Search Results

The Autoject® II for glass syringe is a non-sterile fully automatic injection device. The device is intended for the self-administration of an FDA approved drug. The device is designed for use with 1ml fixed needle pre-filled glass syringe, for use in the home to aid, support and reduce patient liked needle phobia. It has been developed to provide a safe and simple procedure to the patient.

The 'Autoject® II for glass syringe' is composed of simple plastic injection moulded parts and stainless steel springs. The device is a non-sterile, handheld mechanical device intended for self-administered, subcutaneous delivery of an FDA approved drug. The device is designed for use with 1ml fixed needle pre-filled glass syringe, for use in the home to aid, support and reduce patient liked needle phobia. It has been developed to provide a safe and simple procedure to the patient.

Here's a breakdown of the acceptance criteria and study information for the Autoject® II for glass syringe, based on the provided document:

Acceptance Criteria and Reported Device Performance

Note: The submission device generally meets or improves upon the performance of the predicate device. The only significant difference highlighted is the reduced maximum stress exerted on the syringe, which is an improvement.

Study Information

1. Sample size used for the test set and the data provenance:
   • The document does not specify the exact sample size for each individual test (e.g., number of devices tested for force, length, etc.).
   • The data provenance is from non-clinical performance data conducted by Owen Mumford Ltd in the United Kingdom. It is a retrospective comparison against an existing predicate device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   • This information is not provided in the document. The tests seem to be objective engineering and performance verification tests rather than human-expert-based evaluations for ground truth.
3. Adjudication method for the test set:
   • This information is not applicable/provided as the tests are objective performance measurements, not based on expert adjudication.
4. 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 comparative effectiveness study was not done. The device is a mechanical injection device, not an AI-powered diagnostic or assistive tool for human readers.
   • The document explicitly states: "Clinical performance data has not been submitted, and is therefore not included in this Special 510(k) document."
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   • This question is not applicable as the device is a mechanical auto-injector, not an algorithm or AI system.
6. The type of ground truth used:
   • The "ground truth" for the performance comparisons comes from engineering specifications, physical measurements, and Finite Elemental Analysis (FEA) for the mechanical properties and operation of the device, directly compared to the predicate device's established performance.
7. The sample size for the training set:
   • This question is not applicable as the device is a mechanical auto-injector, not a machine learning model that requires a training set.
8. How the ground truth for the training set was established:
   • This question is not applicable as the device is mechanical and does not use a training set.

Ask a specific question about this device