Search Results
Found 6 results
510(k) Data Aggregation
(29 days)
CANE S.R.L.
the Crono S-PID 50 has been designed for use in subcutaneous 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, a perfect combination of high technology and innovative design.
Crono S-PID 50 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 S-PID 50 combines high technology with innovative design. Thanks to the small size of the pump the patients can administer the drug any time during the day without interrupting daily life or leisure activities.
Crono S-PID 50 pump uses 50 ml dedicated syringes.
Crono S-PID 50 has a particular mechanism which pushes directly on the rubber syringe piston, which makes it possible to reach a significant thrust force and high accuracy of administration.
Crono S-PID 50 administers 20 ul per impulse.
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 S-PID 50 is fitted with a liquid cristal 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 information to describe the acceptance criteria and the study proving the device meets them:
Device: Crono S-PID 50 Ambulatory Infusion Pump
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate Device K052217) | Reported Device Performance (Crono S-PID 50) |
|---|---|---|
| Intended Use | Subcutaneous infusion of prescribed liquid medicines. | SAME to Crono Super PID - K052217 |
| Infusion per impulse | 22 μl | 20 μl (SAME to Crono PCA 50 - K052218) |
| Flow rate accuracy | +/-2% | +/-3% (SAME to Crono PCA 50 - K052218) |
| Max. Occlusion pressure | 4.5 bar +/-1 bar | 3 bar +/-1.5 bar |
| Capacity | 10 or 20 ml | 50 ml (SAME to Crono PCA 50 - K052218) |
| Physical Size | 3" x 1.85" x 1.14" (77 x 48x 29 mm) | 3.3" x 2.15" x 1.65" (84.5 x 55 x 42 mm) (SAME to Crono PCA 50 - K052218) |
| Weight | 4.0 oz (115 g) | 4.85 oz (140 g) (battery included) (SAME to Crono PCA 50 - K052218) |
| Battery | Power Source Lithium battery (3V) of the 123 A type. | SAME |
Note regarding acceptance criteria: The document specifically states that the Crono S-PID 50 is "SAME to Crono Super PID - K052217" for its intended use, implying that the acceptance criterion for intended use is alignment with that predicate device. For other characteristics, the comparison is often made to Crono PCA 50 (K052218), indicating that the acceptance criteria for the new device are based on either of the two predicate devices, with the new device demonstrating equivalence or improvement in performance. The table above reflects these comparisons.
2. Sample size used for the test set and the data provenance
The document states: "The results of bench, EMC, and user testing indicates that the new device is as safe and effective as the predicate device." However, no specific sample sizes for the test set (number of devices, number of tests, specific test parameters or conditions) are provided. The data provenance is implied to be from bench testing, EMC (Electromagnetic Compatibility) testing, and user testing, conducted by Canè S.p.A. in Italy. The study appears to be prospective in the sense that these tests were performed explicitly for the submission of the Crono S-PID 50.
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 document refers to "bench, EMC, and user testing" but does not detail the nature of "user testing" or if any experts were involved in establishing "ground truth" beyond standard engineering and testing procedures. For a medical device, ground truth for performance metrics would typically be established through validated testing methodologies and measurements, not necessarily expert consensus in the way a diagnostic imaging study would.
4. Adjudication method for the test set
This information is not provided. Adjudication methods are typically relevant for studies involving subjective assessments or interpretation by multiple human readers, which is not clearly described as part of the Crono S-PID 50's testing. For bench and EMC testing, objective measurements would be compared against predefined 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 MRMC study was performed or mentioned. The device is an ambulatory infusion pump, not a diagnostic AI system, so an MRMC study with human readers assisting AI or vice-versa is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a medical pump, not an algorithm or AI system for diagnostic or interpretive tasks. The "standalone" performance would refer to the pump's mechanical and electronic functioning as a device. The "bench, EMC, and user testing" described would represent the standalone performance evaluation of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance would be established through objective engineering measurements and validated test methodologies against specified performance parameters (e.g., flow rate accuracy, occlusion pressure, infusion per impulse). For instance, flow rate accuracy would be tested by precisely measuring the volume delivered over a set period and comparing it to the programmed delivery, with the true value being the precisely measured volume.
8. The sample size for the training set
This information is not applicable and not provided. The Crono S-PID 50 is a medical device (infusion pump), not a machine learning or AI model that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable and not provided as there is no training set for this type of device.
