(53 days)
The Medtronic MiniMed Paradigm Reservoir MMT-332 is indicated for the subcutaneous infusion of medication, including insulin, from the Paradigm family of infusion pumps and infusion sets. The reservoir is not indicated for use with blood.
The Medtronic MiniMed Paradigm™ Reservoir Model MMT-332 is a disposable, single use medication container intended for use with the Mediconic MiniMed external micro infusion pumps. The reservoir shall be packaged together with a plunger rod and a transfer guard for use in filling the reservoir from a medication vial.
The provided text describes a 510(k) premarket notification for the Modtronic MiniMod Paradigm™ Reservoir MMT-332. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical study results with specific acceptance criteria and performance metrics typically found in efficacy studies.
Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not present in this type of regulatory submission. The 510(k) summary primarily addresses the device's description, intended use, and comparison to its predicate.
Here's a breakdown based on the provided text, indicating where information is present and where it is absent for your specific questions:
1. A table of acceptance criteria and the reported device performance
This information is not present in the 510(k) summary. A 510(k) for this type of device typically relies on demonstrating that the new device does not raise new questions of safety and effectiveness compared to a legally marketed predicate, often through bench testing and, in some cases, limited animal or human use data without specific "acceptance criteria" and "reported device performance" in the way one might expect for a diagnostic or AI-driven device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present. The submission does not detail a "test set" in the context of clinical performance evaluation.
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 information is not present. The concept of "ground truth" established by experts for a test set is not applicable to this type of device submission as described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present. Adjudication methods are not relevant to this type of regulatory submission.
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 information is not present. An MRMC study is not relevant to this type of device (a medication reservoir) and its 510(k) submission. There is no AI component mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present. "Ground truth" in the context of performance accuracy is not discussed for this device.
8. The sample size for the training set
This information is not present. There is no "training set" in the context of this device.
9. How the ground truth for the training set was established
This information is not present. There is no "training set" or "ground truth" discussed for this device.
Summary of the K032005 Submission:
- Device Name: Medtronic MiniMed Paradigm™ Reservoir Model MMT-332
- Predicate Device: Medtronic MiniMed Paradigm™ Reservoir Model MMT-326
- Key Modification: Differences in "volume, filling mechanism, and infusion set connector" compared to the predicate.
- Regulatory Focus: To demonstrate that these modifications have "no untoward effect on the safety and effectiveness of the device" and that the new device is "substantially equivalent" to the predicate. This is a common approach for 510(k) submissions, where direct comparative clinical trials for novel performance criteria are usually not required unless new questions of safety or effectiveness are raised.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).