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The DROPLET® PEN NEEDLES 30G & 33G are intended for use with pen injector devices for the subcutaneous injection of drugs.

DROPLET® PEN NEEDLES 30G & 33G 4G are sterile, single use needles intended for use with pen injector devices for the subcutaneous injection of drugs. The pen needles are OTC devices. 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 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 rubber septum penetration. There is an inner needle shield assembled over the patient end of the cannula to protect the needle point from damage and accidental needle sticks. There is also an outer cover. Each pen needle assembly is protected with a peel away seal to provide a sterility barrier.

The provided document is a 510(k) Premarket Notification for a medical device: Droplet Pen Needle 30G & 33G.

This document describes a submission for a new medical device seeking to demonstrate substantial equivalence to a previously cleared predicate device, not a study proving the device meets acceptance criteria for an AI/ML powered device. Therefore, much of the requested information regarding AI/ML device performance metrics, such as ground truth establishment with experts, MRMC studies, and training/test set details, is not applicable to this document.

However, I can extract the acceptance criteria and non-clinical performance data for this specific medical device, which are based on compliance with an international standard (ISO 11608-2:2012) and biocompatibility testing.

Here's a breakdown of the information that can be extracted and what cannot:

Information that can be extracted from the document:

• Acceptance Criteria (as defined by standard compliance) and Reported Device Performance: This is derived from the "Non-Clinical Performance Data" section.
• Sample size for the test set: Not explicitly stated as "test set" in the context of AI, but the non-clinical tests would have involved samples of the device. The document does not specify the number of units tested for each parameter.
• Data Provenance: The tests were performed by HTL-Strefa S.A. (Poland). The data is non-clinical, related to device performance in laboratory settings, not patient data.
• Type of Ground Truth: For this type of device, the "ground truth" is defined by the technical specifications and requirements outlined in the ISO standard and the results of various physical, chemical, and biological tests.

Information that CANNOT be extracted from the document (as it's not an AI/ML device submission):

• Number of experts used to establish ground truth
• Qualifications of those experts
• Adjudication method for the test set
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study
• Standalone (algorithm only) performance
• Sample size for the training set
• How the ground truth for the training set was established

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for Droplet Pen Needle 30G & 33G

As this is a submission for a physical medical device (hypodermic needle) and not an AI/ML powered device, the "acceptance criteria" are defined by compliance with relevant international standards and successful completion of non-clinical performance and biocompatibility testing. There is no AI model or human-in-the-loop performance measurement.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is demonstrated by its compliance with the requirements of ISO 11608-2:2012 Needle-based injection systems for medical use -- Requirements and test methods -- Part 2: Needles.

Biocompatibility Testing:

The device also successfully passed all required biocompatibility tests according to the 2016 FDA guidance Use of International Standard ISO 10993-1. These tests included:

• Cytotoxicity
• Sensitization
• Irritation or Intracutaneous Reactivity
• Acute Systemic Toxicity
• ISO Two Week Systemic Toxicity Study in the Rat, Repeated Parenteral Administration of Two Extracts
• Material-Mediated Pyrogenicity
• Hemocompatibility
  Reported Biocompatibility Performance: Did not show any adverse biological/biocompatibility reactions.

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

• Sample Size for Test Set: The document does not specify the exact number of units tested for each parameter within the non-clinical performance and biocompatibility testing. This information is typically detailed in the full test reports, which are summarized here.
• Data Provenance: The testing was conducted by HTL-Strefa S.A. based in Poland (ul. Adamówek 7, 95-035 Ozorków, POLAND). The data pertains to non-clinical laboratory testing of the physical device, not patient data, and is thus "prospective" in the sense that the new device was manufactured and then subjected to these tests.

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 submission. Ground truth for physical device performance is established by standardized testing methods and international standards, not by human expert consensus or annotation of data. The qualifications of the personnel conducting the tests would be subject to internal quality system requirements (e.g., ISO 13485).