Ask a specific question about this device
(100 days)
CANE S.R.L.
the Crono Five and Crono PCA 50 has been designed for use in subcutaneous, intravenous, epidural and intrathecal infusions of prescribed liquid medicines.
Crono Five is a new, innovative ambulatory infusion pump that is very appreciated by health care professionals and patients due to its small size and technical features. Crono Five is especially suited for controlled drug administration on patients in hospital or undergoing a therapy at home. The pump is suitable for subcutaneous, intra-venous, epidural and intrathecal infusions allowing 4 different administration modalities: 1. Continuous 2. Bolus dose upon request (PCA) 3. Clinician bolus (managed by clinician) 4. Combined (continuous + bolus upon request + clinician bolus). Crono Five pump uses dedicated syringes which are available in two sizes: 10 and 20 ml. The pump is provided with key-pad lock-out functions in order to avoid un-authorized reprogramming of the drug administration protocol. The liquid crystal display (LCD) can show relevant information to caregivers and patients like programmed values, amount of drug delivered, remaining delivery time etc. Crono PCA 50 is essentially the same as the Crono Five, but has a 50 ml infusion capacity.
The provided text describes the 510(k) premarket notification for the Crono Five and Crono PCA 50 ambulatory infusion pumps. However, it does not contain the level of detail typically found in a study that proves a device meets specific acceptance criteria, especially for AI/ML-driven devices.
Based on the information provided, here's an attempt to answer the questions, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
The document presents a comparison table between the new devices (Crono Five and Crono PCA 50) and a predicate device (Crono PCA - K013822; though Crono go - K013840 is listed under physical characteristics). While this table shows performance characteristics, it doesn't explicitly state "acceptance criteria" against which these performances are measured in a quantifiable sense, beyond general equivalence.
| Characteristic | Crono PCA - K013822 (Predicate Device) | Crono Five / Crono PCA 50 (New Device) | Acceptance Criteria (Implied) | Reported Performance (New Device) |
|---|---|---|---|---|
| Intended Use | subcutaneous, intra-venous, epidural and intrathecal infusions of prescribed liquid medicines. | SAME | Be equivalent to predicate | Same as predicate |
| Physical characteristics | Crono go - K013840 (for size/weight) | Crono Five / Crono PCA 50 | Be equivalent to predicate | Crono Five: 77x48x29 mm, 115g. Crono PCA 50: 84.5x55x42 mm, 140g. (Size and Weight vary from "SAME" for Crono Five and Crono PCA 50, but are considered acceptable in the context of similarity to Crono go) |
| Size | 3" x 1.85" x 1.14" (77 x 48 x 29 mm) | SAME (for Crono Five); 84.5 x 55 x 42 mm (for Crono PCA 50) | Be comparable to predicate | Crono Five: 77x48x29 mm. Crono PCA 50: 84.5x55x42 mm. |
| Weight | 4.0 oz (115 g) (battery included) | SAME (for Crono Five); 140 g (battery included) (for Crono PCA 50) | Be comparable to predicate | Crono Five: 115g. Crono PCA 50: 140g. |
| Battery | Power Source Lithium battery (3V) of the 123 A type. | SAME | Be equivalent to predicate | Same as predicate |
| Infusion per impulse | 22 μl. | Crono Five: 5 μl. Crono PCA 50: 20 μl. | Achieve intended infusion rates and volume with sufficient precision | Crono Five: 5 μl. Crono PCA 50: 20 μl. (These are different but considered acceptable for purpose.) |
| Flow rate accuracy | +/-2%. | Crono Five: +/-2%. Crono PCA 50: +/-3%. | Maintain acceptable flow rate accuracy for intended use | Crono Five: +/-2%. Crono PCA 50: +/-3%. |
| Max. Occlusion pressure | 4.5 bar +/-1 bar. | Crono Five: 2.2 bar +/-0.5 bar. Crono PCA 50: 2.2 bar +/- 0.5 bar. | Have an appropriate safety margin for occlusion pressure | Crono Five: 2.2 bar +/-0.5 bar. Crono PCA 50: 2.2 bar +/- 0.5 bar. (Different but presumably within safe operating limits). |
| Capacity | 10 or 20 ml. | 10, 20 ml or 50 ml. | Meet desired capacity range | 10, 20 ml or 50 ml. |
The primary "acceptance criterion" articulated is "Substantial Equivalence" to the legally marketed predicate device (Crono, K041414). The study (as described) aims to demonstrate that the new device is "as safe and effective" as the predicate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "bench, EMC, and user testing." It does not specify the sample size for these tests (e.g., number of devices tested, number of users involved). The provenance of the data is not explicitly stated beyond the fact that the company (Canė S.r.l.) is based in Italy. It's not clear if the user testing was prospective or retrospective; bench and EMC testing are generally prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. The context of this device (infusion pump) suggests that "ground truth" would be established through engineering specifications, calibration standards, and clinical performance assessments rather than expert interpretation of medical images or data. There's no indication of experts in the sense of medical diagnosticians establishing ground truth. "User testing" would involve healthcare professionals, but their number and specific qualifications for establishing ground truth are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Given the nature of this device (an infusion pump) and the type of testing mentioned (bench, EMC, user testing), an "adjudication method" in the context of expert consensus for diagnostic interpretation is not applicable. Testing would likely involve adherence to engineering standards and verification procedures.