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

The BD Pen Needle has the same intended use/indications for use, technological characteristics, and principles of operation as the predicate device cleared under K162516. The pen needle assembly consists of a double-ended cannula that is assembled into an injection-molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen-injector device. This allows the Non-Patient (NP) end of the cannula to penetrate through the rubber septum of the pen injector cartridge. The Patient and NP ends of the cannula are lubricated using silicone-based lubes for ease of injection and rubber septum penetration. An injection-molded inner shield is assembled over the Patient end of the cannula to protect the point from damage and accidental needle sticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away (tear drop) label to provide a sterile barrier and tamper evidence. The outer cover is also used to remove the hub and cannula from the pen. The peel-away tear-drop label is pre-printed with information, which includes the lot number and needle gauge / length. The BD Pen Needle is a single-use disposable device and is provided sterile (gamma irradiation sterilization). It is non-toxic and non-pyrogenic.

This document is an FDA 510(k) summary for a Becton Dickinson (BD) Pen Needle (K213478). It describes the device, its intended use, and comparative testing against a predicate device (K162516) to demonstrate substantial equivalence.

Based on the provided text, the device in question is a BD Pen Needle, a medical device used with pen injector devices for the subcutaneous injection of drugs. The information focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific acceptance criteria as an AI/ML-driven diagnostic or treatment device with performance metrics like sensitivity, specificity, etc.

Therefore, the requested information regarding AI/ML acceptance criteria, study design (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), training set details, and specific metrics (sensitivity, specificity, AUC) is not applicable to this document.

This 510(k) summary demonstrates substantial equivalence by:**

• Comparing Indications for Use: The subject device has the identical indication for use to the predicate device.
• Comparing Technological Characteristics: The devices share the same fundamental scientific technology (single lumen needle).
• Demonstrating Performance Testing: Non-clinical tests were conducted based on ISO standards and BD internal requirements to show that the design, materials, and manufacturing process changes do not raise new questions of safety or effectiveness.

Here's a breakdown of the relevant information provided in the document:

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

The document does not present acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity, F1-score) and reported performance values as would be typical for an AI-driven device. Instead, it relies on demonstrating equivalence through adherence to relevant standards and direct comparison with a predicate device.

The "acceptance criteria" are implied by the standards and internal test requirements met, and the "reported device performance" is the successful compliance with these tests.

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

The document does not detail specific sample sizes for "test sets" in the context of diagnostic performance evaluation. The "testing" mentioned refers to engineering, functional, and biocompatibility tests on the physical device components and assembled product, adhering to industrial standards. Data provenance (country of origin, retrospective/prospective) is not applicable or specified for these types of tests.

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 is not an AI/ML diagnostic device requiring expert-established ground truth.

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

Not applicable. This is not an AI/ML diagnostic device requiring adjudication of expert interpretations.

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

Not applicable. This is not an AI-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/ML algorithm.

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

Not applicable. For this type of device, "ground truth" is defined by adherence to engineering specifications, material properties, and biological safety standards rather than diagnostic accuracy against a clinical reference.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm that has a "training set."

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

Not applicable.

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

The BD 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 consists of a needle, hub, and shield assembly. The BD Pen Needle is offered in a variety of needle gauge sizes (29G, 30G, 31G, and 32G) and lengths (4mm, 5mm, and 12.7mm). It is a single-use disposable device that is provided sterile. The BD Pen Needle is non-toxic and nonpyrogenic.

The provided text is a 510(k) summary for the BD Pen Needle, which is a medical device. This document is a regulatory submission to the FDA, asserting that the device is substantially equivalent to previously cleared devices. It does not describe a study proving the device meets acceptance criteria in the manner of a clinical trial or a performance study with reported metrics and statistical analyses.

