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Baxter Healthcare Corporation intends to manufacture and market solution administration sets with an alternate design of the spike and drip chamber components.
The provided text is a 510(k) Summary for a medical device (Modified Solution Administration Sets). This document focuses on the description of the device and a summary of nonclinical tests. It does not contain information about clinical studies, acceptance criteria for performance metrics like sensitivity or specificity, or details about ground truth establishment.
Therefore, I cannot fulfill your request for the following reasons:
- No Acceptance Criteria or Reported Device Performance for Clinical Metrics: The document only mentions "functional requirements" for nonclinical tests (air passage, air leakage, tensile strength) and states the device "will meet or exceed all functional requirements." It does not provide specific numerical acceptance criteria (e.g., "sensitivity > 90%") or reported device performance for these types of clinical metrics.
- No Clinical Study Details: The document describes nonclinical tests only. There is no mention of a study involving human subjects, diagnostic accuracy, or any performance metrics that would require ground truth, expert review, or statistical analysis of clinical outcomes.
- No Information on Sample Sizes, Data Provenance, Experts, MRMC Studies, or Standalone Performance: Since no clinical study is described, there's no information about sample sizes for test sets or training sets, data provenance, the number or qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance. The device described (solution administration sets) is a physical medical device, not an AI/algorithm-based diagnostic tool.
In summary, the provided text does not contain the type of information required to answer your specific questions, which are geared towards evaluating AI/diagnostic software performance using clinical study data.
§ 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.