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically relevant for AI/ML diagnostic or image analysis tools where human readers’ performance is being evaluated with and without AI assistance. The Crono Five and Crono PCA 50 are infusion pumps, not AI/ML diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is an infusion pump, which is a hardware device with embedded software for controlling the infusion process. It's not an AI/ML algorithm in the context of standalone diagnostic performance. The "bench testing" would represent the standalone performance of the device against its specifications, but not in the sense of an algorithm operating without human intervention for diagnostic purposes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For an infusion pump, the "ground truth" for performance characteristics (like flow rate accuracy, infusion per impulse, occlusion pressure) would be established by:
- Engineering specifications and standards: Adherence to defined physical and performance parameters, often verified with calibrated equipment.
- Bench testing: Measuring actual output against expected output using precise instrumentation.
- User feedback/testing: Verifying that the device operates as intended in a clinical or simulated clinical environment and meets user requirements for usability and safety.
There is no mention of expert consensus, pathology, or outcomes data in the sense of a medical diagnostic study.
8. The sample size for the training set
This information is not applicable as the device is not described as an AI/ML system that undergoes a "training set" process. It's a medical device (infusion pump) whose performance is established through traditional engineering and clinical testing.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
Ask a specific question about this device
(29 days)
CANE S.R.L.
the Crono Super PID has been designed for use in subcutaneous infusion of prescribed liquid medicines.
Crono Super PID 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 Super PID combines high technology with innovative design. Thanks to the small size of the pump the patients can administer the drug any time daring the day without interrupting daily life or leisure activities. Crono Super PID pump uses dedicated syringes which are available in two sizes: 10 and 20 ml. Crono Super PID has a particular mechanism which pushes directly on the rubber syringe piston, which makes it possible to reach a significant thrust force and high accuracy of administration. Crono Super PID administers 22 µl per impulse. 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 Super PID is fitted with a liquid cristal display which shows the time it takes to complete the delivery, the syringe size and the battery charge status.
The provided text describes a 510(k) premarket notification for the Crono Super PID ambulatory infusion pump, establishing its substantial equivalence to a predicate device (Crono, K041414). This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving novel effectiveness through extensive clinical trials.
Here's an analysis of the acceptance criteria and the "study" that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents a comparison table between the predicate device (Crono - K041414) and the new device (Crono Super PID) to demonstrate substantial equivalence. The "acceptance criteria" here are essentially the performance characteristics of the predicate device that the new device must match or improve upon to be considered substantially equivalent.
| Characteristic | Acceptance Criteria (Predicate Device Crono - K041414) | Reported Device Performance (Crono Super PID) | Met? |
|---|---|---|---|
| Intended Use | Subcutaneous infusion of prescribed liquid medicines. | SAME | YES |
| Size | 3" x 1.85" x 1.14" (77 x 48 x 29 mm). | SAME | YES |
| Weight | 4.0 oz (115 g) (battery included). | SAME | YES |
| Battery | Power Source Lithium battery (3V) of the 123 A type. | SAME | YES |
| Infusion per impulse | 22 µl. | SAME | YES |
| Flow rate accuracy | +/-2%. | SAME | YES |
| Max. Occlusion pressure | 4.5 bar +/-1 bar. | SAME | YES |
| Capacity | 10 or 20 ml. | SAME | YES |
Note: The phrase "SAME" in the "Reported Device Performance" column signifies that the Crono Super PID meets or matches the specified characteristic of the predicate device.