Instead, the document states that the device has the "same technological characteristics as the predicate devices" and that BD has "validated the design of the subject device as part of its design control process in accordance with the Quality System Regulation." It also mentions "functional performance per ISO 11608-2: Needle-based injection systems for medical use - Requirements and test methods- Part 2: Needles." However, no specific acceptance criteria or performance results are provided in the document.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The document refers to ISO 11608-2 but does not detail what specific tests were performed, what the acceptance criteria for those tests were, or what the device's performance results were.
2. Sample size used for the test set and the data provenance: Not mentioned.
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 study involving expert ground truth.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
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, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable, as this is a physical medical device.
9. How the ground truth for the training set was established: Not applicable.

Summary of what is stated in the document regarding testing:

• Testing performed: "functional performance per ISO 11608-2: Needle-based injection systems for medical use - Requirements and test methods- Part 2: Needles."
• Purpose of the testing: To validate the design as part of BD's design control process and to support the compatibility of its pen needle devices with "all leading diabetes pen injectors available on the market to ensure connectivity and dose accuracy."
• Conclusion of testing: "This testing demonstrates the BD Pen Needle device meet requirements for its intended use and supports the proposed clarification."

The document focuses on demonstrating substantial equivalence based on similar technological characteristics and adherence to quality systems and relevant standards, rather than providing detailed study results against specific acceptance criteria.

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BD Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.

Like the predicate devices, BD pen needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes and lengths. BD Pen Needles are sterile (gamma irradiation sterilization), non-toxic and nonpyrogenic.

The pen needle assembly consists of a doubled-ended cannula that is assembled into an injection-molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen-injector device. This allows the Non Patient (NP) end of the cannula to penetrate through the rubber septum of the cartridge. The Patient end and NP end of the cannula are lubricated using silicone based lubes for ease of injection and rubber septum penetration. An injection-molded inner shield is assembled over the Patient end of the Cannula to protect the point from damage and accidental needlesticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away (tear drop) label to provide sterile barrier and tamper evidence. The outer cover is also used to remove the hub and cannula from the pen. The peel-away label is pre-printed with information, which includes the lot number and needle gauge / length. The individual needle assemblies are packaged in polybags and / or cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized to an SAL 10-6 by gamma irradiation. The above information is the same as the predicate device.

Here's a breakdown of the acceptance criteria and study information for the BD 31G and 32G Extra Thin Wall (XTW) Pen Needles with PentaPoint™, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states "Bench tests relating to the performance of the BD 31G and 32G XTW Pen Needle with PentaPoint™ were conducted." However, it does not specify the exact sample sizes used for each individual test.

The data provenance is prospective bench testing, conducted by Becton, Dickinson and Company. There is no information regarding country of origin of data beyond the manufacturer's location in Franklin Lakes, New Jersey, USA.

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

This document describes bench testing, which typically relies on established engineering principles, international standards (like ISO 11608-2 and ISO 7864), and standardized test methods rather than expert consensus on medical images or clinical data. Therefore, the concept of "experts establishing ground truth" in the context of medical image interpretation (e.g., radiologists) is not applicable to this type of device and study. The "ground truth" for these tests is defined by the technical specifications and performance criteria outlined in the ISO standards and internal test methods.

4. Adjudication Method for the Test Set

As this is bench testing against established performance standards, an adjudication method (like 2+1, 3+1, none) typically used for subjective assessments or disagreements in clinical trials is not applicable. The results are objectively measured against predefined thresholds in the standards.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the physical and mechanical performance of the pen needle against predicate devices and international standards, not on human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This device is a mechanical pen needle, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not applicable. The performance described is the device's inherent physical performance.

7. The Type of Ground Truth Used

The ground truth used for these bench tests is based on:

• International Standards: Primarily ISO 11608-2 (Pen-injectors for medical use - Part 2: Needles) and ISO 7864 (Sterile hypodermic needles for single use). These standards define specific measurement criteria, tolerances, and test methodologies.
• Manufacturer's Internal Test Methods: BD Test Method TP700279 for Penetration Testing and BD Test Method TP700381 for Thumb Force Testing.
• Predicate Device Performance: The primary goal of the study was to demonstrate equivalent performance to previously cleared predicate devices (K123300, K100005, K051899).

8. The Sample Size for the Training Set

Not Applicable. This is a mechanical device, and bench testing does not involve a "training set" in the context of machine learning or AI.

