(284 days)
The safety insulin needle for single use is intended for use with pen injector devices for the subcutaneous injection of insulin.
The proposed device, Safety insulin needle for single use is intended for use with pen injector devices for the subcutaneous injection of insulin. It consists of needle tube, hub, safety protective cover, self-destruction seat, spring, hub sheath, safety seat and sealed paper.
The Safety insulin needle for single use is offered in various gauge sized and length.
The proposed device is available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 10°.
The provided text is a 510(k) Summary for a medical device (Safety insulin needle for single use) seeking substantial equivalence to a predicate device. It details non-clinical tests conducted to support this claim, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically associated with performance metrics like sensitivity, specificity, or accuracy for an AI/diagnostic device.
The "acceptance criteria" discussed are compliance with various ISO and ASTM standards and the "study" is a compilation of non-clinical tests demonstrating adherence to these standards and the substantial equivalence to a predicate device. There is no AI component, nor is there a multi-reader multi-case study, stand-alone algorithm performance, or human-in-the-loop analysis mentioned.
Let's break down what is available in the text according to your requested categories:
1. A table of acceptance criteria and the reported device performance
The provided document doesn't present acceptance criteria in the form of performance metrics (like sensitivity/specificity) for a diagnostic device. Instead, it refers to compliance with established international standards for medical devices and biocompatibility.
| Acceptance Criteria Category | Specific Criteria/Standard (Implicit Acceptance) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | ISO 7864:2016 (Sterile hypodermic needles for single use) | Complied with (implicitly, tested and met requirements) |
| ISO 9626:2016 (Stainless steel needle tubing) | Complied with (implicitly, tested and met requirements) | |
| ISO 11608-2:2012 (Needle-based injection systems) | Complied with (implicitly, tested and met requirements) | |
| Material Performance | ISO 10993-1, -4, -5, -10, -11 (Biological evaluation of medical devices) | Complied with (implicitly, patient-contact materials conform to series of standards) |
| ASTM F88/F88M-15 (Seal Strength of Flexible Barrier Materials) | Complied with (implicitly, tested and met requirements) | |
| ASTM F1929-15 (Detecting Seal Leaks in Porous Medical Packaging) | Complied with (implicitly, tested and met requirements) | |
| USP Bacterial Endotoxins Test | Complied with (No pyrogen, Endotoxin Limit 20EU per device) | |
| Biocompatibility | Cytotoxicity standards (e.g., ISO 10993-5) | No cytotoxicity |
| Irritation standards (e.g., ISO 10993-10) | No intracutaneous reactivity | |
| Sensitization standards (e.g., ISO 10993-10) | No skin sensitization | |
| Systemic Toxicity standards (e.g., ISO 10993-11) | No systemic toxicity | |
| Hemolysis standards (e.g., ISO 10993-4) | No Hemolysis | |
| Pyrogen standards (e.g., USP ) | No Pyrogen (Endotoxin Limit 20EU per device) | |
| Sterilization | ISO 11135 (Ethylene Oxide Sterilization) | Sterilization parameter established to achieve SAL of 10^-6 |
| ISO 10993-7 (Ethylene Oxide Sterilization Residuals) | Complied with (implicitly, tested and met requirements) | |
| SAL (Sterility Assurance Level) | 10^-6 | |
| Other | Single Use confirmation | Yes |
| Labeling compliance (21 CFR part 801) | Complied with |
2. Sample sized 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 sample sizes for individual tests. It states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications" and that "all the needle sizes of proposed device have been tested" and "all the needle lengths of the proposed device have been validated and tested". The data provenance is not explicitly stated beyond the manufacturer being Berpu Medical Technology Co., Ltd in China. These are laboratory/physical tests, not clinical data sets in the typical sense.
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. This device is a physical medical instrument (safety insulin needle), not an AI/diagnostic software. Ground truth in this context would refer to objective measurements of physical properties and biological responses according to established standards, not expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 3.
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. The device is a physical safety insulin needle. There is no AI component or human reader interaction in the way an MRMC study would assess.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is defined by the requirements and test methods outlined in the cited ISO and ASTM standards. This involves objective measurements of physical properties (e.g., needle dimensions, seal strength), chemical residues (e.g., EO residuals), and biological responses (e.g., cytotoxicity tests in cell cultures, systemic toxicity in animal models per ISO 10993 series).
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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).