(29 days)
the Crono S-PID 50 has been designed for use in subcutaneous infusion of prescribed liquid medicines.
Canè s.r.l., a company that specializes in the production of ambulatory pumps, has now produced a new generation of compact pumps: Crono, a perfect combination of high technology and innovative design.
Crono S-PID 50 is an ambulatory syringe infusion pump intended for the controlled administration of liquids into the patients. This means that the pump can be worn during the infusion.
Crono S-PID 50 combines high technology with innovative design. Thanks to the small size of the pump the patients can administer the drug any time during the day without interrupting daily life or leisure activities.
Crono S-PID 50 pump uses 50 ml dedicated syringes.
Crono S-PID 50 has a particular mechanism which pushes directly on the rubber syringe piston, which makes it possible to reach a significant thrust force and high accuracy of administration.
Crono S-PID 50 administers 20 ul per impulse.
In case of occlusion, an innovative infusion control system makes it possible to proceed with the infusion automatically and, after the occlusion is eliminated, to complete it.
Crono S-PID 50 is fitted with a liquid cristal display which shows the time it takes to complete the delivery, the syringe size and the battery charge status.
Here's an analysis of the provided information to describe the acceptance criteria and the study proving the device meets them:
Device: Crono S-PID 50 Ambulatory Infusion Pump
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate Device K052217) | Reported Device Performance (Crono S-PID 50) |
|---|---|---|
| Intended Use | Subcutaneous infusion of prescribed liquid medicines. | SAME to Crono Super PID - K052217 |
| Infusion per impulse | 22 μl | 20 μl (SAME to Crono PCA 50 - K052218) |
| Flow rate accuracy | +/-2% | +/-3% (SAME to Crono PCA 50 - K052218) |
| Max. Occlusion pressure | 4.5 bar +/-1 bar | 3 bar +/-1.5 bar |
| Capacity | 10 or 20 ml | 50 ml (SAME to Crono PCA 50 - K052218) |
| Physical Size | 3" x 1.85" x 1.14" (77 x 48x 29 mm) | 3.3" x 2.15" x 1.65" (84.5 x 55 x 42 mm) (SAME to Crono PCA 50 - K052218) |
| Weight | 4.0 oz (115 g) | 4.85 oz (140 g) (battery included) (SAME to Crono PCA 50 - K052218) |
| Battery | Power Source Lithium battery (3V) of the 123 A type. | SAME |
Note regarding acceptance criteria: The document specifically states that the Crono S-PID 50 is "SAME to Crono Super PID - K052217" for its intended use, implying that the acceptance criterion for intended use is alignment with that predicate device. For other characteristics, the comparison is often made to Crono PCA 50 (K052218), indicating that the acceptance criteria for the new device are based on either of the two predicate devices, with the new device demonstrating equivalence or improvement in performance. The table above reflects these comparisons.
2. Sample size used for the test set and the data provenance
The document states: "The results of bench, EMC, and user testing indicates that the new device is as safe and effective as the predicate device." However, no specific sample sizes for the test set (number of devices, number of tests, specific test parameters or conditions) are provided. The data provenance is implied to be from bench testing, EMC (Electromagnetic Compatibility) testing, and user testing, conducted by Canè S.p.A. in Italy. The study appears to be prospective in the sense that these tests were performed explicitly for the submission of the Crono S-PID 50.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The document refers to "bench, EMC, and user testing" but does not detail the nature of "user testing" or if any experts were involved in establishing "ground truth" beyond standard engineering and testing procedures. For a medical device, ground truth for performance metrics would typically be established through validated testing methodologies and measurements, not necessarily expert consensus in the way a diagnostic imaging study would.
4. Adjudication method for the test set
This information is not provided. Adjudication methods are typically relevant for studies involving subjective assessments or interpretation by multiple human readers, which is not clearly described as part of the Crono S-PID 50's testing. For bench and EMC testing, objective measurements would be compared against predefined specifications.
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 MRMC study was performed or mentioned. The device is an ambulatory infusion pump, not a diagnostic AI system, so an MRMC study with human readers assisting AI or vice-versa is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a medical pump, not an algorithm or AI system for diagnostic or interpretive tasks. The "standalone" performance would refer to the pump's mechanical and electronic functioning as a device. The "bench, EMC, and user testing" described would represent the standalone performance evaluation of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance would be established through objective engineering measurements and validated test methodologies against specified performance parameters (e.g., flow rate accuracy, occlusion pressure, infusion per impulse). For instance, flow rate accuracy would be tested by precisely measuring the volume delivered over a set period and comparing it to the programmed delivery, with the true value being the precisely measured volume.
8. The sample size for the training set
This information is not applicable and not provided. The Crono S-PID 50 is a medical device (infusion pump), not a machine learning or AI model that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable and not provided as there is no training set for this type of device.
§ 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).