(77 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 nonpyrogenic, and are available in a variety of needle sizes (29 gauge to 31 gauge) and lengths (3/16" to 1/2").
The provided text is related to a 510(k) submission for UltiCare Disposable Pen Needles and discusses substantial equivalence, not detailed acceptance criteria or a study proving device performance in the way typically required for AI/ML-based diagnostic devices.
The document states that the UltiCare Disposable Pen Needles are "substantially equivalent in intended use, function and basic composition" to predicate devices, and that they "meet the following standards: ISO 11608-2, ISO 9626, ISO 7864." These ISO standards themselves contain specific requirements and test methods that, if met, serve as the de facto acceptance criteria and the "study" demonstrating their fulfillment.
However, the 510(k) summary does not provide the detailed results of these tests, sample sizes, ground truth establishment, or expert involvement as would be required for a performance study of a device that requires image analysis or complex expert interpretation. This is because pen needles are physical medical devices with established performance characteristics defined by international standards for manufacturing and materials, rather than devices that use algorithms to process and interpret data.
Therefore, for your current request format, much of the information you've asked for is not applicable or not explicitly detailed in this type of regulatory submission for this specific physical device.
Here's an attempt to answer your questions based on the provided text, while acknowledging its limitations for an AI/ML context:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly the requirements outlined in the specified ISO standards. The "reported device performance" is the statement that the device "meets" these standards, indicating compliance.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| ISO 11608-2: Pen-injectors for Medical Use - Part 2: Needles - Requirements and Test Methods | The UltiCare Disposable Pen Needles meet this standard. |
| ISO 9626: Stainless Steel Needle Tubing for Manufacture of Medical Devices | The UltiCare Disposable Pen Needles meet this standard. |
| ISO 7864: Sterile Hypodermic Needles for Single Use | The UltiCare Disposable Pen Needles meet this standard. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided document. The sample sizes would be determined by the testing protocols within the ISO standards, but the specific numbers for this submission are not given.
- Data Provenance: Not applicable in the context of clinical data for AI. For physical device testing against ISO standards, the tests are typically performed in a laboratory setting by the manufacturer or a certified testing facility to evaluate manufacturing quality and material properties. The country of origin of the data would be the location of the manufacturing or testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable for this type of device and regulatory submission. "Ground truth" in the context of expert consensus is relevant for diagnostic devices interpreting complex data (e.g., medical images, pathology slides). For pen needles, the "ground truth" is established by direct physical measurements, material science tests, and sterility tests performed according to the ISO standards. There isn't a need for expert consensus on an interpretation.
4. Adjudication method for the test set
- This is not applicable as there is no expert interpretation or consensus-based ground truth being established. The "adjudication" is whether the device's physical and material properties meet the objective, quantifiable requirements of the ISO 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
- No, this was not done. This type of study is completely irrelevant for a physical medical device like a pen needle. MRMC studies are designed for diagnostic support systems, particularly those involving human interpretation of complex data with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, this was not done. Again, this concept applies to AI/ML algorithms, not to a physical medical device like a pen needle.
7. The type of ground truth used
- The "ground truth" for pen needles is based on objective, quantifiable physical and material properties, and sterility parameters as defined by the referenced ISO standards (e.g., needle gauge, length, material composition, penetration force, cannula integrity, sterility). It is not pathology, outcomes data, or expert consensus in the diagnostic sense.
8. The sample size for the training set
- Not applicable. This device does not involve an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth to be established for it.
§ 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).