(208 days)
The OmniPICC P.I. is intended to be used by medical professionals in patients who require either acute or long-term (chronic) peripheral central venous access for the infusion of medications, nutritional or other parenteral solutions, or blood products, and for the withdrawal of blood samples.
The OmniPICCPI Peripherally Inserted Central Catheter is indicated for use in attaining short and long term vascular access for administrations, parenteral nutrition, IV fluids, blood products or blood withdrawal. The catheter may be inserted via the basilic, cephalic and medial veins of the upper extremity. The catheter is intended for implantation dwell time of shorter or greater than 30 days. The maximum recommended infusion rate is 5ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.
The OmniPICCPI is indicated for power injection of contrast media at a maximum recommended infusion rate of 5ml/sec and maximum pressure or pounds per square inch (psi) of 300 psi.
The Peripherally Inserted Central Catheter (OmniPICC P.I.) kit includes a catheter and introduction components. The catheter is a percutaneous catheter inserted peripherally. The catheter is comprised of radiopaque polyurethane tubing. The catheter is attached to an injection molded polyurethane hub with extension leg(s) for access via a luer lock device. Each product is packaged in a sterile tray with appropriately sized introducer components. This PICC product line includes externally communicating central venous catheters of 60 cm that is trimmable from the distal end with a single 5 Fr lumen configuration. These are tested to withstand power injection of 5 cc/sec at a maximum power injection setting of 300 psi.
The provided text is a 510(k) summary for the OmniPICC P.I. (Peripherally Inserted Central Catheter). It focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through an AI/Machine Learning lens.
Therefore, I cannot fulfill your request for information regarding:
- A table of acceptance criteria and reported device performance (in the context of AI/ML).
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study, including effect size.
- Standalone algorithm performance.
- Type of ground truth used (beyond general clinical indications).
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory submission for a medical device (a catheter), not an AI/ML product. The "acceptance criteria" discussed in such a document would typically refer to engineering specifications, biocompatibility, sterilization, and mechanical testing, not the performance metrics of an AI model against a ground truth.
If you have a document describing the validation of an AI/ML medical device, I would be happy to analyze it against your specified criteria.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”