2. Sample size used for the test set and the data provenance
The document states, "The results of bench, EMC, and user testing indicates that the new device is as safe and effective as the predicate device." However, specific sample sizes for these tests are not provided. Similarly, the data provenance (e.g., country of origin, retrospective/prospective) for the bench, EMC, and user testing is not explicitly stated. Given that CANE S.r.l. is an Italian company, it's highly probable that some or all of the testing was conducted in Italy, but this is an inference, not stated fact.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable or not specified. For a 510(k) submission demonstrating substantial equivalence for an infusion pump, the "ground truth" for performance characteristics (like flow rate accuracy) would typically be established through instrumental measurements and engineering verification, not through expert consensus on medical images or clinical outcomes. The document does not mention the involvement of medical experts in establishing ground truth for the technical performance parameters.
4. Adjudication method for the test set
Not applicable or not specified. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of subjective data (e.g., radiological images) where discrepancies between expert readers need to be resolved. This is not relevant for the type of bench and user testing described for an infusion pump, which focuses on objective physical and functional characteristics.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving AI algorithms, where the performance of human readers (e.g., radiologists) is augmented by AI. The Crono Super PID is an ambulatory infusion pump, not a diagnostic device, and does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Crono Super PID is a physical medical device (an infusion pump), not an algorithm. Its performance is inherent to its mechanical and electronic function, not an algorithm's output separate from human interaction in a diagnostic or interpretive context.
7. The type of ground truth used
The ground truth for the performance characteristics of the Crono Super PID would be established through objective engineering measurements and verification. For example:
- Flow rate accuracy: Measured against a calibrated standard using laboratory equipment.
- Max. Occlusion pressure: Measured using pressure sensors.
- Size and Weight: Measured using standard measuring tools.
- Infusion per impulse: Verified through precise volume measurement.
The phrase "bench, EMC, and user testing" suggests these types of objective measurements were performed.
8. The sample size for the training set
Not applicable / Not specified. The concept of a "training set" is primarily relevant for machine learning or AI models. The Crono Super PID is a physical device, and its development and testing do not involve a training set in the AI sense. Its design and manufacturing are based on engineering principles and quality control.
9. How the ground truth for the training set was established
Not applicable. As explained above, there is no "training set" in the context of this device's development as described. The performance data is derived from direct physical and functional testing.
Ask a specific question about this device
(29 days)
CANE S.R.L.
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.
Ask a specific question about this device
(45 days)
CANE S.R.L.
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."
| Characteristic / Test | Acceptance Criteria (Implied) | Reported Device Performance | Comments by AI |
|---|---|---|---|
| Intended Use | Same as predicate device (subcutaneous and intravenous infusion of prescribed liquid medicines) | SAME | Crono F has the same intended use as Crono H. |
| Physical Characteristics | Same as predicate device | SAME | Power source, infusion per impulse, size, weight, and capacity are the same as Crono H. |
| Safety and Effectiveness | As safe and effective as the predicate device (Crono H) | "The results of bench, EMC, and user testing indicates that the new device is as safe and effective as the predicate device." | This is a general statement. Specific performance data from these tests are not provided in the summary. |
| Technological Characteristics | Few technological changes/improvements compared to the predicate without raising new questions of safety/effectiveness. | "has few technological Ciono 1 15 as sare and offective as thus rendering it substantially equivalent to the predicate device." (This sentence appears to be a slight typo in the original document, but the intent is clear). | Crono F has a new design for a "special syringe" allowing reduction of pump size, a mechanism for higher thrust force, and an innovative infusion control system for occlusion. These are presented as improvements that do not negate substantial equivalence. |
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.
Ask a specific question about this device
(42 days)
CANE S.R.L.
The Crono and Crono 30 ambulatory infusion pump devices have been designed for use in subcutaneous infusion of prescribed liquid medicines.