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

Not Applicable. See point 8.

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BD Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.

BD pen needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G and 32G) and lengths (4mm, 5mm, 8mm and 12.7mm). BD Pen Needles are sterile (gamma irradiation sterilization), non-toxic and non-pyrogenic. The pen needle assembly consists of a doubled-ended cannula that is assembled into an injection-molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen-injector device. This allows the Non Patient (NP) end of the cannula to penetrate through the rubber septum of the cartridge. The Patient end and NP end of the cannula are lubricated using silicone based lubes for ease of injection and rubber septum penetration. An injection-molded inner shield is assembled over the Patient end of the Cannula to protect the point from damage and accidental needle-sticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away (tear drop) label to provide sterile barrier and tamper evidence. The outer cover is also used to remove the hub and cannula from the pen. The peel-away label is pre-printed with information, which includes the lot number and needle gauge / length. The individual needle assemblies are packaged in polybags and / or cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized to an SAL 10 by gamma irradiation. The purpose of this Special 510(k) is to expand the needle range to include the 31G and 32G Extra Thin Wall (XTW) pen needles with PentaPoint™ design. The intended use for the modified device remains the same as the predicate devices. Also it is BD's intent to notify the Agency of a non-significant change to the cannula point bevel geometry from 3 bevels (PentaPoint™).

The provided document describes the BD 31G and 32G Extra Thin Wall (XTW) Pen Needles with PentaPoint™ and their performance testing to demonstrate substantial equivalence to predicate devices. It does not describe a study involving an AI/Machine Learning device or a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, some of the requested information regarding AI models, experts, adjudication methods, and training sets is not applicable based on the provided text.

Here's an analysis of the provided information, focusing on the acceptance criteria and performance studies for the pen needle:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each bench test. The studies are bench tests, meaning they are conducted in a controlled laboratory environment on the device itself, rather than with human subjects or patient data. Data provenance is not applicable in the sense of country of origin for patient data, as no patient data was used for these tests. The tests were performed internally by Becton, Dickinson and Company.

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

Not applicable. Ground truth for these performance metrics is established by the specifications defined in the international standards (ISO 11608-2 and ISO 7864) and the internal BD test method (TP700279), not by expert consensus on clinical data.

4. Adjudication method for the test set

Not applicable. The tests are direct measurements against predefined physical and performance specifications, not subjective interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is more relevant for imaging or diagnostic devices where human interpretation is involved.

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

Not applicable. The device described is a physical medical device (pen needle), not an algorithm or AI system.

7. The type of ground truth used

The ground truth used for these performance tests are:

• International Standards: ISO 11608-2 (Needle-based injection systems for medical use — Requirements and test methods — Part 2: Needles) and ISO 7864 (Sterile hypodermic needles for single use). These standards define objective, measurable specifications for the physical and functional characteristics of pen needles.
• Internal Test Method: BD Test Method TP700279 for penetration testing. While the details are not provided, it's assumed to be an objective, repeatable test method.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI or machine learning model 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 a physical medical device.

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BD Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.

BD pen needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G and 32G) and lengths (4mm, 5mm, 8mm and 12.7mm). BD Pen Needles are sterile (gamma irradiation sterilization), non-toxic and non-pyrogenic.

The pen needle assembly consists of a doubled-ended cannula that is assembled into an injection-molded hub using adhesive. The hub has internal threads, which allows it to be screwed onto the pen-injector device. This allows the Non Patient (NP) end of the cannula to penetrate through the rubber septum of the cartridge. The Patient end and NP end of the cannula are lubricated using a silicone based lube for ease of injection and rubber septum penetration. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peelaway (tear drop) label to provide sterility barrier and tamper evidence. The Outer cover is also used to remove the hub and cannula from the pen. The peel-away label is pre-printed with information, which includes the lot number and needle gauge / length. The individual needle assemblies are packaged in bags and / or cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized.

The purpose of the 510(k) is to expand the needle range to include the 23G x 7 mm pen needle size. Future needle range expansions may include 24G to 28G in various lengths for which appropriate verification and validation activities will be conducted. The intended use for the modified device remains the same as the predicate device.

