(8 days)
The Pain Care™ 4200 is indicated to provide continuous infusion for the post-operative management of pain.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a medical device. The document is an FDA 510(k) clearance letter for a device called "Pain Care 4200," indicating that it has been found substantially equivalent to a predicate device.
The clearance letter primarily states:
- Device Name: Pain Care 4200
- Regulation Number: 880.5725 (Infusion Kit)
- Regulatory Class: II
- Product Code: MEB
- Indications For Use: To provide continuous infusion for post-operative management of pain.
It does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any test set.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Information about MRMC comparative effectiveness studies.
- Results of standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Therefore, I cannot fulfill your request with the given input.
§ 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).