(72 days)
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
| Acceptance Criterion (Voluntary Standard / FDA Guidance) | Reported Device Performance |
|---|---|
| ISO 7864 (Sterile hypodermic needles for single use) | Successfully met applicable requirements. |
| ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices) | Successfully met applicable requirements. |
| ISO 11608-2 (Pen-injectors for medical use - Part 2: Needles) | Successfully met applicable requirements. |
| ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) | Materials successfully passed testing. |
| ISO 11135 (Sterilization of health care products - Ethylene oxide) | Sterilization validated using the half-cycle method. |
| ISO 10993-7 (Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals) | Levels of residues of ethylene oxide and its byproducts will not exceed limits presented. |
| Internal Standards | Additional performance testing conducted to internal standards. |
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."
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).