(50 days)
These sets are indicated for the subcutaneous infusion of medication, including insulin from compatible infusion pumps.
Not Found
The provided text is a 510(k) summary for an infusion set and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed performance study with acceptance criteria and results in the way one would expect for an AI/ML device.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not mentioned in this document because it describes a medical device (infusion set) for which performance is typically verified through engineering testing against specifications, rather than clinical studies involving ground truth establishment by experts as seen in diagnostic AI/ML applications.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states: "Verification testing confirmed the product meets their specifications." It does not provide numerical acceptance criteria or specific performance metrics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Product meets its specifications | Confirmed |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document refers to "Verification testing" without detailing the sample size for these tests.
- Data Provenance: Not applicable. The "tests" would be engineering/bench tests of the physical device, not data from a human population.
- Retrospective/Prospective: Not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. Ground truth as understood in AI/ML (e.g., expert consensus on images) is not relevant for the performance verification of an infusion set.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret data, often with and without AI assistance. This document describes an infusion set, which is a physical device.
- Effect size of human reader improvement: Not applicable.
6. If a Standalone (Algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This device is a physical product, not an algorithm.
7. The Type of Ground Truth Used:
- The term "ground truth" as typically used for AI/ML devices is not applicable here. Performance was likely confirmed against engineering specifications using physical measurements and tests (e.g., flow rate, material compatibility, durability).
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
Summary Rationale:
The provided document is a 510(k) summary for an infusion set, which is a physical medical device. The 510(k) process primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. For such devices, performance data typically comes from engineering and bench testing to ensure the product meets its pre-defined specifications, rather than from clinical studies involving human data and expert ground truth establishment that is characteristic of AI/ML diagnostic or prognostic devices. Therefore, most of the questions derived from an AI/ML context are not relevant to this specific submission. The key performance statement is general: "Verification testing confirmed the product meets their specifications."
§ 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.