(84 days)
The Medtronic MiniMed Leapfrog II Infusion Set is indicated for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed infusion pump.
The Medtronic MiniMed® Leapfrog II Infusion Sct. models MMT-801S1, MMT-801L1, MMT-801L2, MMT-801L2, MMT-803S1, MMT-803L1, MMT-803S2, and MMT-803L2, are single use infusion administration sets intended for use with an external infusion pump, such as the Medtronic MiniMed® infusion pump.
The infusion administration set attaches proximally to a medication reservoir by means of a female Luer connector and is inserted into the subcutancous tissue of the user distally through an indwelling catheter made of Fluorinated Ethylene (FEP). Fluid is administered through multi-layer tubing to an indwelling catheter. The indwelling catheter is introduced into the subcutaneous tissue by means of a removable introducer needle. The introducer needle is housed in a plastic needle hub and protected by a plastic needle guard. The needle guard is removed before insertion.
The indwelling catheter is affixed to a plastic base unit. The plastic base unit functions as a site for connection and disconnection. The adhesive patch is integral to the base and is used to secure the unit to the user.
The provided text is a 510(k) summary for a medical device (Medtronic MiniMed Leapfrog II Infusion Set). This type of document is for premarket notification and focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than detailed performance studies or AI algorithm validation. Therefore, most of the information requested in your prompt (acceptance criteria, specific study details, sample sizes, ground truth establishment, MRMC studies, standalone performance, expert qualifications, etc.) is not present in this document.
The document primarily describes the device, its intended use, and states that its technological features are comparable to predicate devices, with a specific modification to the attachment mechanism that "does not affect the safety or effectiveness of the device." This implies that the device is expected to perform similarly to its predicates, but no specific performance metrics or studies are directly described to prove this in the context of the requested details.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. This document does not specify quantitative acceptance criteria or report particular performance metrics beyond stating that a design modification "does not affect the safety or effectiveness."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not describe any specific testing involving a "test set" of data or samples in the way an AI algorithm would be evaluated.
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)
- Cannot be provided. This is not relevant to a 510(k) for an infusion set, which is a physical medical device, not an AI diagnostic tool.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. See point 3.
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
- Cannot be provided. See point 3. This is entirely irrelevant to the type of device described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. See point 3. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. See point 3.
8. The sample size for the training set
- Cannot be provided. See point 3.
9. How the ground truth for the training set was established
- Cannot be provided. See point 3.
Summary of available information relevant to "proving device meets acceptance criteria," albeit in a limited sense for this type of document:
The primary "proof" in a 510(k) process is demonstrating substantial equivalence to legally marketed predicate devices. The document states:
- Predicate Devices: Unomedical A/S (formerly Maersk Medical), model Contour Infusion Set (Quick-set®), and Avail Medical Products Inc., Sof-Site™ Infusion Set, models MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, and MMT-358L9.
- Technological Comparison: "The modified device and the lawfully marketed predicate devices contain similar materials of construction. Features of the modified device are comparable to those of the predicate devices with the exception of the modified attachment mechanism that offers multiple alignments and locking sites for the attachment to the site connection. This modification does not affect the safety or effectiveness of the device."
The "acceptance criteria" here are implicitly tied to the safety and effectiveness profile of the predicate devices. The "study" (or rather, the justification presented in the 510(k)) is this comparison, asserting that the new device's modification does not negatively impact its safety or effectiveness relative to the predicates. Specific test results or performance data are not typically included in the public 510(k) summary, although they would be part of the full submission for FDA review.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.