Sterile Hypodermic Needles for Single Use). It details the substantial equivalence of the proposed device to a predicate device, focusing on non-clinical performance and biocompatibility.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on compliance with a set of international and national standards, which dictate the performance and safety requirements for sterile hypodermic needles. The "reported device performance" is essentially the statement that the device complies with these standards.

Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

The study conducted to prove the device meets the acceptance criteria is a non-clinical performance testing study. This type of study demonstrates equivalence by showing that the proposed device performs comparably to a legally marketed predicate device against established performance and safety standards.

1. Sample sizes used for the test set and the data provenance:

• Test Set Sample Size: The document does not specify the exact sample sizes (number of units) used for each individual test (e.g., how many needles were tested for seal strength, how many samples for biocompatibility). It generally states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications." However, for each listed standard (ISO, ASTM, USP), there are usually defined sample size requirements for the tests prescribed within that standard.
• Data Provenance: The document implies that the testing was performed by or for Zhejiang Kindly Medical Device Co., Ltd., based in Zhejiang Province, China. The testing appears to be retrospective, as it was completed before the 510(k) submission. No specific country of origin is mentioned for the data itself beyond the company's location.

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

• Not Applicable: For this type of medical device (sterile hypodermic needles) and the nature of the non-clinical performance testing, "ground truth" is not established by human experts in the way it would be for AI/imaging diagnostics. Instead, the ground truth is defined by the objective, quantified pass/fail criteria outlined in the referenced international standards (e.g., flow rate requirements, needle stiffness, biocompatibility limits). The "experts" involved are presumed to be the qualified laboratory personnel conducting the tests and interpreting the results against the standard's specifications. Their qualifications are not explicitly stated.

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

• None (Not Applicable): Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, especially for evaluating diagnostic performance (e.g., radiology reads where multiple experts might disagree). This non-clinical study relies on objective, measurable parameters against established standard criteria, so human adjudication in this sense is not relevant.

4. 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 (Not Applicable): An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic tools where human readers interpret medical images or data. This submission is for a physical medical device (hypodermic needles), not an AI diagnostic tool. Therefore, no MRMC study was performed.

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

• No (Not Applicable): This question also pertains to AI algorithm performance. A hypodermic needle does not involve an algorithm, nor does it have "human-in-the-loop performance" in the sense of a software-assisted task.

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

• Standard-defined Objective Criteria: The ground truth for this device is based on the objective, measurable pass/fail criteria specified within the referenced international standards (ISO, ASTM, USP). For example, a needle must meet specific force requirements for penetration, sterility levels, or biocompatibility limits as defined by these standards. This is fundamentally different from a diagnostic ground truth (e.g., confirmed pathology diagnosis for an image).

7. The sample size for the training set:

• Not Applicable: This device is a physical product, not a machine learning model. Therefore, there is no "training set." The performance is validated through direct physical and chemical testing.

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

• Not Applicable: As there is no training set, this question is not relevant.

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Safety Insulin Pen Needle is intended to be used with Insulin Pen for hypodermic injection of insulin and medicinal fluids.

The proposed device, Safety Insulin Pen Needle is intended to be used with Insulin Pen for hypodermic injection of insulin and medicinal fluids. It consists of needle tube, needle hub, spring, needle hub sheath, safety protective sheath, positioning ring, outer protective cap and sealing paper. The needle hub is clear, and the positioning ring and sealing paper contains colorants for the different gauge sizes. The Safety insulin 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 10-6.

The provided text does not describe a device that uses AI or machine learning, nor does it detail acceptance criteria related to such a device's performance based on a test set. Instead, it is a 510(k) premarket notification for a medical device (Safety Insulin Pen Needles), primarily focusing on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing against established ISO and ASTM standards.

Therefore, I cannot extract the information required to populate the table and answer the questions about AI/ML device performance, ground truth, expert consensus, sample sizes for training/test sets, or MRMC studies. The document explicitly states: "No data from human clinical studies have been included to support the substantial equivalence of the proposed device, Safety Insulin Pen Needle, as clinical studies are not required for this medical device."

However, I can provide the acceptance criteria and performance data as presented in the document, which are related to non-clinical tests for a physical medical device, not an AI/ML diagnostic or predictive tool.

