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The MiniMed Quick-serter is indicated to use as an aid for inserting compatible devices. It is for use by a single patient. It is not for use by multiple patients.

The modified MiniMed Quick-serter (MMT-305) is a non-sterile, single patient, multi-use, hand held accessory product designed to be used as an insertion aid for compatible devices, including specific infusion sets. It is used to insert the introducer needle and cannula through the skin and into the subcutaneous tissue. The MiniMed Quick-serter is intended to be used by a patient or clinician as a means to insert an infusion set with minimum discomfort and technique dependency.

The MiniMed Quick-serter consists of a plastic barrel containing a stainless steel spring and a handle. The device user places and securely seats the infusion set into the MiniMed Quick-serter is loaded and locked by pulling the handle (compressing the spring) until it clicks/locks into place. The serter is placed in contact with the insertion site and fired to release the infusion set. This is done by depressing the green side buttons to release the spring, which drives the infusion set forward and the insertion needle and cannula are inserted into the user's subcutaneous tissue. The release button on the top of the device is then pressed to ease the release of the infusion set from the serter.

The provided text describes a 510(k) submission for the "MiniMed Quick-serter" (MMT-305) and compares it to a predicate device (MMT-395). This device is a syringe needle introducer, and the submission is focused on demonstrating substantial equivalence, not necessarily on detailing a study proving the device meets acceptance criteria in the way one would for a novel AI/software medical device.

Therefore, the information I can extract will be specific to the type of device and submission, which involves engineering and biocompatibility testing rather than clinical study protocols for diagnostic accuracy or comparative effectiveness with human readers.

Here's the breakdown based on the provided text:

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

The document lists performance testing that was conducted to verify the device's mechanical properties and functions. The "acceptance criteria" are implied by the statement "Results from performance testing indicate that the product meets the established performance requirements." Specific numerical acceptance criteria are not explicitly detailed for each test in this summary, but the reported device performance for some characteristics is given in the comparison table.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size for individual tests. The tests performed are engineering/mechanical verification, biocompatibility, and usability evaluations, not clinical studies with a "test set" in the context of patient data. The data provenance is internal to Medtronic MiniMed, and the tests are prospective, conducted on the device itself.

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)

This is not applicable to the type of device and testing described. "Ground truth" in this context would refer to established engineering standards, material science properties, and biocompatibility guidelines. The "experts" involved would be engineers, material scientists, and toxicologists conducting and evaluating the tests. No specific number or qualifications are mentioned for this section of the submission. A "Usability Evaluation" was performed, which would involve users, but details on "experts" for ground truth are not provided.

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

This is not applicable. Adjudication methods are typically for clinical trials or diagnostic studies where there might be disagreement in expert opinions on patient data. The tests described are objective engineering and biocompatibility evaluations.

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

This is not applicable. The device is a mechanical introducer, not AI software or a diagnostic tool.

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

This is not applicable. The device is a mechanical device with a human user performing the insertion.

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

The "ground truth" for the performance data in this submission aligns with:

• Established engineering standards: For tests like Cocking Force, Trigger Force, Life Cycle testing, Drop Test, etc., the ground truth is based on predefined engineering specifications and internal standards.
• International standards and regulatory guidance: For biocompatibility testing, the ground truth is based on standards such as ISO 10993-1, -5, -10, -18 and FDA #G95-1 guidance.
• Industry standards: For tasks like Ship Test (ASTM D4169) and Cleaning studies (AAMI TIR12, TIR30).

8. The sample size for the training set

This is not applicable. The device is a mechanical product, not a machine learning model that requires a training set.

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

This is not applicable for the reasons stated above.

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