(41 days)
PainPump1 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. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes.
PainPump1 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.
PainPump1 is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.
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 intraoperatively and postoperatively 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.
PainPump2 is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.
PainPump1 is a disposable syringe infuser which uses sustained vacuum pressure to deliver a continuous infusion of medication to the patient for pain management an/or antibiotic delivery. Medication is delivered to the treatment site using an hourly flow rate. The routes of administration may be intramuscular or subcutaneous.
PainPump2 is an electromechanical pump designed to deliver controlled amounts of medication to the patient for pain management and/or antibiotic delivery. Medication is delivered to the treatment site using an hourly flow rate or combination of hourly flow rate and bolus PCA (Patient Controlled Analgesia) dosing option. The routes of administration may be intramuscular or subcutaneous.
Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided text does not contain explicit acceptance criteria in a numerical or categorical format, nor does it present device performance data against such criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance or clinical study results with acceptance criteria.
The "device description" and "indications for use" sections describe what the devices (PainPump1 and PainPump2) are intended to do and how they function (deliver medication at an hourly flow rate, PainPump2 also offers bolus dosing). They also mention an intended outcome: "significantly decrease narcotic use and pain when used to deliver local anesthetics...when compared with narcotic only pain management." However, these are statements of intent and claims, not specific, measurable acceptance criteria with performance statistics.
Therefore, I cannot populate a table with acceptance criteria and reported device performance from this document.
2. Sample size used for the test set and the data provenance
The document does not mention a test set sample size or data provenance (e.g., country of origin, retrospective or prospective). As a 510(k) summary, it focuses on comparing the proposed device to predicate devices rather than detailing independent clinical or performance studies with a distinct test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information about experts used to establish ground truth or their qualifications. This type of detail is typically found in study protocols or results, which are not present in this 510(k) summary.
4. Adjudication method for the test set
The document does not describe any adjudication method for a test set.
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
The devices are "Infusion Pumps" (PainPump1 and PainPump2), which are mechanical devices for drug delivery. They are not AI-powered imaging or diagnostic devices that would involve "human readers" or "AI assistance" in the context of an MRMC study. Therefore, an MRMC comparative effectiveness study, as typically understood in the context of AI in healthcare, was not performed and is not relevant to these devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Again, as mechanical infusion pumps, the concept of a "standalone algorithm" is not applicable. The devices are physical instruments that deliver medication. Performance would be assessed through engineering tests (e.g., flow rate accuracy, pressure limits, battery life, alarm functionality), not through purely algorithmic assessment. The document does not provide details on such standalone performance tests for these mechanical functions, beyond implying they meet safety and efficacy standards for infusion pumps.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given that these are infusion pumps, "ground truth" would relate to the accuracy of medication delivery, safety features, and clinical outcomes (e.g., pain reduction, decreased narcotic use) as stated in the indications for use. However, the document does not specify the type of "ground truth" data used for performance or clinical validation. It merely claims the devices are intended to achieve certain outcomes, but doesn't detail the studies or the ground truth against which those claims were evaluated.
8. The sample size for the training set
The concept of a "training set" is relevant for machine learning algorithms. Since the PainPump devices are mechanical infusion pumps and not AI/ML-driven, there is no training set in the sense of data used to train an algorithm.
9. How the ground truth for the training set was established
As there is no training set for an AI/ML algorithm, this question is not applicable to the devices described.
In summary:
The provided 510(k) summary for the Stryker PainPump1 and PainPump2 devices primarily focuses on establishing substantial equivalence to previously cleared predicate devices (K031249, K030661, K040337). It describes the devices' functions and indications for use. However, it does not contain the detailed clinical study design, performance metrics, acceptance criteria, sample sizes (for test or training sets), expert qualifications, or adjudication methods typically found in documents describing performance studies for diagnostic or AI-powered devices. The acceptance is based on the devices being functionally equivalent to already-approved devices, rather than on new, independent, detailed performance studies with explicit acceptance criteria provided in this summary.
§ 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).