Search Results

The Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. It is sterile and for single use only. It can be used by the patient at home or healthcare professionals at medical/health care centers.

The Disposable Insulin Pen Needle consists of a needle tube, a needle hub, a needle container, a needle shield and a seal. The needle tube is a double-ended needle that can be assembled into the needle hub using UV glue. The needle hub has the means of needle assembly attachment to allow it to be screwed onto the pen-injector device. This allows the Non-Patient (NP) end of the needle to penetrate through the rubber septum of the pen injector cartridge. The Patient and NP ends of the needle are lubricated using silicon oil for ease of injection and rubber septum penetration. The needle shield is assembled over the Patient end of the needle to protect the point from damage and accidental needle sticks. This needle assembly is inserted into a needle container and sealed with a peel-away label to provide a sterile barrier and tamper evidence. The peelaway label is pre-printed with information, which includes the lot number and needle gauge / length. It is supplied with several models. Different models are distinguished by needle gauge and length. The Disposable Insulin Pen Needle is a single-use disposable device and is provided sterile (EO sterilization). It is non-toxic and nonpyrogenic.

Here's a breakdown of the requested information based on the provided FDA 510(k) summary for the Hantech Medical Device Co., Ltd. Disposable Insulin Pen Needle (K222739).

It's important to note that this document is a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device, rather than a full study proving a device meets novel acceptance criteria. Therefore, many of the typical AI/ML study components (like expert consensus, adjudication, MRMC studies, training set details) are not applicable here. This submission focuses on demonstrating that the new device performs similarly to an already approved device through established engineering and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are generally derived from recognized international and national standards, and "reported device performance" indicates conformity to these standards.

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

The document does not specify a "test set" in the context of clinical data or AI model evaluation. Instead, testing refers to product compliance with international standards for medical devices. The sample sizes for these specific engineering and biocompatibility tests are not detailed in this summary, but would typically be defined by the relevant ISO standards (e.g., a certain number of units for sterility testing or mechanical strength tests).

• Data Provenance: The tests were conducted by the manufacturer, Hantech Medical Device Co., Ltd., which is located in Ningbo, Zhejiang, China. The testing would be prospective in the sense that physical devices were manufactured and then tested to demonstrate compliance.

3. 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 510(k) submission, "ground truth" is not established by human experts interpreting clinical data. Instead, it's established by objective measurements against predefined engineering standards and biocompatibility requirements. The "experts" involved would be qualified laboratory technicians, engineers, and biocompatibility specialists carrying out the specified tests following established protocols.

4. Adjudication Method for the Test Set

Not applicable. There is no qualitative assessment by human readers that would require an adjudication method. Test results are quantitative measurements or assessments against scientific criteria.

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

Not applicable. This device is a physical medical product (insulin pen needle), not an AI/ML diagnostic or assistive technology. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. As noted above, this is a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this substantially equivalent device is the demonstrated compliance with recognized international and national standards for mechanical performance, sterility, and biocompatibility, as well as comparison to the characteristics of a legally marketed predicate device. This is based on objective laboratory and quality control testing, not clinical outcomes data, pathology, or expert consensus on interpretations.

8. The Sample Size for the Training Set

Not applicable. This is 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 not an AI/ML device, so no training set or its associated ground truth establishment is relevant.

Ask a specific question about this device

Disposable Insulin Pen Needle(Model CT) : Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.

Disposable Insulin Pen Needle(Model ST) : Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. Additionally, it has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks from the patient end of the needle due to the effect of safe-lock guard.

Disposable Insulin Pen Needle, could be divided into Model CT (normal type) and model ST(safety type) according to whether there is sharps protection features. Model CT consists of needle hub, needle container, needle tube, needle shield and seal (dialyzing paper). Model ST consists of needle hub, needle container, protective cap, needle tube, spring, slider, protective jacket and seal (dialyzing paper). The device is sterilized by EO gas and for single use. The shelf life is 5 years.

Needle tube is fixed in the center of the needle hub with UV glue, the needle tip is protected with needle shield or protective jacket before use, medical dialyzing paper is covered and sealed needle container to maintain sterile of the cartridge end of needle can be inserted into the rubber of insulin pen, meanwhile the needle hub is connected to insulin pen with screw thread to provide sterile fluid path for injection of insulin during use. When Disposable Insulin Pen Needle is connected to insulin pen operates on the principles of common piston syringes. The patient end and the cartridge end of the needle tube are lubricated with silicone oil for ease of injection and rubber penetration.

Model ST has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks from the patient end of the needle due to the effect of safe-lock guard.

