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SureFine Pen Needle is intended for use with a pen injector for the subcutaneous injection of insulin.

SureFine Pen Needle is designed for use with a pen injector for the subcutaneous injection of insulin. The pen needle consists of a needle, hub, and shield assembly. Blister paper covers primary container. The primary container maintains sterility of the needle because primary container covers the hub and needle cap with blister paper sealed on the opening hole of primary container.

The needle hub can be connected screwed onto the pen. The needle shield is intended to provide physical protection to the needle tube.

SureFine Pen Needle is offered in various gauges sizes (29G, 30G, 31G, 32G) and Lengths (4mm, 6mm, 8mm, 12.7mm). These are sterile (EO gas sterilization), non-toxic, and non-pyrogenic. The pen needles are disposable, single use devices.

The SureFine Pen Needle device, K250658, is a Class II hypodermic single lumen needle intended for use with a pen injector for the subcutaneous injection of insulin. The information provided is from an FDA 510(k) Clearance Letter.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SureFine Pen Needle are based on compliance with international standards ISO 9626, ISO 11608-2, and ISO 10993-1, 10993-4, 10993-5, 10993-7, 10993-10, and 10993-11 for biocompatibility and sterilization validation according to ISO 11135.

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

The document does not explicitly state the specific sample sizes for each test mentioned (ISO 9626, ISO 11608-2, Biocompatibility). However, it indicates that "Bench tests for the device's performance were conducted" and "Biocompatibility of the SureFine Pen Needle was evaluated". The testing was conducted by Shina Med Corporation, a company based in the Republic of Korea. The nature of these tests (bench testing, lab-based biocompatibility) suggests they are prospective tests performed on manufactured samples of the device. The data provenance is primarily from internal testing and validation by the manufacturer, following international standards.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the "test set" in the context of device performance. The testing performed is against established international standards (ISO 9626, ISO 11608-2, ISO 10993 series), which themselves represent a form of "ground truth" for device safety and performance criteria. The evaluation results are reported as "Pass" or "Met," implying adherence to these predefined standards rather than an expert panel establishing a de novo ground truth for each specific test.

4. Adjudication Method for the Test Set

No information is provided regarding an adjudication method (such as 2+1, 3+1, none). The evaluation is based on objective measurements and established criteria set forth by the ISO standards. For instance, a flow rate test would have a pass/fail threshold, not require expert adjudication in the traditional sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document describes bench tests and biocompatibility evaluations for a medical device (pen needle), not a diagnostic or AI-assisted system that would typically undergo an MRMC comparative effectiveness study involving human readers. Therefore, there is no mention of an effect size of human readers improving with or without AI assistance.

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

No. This device is a physical medical instrument (a pen needle), not a software algorithm or AI system. Therefore, the concept of "standalone performance" in the context of algorithms is not applicable here.

7. The Type of Ground Truth Used

The ground truth used for demonstrating the device's performance is adherence to established international standards and regulatory requirements:

• ISO 9626: Specifies requirements for stainless steel needle tubing for the manufacture of hypodermic needles.
• ISO 11608-2: Specifies requirements and test methods for single-use needles used with pen-injectors.
• ISO 10993 series: Biological evaluation of medical devices, covering various aspects of biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, pyrogenicity).
• ISO 11135: Specifies requirements for the development, validation, and routine control of an ethylene oxide sterilization process for medical devices.
• ISO 10993-7: EtO residual limits.
• LAL testing: To ensure absence of bacterial endotoxins.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning or AI algorithm, so there is no "training set."

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

Not applicable, as there is no training set for a physical medical device.

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Verifine® Pen Needle is intended for use with pen injector device for the subcutaneous injection of drugs.

