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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").

AI/ML Overview

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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