(23 days)
Verifine® Pen Needle is intended for use with pen injector device for the subcutaneous injection of drugs.
Verifine® Pen Needles, manufactured by Promisemed Hangzhou Meditech Co., Ltd, are designed for use with pen injectors for the administration of drugs. These are standard pen needles without integrated safety features. The devices are single-use, non-pyrogenic, and maintain a Sterility Assurance Level (SAL) of 10 °. The differences between the PromiseMed current cleared common type needle pen and the new design primarily involve changes to the trade name, the addition of new models, and modifications in some materials and dimensions. Key updates include a change in the trade name, the introduction of new models (FPN and NPN), the addition of new needle sizes and a 5-bevel needle tip option, and a shift from a specific intended use (administering insulin) to a general intended use (administering drugs). The materials used have also been slightly modified, such as changing the needle shield material from polypropylene (PP) to polyethylene (PE) for certain models, which only contact intact skin, ensuring no increased risk. These devices are intended for over-the-counter (OTC) use and require manual insertion by the user during drug administration.
The provided text is a 510(k) summary for a medical device (Verifine® Pen Needles). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new device meets acceptance criteria through a clinical or performance study that quantifies specific metrics like sensitivity, specificity, accuracy, or human reader improvement with AI assistance.
The context of your request (acceptance criteria, effect size, MRMC studies, ground truth) is typical for the evaluation of AI/ML-enabled medical devices, especially those involving image analysis or diagnostic support. The provided document describes a physical medical device (hypodermic needle) where the primary concerns are mechanical performance, biocompatibility, and compatibility with existing pen injectors. Therefore, information related to AI/ML device evaluation criteria is largely not applicable to this document.
Here's a breakdown of why many of your excellent questions cannot be answered by this document, followed by what can be extracted:
Why most questions are not applicable:
- AI/ML Device Evaluation: The document does not describe an AI/ML device. It's a pen needle. Therefore, concepts like "effect size of human readers improve with AI vs without AI assistance," "standalone (algorithm only) performance," "number of experts for ground truth," "adjudication method," "sample size for training set," or "data provenance" (in the context of image data) are irrelevant.
- Clinical Performance Data: The summary explicitly states: "No clinical data was necessary to determine the substantial equivalence of this device." This means there was no human-centric clinical study (like an MRMC study) performed to evaluate the diagnostic or treatment benefits in a clinical setting against a "ground truth" established by experts.
What can be extracted or inferred from the document regarding acceptance criteria and device performance for this physical device:
The "acceptance criteria" here are implied by the standards and bench testing performed to demonstrate substantial equivalence to the predicate device and compliance with relevant ISO standards.
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on demonstrating that changes to the device (new models, sizes, material change, labeling updates) do not raise new questions of safety or effectiveness and that the modified device still meets the performance attributes of the predicate and relevant standards.
| Acceptance Criterion (Implied) | Reported Device Performance (as stated or inferred) |
|---|---|
| Mechanical/Dimensional Compliance | |
| - Conformance to drawing requirements for needle dimensions | "The needle's dimensions, including the container, shield, and hub, were measured, and found to comply with drawing requirements." |
| Performance (Functional) | |
| - Dose Accuracy (per ISO 11608-2) | "The testing confirmed that the needles meet the performance criteria outlined in ISO 11608-2." |
| - Needle Removal Torque (per ISO 11608-2) | "The testing confirmed that the needles meet the performance criteria outlined in ISO 11608-2." |
| Biocompatibility | |
| - Non-toxicity of needle shield material (PE) (per ISO 10993-1) | "The new material [PE] was tested and found to be biocompatible and non-toxic as per ISO 10993-1." |
| "Results confirmed that the material is non-toxic and safe for use." | |
| - Non-cytotoxicity (PE) | Tested for cytotoxicity, results confirmed non-toxic. |
| - Non-skin irritation (PE) | Tested for skin irritation, results confirmed non-toxic. |
| - Non-intracutaneous reactivity (PE) | Tested for intracutaneous reactivity, results confirmed non-toxic. |
| - Non-sensitization (PE) | Tested for sensitization, results confirmed non-toxic. |
| Sterility | "Maintain a Sterility Assurance Level (SAL) of 10-6." (Stated in Device Description as a characteristic). |
| Labeling Compliance | |
| - Metric size labeling compliance on unit packaging (per ISO 11608-2) | "Visual inspections were conducted on unit packaging to ensure metric size labeling compliance with ISO 11608-2." |
| - Updated indications for use, warnings, directions, compatible pens | "These changes are meeting for requirement of ISO 11608-2:2022." |
| General Safety & Effectiveness | "The tests demonstrated that the product modifications did not introduce any new risks related to safety or effectiveness when compared to the predicate device." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in terms of a "test set" as one would for an AI/ML model or a clinical trial. However, non-clinical performance and biocompatibility testing were conducted. The sample size for these specific engineering tests (e.g., how many needles were tested for dose accuracy) is not detailed in this summary.
- Data Provenance: The tests were "completed by Promisemed Hangzhou Meditech Co., Ltd." (China). The data origin is thus the manufacturer's testing facilities. The tests are "non-clinical" (benchtop/lab-based), not from patients. It's not retrospective or prospective in the sense of clinical data collection.
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):
- Not Applicable. Ground truth, in the AI/ML sense (e.g., expert consensus on clinical images), is not relevant here. Performance is measured against engineering specifications and international standards (ISO).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No adjudication method for expert review of data is mentioned or relevant.
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. An MRMC study was NOT done. This type of study is specifically for evaluating diagnostic performance of AI/ML systems with human readers. The device is a physical pen needle, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. There is no algorithm or software being evaluated for standalone performance. Performance tests are against ISO standards for the physical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For this device, the "ground truth" or reference for performance is established by international standards (e.g., ISO 11608-2 for pen needles, ISO 10993-1 for biocompatibility) and the manufacturer's engineering specifications/drawing requirements. It is not clinical diagnostic ground truth.
8. The sample size for the training set:
- Not Applicable. The concept of a "training set" is for AI/ML models. This is a physical device.
9. How the ground truth for the training set was established:
- Not Applicable. Same as above.
§ 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).