4. Adjudication method for the test set

• Not applicable for this type of medical device submission. Adjudication methods like 2+1 or 3+1 are used in subjective assessments (e.g., image interpretation) where there might be disagreement among human readers or annotators. For objective physical device tests, results are typically measured and compared against defined thresholds.

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 hypodermic needle, not an AI-powered device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

• Not applicable. This device does not involve any algorithm.

7. The type of ground truth used

• The "ground truth" for this device is defined by the technical specifications and performance requirements outlined in the ISO 11608-2:2012 standard and the established biocompatibility criteria from ISO 10993-1. Performance is measured objectively against these established standards.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is a physical device, not an AI model.

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

• Not applicable. There is no "training set" or need for "ground truth establishment" in the AI/ML sense for this device.

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The DROPLET® PEN NEEDLE 34G is intended for use with pen injector devices for the subcutaneous injection of drugs.

DROPLET® PEN NEEDLES 34G are sterile, single use needles intended for use with pen injector devices for the subcutaneous injection of drugs. The pen needles are OTC devices. The pen needle assembly consists of a double-ended 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 cartridge end of the cannula to penetrate through the rubber septum of the cartridge. The patient end of the cannula are lubricated using a siliconebased lubricant for ease of injection and rubber septum penetration. There is an inner needle shield assembled over the cannula to protect the needle point from damage and accidental needle sticks. There is also an outer cover. Each pen needle assembly is protected with a peel away seal to provide a sterility barrier.

The provided text is a 510(k) Summary for the DROPLET® PEN NEEDLE 34G. It details the device's characteristics and compares it to predicate devices to establish substantial equivalence, rather than describing a study proving the device meets specific acceptance criteria in the context of diagnostic performance or clinical outcomes.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or cannot be extracted directly from this document. The document focuses on regulatory clearance based on substantial equivalence to existing devices, primarily through non-clinical performance and scientific rationale, rather than a clinical trial demonstrating diagnostic or treatment effectiveness against specific performance metrics.

However, I can extract the acceptance criteria related to non-clinical performance and the "study" (bench testing and validations) that demonstrates compliance with those criteria.

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

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

The document does not specify the exact sample sizes (N numbers) for each individual non-clinical test (e.g., how many needles were tested for flow rate, or how many units for package integrity). It refers to compliance with ISO standards which typically involve specific sampling plans. The data provenance is internal testing performed by HTL-STREFA S.A. (manufacturer located in Poland). The studies are non-clinical (bench testing, lab validations).

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 non-clinical device clearance based on engineering and material performance standards. There is no "ground truth" established by medical experts for diagnostic or clinical performance. Compliance with standards like ISO 11608-2:2012 is generally assessed by qualified technicians and engineers.

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

Not applicable. This is not a clinical study involving human reader interpretation. Test results are objective measurements against defined 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. This is a medical device (pen needle) and the submission is for non-clinical performance and substantial equivalence, not an AI-powered diagnostic or assistive technology.

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 device.

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

For non-clinical performance, the "ground truth" is adherence to established international standards and specifications (e.g., ISO 11608-2:2012 for needle performance, ISO 10993-1 for biocompatibility, ISO 11135-7:2014 for sterilization). These standards define acceptable limits and methodologies.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning model.

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

Not applicable. There is no "training set" as this is not a machine learning model.

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Droplet® Pen Needles are intended for use with pen injector devices for the subcutaneous injection of drugs.

The Droplet® Pen Needles are sterile, single use 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 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 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 rubber septum penetration.

There is an inner needle shield assembled over the patient end of the cannula to protect the needle point from damage and accidental needle sticks. There is also an outer cover. Each pen needle assembly is protected with a peel away seal to provide a sterility barrier.

This is a 510(k) summary for a medical device (pen needles), not an AI/ML device. Therefore, the requested information about acceptance criteria, study sizes, expert involvement, and ground truth establishment is not applicable in the context of AI/ML device evaluation.

