(91 days)
The Invisiject™ Reusable Auto-Injector is a reusable device indicated for use by the patient to assist with the self-administered injection of a fixed dose of AVONEX® from a pre-filled syringe through a single lumen hypodermic needle. The auto-injectors are intended to be used in any setting including the home.
The Invisiject" Reusable Auto-Injector is a reusable, spring-loaded injection device that is designed to deliver 0.5 mL of AVONEX® from a pre-filled syringe. Using the Auto-Injector instead of direct injection with the pre-filled syringe provides an alternative method of injection to address needle phobia and injection anxiety by covering the svringe and needle during the injection process. The product consists of four separate components that are used to prepare and inject the drug from the pre-filled syringe through the single lumen hypodermic needle. The components, a Syringe Adapter, Syringe Holder, Base Unit, and Power Pack are packaged together in a plastic case, which doubles as the Handling Console used for assembly and charging the Power Pack. The AVONEX® pre-filled syringes and commercially available single lumen hypodermic needles are provided separately.
The Invisiject™ Reusable Auto-Injector is not an AI/ML device. The provided text is a 510(k) summary for a medical device that assists in the self-administration of injections. Therefore, many of the typical questions regarding acceptance criteria for AI/ML devices (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies) are not applicable to this document.
However, I can extract the acceptance criteria and performance information that is relevant to this traditional medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Applicability to ISO 11608-1 | Met applicable sections and methods of ISO 11608-1, "Pen-injectors for Medical Use - Part 1: Requirements and Test Methods" |
| Penetration depth | Assessed and met requirements/specifications |
| Activation force for injection | Assessed and met requirements/specifications |
| Loading force | Assessed and met requirements/specifications |
| Injection time | Assessed and met requirements/specifications |
2. Sample size used for the test set and the data provenance
Not applicable. This is not an AI/ML device, and the performance assessment was based on physical device testing according to an ISO standard, not a data-driven test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/ML devices (e.g., expert consensus on medical images) is not relevant here. Device performance was assessed against engineering specifications derived from an ISO standard.
4. Adjudication method for the test set
Not applicable.
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/ML device and no MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance assessment was established by the requirements and test methods specified in the ISO standard, ISO 11608-1, "Pen-injectors for Medical Use - Part 1: Requirements and Test Methods," along with specific engineering specifications for penetration depth, activation force, loading force, and injection time.
8. The sample size for the training set
Not applicable. This is not an AI/ML device and does not have a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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).