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The "Microjet Crono K" and "Crono go" ambulatory infusion pump device has 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 K, 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 K 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 K 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 K 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 K is fitted with a liquid crystal display which shows the time it takes to complete the delivery and battery charge status.

Here's an analysis of the provided information regarding the Microjet Crono K and Crono go ambulatory infusion pumps, focusing on acceptance criteria and the study that proves the device meets them:

Disclaimer: The provided document is a 510(k) summary from 2002, which typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trial results with detailed performance metrics and statistical analyses as might be found in a more recent PMA or extensive clinical study report. Therefore, some of the requested information (like specific effect sizes for MRMC studies or detailed ground truth methodologies) is not explicitly present in this type of submission.

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary primarily demonstrates substantial equivalence to a predicate device (Cadd-Legacy 1 Ambulatory Infusion Pump, K982838) by comparing characteristics and showing that the new device is as safe and effective. It does not explicitly list quantified acceptance criteria with specific performance thresholds (e.g., a "must achieve X% accuracy"). Instead, "acceptance criteria" are implied by the comparison to the predicate device, where the new device must perform at least as well as or similarly to the predicate device in aspects like safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the implied acceptance criteria for substantial equivalence consists of bench testing, EMC (Electromagnetic Compatibility) testing, and user testing.

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

• Sample Size: The document does not specify the sample size for the bench testing, EMC testing, or user testing. These are typically internal validation studies that are summarized to support the 510(k) rather than detailed clinical trial reports with specific patient numbers.
• Data Provenance: The studies were conducted by CANÉ S.r.l. (the manufacturer) in Rivoli-Cascine Vica (Torino), Italy. The data is retrospective in the sense that these tests were performed and summarized to support the 510(k) submission. It's not a prospective, multi-center clinical trial report.

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

• The document does not provide details on the number of experts, their qualifications, or how ground truth was established specifically for the test sets (bench, EMC, user testing). Such information is generally not required for a 510(k) summary demonstrating substantial equivalence for this type of device. The "user testing" would likely involve medical professionals and/or patients, but their expert role in establishing a formal "ground truth" (as in diagnostic accuracy studies) is not described.

4. Adjudication Method for the Test Set:

• The document does not describe any formal adjudication method for the test sets (bench, EMC, user testing). Adjudication methods like '2+1' or '3+1' are typical in diagnostic imaging studies where consensus among multiple readers is needed to define a ground truth for ambiguous cases. This is not applicable to the types of tests mentioned (bench, EMC, user testing) for an infusion pump.

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

• No MRMC comparative effectiveness study was mentioned or performed as part of this 510(k) submission. MRMC studies are specific to diagnostic devices where human readers interpret medical images or data, and their performance with and without AI assistance is compared. This is not relevant for an infusion pump.

6. Standalone (Algorithm Only) Performance Study:

• While the device itself is an "algorithm" in the sense that it controls infusion, no separate "standalone" algorithm-only performance study (without human-in-the-loop performance), as understood in AI/ML medical devices (e.g., an automated diagnostic algorithm without human oversight), was conducted or reported. The device's performance inherently involves its interaction with a user (loading medication, setting parameters) and patient (receiving infusion). The "bench testing" would evaluate the device's mechanical and electrical functions in a controlled environment, which could be considered an "algorithm-only" performance aspect to some extent, but not in the context of an AI-driven diagnostic or interpretative algorithm.

7. Type of Ground Truth Used:

• For bench testing: The "ground truth" would be established by engineering specifications, known physical principles, and validated measurement techniques. For example, flow rate accuracy would be compared against a known standard, occlusion detection against intentionally induced blockages, and battery life against expected draw under defined conditions.
• For EMC testing: The "ground truth" is established by adherence to international standards and regulatory limits for electromagnetic emissions and immunity (e.g., IEC 60601-1-2 or similar).
• For user testing: The "ground truth" or validation would be based on observed functional success, ease of use, and user feedback compared to the predicate device or established usability principles. This is not a pathology or outcomes data type of ground truth.

8. Sample Size for the Training Set:

• Not applicable / Not specified. This device is an infusion pump, not an AI/ML-based system that uses a "training set" in the computational learning sense. The device's design and functionality are based on engineering principles and prototypes, not on a machine learning training dataset.

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

• Not applicable. As the concept of a "training set" for an AI/ML model does not apply here, there is no ground truth established for such a set. The "ground truth" for the device's design and engineering would be based on fundamental scientific and engineering principles, functional requirements, and safety standards.

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The Microjet Crono PCA ambulatory infusion pump device has been designed for use in intravenous or subcutaneous infusion of medicines for pain management.

Microjet Crono PCA has been designed for the analgesic therapy with a flexible and precise drug's administration causing the minimum discomfort to the patient allowing to walking about. Microjet Crono PCA results to be, within its field, the most innovative instrument available in the market due to small dimension and easy-to-use. Outstanding technology degree has allowed to obtain high reliability degree for long time use without maintenance. A microprocessor runs the electronic circuitry allowing to program the flow seeing the duration of the infusion. A button allows the patient to administer an additional bolus as well seeing the infused volume when in process. The screen also allows to indicate the total of bolus that have been delivered within the infusion in course. A safety system is foreseen to unlock the keyboard to avoid unauthorized variation of the programmed parameters. In the event of occlusion of the catheter, Microjet Crono PCA allows to carry on the administration after the occlusion has been removed. This function is capable to highly reduce the risk of infusion not brought to end. Microjet Crono PCA is equipped with a liguid crystal display where the programmed data can be seen as well as the battery status.

