(50 days)
The SteadiSet infusion set is indicated for the subcutaneous infusion of insulin administered by an external pump. The infusion set is indicated for single use.
The subject device, SteadiSet infusion set, is a sterile, non-pyrogenic, intravascular administration set device used to administer insulin from a reservoir cartridge to a patient subcutaneously through a cannula. The infusion set administers insulin by means of a compatible external pump.
The infusion set consists of an inserter, tube set, and disconnect cover. The inserter consists of a housing, insertion buttons, an infusion set hub (with cannula) and adhesive patch with protective liner. The inserter facilitates insertion of the cannula subcutaneously. The cannula is a soft medical-grade polymer extruded over a stainless-steel coil.
The tube set provides the insulin pathway between the hub's indwelling cannula and an external insulin pump cartridge. The tube set consists of infusion set tubing with a reservoir connector (proximal end) and hub connector (distal end).
The disconnect cover can be connected to the hub to provide cover when the infusion set tubing is disconnected from the hub.
The device is sterilized by Ethylene Oxide (ETO) and is a single-patient, single-use device.
This FDA 510(k) clearance letter pertains to a medical device, the SteadiSet infusion set, not an AI or software as a medical device (SaMD). Therefore, many of the requested elements for AI/SaMD studies (such as sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or not found within this type of documentation for a physical infusion set.
However, I can extract the relevant information regarding the clinical trial conducted for the device.
Acceptance Criteria and Study for SteadiSet Infusion Set
Based on the provided FDA 510(k) clearance letter for the SteadiSet infusion set, the "acceptance criteria" are not explicitly defined as specific numerical thresholds for performance metrics (such as sensitivity or specificity) in the way they would be for an AI model. Instead, the "acceptance criteria" are implied by the overall demonstration of safety and effectiveness as required for substantial equivalence to a predicate device.
The study that proves the device meets (these implied) acceptance criteria is a clinical study.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic/Acceptance Criteria (Implied) | Reported Device Performance (from Clinical Study) |
|---|---|
| Safe for a maximum of 7 days of use | No device-related serious adverse events reported. |
| Effective for a maximum of 7 days of use | Demonstrated effectiveness for insulin infusion for a maximum of 7 days of use. |
| Substantially Equivalent to Predicate Device (K242692) | Concluded to be substantially equivalent (SE) to the predicate device, despite some technological differences, as these differences "do not raise new questions of safety and effectiveness." |
2. Sample Size and Data Provenance for Test Set (Clinical Study)
- Sample Size: A total of 260 subjects were enrolled.
- Data Provenance: The clinical study was conducted in the US at 15 investigational centers. This indicates prospective, real-world data collection in a clinical setting.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. For a physical medical device like an infusion set, "ground truth" is typically established through direct clinical observation of patient outcomes (safety and effectiveness) rather than expert consensus on diagnostic images or data. The assessment of safety and effectiveness would have been based on clinical endpoints and observed adverse events, which are measured directly.
4. Adjudication Method for Test Set
- Not Applicable. Clinical trial outcomes (adverse events, device function) are typically evaluated by the investigational site staff and potentially reviewed by a clinical events committee, but the concept of "adjudication method" as applied to expert consensus for AI ground truth does not directly apply here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study is relevant for diagnostic imaging AI, comparing human reader performance with and without AI assistance. It is not applicable to a physical infusion set.
6. Standalone Performance Study
- No, not in the context of an algorithm. The clinical study did evaluate the standalone performance of the device (the infusion set itself) in 260 subjects. However, this definition of standalone performance does not refer to an algorithm without human-in-the-loop, as the device is a physical product directly interacting with the patient.
7. Type of Ground Truth Used
- Clinical Outcomes Data: The ground truth was established by direct observation of clinical outcomes, specifically the absence of device-related serious adverse events and the demonstration of effective insulin infusion over the study period (maximum of 7 days).
8. Sample Size for Training Set
- Not Applicable. This device is a physical product, not an AI model requiring a training set.
9. How Ground Truth for Training Set Was Established
- Not Applicable. As there is no AI model or training set, this question is not relevant.
§ 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.