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The portable Crono infusion devices have been designed for use in subcutaneous and intravenous 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 F, a perfect combination of high technology and innovative design. The infusion pumps which use normal commercial syringes are inevitably cumbersome and thus difficult to use in everyday life. This provokes in the patients a refuse of the therapy. A special syringe, an integral part of the Crono F 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. Patients 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 F has a particular mechanism which pushes directly the rubber syringe piston: so it is possible to reach a thrust force up to 3 times higher with respect to conventional pumps. In case of catheter occlusion, an innovative infusion control system makes it possible to proceed with the infusion automatically and, after the occlusion is eliminated, to complete it. For a better absorption of the drug, Crono F makes the infusion up to 3 times more fractionated with respect to traditional pumps (22 µl per impulse, using a 10/20 ml syringe). Crono F is fitted with a liquid crystal display which shows the time it takes to complete the delivery and battery charge status.

The provided document is a 510(k) premarket notification for a medical device called Crono F, an ambulatory infusion pump. The document focuses on demonstrating substantial equivalence to a predicate device (Crono H, K013855) rather than providing extensive details on a comprehensive clinical study with specific acceptance criteria and detailed performance data often seen for novel devices.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the sense of predefined thresholds for performance metrics. Instead, it relies on demonstrating that the Crono F device is "as safe and effective as" the predicate device, Crono H. The demonstration of equivalence is the primary "acceptance criterion."

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not specified. The document mentions "bench, EMC, and user testing" but does not provide the number of devices or subjects used in these tests.
• Data Provenance: Not explicitly stated. Given that Canè S.r.l. is an Italian company (Via Pavia, 105/I 10090 Rivoli-Cascine Vica (Torino) Italy), it's reasonable to infer that some testing might have occurred in Italy or by an associated European entity. The documentation is for FDA clearance in the USA. The data is retrospective in the sense that it's being submitted for a device already developed, not from a new prospective clinical trial designed for primary endpoint assessment for this 510(k).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This type of information is usually relevant for diagnostic devices that rely on expert interpretation (e.g., radiology images). For an infusion pump, the "ground truth" for performance would be objective measurements (e.g., flow rate accuracy, pressure limits, battery life, alarm functionality) typically evaluated through bench testing and, potentially, user studies for usability. Expert consensus on diagnoses is not relevant here.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this mainly applies to diagnostic assays or image interpretation where human experts might disagree.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC study was not done, as this is an infusion pump, not a diagnostic device involving multiple readers interpreting cases.

6. Standalone Performance:

Yes, the "bench, EMC, and user testing" implicitly evaluates the standalone performance of the device without human-in-the-loop assistance for its core function (infusion). However, the specific metrics and results of these tests are summarized very broadly ("as safe and effective") rather than detailed.

7. Type of Ground Truth Used:

The "ground truth" for an infusion pump would involve:

• Bench Test Results: Objective measurements of fluid delivery accuracy, pressure capabilities, alarm thresholds, battery performance, etc., against predefined engineering specifications.
• EMC (Electromagnetic Compatibility) Test Results: Verification that the device performs within electromagnetic standards.
• User Testing Observations: Data on usability, ease of programming, alarm recognition, and overall user experience.
• Predicate Device Data: Performance data from the Crono H would serve as a crucial reference for substantial equivalence.

The document does not detail specific ground truth data but relies on the statement that these tests demonstrate equivalency.

8. Sample Size for the Training Set:

Not applicable. This device is an electromechanical infusion pump, not an AI/ML algorithm that requires a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no "training set" for an AI/ML algorithm involved in this device submission.

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