Verifine® Pen Needles, manufactured by Promisemed Hangzhou Meditech Co., Ltd, are designed for use with pen injectors for the administration of drugs. These are standard pen needles without integrated safety features. The devices are single-use, non-pyrogenic, and maintain a Sterility Assurance Level (SAL) of 10 °. The differences between the PromiseMed current cleared common type needle pen and the new design primarily involve changes to the trade name, the addition of new models, and modifications in some materials and dimensions. Key updates include a change in the trade name, the introduction of new models (FPN and NPN), the addition of new needle sizes and a 5-bevel needle tip option, and a shift from a specific intended use (administering insulin) to a general intended use (administering drugs). The materials used have also been slightly modified, such as changing the needle shield material from polypropylene (PP) to polyethylene (PE) for certain models, which only contact intact skin, ensuring no increased risk. These devices are intended for over-the-counter (OTC) use and require manual insertion by the user during drug administration.

The provided text is a 510(k) summary for a medical device (Verifine® Pen Needles). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new device meets acceptance criteria through a clinical or performance study that quantifies specific metrics like sensitivity, specificity, accuracy, or human reader improvement with AI assistance.

The context of your request (acceptance criteria, effect size, MRMC studies, ground truth) is typical for the evaluation of AI/ML-enabled medical devices, especially those involving image analysis or diagnostic support. The provided document describes a physical medical device (hypodermic needle) where the primary concerns are mechanical performance, biocompatibility, and compatibility with existing pen injectors. Therefore, information related to AI/ML device evaluation criteria is largely not applicable to this document.

Here's a breakdown of why many of your excellent questions cannot be answered by this document, followed by what can be extracted:

Why most questions are not applicable:

• AI/ML Device Evaluation: The document does not describe an AI/ML device. It's a pen needle. Therefore, concepts like "effect size of human readers improve with AI vs without AI assistance," "standalone (algorithm only) performance," "number of experts for ground truth," "adjudication method," "sample size for training set," or "data provenance" (in the context of image data) are irrelevant.
• Clinical Performance Data: The summary explicitly states: "No clinical data was necessary to determine the substantial equivalence of this device." This means there was no human-centric clinical study (like an MRMC study) performed to evaluate the diagnostic or treatment benefits in a clinical setting against a "ground truth" established by experts.

What can be extracted or inferred from the document regarding acceptance criteria and device performance for this physical device:

The "acceptance criteria" here are implied by the standards and bench testing performed to demonstrate substantial equivalence to the predicate device and compliance with relevant ISO standards.

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on demonstrating that changes to the device (new models, sizes, material change, labeling updates) do not raise new questions of safety or effectiveness and that the modified device still meets the performance attributes of the predicate and relevant standards.

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

• Test Set Sample Size: Not explicitly stated in terms of a "test set" as one would for an AI/ML model or a clinical trial. However, non-clinical performance and biocompatibility testing were conducted. The sample size for these specific engineering tests (e.g., how many needles were tested for dose accuracy) is not detailed in this summary.
• Data Provenance: The tests were "completed by Promisemed Hangzhou Meditech Co., Ltd." (China). The data origin is thus the manufacturer's testing facilities. The tests are "non-clinical" (benchtop/lab-based), not from patients. It's not retrospective or prospective in the sense of clinical data collection.

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. Ground truth, in the AI/ML sense (e.g., expert consensus on clinical images), is not relevant here. Performance is measured against engineering specifications and international standards (ISO).

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

• Not Applicable. No adjudication method for expert review of data is mentioned or relevant.

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. An MRMC study was NOT done. This type of study is specifically for evaluating diagnostic performance of AI/ML systems with human readers. The device is a physical pen needle, not an AI diagnostic tool.

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

• Not Applicable. There is no algorithm or software being evaluated for standalone performance. Performance tests are against ISO standards for the physical device.

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

• For this device, the "ground truth" or reference for performance is established by international standards (e.g., ISO 11608-2 for pen needles, ISO 10993-1 for biocompatibility) and the manufacturer's engineering specifications/drawing requirements. It is not clinical diagnostic ground truth.

8. The sample size for the training set:

• Not Applicable. The concept of a "training set" is for AI/ML models. This is a physical device.

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

• Not Applicable. Same as above.

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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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Pen Needle is intended for use with pen injector devices for the subcutaneous injection of drugs.

