(50 days)
The Medley PCA Module is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of medications or fluids.
The Medley PCA Module is indicated for use on adults, pediatrics, and neonates for continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), subcutaneous, or epidural.
The Medley PCA Module functions as part of the Medley™ Medication Safety System. In combination with the Medley" Programming Module (PM), the PCA Module will deliver fluids in a manner similar to current PCA pumps on the market. The Medley" PCA Module uses standard non-dedicated, single-use, administration sets and syringes with luer-lock connectors, of type designed for use on syringe-type PCA pumps.
The provided document is a 510(k) summary for the ALARIS Medical Systems® Medley™ PCA Module. It states that the device is substantially equivalent to predicate devices and meets specified performance requirements. However, it does not provide specific acceptance criteria or detailed results from a study proving these criteria are met.
Therefore, I cannot populate the table or answer most of the questions using the information given. The document explicitly states: "The performance data indicate that the Medley PCA Module meets specified requirements, and is substantially equivalent to the predicate devices," but it does not detail those requirements or the specific performance data.
Here's what can be inferred or stated based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Meets specified requirements (specific criteria not detailed) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified.
- Data provenance: Not specified (country of origin or retrospective/prospective nature of any studies).
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 specified, as no detailed study or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
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
- No mention of an MRMC study, AI, or human reader improvement. This device is a PCA infusion pump, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not specified. This is a medical device (infusion pump), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not specified, as no detailed study or ground truth establishment is described. The performance data would likely relate to engineering specifications for pump accuracy, safety features, etc.
8. The sample size for the training set
- Not applicable/Not specified, as no machine learning or AI training is described.
9. How the ground truth for the training set was established
- Not applicable/Not specified.
§ 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).