Here's a summary of the non-clinical performance data and criteria as per the document:

A. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

B. Information Not Applicable to this Submission (AI/ML Specifics)

The following information is not present in the provided document, as it pertains to AI/ML device studies, which this submission does not involve:

1. Sample size used for the test set and data provenance: Not applicable. The tests are physical/chemical evaluations of the device, not performance on a data set.
2. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as there is no "ground truth" established by experts in the context of an AI/ML model for this device. The ground truth refers to the physical and chemical properties conforming to established engineering and biological standards.
3. Adjudication method for the test set: Not applicable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable. This is for AI-assisted human reading performance.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
6. The type of ground truth used: For this device, the "ground truth" is defined by compliance with the referenced ISO, ASTM, and USP standards for manufacturing quality, performance characteristics (e.g., fluid flow, needle strength), sterility, and biocompatibility.
7. The sample size for the training set: Not applicable, as this is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable.

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The Disposable Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.

The proposed device, Disposable Insulin Pen Needle, is a single use device, which is designed for used with a pen injector for the subcutaneous injection of insulin. It consist of needle tube, inner sheath, cup, hub and sealed paper. The hub can be connected screwed onto the insulin pen. The proposed device is available in following specifications: Gauge 33G, 32G, 31G, 30G, 29G, 28G and Length (mm) 4mm, 6mm, 8mm, 12mm.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Disposable Insulin Pen Needle:

This document is a 510(k) summary for a medical device seeking market clearance, specifically a Disposable Insulin Pen Needle. For such a device, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are generally based on compliance with recognized consensus standards and non-clinical performance testing rather than clinical trials or AI/software performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines a comprehensive set of non-clinical tests and biocompatibility tests. The acceptance criteria are implicit in verifying that the proposed device "met all design specifications" and that "the test result comply with the related standard requirements."

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

The document states, "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." It also mentions "aging samples" for shelf life evaluation and testing of "all proposed models" for needle gauge differences.

• Sample Size: The exact sample sizes for each specific test are not provided in this summary. However, for medical device testing against standards, specified sample sizes are typically defined within the standards themselves or agreed upon with regulatory bodies.
• Data Provenance: The tests were conducted by Zhejiang Kindley Medical Devices Co.,Ltd in China (PRC), as they are the submitter. The data is retrospective in the sense that the tests were performed on the device prototypes and models before submission for clearance.

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

This type of information is not applicable to this document. The "ground truth" for a medical device like an insulin pen needle is established by its physical and functional properties meeting recognized international standards (e.g., ISO, ASTM). It does not involve expert clinical assessment of images or data in the way AI performance studies would.

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

This is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are used in clinical trials or diagnostic studies where there's a need for expert consensus on patient outcomes or diagnoses, particularly when dealing with subjective interpretations or complex clinical endpoints. For a mechanical device tested against engineering standards, the results are typically objective measurements.

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. An MRMC study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. This document describes a physical medical device (insulin pen needle) and its non-clinical performance against engineering standards. There is no AI component or human reader interpretation involved in its evaluation.

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

This is not applicable. This describes a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device's performance is derived from compliance with established international consensus standards (e.g., ISO 7864, ISO 9626, ISO 11608-2, ISO 10993, ANSI/AAMI/ISO 11135-1, ASTM F88/F88-15, ASTM F1929-15, USP ). These standards define the acceptable physical, mechanical, chemical, and biological properties for hypodermic needles and pen needles.

8. The sample size for the training set:

There is no training set in the context of this device's evaluation. "Training set" refers to data used to train machine learning models. This is about physical device testing.

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

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

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The Blood Collecting Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

The Safety Blood Collecting Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The Blood Collecting Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

The Safety Blood Collecting Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The Blood Collecting Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

The Safety Blood Collecting Set is intended to be used with vacuum blood collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The Blood Collecting Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

The Safety Blood Collecting Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The proposed devices are blood collection devices form a channel between patient's vein and the vacuum blood collection tube. The patient-end needle is punctured into vein, and non-patient end needle will penetrate into vacuum blood collection tube, blood will flow into blood collection tube under the action of differential pressure. The proposed devices are divided into several types and available in different specifications.

