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The Medtronic MiniMed MicroMed 407C Drug Infusion Pump is indicated for infusion of medication labeled subcutaneous and intrathecal infusion. The pump is intended for therapies at set and variable rates, for therapies including, but not limited to chemotherapy, antibiotic therapy, and controlled analgesia.

The MicroMed 407C external pump is a syringe-reservoir, rate-programmable pump designed for infusion of medication labeled for subcutaneous and, intratheral infusion, at set and variable rates, as prescribed by the user's physician. The 407C is restricted to sale by or on the order of a physician, It is not intended nor indicated for the delivery of blood products. The principal features of the 407C Medication Pump also known as the MicroMed 407C described in this submission are: The features of device that is the subject to this submission are identical to those of the predicate device (K991013). The only change is expansion of the indications for use to include intrathecal in fusion.

This document is a 510(k) summary for the Medtronic MiniMed MicroMed 407C infusion pump. It details a request for an expanded indication for use to include intrathecal infusion, in addition to the previously cleared subcutaneous infusion.

Here's an analysis of the provided text in relation to your questions, noting that this particular document mostly focuses on regulatory submission and equivalency, and therefore lacks significant detail regarding a device performance study with acceptance criteria.

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

Based on the provided text, there is no specific table of acceptance criteria or performance metrics reported for this device in the context of a new study. The submission focuses on demonstrating substantial equivalence to a predicate device for an expanded "indications for use."

The document states: "The features of device that is the subject to this submission are identical to those of the predicate device (K991013). The only change is expansion of the indications for use to include intrathecal infusion. This change to the indications for use will have no untoward effect on the safety and effectiveness of the device."

This implies that because the device itself hasn't changed structurally or functionally from its predicate, and the expanded indication is for a similar type of infusion route (just a different anatomical location), a detailed new performance study with specific acceptance criteria beyond simply demonstrating "no untoward effect on safety and effectiveness" for the new route might not have been
deemed necessary or explicitly documented within this summary. It relies on the existing safety and effectiveness profile of the identical predicate device.

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

Not applicable. The document does not describe a clinical performance study with a test set. It relies on demonstrating substantial equivalence to a predicate device.

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. No test set or ground truth establishment by experts is described in this regulatory summary.

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

Not applicable. No test set or adjudication method is described.

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 an infusion pump, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI is irrelevant to this submission.

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

Not applicable. This device is an infusion pump, not an algorithm.

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

Not applicable. No ground truth is described as part of a performance study. The "ground truth" for the regulatory submission is based on the previously cleared predicate device's established safety and effectiveness.

8. The sample size for the training set

Not applicable. The document does not describe the development or training of a software algorithm or model.

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

Not applicable. No training set or ground truth establishment for a training set is described.

Summary of what the document does provide:

• Device Name: MicroMed 407C
• Predicate Device: Medtronic MiniMed Model 407C Medication Pump (K991013) and SIMS Deltec CADD-Micro, Model 5900.
• Key Change: Expansion of Indications for Use from "subcutaneous administration only" to include "subcutaneous and intrathecal infusion."
• Reason for Substantial Equivalence: The technological features of the device are "identical" to the previously cleared 407C Medication Pump. The change is solely in the indication for use, with the assertion that this change will have "no untoward effect on the safety and effectiveness."
• Intended Use: Infusion of medication labeled for subcutaneous and intrathecal infusion, at set and variable rates, for therapies including chemotherapy, antibiotic therapy, and controlled analgesia.

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