(49 days)
The Innoject auto-injector is a semi-automatic injection system intended to be used for the manual transfer, containment and subcutaneous or intracavernosal injection of liquid drugs and biologics under the direction of a physician and according to approved drug or biologic labeling. The Innoject auto-injector system includes an automatic needle retraction mechanism that is intended to aid in the prevention of accidental needle sticks. The Innoject auto-injector system is intended to mask needle insertion, injection and needle withdrawal from patient view.
The Innoject auto-injector consists of a syringe cartridge with prefixed needle, power pack housing with spring loaded mechanism to insert a hypodermic needle into a patient to predetermined depth below the skin surface and a window tube with spring-loaded retraction mechanism. It is button actuated, and once activated, the device automatically performs all three steps of the injection process, needle insertion, drug injection and needle withdrawal. The Innoject auto-injector is individually packaged and ETO sterilized for single use.
The provided document describes the Innoject Auto-injector, a semi-automatic injection system. However, the document is a 510(k) premarket notification for substantial equivalence, not a detailed study report with specific acceptance criteria and performance metrics in the format requested.
The document states that "The device met all the requirements and specifications. In all instances, the Innoject auto-injector functioned as intended and the observed results were as expected." but does not provide the quantitative acceptance criteria or detailed results of these tests.
Therefore, much of the requested information cannot be extracted directly from this document.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not explicitly stated in quantitative terms) | Reported Device Performance |
|---|---|
| Dose accuracy | Met requirements/specifications, functioned as intended. |
| Dead space | Met requirements/specifications, functioned as intended. |
| Flow rate | Met requirements/specifications, functioned as intended. |
| Injection time / dwell time | Met requirements/specifications, functioned as intended. |
| Reliability (number of activations without failure) | Met requirements/specifications, functioned as intended. |
| Accuracy of penetration depth | Met requirements/specifications, functioned as intended. |
| Needle bond strength | Met requirements/specifications, functioned as intended. |
| Absence of leakage | Met requirements/specifications, functioned as intended. |
| Verification of non-coring needle properties | Met requirements/specifications, functioned as intended. |
| Needle penetration force | Met requirements/specifications, functioned as intended. |
| Device actuation force | Met requirements/specifications, functioned as intended. |
| Force necessary to defeat the button safety | Met requirements/specifications, functioned as intended. |
| Force necessary to remove the cap | Met requirements/specifications, functioned as intended. |
| Torque necessary to rotate the actuation button | Met requirements/specifications, functioned as intended. |
| Verification of syringe markings accuracy | Met requirements/specifications, functioned as intended. |
| Chemical resistance | Met requirements/specifications, functioned as intended. |
| Free fall resistance | Met requirements/specifications, functioned as intended. |
| Environmental stability | Met requirements/specifications, functioned as intended. |
Note: The document only generically states "The device met all the requirements and specifications" without providing the specific quantitative requirements (e.g., "Dose accuracy: +/- 5%").
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. This is likely internal testing data generated by Innoject, Inc., as per the "extensive testing performed by the company" statement, but details like country of origin or retrospective/prospective nature are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a medical instrument (hardware), and the performance data described relates to its physical and functional characteristics (e.g., mechanical forces, accuracy of fluid delivery, material properties), not diagnostic interpretation requiring expert ground truth establishment in the way an AI diagnostic tool would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 3 above.
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. This is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical auto-injector, not an algorithm. The document describes its standalone mechanical performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests conducted, the "ground truth" would be established by standard engineering and metrology principles and validated measurement techniques for each parameter (e.g., using calibrated scales for dose accuracy, force gauges for penetration force, timing devices for injection time). It's based on objective physical measurements against predefined engineering specifications, not expert consensus or medical outcomes data in the typical sense for a diagnostic device.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8 above.
§ 880.6920 Syringe needle introducer.
(a)
Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.(b)
Classification. Class II (performance standards).