(88 days)
PainPump2 delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. The pump infuses the medication at an hourly flow rate and provides the option for patient controlled bolus doses. Medications are infused through intramuscular or subcutaneous routes. PainPump2 is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous.
The Stryker PainPump2 delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. The pump infuses the medication at an hourly flow rate and provides the option for patient controlled bolus doses. Medications are infused through intramuscular or subcutaneous routes. The Stryker PainPump2 is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous. The Stryker PainPum2 is a kit that is comprised of an infusion set(s), introducer needle(s), syringe, and catheter securement accessories.
The provided document is a 510(k) premarket notification for the Stryker PainPump2, which focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This type of submission generally does not include detailed studies with specific acceptance criteria and performance metrics in the way a clinical trial for a novel device or software exhibiting AI/ML capabilities would.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth are not present in this document. The submission relies on a comparison of intended use, safety, and effectiveness to already cleared devices rather than providing new performance data from a clinical study.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Applicable / Not Provided: The submission does not present specific quantitative acceptance criteria or performance metrics for the Stryker PainPump2 in the way a diagnostic device or AI algorithm would. Its primary claim is substantial equivalence to predicate devices (I-Flow Corporation infusion pump systems and I-Flow/Sims Portex catheters) based on intended use, safety, and effectiveness.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: The document does not describe a "test set" in the context of performance evaluation with specific sample sizes. There's no mention of a study involving patient data to assess the device's performance. The substantial equivalence argument is based on comparing the device's design and intended use to existing, cleared devices.
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)
- Not Applicable / Not Provided: As there is no described test set or ground truth establishment process related to a performance study, this information is not relevant to this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No test set or adjudication method is described.
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 / Not Provided: This question is relevant for AI/ML-powered diagnostic tools. The Stryker PainPump2 is an electromechanical ambulatory infusion pump; it does not involve human readers or AI assistance in the way a diagnostic imaging system would.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided: This device is a physical infusion pump, not an algorithm. Therefore, no standalone algorithm performance study was conducted or is relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided: No performance study with a "ground truth" is described in the document.
8. The sample size for the training set
- Not Applicable / Not Provided: As this is an electromechanical device and not an AI/ML algorithm, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: This question is not relevant for the type of device and submission provided.
§ 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).