The provided text describes the performance testing of the BD 23G X 7mm Pen Needle, focusing on its equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each bench test. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective. The tests are described as "bench tests," implying laboratory-based evaluations rather than clinical studies with human subjects.

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

This information is not applicable and not provided in the document. Bench testing for medical devices like pen needles typically relies on objective measurements against international standards (e.g., ISO) and internal design specifications, rather than expert consensus on subjective observations.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are not applicable to the described bench tests. These methods are typically used in clinical trials involving interpretation of medical images or patient outcomes, where human experts might disagree on subjective assessments. The tests for the pen needle are objective, measurable parameters.

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

No, an MRMC comparative effectiveness study was not done. The document describes bench tests comparing the new device to predicate devices on physical and mechanical properties, not a study involving human readers or AI assistance.

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

This is not applicable. The device is a physical medical instrument (pen needle), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests was established by international standards (ISO 11608-2, ISO 7864) and internal BD design verification protocols. These standards define the acceptable physical and mechanical properties of pen needles. For example, the patency of the lumen is verified by the passage of a stylet of a specific diameter, which is a direct, objective measurement against a defined standard, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical pen needle, not an AI model requiring a training set.

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

This information is not applicable, as there is no training set for a physical device like a pen needle.

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BD Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.

BD pen needles are single use, sterile, medical devices designed to be use in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G and 31G) and lengths (5mm, 8mm and 12.7mm). BD Pen Needles are sterile (gamma irradiation sterilization), nontoxic and non-pyrogenic. The pen needle assembly consists of a doubled-ended cannula that is assembled into an injection-molded hub using adhesive. The hub has internal threads, which allows it to be screwed onto the pen-injector device. This allows the Non Patient (NP) end of the cannula to penetrate through the rubber septum of the cartridge. The Patient end and NP end of the cannula are lubricated using a silicone based lube for ease of injection and rubber septum penetration. An injection-molded inner shield is assembled over the Patient end of the Cannula to protect the point from damage and accidental needlesticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away (tear drop) label to provide sterility barrier and tamper evidence. The Outer cover is also used to remove the hub and cannula from the pen. The peel-away label is pre-printed with information, which includes the lot number and needle gauge / length. The individual needle assemblies are packaged in bags and / or cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized. The purpose of this 510(k) Premarket Notification is to expand the product offering to include a 32G x 4mm Pen Needle. The intended use for the modified device remains the same as the predicate device.

This document describes the regulatory submission for the BD 32G x 4mm Pen Needle, demonstrating its substantial equivalence to predicate devices. The primary study presented is a clinical evaluation of glycemic control.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set (Clinical Study): The document does not explicitly state the sample size (number of subjects) for the clinical study "BDDC-08-011". It only mentions "subjects' glycemic control".
• Data Provenance: The document does not specify the country of origin for the clinical study data. It is a "clinical study conducted on the BD 32G x 4mm Pen Needle," indicating it was prospective.
• Test Set (Bench Testing): The document does not specify sample sizes for each bench test performed according to ISO 11608-2.

3. Number of Experts and Qualifications for Ground Truth

This type of submission (510(k) for a medical device like a pen needle) does not typically involve "experts" establishing ground truth in the way it would for AI/diagnostic algorithms.

• For the Clinical Study: The "ground truth" for glycemic control would be established through objective laboratory measurements (fructosamine levels) and clinical observation of safety profiles. While medical professionals (e.g., endocrinologists, nurses) would oversee the study, their role is not to establish a "ground truth" in the diagnostic sense, but to collect and interpret data against pre-defined clinical endpoints. No specific number or qualification of experts for "ground truth establishment" is provided or expected.
• For Bench Testing: The "ground truth" is based on adherence to the specified International Standard ISO 11608-2. This is based on objective, quantifiable measurements and visual inspections against defined criteria within the standard. The "experts" involved would be qualified technicians and engineers performing these standardized tests, but their qualifications are not detailed in the summary.

