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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™ Safety Syringe is intended to inject fluid into, or withdraw fluid from the body. The safety mechanism aids in the prevention of needle stick injuries.

The UltiCare™ 3 mL Luer Lock Safety Syringes with Needle is a standard piston type syringe with a removable needle and protective shield. This sterile, single-use, disposable 3 ml piston syringes consist of a syringe barrel, plunger rod with gasket, removable single lumen needle, needle cap, and protective shield. The UltiCare Safety Syringes are non-toxic and non-pyrogenic, and will be available in a range of needle gauges and lengths between the smallest (27G x 5/16") and the largest (21G x 1 1/2").

This document is difficult to parse completely and does not contain all the information requested. This looks like a 510(k) summary for a medical device (UltiCare™ 3mL Luer Lock Safety Syringes with Needle), which demonstrates substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria based on algorithm performance.

However, I can extract information related to the device's performance testing as described in the summary, which is analogous to acceptance criteria for a physical device.

Here's what can be extracted:

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

For a physical medical device like a syringe, "acceptance criteria" often refer to compliance with recognized standards. The document states the device was "designed and successfully tested to meet the applicable requirements" of several ISO standards. Specific, quantitative acceptance criteria and their corresponding performance reported are not explicitly detailed in a table format in the provided text. Instead, the document provides a list of standards the device met.

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

The document does not specify the sample sizes used for the performance tests (e.g., how many syringes were tested for compliance with ISO standards). It also does not mention data provenance in terms of country of origin or retrospective/prospective for these engineering and material performance 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)

This is a physical device, not an AI algorithm involving interpretation. Therefore, the concept of "experts establishing ground truth" in the context of radiologists or similar interpretative tasks is not applicable. Compliance with standards would typically be verified by qualified testing laboratories and personnel, but no specific details are provided.

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

Not applicable for physical device testing against engineering 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, as this is not an AI algorithm but a physical medical device. The document explicitly states: "No prospective clinical trials were conducted in support of this Traditional 510(k)."

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

Not applicable, as this is not an AI algorithm.

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

For the performance testing, the "ground truth" or reference is defined by the specifications and methodologies outlined in the referenced ISO and USP standards. For example, for biocompatibility, the ground truth is "meeting the biocompatibility requirements of ISO 10993" including specific tests like "cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity testing, and hemocompatibility." For pyrogenicity, it's "successfully passed pyrogenicity testing (USP Rabbit Method)."

8. The sample size for the training set

Not applicable, as this is not an AI algorithm.

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

Not applicable, as this is not an AI algorithm.

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