The proposed device, Pen Needle, is designed for use with pen injectors for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. It is provided sterile, single use. The proposed device consists of four components, which are 1) Needle Container 2) Needle Shield 3) Needle Tube and 4) Needle Hub. Needle Container, together with Sealed Paper can forming the unit packaging of Pen Needle, that maintains the sterility of Pen Needle Hub can be connected screwed onto the pen injectors.

The provided document is a 510(k) premarket notification for a medical device (Pen Needle) and focuses on demonstrating substantial equivalence to a predicate device. It is not an AI/ML medical device submission. Therefore, the document does not contain information typically found in an AI/ML medical device acceptance criteria and study section, such as:

• A table of acceptance criteria and reported device performance for an AI/ML algorithm.
• Sample sizes used for a test set or data provenance for an AI/ML algorithm.
• Number of experts or qualifications of experts used for AI ground truth.
• Adjudication methods for AI test sets.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone AI performance.
• Type of ground truth used for AI/ML.
• Sample size or ground truth establishment for an AI/ML training set.

The document discusses non-clinical tests performed to verify the Pen Needle met design specifications and complied with ISO standards, focusing on manufacturing quality, sterility, and biocompatibility rather than an AI algorithm's performance.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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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.

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Sterile, single use needles intended for use with pen injector devices for the subcutaneous injection of drugs

The Insupen Pen Needle/ Insupen ORIGINAL Pen needle/ Insupen ADVANCED Pen Needle are sterile, single use, single patient pen needles intended for use with pen injector devices for the subcutaneous injection of drugs. Pen needles are used by consumers, caregivers and healthcare professionals. The intended patients for this device is the population from newborn to elderly. The device can be used both in domestic and professional environment. It is considered MR unsafe. The list of drugs tested and intended to be used with Pikdare's pen needle are Insulin, peptic hormone, peptic glucagon-like-1, and drug for the treatment of osteoporosis. All compatibility is checked following the requirements of ISO 11608-2:2012.

The pen needle assembly consists of a double-ended cannula that is assembled into an injection molded hub by gluing. The hub has internal threads which allow it to be screwed onto the pen injector device. This allows the cartridge end of the cannula to penetrate through the rubber septum of the cartridge. The patient end and the cartridge end of the cannula are lubricated using a silicone based lubricant for ease of injection and pen cartridge septum penetration. There is an inner needle shield assembled over the patient end of the cannula to protect the needle tip from damage and accidental needle sticks. Each pen needle is protected with a sealed medical paper which together with the primary container provide a sterility barrier. The pen needle is packaged in boxes and sterilized with ETO. It is intended for single patient and single use only. To use a pen needle, the user needs to remove the medical paper, screw the needle onto the pen injector device. Then the user removes both the outer cap and the inner protective cap to expose the needle and make an injection. After the injection, the needle is unscrewed from the pen injector device and disposed in an appropriate container respecting applicable regulations and laws.

The document describes the acceptance criteria and study results for the Pikdare Insupen Pen Needle, Insupen ORIGINAL Pen Needle, and Insupen ADVANCED pen needle.

1. Table of acceptance criteria and the reported device performance:

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

The document states that "Test were performed on both products, the total availability on sample of the fact that the Predicate Device is manufactured in Pikdare factory in Italy (Pikdare is the contract manufacturer of Droplet G34 Pen Needle)." This implies the testing was done on the actual manufactured products (both the subject device and the predicate device).

• Sample size: Not explicitly stated with a specific number for each test, but it is implied that sufficient samples were used to meet the requirements of the listed ISO standards.
• Data provenance: The predicate device is manufactured in Italy by Pikdare S.p.A. The testing described for both the subject device and the predicate device was presumably performed by or on behalf of Pikdare S.p.A. in Italy. All tests refer to recognized international standards (ISO).
• Retrospective or prospective: The data appears to be prospective, collected specifically for the 510(k) submission to demonstrate compliance with standards and substantial equivalence.

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

Not applicable. This is a medical device (pen needle) conformity assessment, not an AI or diagnostic imaging study that relies on expert interpretation for ground truth. The "ground truth" here is defined by meeting the objectively measurable criteria specified in ISO and ASTM standards.