4. Adjudication Method

• Clinical Study: Not applicable in the context of diagnostic AI. Clinical endpoints are typically adjudicated by an independent committee (e.g., Clinical Events Committee) if there are subjective elements, but the document does not specify any such process. For glycemic control, the primary data (fructosamine levels) are objective.
• Bench Testing: Not applicable. Measurements are objective and compared against ISO standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This type of study is more relevant for diagnostic imaging or interpretation tasks where human readers might be assisted by AI. For a pen needle, the focus is on physical and functional performance and direct clinical outcomes like glycemic control, not AI-assisted interpretation.

6. Standalone (Algorithm Only) Performance Study

• No standalone (algorithm only) performance study was done. This device is a physical medical device (pen needle), not an AI algorithm. Therefore, "algorithm only performance" is not applicable.

7. Type of Ground Truth Used

• Clinical Study (BDDC-08-011): The ground truth for the clinical study was based on outcomes data, specifically "fructosamine levels" to assess glycemic control, and an evaluation of the "safety profile." Fructosamine is an objective biochemical marker indicating average blood glucose levels over a period.
• Bench Testing: The ground truth for bench tests was adherence to specified objective criteria and measurements as defined by the international standard ISO 11608-2.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical device and does not involve AI/machine learning algorithms that require a "training set."

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

• Not applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it is irrelevant in this context.

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Becton Dickinson Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.

The BD Pen Needles are designed for use with a pen injector for subcutaneous injection of a desired dose of a drug, including insulin and exenatide. The pen needle consists of a needle, hub, and shield assembly. The Becton Dickinson pen needles are offered in various gauges sizes (29G, 30G, and 31G) and lengths (5mm, 8mm, and 12.7mm). BD Pen Needles are sterile (gamma irradiation), non-toxic, and non-pyrogenic. The pen needles are disposable, single use devices.

The provided text does not contain specific acceptance criteria or details of a study that proves the device meets such criteria. Instead, it is a 510(k) summary for the BD Pen Needles, focusing on demonstrating substantial equivalence to a predicate device.

However, based on the information provided, here's what can be inferred and what is explicitly stated regarding performance and equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative or qualitative acceptance criteria (e.g., minimum tensile strength, flow rate parameters, sharpness index) are listed, nor is a study proving that these criteria were met described. The submission relies entirely on the assertion of "identical technological characteristics" and "equivalent performance" to the predicate device.

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

• Sample Size: Not specified. The document does not describe a test set or specific testing performed for this 510(k) submission.
• Data Provenance: Not applicable, as no new clinical or performance data is presented. The submission relies on the established safety and effectiveness of the predicate device.

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

• Not applicable. No ground truth establishment by experts is described, as no new performance data or clinical study results are provided for evaluation.

4. Adjudication method for the test set

• Not applicable. No test set or adjudication method is described.

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 medical needle, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a medical needle, not an algorithm.

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

• Not applicable. The submission is based on substantial equivalence and regulatory compliance with existing device performance standards for the predicate device, rather than new ground truth derived from a specific study for this submission.

8. The sample size for the training set

• Not applicable. No training set is mentioned as this is not an AI/ML device or a device requiring a training phase in this context.

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

• Not applicable. No training set is mentioned.

Summary of the Study (or lack thereof) to Prove Acceptance Criteria:

The 510(k) summary primarily argues for substantial equivalence to a predicate device ("BD Pen Needles" manufactured by the same company and "Disetronic PenFine Injection Pen Needles"). The core of the submission's "proof" is the statement that:

• "The BD Pen Needle and the predicate device have the identical technological characteristics and perform equivalently."
• The "only difference between the devices is that the principal device is indicated for delivery of exenatide."

Therefore, this 510(k) package does not describe a specific study with acceptance criteria, sample sizes, experts, or ground truth generation to "prove" the device meets acceptance criteria in the way one might expect for a novel device or a device requiring new clinical evidence. Instead, it asserts that because the device is technologically identical and performs equivalently to already cleared predicate devices, it is safe and effective when used as intended. The FDA's clearance (K051899) confirms they accepted this substantial equivalence argument.

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