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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.

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The Autoject 2 is a hand held mechanical device intended for a self-administered automated subcutaneous injection of FDA approved drugs. The device is designed for use with a 1ml glass fixed needle syringe, for use in the home by the patient or care-giver to aid and support a recommended treatment regime.

The Autoject 2 O.T.C is a hand held non-sterile semi-automatic device using pre-filled 1ml glass syringes capable of a subcutaneous injection of FDA approved drugs. The devices are designed for re-usable use to aid and support patient/ care-giver use in the home with a treatment regime.

The provided text describes a medical device, the Autoject 2, and indicates that a 510(k) premarket notification was submitted and found substantially equivalent to a predicate device. However, the document does not contain details about specific acceptance criteria, comprehensive study designs, or detailed performance metrics that would typically be found in a robust study report proving a device meets acceptance criteria.

The information primarily focuses on the device's description, intended use, and a list of tests performed. It mentions "User Trials" but provides no specifics on their methodology or results beyond a general statement of "success."

Therefore, I cannot populate all the requested sections with specific, quantitative data. I will extract what is available and clearly state what information is not present in the provided text.

Here's an attempt to answer based solely on the provided text, highlighting the absence of detailed information:

1. A table of acceptance criteria and the reported device performance

Note: The document only lists tests and states "proving the correct action" or "clearly indicates the success." It does not provide specific acceptance criterion values (e.g., "Force to Fire < 10N") or quantitative results for these tests.

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 (Test Set): Not specified. The document mentions "User Trials" and "a number of tests" but does not quantify the number of devices or subjects used in these tests.
• Data Provenance: Not specified. The country of origin of the data is not mentioned, nor is it explicitly stated whether the data is retrospective or prospective. It is implied to be prospective testing for this 510(k) submission.

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/Not specified. For a mechanical device like Autoject 2, "ground truth" would typically refer to objective measurements of force, function, and drop test outcomes, and user feedback. The document does not describe the involvement of "experts" in establishing ground truth for these performance tests or user trials.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/Not specified. The document does not describe any adjudication methods, as this is typically relevant for subjective assessments, particularly in image interpretation or complex diagnostic scenarios, which are not detailed here.

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 device is a mechanical syringe needle introducer, not an AI diagnostic assistant. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a mechanical medical device, not an algorithm. Performance tests would inherently involve the device acting "standalone" in its mechanical functions, but this terminology typically applies to AI algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests would be objective physical measurements (e.g., force, direct observation of function, adherence to environmental conditions) and for the user trials, it would be patient/caregiver preference data (likely survey responses or qualitative feedback). The document provides no details on how this "ground truth" was rigorously established or quantified.

8. The sample size for the training set

Not applicable. This is a mechanical device, not a machine learning model, so there is no "training set" in the context of AI.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for a mechanical device.

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