The document describes non-clinical performance data for the pen needles as part of the substantial equivalence determination process for a Class II medical device.

Here's a breakdown of the relevant sections from the document that align with your request (non AI/ML related):

1. Table of Acceptance Criteria and Reported Device Performance: This information is available in the "Non-Clinical Performance Data" section on pages 7-9. It outlines the requirements from ISO 11608-2:2012 for various test parameters and states that the device met these requirements.

   Test Parameter	Requirement - ISO 11608-2:2012	Reported Device Performance
   Materials	The needle shall be made of tubing materials specified in ISO 9626.	Requirement met
   Dimensions	The needles shall fit the test apparatus specified in item 7.3 of ISO 11608-2.	Requirement met
   Determination of flow rate through the needle (not required by the standard)	The needle was tested in accordance with Annex A to ISO 11608-2 to determine flow rate through the needle.	Requirement met
   Bond between hub and needle tube	The union of the hub and needle tube shall not break when tested in accordance with Clause 9 of ISO 11608-2.	Requirement met
   Freedom from defects	The needle tube shall fulfill the requirements of ISO 7864, clause11.3.	Requirement met
   Lubrication	The needle tube should be lubricated at both the patient end and the cartridge end. The lubricant shall not, under normal or corrected-to-normal vision, be visible as droplets of fluid on the outside surface of the needle tube.	Requirement met
   Dislocation of measuring point at patient end	Dislocation of the cannula point at the patient end shall be in accordance with Table 2 when tested in accordance with Clause 8 (of ISO 11608-2).	Requirement met
   Determination of functional compatibility with needle-based injection systems	Compatibility with any NIS (Needle-based Injection System) shall be claimed only after testing in accordance with Clause 11.	Requirement met
   Ease of assembly and disassembly	Attachment of the needle shall be possible without removing the needle from its opened unit packaging. Compliance is checked according to the requirements of Clause 11.	Requirement met
   Pre-conditioning of needles	All requirements of the standard related to preconditioning of needles were met.	Requirement met

   Biocompatibility Test Summary:

   Test method	Compliance with	Result
   Cytotoxicity Study Using the ISO Elution Method	ISO 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity	The test article showed no evidence of causing cell lysis or toxicity.
   ISO Guinea Pig Maximization Sensitization Test	ISO 10993-10 - Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization	The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig maximization test.
   ISO Intracutaneous Study in Rabbits	ISO 10993-10 - Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization	The test article met the requirements of the test.
   ASTM Hemolysis Study	ASTM F756, Standard Practice for Assessment of Hemolytic Properties of Materials and ISO 10993-4 - Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood	Both the test article in direct contact with blood and the test article extract were non-hemolytic.
   ISO Two Week Toxicity Study in the Rat, Repeated Parenteral Administration of Two Extracts	ISO 10993-11 - Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity	There were no microscopic changes considered to be a test article related response. Parenteral administration of the test article extract did not produce systemic toxicity in rats.
   ISO Systemic Toxicity Study in Mice	ISO 10993-11 - Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity	There was no mortality or evidence of systemic toxicity from the extracts injected into mice. Each test article met the requirements of the study.
   USP Rabbit Pyrogen Study, Material-mediated	ISO 10993-11 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity	The total rise of rabbit temperatures during the 3 hour observation period was within acceptable USP limits. The test article was judged as non-pyrogenic.
   USP Pyrogen Study - Material Mediated	USP, General Chapter , Pyrogen Test as recommended by ISO 10993-11 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity	The test article was judged as nonpyrogenic.

2. Sample size used for the test set and the data provenance: This information is not specified in the document beyond the tests being performed in accordance with the listed ISO standards. The document doesn't provide details on the number of pen needles used for each specific test or the country of origin of the testing data. It only states the device "successfully passed all the required non-clinical testing." The nature of these tests (mechanical and biological safety testing) often does not involve human subjects, thus "retrospective or prospective" is not applicable in the typical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable to the non-clinical performance and biocompatibility testing described for a physical medical device like a pen needle. The "ground truth" for these tests is defined by the objective performance criteria outlined in the ISO and ASTM standards.

