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The Accu-Chek LinkAssist is an insertion device, which is intended specifically for placement of compatible Accu-Chek infusion sets.

The Accu-Chek LinkAssist is an insertion aid for automatic application of the Accu-Chek infusion sets with compatible adapter. It permits introduction of the infusion set cannula into the subcutaneous fatty tissue.

The Accu-Chek LinkAssist is made of plastic and stainless steel components and has spring loaded mechanisms. The device is non-invasive, non-sterile and intended for multiple uses by the same patient. The connection between the Accu-Chek LinkAssist device and the infusion set is established by means of a compatible sterile adapter.

This 510(k) submission for the Accu-Chek LinkAssist, K063146, does not contain the detailed information required to fulfill your request regarding acceptance criteria and a study proving device performance.

Here's why and what information is available:

The document explicitly states: "Performance and functional testing of the Accu-Chek LinkAssist have been verified and validated and no new issues were raised regarding safety and effectiveness." However, it does not provide the specific acceptance criteria, the study design, or the results of this testing.

Therefore, I cannot populate the table or answer the specific questions about sample size, ground truth, expert involvement, or comparative effectiveness.

Information that can be extracted from the provided text:

510(k) Summary for Accu-Chek LinkAssist (K063146)

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

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.
• Data Provenance: Not specified.

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 as no specific human expert evaluation in performance testing is described for establishing ground truth.

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

• Not specified.

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 insertion aid, not an AI or imaging diagnostic device that would involve human "readers."

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

• This device is a standalone mechanical device. Its performance testing would be focused on its mechanical function, not an algorithm.

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

• Not specified. For a mechanical device, ground truth would typically refer to objective measurements of its function (e.g., proper insertion depth, force, ease of use).

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not a machine learning model that requires a "training set."

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

• Not applicable.

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