(29 days)
the Crono go has been designed for use in subcutaneous infusion of prescribed liquid medicines.
Crono go 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 go combines high technology with innovative design. Thanks to the small size of the pump Crono go can administer the drug any time during the day without interrupting daily life or leisure activities. Crono go pump uses dedicated syringes which are available in two sizes: 10 and 20 ml. Crono go has a particular mechanism which pushes directly on the rubber syringe piston, which guarantees a significant thrust force and high accuracy of administration. Additional bolus doses can be easily administered by pressing a dedicated button, and the administered bolus dose is shown on the display screen. 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 go is fitted with a liquid crystal 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 text to extract the requested information about device acceptance criteria and study details.
Important Note: The provided text is a 510(k) summary and FDA clearance letter for a medical device (Crono go ambulatory infusion pump). This type of document is heavily focused on demonstrating substantial equivalence to a predicate device, rather than presenting a novel clinical study with a defined set of acceptance criteria in the traditional academic sense. Therefore, some of the requested categories (e.g., ground truth for training data, MRMC studies, number of experts for ground truth) are not applicable (N/A) or cannot be explicitly found in this type of regulatory submission. The "acceptance criteria" here are aligned with the performance specifications demonstrated to show equivalence.
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate Device K013840) | Crono go (New Device) Reported Performance |
|---|---|---|
| Intended Use | Subcutaneous infusion of prescribed liquid medicines. | SAME |
| Size | 3" x 1.85" x 1.14" (77 x 48 x 29 mm) | SAME |
| Weight | 4.0 oz (115 g) (battery included) | SAME |
| Battery | Power Source Lithium battery (3V) of the 123 A type. | SAME |
| Infusion per impulse | 22 μl | SAME |
| Flow rate accuracy | +/- 2% | +/- 2% (Reported as "SAME" as predicate) |
| Max. Occlusion pressure | 4.5 bar +/-1 bar | 4.5 bar +/-1 bar (Reported as "SAME" as predicate) |
| Capacity | 10 or 20 ml | SAME |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "bench, EMC, and user testing" but does not give specific numbers of units tested or duration of tests.
- Data Provenance: The device manufacturer, Canè S.r.l., is based in Rivoli-Cascine Vica (Torino), Italy. It can be inferred that testing was conducted by or under the supervision of the manufacturer, likely in Italy. The study is retrospective in the sense that it's comparing a new device against an existing, cleared predicate device's specifications. It is, however, prospective testing of the "Crono go" device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- N/A. This information is not relevant or typically provided in a 510(k) submission for an infusion pump. The "ground truth" for performance is based on engineering specifications and direct measurement, not expert interpretation.
4. Adjudication Method for the Test Set
- N/A. Not applicable, as expert adjudication is not used for mechanical device performance testing. Performance is measured against predefined engineering 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. This is not an AI-assisted diagnostic device, but rather a standalone medical pump. Therefore, MRMC studies and AI assistance are not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The device itself is a standalone infusion pump. The performance characteristics (flow rate accuracy, occlusion pressure) are measured independently of human interaction during the actual infusion process, reflecting the device's inherent functional capabilities. The user testing mentioned would pertain to usability and safety aspects of human interaction with the device, not its core mechanical performance.
7. The Type of Ground Truth Used
- Engineering Specifications and Direct Measurement: The ground truth for the device's performance characteristics (e.g., flow rate accuracy, occlusion pressure) is based on established engineering principles, metrology, and direct measurement against predetermined acceptable ranges. For comparison, the "ground truth" is also the established performance of the predicate device.
8. The Sample Size for the Training Set
- N/A. This device does not involve a "training set" in the context of machine learning or AI models. It's a mechanical device whose performance is engineered and then verified.
9. How the Ground Truth for the Training Set was Established
- N/A. As above, no training set is applicable.
§ 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).