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

Not applicable, for the same reason as point 3. The assessment is based on objective measurements against predefined 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. This is not an AI-assisted diagnostic device.

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

Not applicable. This is not an AI-based device.

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

The "ground truth" is defined by the technical specifications and performance requirements established by recognized international standards (e.g., ISO 11608-2, ISO 9626, ISO 10993-1, ISO 7864, ASTM F756, USP General Chapter ). The device performance is objectively measured against these established criteria.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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The BD AutoShield Duo™ Pen Needle is intended for use with pen injector devices for the subcutaneous injection of drugs.

The product has two safety shields, which lock in place after use (patient-end) and upon removal of the needle from the pen (pen connection-end). The locked shields help reduce the occurrence of needle sticks from both ends of the needle.

The pen needle assembly consists of a double-ended cannula that is assembled onto an injection molded hub. The internal threads allow the subject device to be screwed onto a pen injector device, further enabling the non-patient end of the cannula to penetrate through the septum of the pen injector cartridge.

The patient and non-patient ends of the cannula are visible prior to attachment to the pen injector device. The BD AutoShield Duo™ Pen Needle has safety mechanisms on both the patient and non-patient ends of the needle, allowing the needle to be shielded and locked after use, which is designed to reduce the occurrence of accidental needle-stick injuries. The BD AutoShield Duo™ Pen Needle is a single use disposable device and is provided sterile. The subject device is non-toxic and non-pyrogenic.

The provided document describes the FDA 510(k) clearance for the BD AutoShield Duo™ Pen Needle. It focuses on demonstrating substantial equivalence to a predicate device (K110703) rather than a comprehensive study proving the device meets specific acceptance criteria for a novel functionality.

Therefore, much of the requested information regarding detailed acceptance criteria and a study to prove meeting them, particularly in the context of AI/ML or comparative effectiveness, is not directly applicable or available in this document. This submission is for a medical device that has minor administrative updates to its intended use statement, harmonizing it with other existing pen needles, and confirms its continued safety and effectiveness through non-clinical testing.

Here's an attempt to extract and infer the information based on the provided text, while noting the limitations:

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

The document doesn't present a specific table of acceptance criteria with corresponding performance metrics as would be typical for a new device claiming specific performance against a novel metric. Instead, it refers to compliance with established international standards and internal BD test requirements. The "performance" is generally stated as "passed" or "met requirements".

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

The document does not explicitly state the sample sizes for each specific test conducted (e.g., number of needles tested for each ISO standard). It generally mentions that testing was conducted to validate the design.

• Sample Size: Not specified in the provided text for individual tests.
• Data Provenance: The testing was conducted by BD (Becton, Dickinson and Company) as part of its design control process, implying internal, prospective testing for regulatory submission. The country of origin of the data is not specified beyond being generated by Becton, Dickinson and Company in Franklin Lakes, New Jersey.

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

This information is not applicable to the type of tests described. The "ground truth" for these tests (functional performance, biocompatibility, sterility) is established by adhering to widely accepted international standards (ISO, ASTM, USP) and internal engineering/quality requirements, rather than expert consensus on subjective evaluations.

4. Adjudication method for the test set

Not applicable. The tests performed are objective, measurable parameters against defined standards, not requiring an adjudication method like those used for subjective clinical assessments or AI model evaluations.

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. The BD AutoShield Duo™ Pen Needle is a physical medical device (pen needle), not an AI/ML software device or a diagnostic tool that involves human readers or AI assistance in interpretation. No MRMC study was mentioned or implied.

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

Not applicable. This is not an algorithm or AI product.

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

As mentioned in point 3, the ground truth for the non-clinical tests is based on the specifications and acceptance criteria defined within established international standards (ISO, USP, ASTM) and the manufacturer's own validated internal requirements for device function, safety, and sterility. For example:

• Functional: Compliance with dimensional tolerances, force measurements, safety mechanism activation as per ISO standards.
• Biocompatibility: Absence of toxicological responses as per ISO 10993 series.
• Sterility: Sterility assurance level (SAL) of 10-6 as per ISO 11137-2.

