(14 days)
The DOSI-FUSER is designed to provide parenteral drug infusions at a constant flow without impeding patient mobility. It is indicated for patients requiring slow infusion of medication, which may be administered intravenously or via intra-arterial, epidural or subcutaneous routes. The device allows patients to be mobile, thus making it suitable for ambulatory use.
DOSI-FUSER is an Elastomeric Infusion Pump. It is a sterile and disposable infusion device, that operates by the action of compression of the elastomeric balloon that contains the liquid to instill. The liquid is supplied at a constant flow rate.
DOSI-FUSER is a system for continuous and portable infusion of medication with a self-pressured container. It is a sterile and disposable device.
The fluid contained in the balloon passes to the tube connected to the reservoir, goes through the filter (where particles in the fluid are retained and air bubbles are removed) and reaches the capillary. which fixes the flow rate that the patient will receive. The connector at the extreme of the tube must obviously be connected to a cannula. needle, etc. that contacts the blood vessel.
The provided text is a 510(k) summary for the DOSI-FUSER, an elastomeric infusion pump. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes for test/training sets, expert qualifications, or adjudication methods.
Therefore, I cannot populate the requested table and answer the detailed questions based on the provided input.
The document primarily focuses on establishing substantial equivalence to a legally marketed predicate device (SINGLEDAY INFUSOR 2 ml./h) for market clearance, rather than presenting a performance study with detailed acceptance criteria and supporting data.
Here's what can be gathered from the provided text, and what cannot:
- 1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The document is a 510(k) summary for regulatory clearance, not a detailed performance study report.
- 2. Sample sized used for the test set and the data provenance: This information is not present.
- 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 present.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not present.
- 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: This information is not present. The device is an elastomeric infusion pump, not an AI-assisted diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present. The device is an elastomeric infusion pump, not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not present.
- 8. The sample size for the training set: This information is not present.
- 9. How the ground truth for the training set was established: This information is not present.
In summary, the provided document is a regulatory submission for device clearance and does not contain the detailed performance study data requested.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).