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The portable Quark infusion device has been designed only for use in subcutaneous infusion for insulin infusion therapy. Canè S.r.l. declines all responsibility for the administration of drugs in treatments and with methods other than the above.
The Microjet Quark U-100 ambulatory infusion pump has been designed only for use in subcutaneous infusion of insulin for the treatment of diabetes mellitus. (Home use. prescription device)

Microjet Quark U-100 is an ambulatory insulin pump using syringe, battery powered and available to employ 2 ml syringes. A special micromotor acting the mechanical parts transforming the rotating movement of the motor into a linear movement of the slider which determines the moving of the syringe piscon. The characteristics of the pump working allow w administer insuling to two infusion ways: the fust one, basal rate, cnsure an insulin basal feed within 24 hours, the second one, bolus, allows to administer insulin additional doses and finds its most common use at meal-time. During the basal rate, the motor is driven with impulses at regular intervals by mean of a particular clectronic circuit and the infusion is effected by administering of small quantities repeated over the time. The programmed insulin quantity is distributed with 304 administrations within 24 hours, one every 4 minutes and 44 seconds. The bolus is delivered with fast insulin administrations of 0.5 International Units (U1) each time, with intervals of 10 seconds pauses. The administration of the insulin basal quantity is programmed operating on a specific selector allowing an accurate delivery of insulin, depending on the various daily needs. Insulin delivery as bolus is programmed using a specific button. The pump starts delivering insulin in basal speed to the sclected value. It remains operating until, by mean of manual command, the administration of the bolus is primed; after it returns automatically to work again. The pump is equipped of safety systems, acoustic signals for different operating functions and acoustic alert signals in the event of irregular working.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

Device: Microjet Quark Model U-100 (Insulin Infusion Pump)
Predicate Device: Dana Diabecare infusion pump, K001604

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by comparing the Microjet Quark to the predicate device, the Dana Diabecare infusion pump. The study aims to demonstrate substantial equivalence to the predicate device.

Conclusion from Study: The conclusion states that "Microjet Quark is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device."

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

The provided submission materials do not explicitly state the sample size for any testing.

The document mentions "bench, clinical, and user testing," but no specifics on the number of samples or participants for each.

The data provenance (country of origin, retrospective/prospective) is not specified in the provided text. Given that the manufacturer, CANÈ S.r.l., is based in Italy, it is plausible that some testing occurred there, but this is not confirmed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the submission. There is no mention of expert involvement in establishing ground truth for any test sets.

4. Adjudication Method for the Test Set

This information is not provided in the submission. There is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described.

The study's focus was on demonstrating substantial equivalence through "bench, clinical, and user testing" against a predicate device, rather than comparing human reader performance with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device described is an insulin infusion pump, a hardware device, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance and "human-in-the-loop" is not applicable in this context. The device itself performs the function (insulin delivery).

7. The Type of Ground Truth Used

The primary "ground truth" for this substantial equivalence determination is the performance and characteristics of the predicate device (Dana Diabecare, K001604).

The studies conducted (bench, clinical, and user testing) would have generated data to demonstrate that the Microjet Quark performs safely and effectively in a manner comparable to the predicate. For example:

• Bench testing: Involves objective measurements of device performance, such as accuracy of insulin delivery, battery life, alarm functionality, etc., compared to specifications or the predicate's known performance.
• User testing: Likely involved evaluating ease of use, alarm comprehension, and overall user experience, often in comparison to the predicate device or established usability principles.
• Clinical testing: Would assess actual physiological impact in patients, though details here are sparse.

8. The Sample Size for the Training Set

This information is not applicable as the device is a mechanical/electronic medical device, not an AI/machine learning algorithm requiring a training set in the typical sense.

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

This information is not applicable for the same reasons as point 8.

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