(74 days)
General surgical fluid irrigation and infiltration.
The 3600 Pressure Infusor indications for use are general surgical fluid irrigation and infiltration.
The principles of operation and technology incorporated in the 3600 Pressure Infusor are equivalent to pressurized irrigation systems, which use compressed nonflammable gases within a closed bladder (inflatable cuff to apply direct pressure externally to a bag of fluid for infusion of fluids.
The provided text is a 510(k) summary for a medical device (3600 Pressure Infusor) and the FDA's response. It does not contain information about acceptance criteria or a study proving device performance in the way typically seen for AI/ML medical devices.
Instead, this document describes a traditional medical device submission for substantial equivalence. The "study" here is essentially the comparison to predicate devices, and the "acceptance criteria" are implied by the FDA's finding of substantial equivalence.
Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) do not apply to this type of regulatory submission.
Here's how to interpret the document in the context of the prompt:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as described in the 510(k)) |
|---|---|
| Device operates on similar principles to legally marketed predicate devices. | "The principles of operation and technology incorporated in the 3600 Pressure Infusor are equivalent to pressurized irrigation systems, which use compressed nonflammable gases within a closed bladder (inflatable cuff) to apply direct pressure externally to a bag of fluid for infusion of fluids." |
| Device has similar technological characteristics to predicate devices. | "The principles of operation and technology incorporated in the Valley West, Inc. 3600 are similar to other irrigation devices with the function to pressurizing bags of fluid..." |
| Device has the same intended use as predicate devices. | Indication for Use: "General surgical fluid irrigation and infiltration." (This is implicitly similar to predicate devices for the purpose of substantial equivalence). |
| Device does not raise new questions of safety or effectiveness compared to predicate devices. | The FDA's finding of "substantial equivalence" implies this was satisfied. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This is a comparison to predicate devices, not a performance study with a test set of data.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in the sense of expert consensus on diagnostic or prognostic outcomes, is not part of a substantial equivalence submission for this type of device.
4. Adjudication method for the test set
- Not applicable.
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. This is not an AI/ML device, nor is it a study comparing human readers with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Not applicable in the common sense for AI/ML. The "ground truth" for this submission is established through comparison to legally marketed predicate devices and their established safety and effectiveness.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
In summary: The provided document is a 510(k) premarket notification for a traditional medical device (a pressure infusor). The "study" is the comparison to predicate devices, and the "acceptance criteria" are met by demonstrating substantial equivalence to those legally marketed devices based on shared principles of operation, technological characteristics, and intended use. The concepts of test/training sets, expert consensus for ground truth, and reader studies are not relevant to this type of regulatory submission.
§ 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).