(106 days)
The ClearStar pump can be used for adult and pediatric patients provided the patients can tolerate a feeding range within the pump operational specifications. Those specifications are:
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- The flow rate range is 1-300 ml/hr in I mL/hr increments
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- The flow rate accuracy is ± 10% or ± 0.5 mL/hr, whichever is greater
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- The occlusion pressure limit is 26-30 psi.
If these specifications are not appropriate for a given patient, the ClearStar pump should not be used.
- The occlusion pressure limit is 26-30 psi.
The ClearStar pump raises no new questions of safety or effectiveness above those currently associated with enteral feeding pumps. The operator's manual for the ClearStar pump provides warnings regarding volume sensitive patients similar to those found in the operating manuals of the Companion and Quantum enteral feeding pumps. The pump's automatic clog clearing function has been designed to ensure that the nominal pressure exerted on a clog is in the 26 to 30 psi range. Additionally, to ensure that the patient is not underfed, the pump, if unsuccessful in clearing a clog before ten (10) minutes have elapsed, will alarm occlusion. Finally, the pump can only be in the clog clearing mode a maximum of twenty (20) minutes or ten times in any consecutive four (4) hour period. If twenty (20) minutes or ten times are exceeded, the pump will alarm occlusion.
The provided text describes the "ClearStar Enteral Nutrition Pump" and its safety and effectiveness. It outlines performance specifications and how these were designed and verified, but it does not contain information about a study proving the device meets acceptance criteria in the context of a medical AI device submission.
Therefore, I cannot fulfill your request for details on a study proving a device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.
The document is a 510(k) summary for a medical device (an enteral feeding pump), which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This process primarily focuses on comparing the new device's indications for use and technological characteristics to an existing device, and verifying that it raises no new questions of safety or effectiveness. It does not typically involve the type of clinical performance studies and ground truth establishment methodologies that are relevant for AI/ML-based medical devices as outlined in your prompt's questions.
Here's a breakdown of what can be extracted regarding acceptance criteria and performance based on the provided text, but it's important to understand this is not in the context of an AI/ML study:
ClearStar Enteral Nutrition Pump: Acceptance Criteria and Reported Performance
The document describes the design and expected performance characteristics of the ClearStar pump, particularly concerning its clog-clearing function and pressure limits.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Design Goal / Specification) | Reported Device Performance (as described) |
|---|---|
| Nominal pressure exerted on a clog during automatic clog clearing | 26 to 30 psi range |
| Maximum time for unsuccessful clog clearing before alarming occlusion | 10 minutes |
| Maximum duration in clog clearing mode within any consecutive 4-hour period | 20 minutes |
| Maximum number of times in clog clearing mode within any consecutive 4-hour period | 10 times |
| Pressure build-up during occlusion relative to feeding tube pressure limit (40 psi) | Maintained safely below the maximum pressure specification of the feeding tubes (implied |
§ 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).