(108 days)
These sets are indicated for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.
Comfort™ and Inset™ Subcutaneous Infusion Sets For Use with the Abbot Pump
Based on the provided documents, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Product meets its specifications | Verification testing confirmed the product meets its specifications. |
| Substantial Equivalence to Predicate Devices (Unomedical Comfort K972135 and Inset K032854) | The new products are substantially equivalent to products currently legally marketed in the USA. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states "Verification testing confirmed the product meets their specifications." However, it does not specify the sample size used for this testing, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective nature).
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 provided in the document. The submission is for a medical device (subcutaneous infusion set), not an AI/imaging device requiring expert ground truth establishment in the typical sense. The "ground truth" here would be the device's adherence to its mechanical/performance specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable to this type of device submission. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or performance assessment, which is not the primary focus for a physical infusion set.
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
An MRMC comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic tools or imaging devices, not for a subcutaneous infusion set.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical medical device (infusion set), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" for the performance data would be the engineering specifications and functional requirements of the infusion set. The verification testing would have assessed these against objective measurements (e.g., fluid flow rate, connection integrity, material strength, biocompatibility, etc.). The document does not explicitly state the specific types of ground truth used, but it implies adherence to design and performance specifications.
8. The sample size for the training set
This is not applicable. There is no "training set" for a physical medical device like an infusion set. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
§ 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.