Search Results

The Modified Easy-Ject Automatic Injector Device (also known as EZ-Ject) is an automatic injection device with a cooling mechanism for injection and needle withdrawal.

The Modified Easy-Ject Automatic Injector is a hand held device that performs automates a disk shaped cooling element that cools the skin prior to the needle injection. The Modified Easy-Ject Automatic Injector Device is an automatic injection device with a cooling mechanism for injection and needle withdrawal.

The provided text is a 510(k) summary for the EZ-JECT Automatic Injector Device. It describes the device, its intended use, and its comparison to a predicate device. However, it does not include information about acceptance criteria or a study proving the device meets acceptance criteria in the format requested.

The document is purely a regulatory submission, focusing on establishing substantial equivalence to a predicate device, rather than providing performance data against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

To answer your request, I would need a document that includes:

• A section explicitly defining acceptance criteria (e.g., "The device must achieve X performance metric with Y confidence").
• A study report detailing the methodology, results, and conclusions regarding those acceptance criteria.

Ask a specific question about this device