(47 days)
The SmartInfuser PainPump™ is intended to provide continuous delivery of a local anesthetic through a catheter inserted directly into the surgical site for postoperative pain management.
The device comprises of the following parts:
- SmartCatheter -
- SmartInfuser set with SmartReg flow regulator (regulating set) -
- Compression unit (pump) -
- 100 ml or 250 ml infusion bag (empty) -
- Peel-off introducer -
- -Medication label
- Pump label -
- Carrying pouch made of synthetic cloth -
The empty infusion bag is included as a back-up container. Under normal circumstances, a standard solution bag filled by a pharmacist according to the physician's prescription will be used.
The provided text is a 510(k) summary for a medical device called the SmartInfuser PainPump™. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria based on performance metrics.
Therefore, much of the requested information regarding acceptance criteria, performance data, sample sizes, expert involvement, and ground truth establishment from a study proving criteria is not available in the provided document.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The 510(k) summary asserts "equivalent performance characteristics" to the predicate device, but it does not specify what those characteristics are, what the acceptance criteria for those characteristics would be, or the SmartInfuser PainPump™'s reported performance against them.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided. The document makes no mention of a specific test set or clinical study. The substantial equivalence claim is based on the device's design and intended use being similar to the predicate.
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):
This information is not provided. As no specific test set or study is described, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided.
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:
This is not applicable to this device. The SmartInfuser PainPump™ is an infusion pump, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical infusion pump.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not provided as no specific study with ground truth establishment is described. The "ground truth" for a 510(k) submission like this is primarily the established safety and effectiveness of the predicate device and the demonstration that the new device shares those characteristics.
8. The sample size for the training set:
This information is not provided. There is no mention of a "training set" as this device is not an AI/ML algorithm.
9. How the ground truth for the training set was established:
This information is not provided.
Summary of available information related to equivalence:
- Acceptance Criteria Implied: The implicit acceptance criterion for this 510(k) submission is that the SmartInfuser PainPump™ is substantially equivalent to the predicate device, the Painbuster Infusion Kit (K982946), in terms of intended use and performance characteristics.
- Study Proving Equivalence: The "study" is the 510(k) submission process itself, where the manufacturer provides information and justification (as presented in the "Substantial Equivalence" section) that the new device has "equivalent performance characteristics" and "the same intended use" as the predicate. The FDA's review and clearance (indicated by the letter) constitute the acceptance that this "study" or review process successfully demonstrated equivalence.
- Reported Device Performance (against equivalence): The document explicitly states: "The SmartInfuser PainPump™ has the same intended use as the Painbuster Infusion Kit, cleared under 510(k) no. K9982946 and has equivalent performance characteristics. It is therefore substantially equivalent to that device." This is the core "performance" reported in the context of a 510(k) – that it performs equivalently to a legally marketed device.
In essence, for a 510(k) submission like this, the "acceptance criteria" revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than meeting specific quantifiable performance metrics through a novel clinical trial. The "study" is the comparison made by the manufacturer and accepted by the FDA based on the provided documentation.
§ 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).