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The UltiCare™ Disposable Pen Needles are used with pen injector devices for the subcutaneous injection of drugs.

The UltiCare™ Disposable Pen Needles are sterile, single-use, hypodermic single lumen needles designed for use with pen injectors for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. The UltiCare™ Disposable Pen Needles consist of a double-ended cannula, a needle hub, a needle shield and the needle primary container. The UltiCare™ Disposable Pen Needles are non-toxic and are available in a variety of needle sizes (29 gauge to 32 gauge) and lengths (5/32" to 1/2").

The provided text is a 510(k) summary for a medical device, the UltiCare™ Disposable Pen Needles. This document primarily focuses on establishing substantial equivalence to a predicate device through non-clinical performance testing and comparison of characteristics. It does not describe an AI medical device or a study involving human readers or AI assistance.

Therefore, I cannot provide the information requested in your prompt as it pertains to AI/algorithm performance, multi-reader multi-case studies, ground truth establishment for AI models, or training sets, because this document describes a physical medical device (pen needles) and not an AI-powered one.

The document details the following about the UltiCare™ Disposable Pen Needles:

• Acceptance Criteria and Device Performance: The primary acceptance criteria for this device are its compliance with various ISO standards, specifically ISO 11608-2:2012 for needles and ISO 10993-1 for biocompatibility, and meeting the requirements outlined in those standards. The document explicitly states that the device "Meets requirements" for all listed parameters from ISO 11608-2:2012.

  Test Parameter	Clause no. & requirement of ISO 11608-2:2012	Reported Device Performance Results
  Materials	4.1 The needle shall be made of tubing materials specified in ISO 9626.	Meets requirements
  Dimensions	4.2 The needles shall fit the test apparatus specified in item 7.3 of ISO 11608-2.	Meets requirements
  Determination of flow rate through the needle	4.3 The needle was tested in accordance with Annex A to ISO 11608-2 to determine flow rate through the needle.	Meets requirements
  Bond between hub and needle tube	4.4 The union of the hub and needle tube shall not break when tested in accordance with Clause 9 of ISO 11608-2.	Meets requirements
  Needle points	4.5 When examined under a magnification of x2,5, needle points shall appear sharp and free from feather edges, burrs and hooks.	Meets requirements
  Freedom from defects	4.6 The needle tube shall fulfill the requirements of ISO 7864, 11.3.	Meets requirements
  Lubrication	4.7 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.	Meets requirements
  Dislocation of measuring point at patient end	4.8 Dislocation of the cannula point at the patient end shall be in accordance with ISO 11608-2 Table 2 when tested as per Clause 8 (of ISO 11608-2).	Meets requirements
  Determination of functional compatibility with needle-based injection systems	4.9 Compatibility with any NIS shall be claimed only after testing in accordance with Clause 11.	Meets requirements
  Ease of assembly and disassembly	4.10 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.	Meets requirements
  Sterility	4.11 The needle in its unit packaging shall has been subjected to a validated sterilization process.	Meets requirements
  Pre-conditioning of needles	6 All requirements of the standard related to preconditioning of needles were met	Meets requirements
  Biocompatibility	Testing per ISO 10993-1 (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemocompatibility, Subacute/subchronic toxicity)	Did not show any adverse biological/biocompatibility reactions.

  The document concludes that "UltiCare Disposable Pen Needles successfully passed all the required non-clinical testing."

• Sample size and data provenance: Not applicable in the context of an AI study. The tests apply to the design and manufacturing of the physical pen needles.

• Number of experts and qualifications: Not applicable for establishing ground truth as this is a physical device measured against engineering and biological standards, not an AI model requiring human interpretation of data. The "expertise" lies in the adherence to ISO standards and good manufacturing practices.

• Adjudication method: Not applicable.

• MRMC Comparative Effectiveness Study: Not applicable. Clinical data was stated as "not required" for this device.

• Standalone Performance: The performance described is the standalone performance of the physical device according to specified international standards.

• Type of Ground Truth: The ground truth for this device is based on international standards (ISO 11608-2:2012, ISO 10993-1, USP ) and engineering specifications (e.g., specific dimensions, material properties).

• Sample size for training set: Not applicable as this is not an AI/machine learning device.

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

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The UltiCare Disposable Pen Needles are used with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.

The UltiCare Disposable Pen Needles are sterile, single-use, Type A, hypodermic single lumen needles designed for use with insulin pen injector devices. The UltiCare Disposable Pen Needles consist of a double-ended cannula, a needle hub, a needle shield and the needle primary container. The UltiCare Disposable Pen Needles are non-toxic and non-pyrogenic, and are available in a variety of needle sizes (29 gauge to 32 gauge) and lengths (3/16" to 1/2").

The provided document describes the UltiMed UltiCare Disposable Pen Needles and their substantial equivalence to predicate devices, rather than an AI device. As such, the typical acceptance criteria and study designs for AI/ML devices, such as those related to effect size for human readers with AI assistance, standalone algorithm performance, or training set details, are not applicable.

The acceptance criteria for the UltiMed UltiCare Disposable Pen Needles are based on meeting established voluntary standards and FDA guidance for medical devices of this type, demonstrating substantial equivalence to predicate devices. The study conducted to prove the device meets these criteria is primarily non-clinical performance testing and biocompatibility testing.

Here's the information based on the document:

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 a "test set" in the context of an AI/ML algorithm. For the non-clinical performance testing of the pen needles, the sample sizes for the various tests (e.g., those detailed in ISO standards) are not explicitly stated. This would typically be defined within the test protocols for each specific standard. The data provenance is implied to be from laboratory testing conducted by UltiMed Inc.

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 an AI/ML context is not relevant for this device. The "ground truth" for the device's performance is determined by its physical and material properties meeting the specifications of the referenced ISO standards.

4. Adjudication method for the test set

Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth from multiple expert opinions, neither of which is described for this device.

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 an AI device.

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

Not applicable, as this is not an AI device.

7. The type of ground truth used

The "ground truth" for this device's performance is based on objective measurements and adherence to established voluntary international and national standards. For example, for mechanical properties, there would be measurable criteria outlined in ISO 7864; for biocompatibility, the results of tests outlined in ISO 10993-1 would form the ground truth; for sterilization, the validation to ISO 11135.

8. The sample size for the training set

Not applicable, as this is not an AI device and therefore has no "training set."

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

Not applicable, as this is not an AI device and therefore has no "training set."

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