(132 days)
Provide controlled, continuous, intravenous fluid therapy for ambulatory patients.
An infusion pump used to pump fluids into a patient in a controlled manner.
The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study report with quantified performance metrics for the Prepare™ Home Infusion Pump. The 510(k) summary primarily states that the device has been "functionally tested to confirm documented performance which demonstrates substantial equivalence to the predicate device."
Therefore, I cannot populate all sections of your request. However, I will extract and present the available information to the best of my ability, indicating where data is not provided in the input.
Acceptance Criteria and Study Details for Prepare™ Home Infusion Pump
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device | Confirmed documented performance. Demonstrates substantial equivalence to the predicate device (Homepump, Block Medical, Inc.) in design, material, intended use, and function. |
| Safety and Effectiveness | Deemed safe and effective for its intended use and meets all regulatory requirements to be found substantially equivalent. |
| Controlled, Continuous Intravenous Fluid Therapy | Functions to pump fluids into a patient in a controlled manner. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "functional testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The concept of "ground truth" as typically applied in AI/diagnostic studies (e.g., expert consensus on medical images) does not directly apply to the functional testing of an infusion pump, which would likely involve engineering and performance specifications.
4. Adjudication method for the test set
- Not applicable/Not specified. Functional testing of a physical device like an infusion pump would follow established engineering test protocols rather than an adjudication method for interpreting medical data.
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
- Not applicable. The Prepare™ Home Infusion Pump is a physical medical device, not an AI software or diagnostic tool that would involve human readers or AI assistance in the way typically assessed by an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical pump, not an algorithm. Its performance is inherent to its mechanical and electronic functions.
7. The type of ground truth used
- Not explicitly stated in terms of "ground truth" as it would be for diagnostic accuracy. However, for an infusion pump, the "ground truth" for performance would be established by:
- Engineering specifications: Predefined flow rates, accuracy tolerances, alarm thresholds, and other functional parameters.
- Regulatory standards: Adherence to established industry and regulatory standards for infusion pump performance.
- Comparison to predicate device: The core of the 510(k) summary is the demonstration of substantial equivalence to the legally marketed predicate device (Homepump). Therefore, the predicate's known performance characteristics serve as a benchmark.
8. The sample size for the training set
- Not applicable. This device is a physical product, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for a physical device.
§ 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).