8. The sample size for the training set

Not applicable. This is not an AI/ML product that utilizes a training set.

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

Not applicable, as there is no training set for this type of device submission.

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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

• Maximum EO residual . | - Meets requirements of ISO 10993 series standards.
• All listed specific tests performed.
• Particulate matter for injections performed per USP . |
  | Sharps Protection Features | - For Model ST: Meet requirements of safe-lock guard activation and safety overriding/unlocking force after activation (triggering performance) as per ISO 23908:2011 (Sharps injury protection). | - Model ST meets the requirements of safe-lock guard activation and safety overriding/unlocking force after activation per ISO 23908:2011. |
  | Clinical Simulated Use | - For Model ST: Demonstrate sharps injury prevention feature through clinical simulated use testing, according to ISO 23908:2011 and FDA Guidance for Industry and FDA Staff-Medical Devices with Sharps Injury Prevention Features. | - Clinical simulated use testing completed for Model ST. Test results show good sharps injury prevention feature. |
  | Hub/Needle Bond Strength | - Conform with ISO 11608-2. | - Conform with ISO 11608-2. |
  | Method of Attachment | - Screw structure, conform with ISO 11608-2. | - Screw structure, conform with ISO 11608-2. |
  | Needle Tip Configuration | - Tri-bevel edge needle. | - Tri-bevel edge needle. |
  | Endotoxin Limit | - 20 EU per device. | - 20 EU per device. |

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 , 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.

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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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Promisemed X-safety pen needle is intended for use with needle based injector for the injection of drugs.

X-Safety Pen Needle is a single-use, double-ended, sterile needles for needlebased injection systems (NISs) that fulfil the specifications of ISO 11608-1. This device is constructed as a double-ended, stainless steel needle of various sizes that is with a threaded plastic hub. The device includes needle shielding safety features (at both patient-end and cartridge-end or at patient-end only) to reduce the risk of needle stick injury and its container can be provided as short or long type. It is packaged in a sealed sterility barrier, and the needle is lubricated. This is a single-use device and delivered sterilization process is validated according to EN ISO 11135. Sterilization process undergoes routine control.

The Promisemed X-Safety Pen Needle is a single-use, double-ended, sterile needle intended for use with needle-based injection systems for drug injection. The device performance was assessed through various bench tests compliant with ISO, ASTM, and USP standards.

The acceptance criteria and reported device performance are summarized in the table below:

Table_1: Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample Size and Data Provenance: The document does not specify exact sample sizes for each test. However, it indicates that testing was conducted on the "final, packaged, and sterile devices," implying a representative sample. The data provenance is from Promisemed Hangzhou Meditech Co., Ltd. in China, as they are the manufacturer and submitter of the 510(k). The studies appear to be prospective bench studies performed by the manufacturer or their designated testing facilities to demonstrate compliance with international and national standards.

2. Number of Experts and Qualifications for Ground Truth: Not applicable. These are bench performance tests evaluating physical, chemical, and biological properties according to standardized protocols, not human-interpreted diagnostic results. Thus, no medical experts were involved in establishing ground truth for these types of tests. The "ground truth" is defined by the objective pass/fail criteria of the scientific standards themselves.

3. Adjudication Method for Test Set: Not applicable. As these are objective bench tests with predefined pass/fail criteria from international standards, there is no need for expert adjudication.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices that involve human interpretation of results, not for the performance of a hypodermic needle.

5. Standalone Performance: Yes, the described studies represent the standalone performance of the device (Promisemed X-Safety Pen Needle) against established technical and safety standards. There is no human-in-the-loop performance component in these specific evaluations.

6. Type of Ground Truth Used: The ground truth for these tests is based on objective, standardized criteria established by international and national organizations (e.g., ISO, ASTM, USP). For instance, for material composition, the ground truth is the chemical specification of 304 Stainless steel; for cytotoxicity, it's the absence of cytotoxic effects as defined by ISO 10993-5; for sterility, it's achieving a Sterility Assurance Level (SAL) of 10^-6.

7. Sample Size for Training Set: Not applicable. This device is a medical instrument (pen needle), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

8. How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this device.

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