The provided document is a 510(k) Pre-market Notification from the FDA for blood collection needles and sets. It describes non-clinical testing performed to establish substantial equivalence to predicate devices, but it does not contain information about studies involving human or expert evaluation of AI/algorithm performance, which is what your request is focused on. Therefore, I cannot provide details on the requested criteria related to AI/algorithm acceptance criteria, ground truth, expert involvement, or MRMC studies.

However, I can extract the acceptance criteria and performance related to the non-clinical tests performed on the physical device.

Here's the relevant information based on the non-clinical tests described in the document:

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 specify the sample sizes or data provenance (country of origin, retrospective/prospective) for the non-clinical tests. It only states that tests were "performed on the proposed device" and "on aging samples."

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. This document describes non-clinical testing of a physical medical device (blood collection needles/sets), not an AI/algorithm. No experts were mentioned for establishing ground truth for a test set in the context of AI evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This document is not about AI/algorithm evaluation.

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 document is not about AI/algorithm performance or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is not about an AI/algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" refers to the established standards and specifications outlined in the referenced ISO, ASTM, and USP documents, as well as the company's own design specifications. For the simulated clinical study, "pre-established criteria" defined the success of the safety mechanism.

8. The sample size for the training set
Not applicable. This document is not about an AI/algorithm and therefore has no "training set."

9. How the ground truth for the training set was established
Not applicable. This document is not about an AI/algorithm and therefore has no "training set."

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The Epidural Anesthesia Needles are intended to be used for injection into the epidural space/or placing the enidural catheter into the epidural space.

The Spinal Anesthesia Needles are intended to be used for injection of local anesthetic agent into the subarachnoid cavity for pain management.

The Combined Anesthesia Needles are intended for injection of local anesthetics into the spinal and epidural spaces of a patient to provide regional anesthesia. The administration of the spinal anesthesia onset and the placement of an epidural catheter allows for bolus injections or continuous infusion of local anesthetics or other drugs into the epidural space.

The proposed device, Epidural Anesthesia Needles are available in a series combination of needle size and length. The needle tubing is stabilized during puncture with use of an inner stylet. The stylet is withdrawn after the epidural anesthesia needle its anatomical site for neuraxial anesthesia. Then an epidural catheter is introduced into epidural cavities for convenience of injecting anesthetic continuously.

The proposed device, Spinal Anesthesia Needles are available in a series combination of needle size and length. The spinal anesthesia needle has a tightly fitting removable stylet that completely occludes the lumen to avoid block. The stylet is withdrawn after the spinal anesthesia needle has penetrated into the subarachnoid space for injecting anesthetic. The needles are available in Sprotte and Quincke two type.

The proposed device, Combination Anesthesia Needle are instruments for a spinal (subarachnoid) injection of anesthetics, followed by the placement of an epidural catheter to allow modification of the spinal analgesia if necessary, or continuous infusion of local anesthetics into the epidural space for subsequent pain relief if required. The needles are a matched set. The epidural needle and the spinal needle are locked by conical fitting that enable the spinal needle to be locked into position once the dura has been pierced so that it is secured to the epidural needle to prevent accidental displacement.

Here's the information about the acceptance criteria and study as extracted from the provided text, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." However, specific sample sizes for these non-clinical tests are not provided in the given text. The data provenance is also not explicitly stated beyond referring to international and US standards. It can be inferred that these non-clinical tests were conducted in a laboratory setting. The study is retrospective in the sense that it relies on existing predicate devices for comparison and established standards, rather than new prospective human trials.

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

This information is not provided in the document. The study relies on compliance with recognized standards and non-clinical testing rather than expert-derived ground truth based on patient data.

4. Adjudication Method for the Test Set

This information is not applicable as the study did not involve human interpretation of results requiring adjudication. It focused on objective performance against technical 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

No MRMC comparative effectiveness study was done. This document pertains to the clearance of medical needles, which are physical devices, not an AI or imaging diagnostic tool that would typically involve human readers.

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

This question is not applicable as the submission is for physical medical needles, not an algorithm or AI system.

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

The "ground truth" for the non-clinical tests appears to be defined by:

• Compliance with established international and US standards (e.g., ISO, ASTM, USP).
• Comparison to predicate devices in terms of technical characteristics and performance (e.g., biocompatibility test results like "No Cytotoxicity").

8. The sample size for the training set

This information is not applicable as this is not an AI/machine learning device requiring a training set.

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

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

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