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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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