The provided text is a 510(k) Premarket Notification for a Disposable Insulin Pen Needle. It focuses on demonstrating substantial equivalence to predicate devices through design comparisons and a summary of performance testing. The document does not describe a study that involves acceptance criteria for device performance based on AI or diagnostic accuracy. Instead, it details the physical and functional performance of the device based on established medical device standards.

Therefore, I cannot provide information about:

• A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI.
• Sample size used for the test set and data provenance for an AI model.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• MRMC comparative effectiveness study or human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

However, I can extract information regarding the device's general performance testing and criteria based on the provided document:

The device's performance is evaluated against recognized international standards for medical devices and sterility.

Here's a summary of the performance testing and criteria mentioned, which serves as the "acceptance criteria" in the context of this medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of diagnostic performance or AI. Instead, it refers to samples of the device being manufactured and subjected to various physical, chemical, and biological tests according to the standards listed above. The provenance of these test samples would be the manufacturer's production line (Ningbo Medsun Medical Co., Ltd., China). The tests are prospective in the sense that they are performed on the manufactured device models to demonstrate compliance.

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

Not applicable, as this is not a diagnostic device involving expert interpretation or AI. The "ground truth" here is compliance with established international and national medical device standards, which are defined by committees of experts in the field.

4. Adjudication Method for the Test Set

Not applicable. The criteria are objective measurements and validations against standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable, as this is not a diagnostic device or AI-driven system.

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

The "ground truth" is defined by the technical specifications and performance requirements outlined in the cited international and national standards (e.g., ISO 11135, ISO 11608-2, ISO 9626, ISO 7864, ISO 10993 series, ASTM D4169-16, ASTM F1929-2015, USP <788>, ISO 23908:2011). These standards represent established scientific and engineering principles for medical device safety and efficacy.

8. The Sample Size for the Training Set

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

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

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

Ask a specific question about this device

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 <85>). 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.

Ask a specific question about this device

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

The subject 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 consists of needle tube, inner sheath, outer sheath, hub and sealed paper. The hub can be connected screwed onto the insulin pen. The subject device is not intended for neonates, newborn infants or children. The subject device is used in conjunction with following pen injector during clinical use.

This document is a 510(k) Summary for a Disposable Insulin Pen Needle. It does not describe an AI/ML medical device, but rather a physical, single-use medical device. Therefore, the questions related to AI/ML device performance, such as MRMC studies, training/test sets, and ground truth establishment, are not applicable.

The acceptance criteria and proof of "performance" for this device are demonstrated through non-clinical bench testing to show compliance with various international standards and substantial equivalence to a predicate device.

Here's an interpretation based on the provided document, restructured to address the questions where applicable for a non-AI/ML device:

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

For a physical device like a pen needle, "acceptance criteria" are generally compliance with relevant standards and demonstration of substantial equivalence to a predicate device. The "reported device performance" refers to the results demonstrating this compliance.

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

The document states "Non-clinical tests were conducted..." but does not specify the sample sizes for these tests. Data provenance is implied to be from the manufacturer's internal testing in China (Jiangsu Caina Technology Co., Ltd. is based in China), as is typical for 510(k) submissions focusing on bench testing. The tests are "non-clinical," meaning they are not performed on human subjects and are simulated or lab-based.

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 there is no "ground truth" in the context of an AI/ML system or a clinical test set in this document. The "ground truth" for a physical device is its adherence to a standard's specifications as verified by laboratory testing.

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

This question is not applicable for the type of bench testing described. Adjudication methods are relevant for human expert review, typically in clinical studies or image interpretation.

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. This document details the submission for a physical medical device (pen needle), not an AI-assisted diagnostic or therapeutic device.

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

This question is not applicable as it pertains to AI/ML algorithms.

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

As explained in point 3, the concept of "ground truth" for this device relates to compliance with established international and ASTM standards as measured through instrumental and chemical analyses in a laboratory setting. There is no biological or expert consensus ground truth defined in the context of this device's performance evaluation for a 510(k).

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI/ML device.

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

This question is not applicable. There is no "training set" or "ground truth" for a training set.

In summary: The provided document is a 510(k) summary for a Disposable Insulin Pen Needle. Its "acceptance criteria" and "proof of performance" are entirely based on non-clinical bench testing and adherence to recognized international and ASTM standards, along with demonstrating substantial equivalence to a previously cleared predicate device. The concepts of AI/ML performance evaluation, such as training/test sets, human readers, ground truth establishment by experts, and MRMC studies, are not relevant to this type of device submission.

Ask a specific question about this device