(42 days)
The Crono and Crono 30 ambulatory infusion pump devices have been designed for use in subcutaneous infusion of prescribed liquid medicines.
Canc 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. The infusion pumps witch use normal commercial syringes are inevitably cumbersome and thus difficult to mee in everyday life. This provokes in the patients a refuse of the therapy. A special syringe, an integral part of the Crono allows an efficient reduction of the pump size. In this way, the patients can freely carry out the therapy at any time of the day, even during their everyday life. Points who have been following a liquid medicine therapy for a long time, often experience difficulties in absorbing the drug subcutaneously; this may lead to a catheter occlusion with consequent interruption of the infusion. Crono has a particular mechanism which pushes directly the rubber syringe piston: so it is possible to reach a thrust force up to 3 timss ligher with respect to conventional pumps. In case of catheter occlusion, an innovative influsion control system makes it possible to proceed with the infusion automatically and, after the occlusion is climinated, to complete it. For a better absorption of the drug, Crono makes the infusion up to 3 times more fractionated with respect to traditional pumps (22 ul per impulse, using a 10/20 ml syringe). Crono is fitted with a liquid crystal display which shows the time it takes to complete the delivery and battery charge status. The Crono 30 is essenially the same as the Crono, but has a 30 ml infusion capacity. It infuses at a rate of 3 ml per impulse.
The provided document is a 510(k) summary for the Crono and Crono 30 ambulatory infusion pumps. It aims to demonstrate substantial equivalence to a predicate device (Crono, K013234), rather than a de novo approval requiring extensive performance criteria and studies as one might find for a novel AI device. Therefore, the information requested, particularly regarding AI-specific criteria, multi-reader studies, and detailed ground truth establishment for AI models, is not applicable or available in this document.
However, I can extract the relevant information from the document regarding the device's acceptance criteria and the studies performed to demonstrate equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria (Implicit) and Reported Device Performance
The acceptance criteria are not explicitly listed in a quantitative table with specific thresholds, but rather implied by the comparison to the predicate device and the successful completion of a 510(k) submission. The "reported device performance" is essentially that the new device performs "the same" or has "few technological differences" to the predicate, and is deemed "as safe and effective."
| Characteristic | Predicate Device (Crono, K013234) | New Device (Crono and Crono 30) | Implied Acceptance Criterion | Reported Device Performance |
|---|---|---|---|---|
| Intended Use | Subcutaneous infusion of prescribed liquid medicines. | SAME | Equivalent to Predicate | SAME |
| Power Source | Lithium battery (3V) of the 123 A type. | SAME | Equivalent to Predicate | SAME |
| Infusion per Impulse | 22 µl | 22µl or 33 µl for Crono 30 (with 30 ml syringe) | Equivalent or functionally improved (Crono 30) | 22µl (Crono), 33µl (Crono 30) |
| Size | 3" x 1.85" x 1.14" (77 x 48 x 29 mm) | SAME. For Crono 30: 3.15" x 1.89" x 1.38" (80 x 48 x 35 mm) | Equivalent or slightly larger for increased capacity (Crono 30) | Same (Crono), Slightly larger (Crono 30) |
| Weight | 4.0 oz (115 g) (battery included) | SAME. Crono 30: 125 g (battery included) | Equivalent or slightly heavier for increased capacity (Crono 30) | Same (Crono), Slightly heavier (Crono 30) |
| Capacity | 10 or 20 ml | 10, 20, or 30 ml | Equivalent or functionally improved | 10, 20, or 30 ml |
| Warranty | 2 years | SAME | Equivalent to Predicate | SAME |
| Safety and Effectiveness | Demonstrated by predicate device. | "as safe and effective" as the predicate device. | Equivalent to Predicate | Bench, EMC, and user testing indicate safety and effectiveness are equivalent. |
2. Sample size used for the test set and the data provenance
The document mentions "bench, EMC, and user testing" but does not provide specific sample sizes for these tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective). This is typical for a 510(k) for a relatively low-risk device where the primary goal is demonstrating equivalence through engineering and limited usability testing.
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 testing described (bench, EMC, user) does not typically involve expert consensus for "ground truth" in the way an AI diagnostic or prognostic device would. The "ground truth" for an infusion pump would be its mechanical and electrical performance specifications and user satisfaction/safety, which are assessed through engineering tests and usability studies rather than expert medical interpretation of data.
4. Adjudication method for the test set
Not applicable/not provided. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies, especially for image-based AI, which is not relevant here.
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. This device is an ambulatory infusion pump, not an AI-assisted diagnostic or prognostic tool. Therefore, an MRMC study and AI-specific effect sizes are not relevant.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This device does not have a standalone algorithm or AI component in the context of typical AI medical devices. It is a mechanical-electronic pump.
7. The type of ground truth used
The "ground truth" implicitly used for this device would be:
- Engineering specifications and regulatory standards: For bench and EMC testing, adherence to established performance parameters (e.g., infusion rate accuracy, alarm functionality, electromagnetic compatibility).
- User feedback/observation: For user testing, to ensure ease of use, patient acceptance, and safety in a real-world (or simulated real-world) context.
- Predicate device performance: The ultimate "ground truth" for a 510(k) is that the new device is "as safe and effective" as the legally marketed predicate.
8. The sample size for the training set
Not applicable. This device does not use a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device in the AI sense.
§ 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).