The provided text describes the Microjet Crono PCA ambulatory infusion pump and its substantial equivalence to a predicate device. However, it does not contain information typically found in a study proving a device meets acceptance criteria, such as specific performance metrics with numerical targets, details about a test dataset (sample size, provenance, ground truth establishment), expert qualifications, or MRMC study results.

Instead, the document focuses on:

• Device Identification: Name, classification, and common use.
• Equivalent Legally Marketed Devices: Comparison to a predicate device (Cadd-Legacy PCA Model 6300).
• Indications for Use: Intravenous or subcutaneous infusion of medicines for pain management.
• Description of the Device: Physical characteristics, features like microprocessor control, patient bolus button, safety system, and occlusion detection.
• Safety and Effectiveness, comparison to predicate device: States that "The results of bench, EMC, and user testing indicates that the new device is as safe and effective as the predicate device."
• Substantial Equivalence Chart: Compares functional and physical characteristics with the predicate device.

Given that this is a 510(k) summary, it aims to demonstrate substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance data like a novel device might. The "acceptance criteria" here are implicitly tied to demonstrating equivalence to the predicate device's safety and effectiveness.

Therefore, many of the requested details about acceptance criteria and study particulars cannot be extracted from the provided text.

Here is what can be inferred or directly stated based on the text (with many fields unanswerable):

Acceptance Criteria and Reported Device Performance

The document does not explicitly list numerical acceptance criteria. Instead, the "acceptance criterion" is implicitly demonstrating that the Microjet Crono PCA is "as safe and effective" as the Cadd-Legacy PCA Model 6300, based on "bench, EMC, and user testing." The comparison chart provides the basis for this claim of equivalence.

The "study" refers to "bench, EMC, and user testing." No specific details about the methodology, sample sizes, or results of these tests beyond the general conclusion are provided.

Unanswerable Information (Based on provided text):

1. Sample size used for the test set and the data provenance: Not specified. The document mentions "bench, EMC, and user testing" but no details on sample size (e.g., number of devices tested, number of users, number of cases/simulations). Data provenance is not mentioned.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/specified. This is not a diagnostic device or a study involving expert interpretation of data. The "ground truth" for a pump's function typically comes from engineering specifications and objective measurements (bench testing) and user feedback/performance in simulated or actual (but controlled) use.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/specified.
4. 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 a diagnostic device involving human readers or AI assistance.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, and its function involves both the device itself and human interaction (programming, patient use of bolus). The "bench" testing could be considered "standalone" in a technical sense, but it's not specific to an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a device like an infusion pump, "ground truth" would likely involve engineering specifications, calibration standards, and objective measurements (e.g., flow rate accuracy, occlusion pressure thresholds, battery life, structural integrity). For "user testing," ground truth would relate to usability and performance as expected by users and design requirements. The document does not specify.
7. The sample size for the training set: Not applicable/specified. This is not a machine learning or AI-based device that typically has a "training set."
8. How the ground truth for the training set was established: Not applicable/specified.

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The portable Crono infusion device has been designed only for use in subcutaneous infusion of prescribed liquid medicines.
The Microjet Crono ambulatory infusion pump device has been designed for use in subcutaneous infusion of prescribed liquid medicines.

Cane 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 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 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 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 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 is fitted with a liquid crystal display which shows the time it takes to complete the delivery and battery charge status.

The provided text describes a 510(k) summary for the Microjet Crono Ambulatory Infusion Pump. It does not contain information typically found in acceptance criteria and study designs for evaluating device performance against specific metrics like sensitivity, specificity, or image quality, which are more common in studies for diagnostic devices or AI algorithms.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (Cadd-Legacy 1 Ambulatory Infusion Pump) by comparing general characteristics and safety/effectiveness conclusions based on "bench, EMC, and user testing."

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the traditional sense, nor can I answer questions related to sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. These types of studies were not conducted or described in the provided submission for this device.

The "acceptance criteria" in this context are implicitly the characteristics listed in the "Substantial Equivalence Chart" and the general safety and effectiveness claims.

Here's a breakdown of what can be extracted based on the provided text, addressing only the relevant points:

1. A table of (implicit) acceptance criteria and the reported device performance

The acceptance criteria here are based on similarity to the predicate device and the successful completion of specified tests.

2. Sample sized used for the test set and the data provenance: Not applicable. The document mentions "bench, EMC, and user testing" but does not specify sample sizes for these tests or the provenance of any data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment by experts is not described for this type of device submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are not described.

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 not an AI-powered diagnostic tool, so MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an infusion pump, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the traditional sense. The "ground truth" for this submission is implicitly established by the performance of the predicate device and the successful completion of engineering and usability tests.

8. The sample size for the training set: Not applicable. There is no mention of a training set for an algorithm.

9. How the ground truth for the training set was established: Not applicable. There is no mention of a training set for an algorithm.

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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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