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The portable Crono infusion device has been designed only 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 H, 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 H 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 iron chelation 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 H 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 H makes the infusion up to 3 times more fractionated with respect to traditional pumps (22 ml per impulse, using a 10/20 ml syringe). Crono H is fitted with a liquid crystal display which shows the time it takes to complete the delivery and battery charge status.

This document is a 510(k) summary for the Microjet Crono H ambulatory infusion pump. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (i.e., a study involving AI/machine learning performance assessment).

Here's what can be extracted from the document based on the provided format, with explanations where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria for performance metrics (e.g., accuracy, precision of infusion) in a quantitative sense with corresponding reported performance values. Instead, it relies on a comparison to a predicate device to establish substantial equivalence.

2. Sample size used for the test set and the data provenance

The document mentions "bench, EMC, and user testing" but does not specify sample sizes for any of these tests, nor does it provide details on the data provenance (e.g., country of origin, retrospective/prospective nature).

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 is for a medical device (infusion pump) and does not involve "ground truth" derived from expert consensus in the way a diagnostic imaging AI algorithm would.

4. Adjudication method for the test set

Not applicable, as the evaluation type does not involve an adjudication process as described (e.g., for expert consensus on images).

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 such study was mentioned. The device is an ambulatory infusion pump, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical infusion pump, not a standalone algorithm.

7. The type of ground truth used

The concept of "ground truth" as typically applied to AI/machine learning data sets (e.g., expert consensus, pathology, outcome data) is not relevant here. The evaluation relies on engineering tests (bench testing, EMC testing) and user testing to assess the device's functional performance, safety, and effectiveness in comparison to a predicate device.

8. The sample size for the training set

Not applicable. This is a medical device submission, not an AI/machine learning model submission where a "training set" would be used.

9. How the ground truth for the training set was established

Not applicable.

Summary of the K013855 Submission's Approach to Demonstrating Safety and Effectiveness:

The K013855 submission for the Microjet Crono H ambulatory infusion pump focuses on demonstrating substantial equivalence to a previously legally marketed device (Cadd-Legacy 1 Ambulatory Infusion Pump, K982838). The primary method for proving this is through a detailed comparison of characteristics and results from "bench, EMC, and user testing," which reportedly showed the new device to be "as safe and effective as the predicate device."

The document does not detail acceptance criteria in a quantitative, performance-metric-based fashion. Instead, the "acceptance criterion" is implicitly met by showing that the new device's characteristics and performance are comparable to, or better than, the predicate device across various features, particularly in its fundamental function as an infusion pump. The "study" that proves this is the collection of "bench, EMC, and user testing" data, which are not described in detail regarding methodologies, sample sizes, or specific performance outcomes.

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The portable CD4, CD4/20 infusion devices have been designed only for use in subcutaneous infusion of prescribed liquid medicines.

This infusion device has been manufactured since 1978 and has, during all this time, proved to be highly reliable in terms of sturdiness, reliability, accuracy and easy operation. Moreover, it does not require particular maintenance work. Microjet CD4 is a portable, battery-operated infusion device for use with 5 ml and 10 ml syringes (20 ml syringes are used with model CD4/20). A special micromotor actuates mechanical members that transform the motor rotary motion into the pusher linear motion which, in turn, causes the syringe piston to advance. The infusion device operating features enable to make infusions with varying amounts of medicine and different infusion times. During infusion, the motor is controlled by a special electronic circuit with regular pulses; therefore, infusion is carried out by delivering small amounts of medicine repeated with the passing of time.

The provided text describes a 510(k) summary for the Microjet CD4, CD4/20 Ambulatory Infusion Pump. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of AI/ML performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device for market clearance.

Therefore, most of the requested information regarding AI/ML device performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment is not present in the provided document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device's characteristics and compares them to a predicate device, but it does not specify quantitative acceptance criteria or performance metrics in the way one would for an AI/ML system (e.g., sensitivity, specificity, AUC).

Instead, the "performance" is implicitly deemed acceptable by demonstrating substantial equivalence to a legally marketed predicate device. The characteristics compared are:

The "study" that proves the device meets acceptance criteria is described as "bench, EMC, and user testing," which concluded that the new device is "as safe and effective as the predicate device" and has "few technological differences."

Missing Information (Relevant to AI/ML Performance):

• Specific quantitative acceptance criteria (e.g., accuracy, precision, recall) for AI/ML performance.
• Reported device performance against such criteria.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The document mentions "bench, EMC, and user testing" but does not quantify the number of units or users involved in these tests.
• Data Provenance: Not specified, other than it being part of internal testing by CANÈ S.r.l. (Italy).
• Retrospective/Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable to this type of device submission. Ground truth, in this context, would relate to the physical and functional performance of the infusion pump itself, not diagnostic interpretations by experts.

4. Adjudication method for the test set:

• Not applicable.

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 is not an AI/ML diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a standalone medical device (infusion pump), not an algorithm.

7. The type of ground truth used:

• The "ground truth" for this device would be established through engineering specifications, laboratory measurements for accuracy and reliability, and possibly usability assessments during user testing. The document refers to "bench, EMC, and user testing data" to support its claims of safety and effectiveness, implying these physical and functional validations served as the basis for comparison.

8. The sample size for the training set:

• Not applicable. This device does not use an AI/ML training set.

9. How the ground truth for the training set was established:

• Not applicable. This device does not use an AI/ML training set.

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