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The Syringe Grip for the AVONEX prefilled syringe is a reusable device indicated for the self-administered injection of a fixed dose of AVONEX from a pre-filled syringe through a single lumen hypodermic needle. The devices are intended to be used in any setting including the home.

The Syringe Grip for the AVONEX pre-filled syringe is a reusable, grip/handle that is designed to assist the user with the Intramuscular injection of 0.5 mL of AVONEX from a prefilled syringe and single lumen hypodermic needle. The syringe is securely snapped into the one-piece plastic grip/handle for the primary purpose of providing patients more surface area, hence leverage, with which to hold the syringe while performing manual injections. Using the Syringe Grip for the AVONEX pre-filled syringe instead of direct injection with the re-filled syringe offers the patient a more comfortable and ergonomic handle to more easily only and inject the drug. The AVONEX pre-filled syringes and commercially available single humen hypodermic needles are provided separately.

The provided text describes a 510(k) summary for the "Syringe Grip for the AVONEX pre-filled syringe," a medical device designed to assist patients in self-administering injections.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "The device has no functional requirements so performance data is not applicable." Therefore, there was no formal test set, sample size, or data provenance related to a performance study mentioned for this device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. As stated above, no performance study requiring ground truth establishment was conducted or deemed necessary.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC comparative effectiveness study was not performed. The device is a physical aid, not an AI or imaging diagnostic tool.

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

Not applicable. The device is a mechanical aid, not an algorithm.

7. The Type of Ground Truth Used

Not applicable.

8. The Sample Size for the Training Set

Not applicable. There was no mention of a training set for this device, as it is a mechanical aid and not a learning-based system.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of the Study:

The "study" presented in this 510(k) pertains to demonstrating substantial equivalence to legally marketed predicate devices, rather than a performance study with quantitative metrics.

The core of the submission relies on:

• Comparison to Predicate Devices: The Syringe Grip is compared to the Invisiject reusable auto-injector (K032425) and the Carpuject syringe holder (K820164). The key difference highlighted is that the Syringe Grip is a manual device, while the predicate is a spring-assist device.
• Design Rationale: The firm states that the device is designed to securely capture the syringe and provide a more comfortable and ergonomic grip for the patient during self-injection.
• Absence of Functional Requirements: A crucial point is the statement: "The device has no functional requirements so performance data is not applicable." This indicates that the regulatory body, in this context, did not require a formal performance study with acceptance criteria linked to quantitative measurements or clinical outcomes for this specific type of accessory. The acceptance criteria were therefore implicitly met by its design and its substantial equivalence to other legally marketed devices with similar intended use.

In essence, the "study" for this device was a regulatory submission demonstrating that its design and intended use are sufficiently similar to existing devices to be considered substantially equivalent, without the need for a separate performance validation study.

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