4. Adjudication method for the test set: Not applicable. The tests involve objective measurements against established technical standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is not about AI/ML or diagnostic imaging that involves human readers.

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

7. The type of ground truth used: For the non-clinical performance data, the ground truth is the objective technical specifications and safety requirements defined by international standards (ISO 11608-2:2012, ISO 9626, ISO 7864) and biocompatibility standards (ISO 10993 parts 5, 10, 11; ASTM F756; USP General Chapter ).

8. The sample size for the training set: Not applicable, as this is not an AI/ML device that undergoes training.

9. How the ground truth for the training set was established: Not applicable.

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The Droplet® Pen Needles are intended for use with pen injector device for the subcutaneous injection of insulin.

The Droplet® Pen Needles are sterile, single use needles designed to be used with commercially available pen-injectors for the subcutaneous injection of insulin. Pen needles are used by consumers, caregivers and healthcare professionals. 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 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 rubber septum penetration. There is an inner needle shield assembled over the patient end of the cannula to protect the needle point from damage and accidental needle sticks. There is also an outer protective container. Each pen needle assembly is protected with a peel away seal to provide a sterility barrier. To use a pen needle, the user needs to remove the seal, remove the outer protective cap and attach it to the pen injector. Then the user removes the inner protective cap to expose the needle and make an injection. Following the injection the user inserts the used pen needle into the outer cap to remove the pen needle from the pen injector and dispose of it immediately. The pen needle is individually packaged and sterilized with Gamma radiation. It is intended for single use only. Droplet® Pen Needles are available in the following lengths and gauges: 4 mm x 32G, 5 mm x 32G, 6 mm x 32G, 8 mm x 32G, 5 mm x 31G, 6 mm x 31G, 8 mm x 31G, 10 mm x 29G, 12 mm x 29G.

Here's a breakdown of the acceptance criteria and study information for the Droplet® Pen Needles, extracted from the provided text:

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 numerical sample sizes used for each specific test in the "Non-Clinical Performance Data" section. It broadly states that "Verification/Validation testing was done according to the requirements of ISO 11608-2:2012 as summarized below. All testing met the applicable requirements." Similarly, for biocompatibility, it states "The selection of biocompatibility tests was made based on the requirements of ISO 10993-1. All the tests have been successfully passed." The sterility testing states "Droplet® Pen Needles have passed all relevant sterility tests successfully."

The data provenance is for a manufacturing company located in Poland (HTL-Strefa S.A.). The data would be considered prospective as it's generated for the purpose of a 510(k) submission, meaning the tests were conducted specifically for this device to demonstrate its performance.

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

This information is not provided in the document. The tests performed are primarily engineering and laboratory-based, adhering to international standards (ISO), rather than relying on human expert assessment for "ground truth" in the way clinical studies or image interpretations might.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. The testing described is objective, standards-based, and performed in a laboratory/technical setting, rather than through expert human 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

There was no MRMC comparative effectiveness study done. This document describes a medical device (pen needles) that does not involve AI or human readers in an interpretive capacity.

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

There was no standalone (algorithm only) performance study done. This device is a physical medical instrument, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for the performance data in this submission is based on established international standards and objective measurement criteria. For example:

• Physical and mechanical properties are compared against the specifications in ISO 11608-2:2012 (e.g., materials per ISO 9626, bond strength per Clause 9, freedom from defects per ISO 7864).
• Biocompatibility is evaluated against the requirements of ISO 10993-1.
• Sterility is validated according to ISO 11137-1.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is a physical medical product, not an AI/machine learning model that requires a training set.

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

This information is not applicable/not provided, as there is no training set for this type of device.

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