(86 days)
Indicated for subcutaneous delivery of medicine, including insulin, from an external infusion pump.
Not Found
I'm sorry, but your document, which is an FDA 510(k) clearance letter, does not contain the specific information needed to answer your request about acceptance criteria and a study proving device performance.
This document primarily states that the FDA reviewed Medx-Set Limited's LIGHTY DD INFUSION SET and determined it to be "substantially equivalent" to legally marketed predicate devices. This is a regulatory finding that focuses on equivalence, not on detailed performance studies or specific acceptance criteria and their fulfillment via a study report.
Here's a breakdown of why the requested information isn't available in your provided text:
- Acceptance Criteria and Reported Device Performance (Table): The document does not define any specific performance metrics (e.g., flow rate accuracy, leak rate, biocompatibility results) or numerical acceptance criteria for those metrics. It also doesn't report any device performance results against such criteria.
- Sample Size, Data Provenance, Experts for Ground Truth, Adjudication Method: These details are typical of a clinical or performance study report, which is not what this FDA clearance letter is. The letter doesn't mention any specific test sets, ground truth establishment, or expert involvement.
- MRMC Comparative Effectiveness Study: There is no mention of a multi-reader multi-case study, human reader improvement with AI, or AI assistance. The device is an infusion set, not an AI-powered diagnostic tool.
- Standalone (Algorithm Only) Performance: As the device is an infusion set, there is no "algorithm" or standalone performance of an AI system to report.
- Type of Ground Truth: This concept is relevant for AI or diagnostic devices where a "true" condition needs to be established. An infusion set's performance is typically evaluated through engineering tests, physical properties, and safety assessments rather than ground truth against a clinical diagnosis.
- Training Set Sample Size and Ground Truth Establishment (for Training Set): These are again concepts specific to machine learning or AI model development, which is not applicable to a physical medical device like an infusion set.
In summary, the provided FDA 510(k) clearance letter is a regulatory document confirming substantial equivalence, not a detailed performance study report. Therefore, it does not contain the information you are seeking regarding acceptance criteria and performance study details.
§ 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.