Canc 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 witch use normal commercial syringes are inevitably cumbersome and thus difficult to mee 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. Points 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 timss ligher with respect to conventional pumps. In case of catheter occlusion, an innovative influsion control system makes it possible to proceed with the infusion automatically and, after the occlusion is climinated, 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 ul 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 Crono 30 is essenially the same as the Crono, but has a 30 ml infusion capacity. It infuses at a rate of 3 ml per impulse.
The provided document is a 510(k) summary for the Crono and Crono 30 ambulatory infusion pumps. It aims to demonstrate substantial equivalence to a predicate device (Crono, K013234), rather than a de novo approval requiring extensive performance criteria and studies as one might find for a novel AI device. Therefore, the information requested, particularly regarding AI-specific criteria, multi-reader studies, and detailed ground truth establishment for AI models, is not applicable or available in this document.
However, I can extract the relevant information from the document regarding the device's acceptance criteria and the studies performed to demonstrate equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria (Implicit) and Reported Device Performance
The acceptance criteria are not explicitly listed in a quantitative table with specific thresholds, but rather implied by the comparison to the predicate device and the successful completion of a 510(k) submission. The "reported device performance" is essentially that the new device performs "the same" or has "few technological differences" to the predicate, and is deemed "as safe and effective."
| Characteristic | Predicate Device (Crono, K013234) | New Device (Crono and Crono 30) | Implied Acceptance Criterion | Reported Device Performance |
|---|---|---|---|---|
| Intended Use | Subcutaneous infusion of prescribed liquid medicines. | SAME | Equivalent to Predicate | SAME |
| Power Source | Lithium battery (3V) of the 123 A type. | SAME | Equivalent to Predicate | SAME |
| Infusion per Impulse | 22 µl | 22µl or 33 µl for Crono 30 (with 30 ml syringe) | Equivalent or functionally improved (Crono 30) | 22µl (Crono), 33µl (Crono 30) |
| Size | 3" x 1.85" x 1.14" (77 x 48 x 29 mm) | SAME. For Crono 30: 3.15" x 1.89" x 1.38" (80 x 48 x 35 mm) | Equivalent or slightly larger for increased capacity (Crono 30) | Same (Crono), Slightly larger (Crono 30) |
| Weight | 4.0 oz (115 g) (battery included) | SAME. Crono 30: 125 g (battery included) | Equivalent or slightly heavier for increased capacity (Crono 30) | Same (Crono), Slightly heavier (Crono 30) |
| Capacity | 10 or 20 ml | 10, 20, or 30 ml | Equivalent or functionally improved | 10, 20, or 30 ml |
| Warranty | 2 years | SAME | Equivalent to Predicate | SAME |
| Safety and Effectiveness | Demonstrated by predicate device. | "as safe and effective" as the predicate device. | Equivalent to Predicate | Bench, EMC, and user testing indicate safety and effectiveness are equivalent. |
2. Sample size used for the test set and the data provenance
The document mentions "bench, EMC, and user testing" but does not provide specific sample sizes for these tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective). This is typical for a 510(k) for a relatively low-risk device where the primary goal is demonstrating equivalence through engineering and limited usability testing.
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 (bench, EMC, user) does not typically involve expert consensus for "ground truth" in the way an AI diagnostic or prognostic device would. The "ground truth" for an infusion pump would be its mechanical and electrical performance specifications and user satisfaction/safety, which are assessed through engineering tests and usability studies rather than expert medical interpretation of data.
4. Adjudication method for the test set
Not applicable/not provided. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies, especially for image-based AI, which is not relevant here.
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 an ambulatory infusion pump, not an AI-assisted diagnostic or prognostic tool. Therefore, an MRMC study and AI-specific effect sizes are not relevant.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This device does not have a standalone algorithm or AI component in the context of typical AI medical devices. It is a mechanical-electronic pump.
7. The type of ground truth used
The "ground truth" implicitly used for this device would be:
- Engineering specifications and regulatory standards: For bench and EMC testing, adherence to established performance parameters (e.g., infusion rate accuracy, alarm functionality, electromagnetic compatibility).
- User feedback/observation: For user testing, to ensure ease of use, patient acceptance, and safety in a real-world (or simulated real-world) context.
- Predicate device performance: The ultimate "ground truth" for a 510(k) is that the new device is "as safe and effective" as the legally marketed predicate.
8. The sample size for the training set
Not applicable. This device does not use a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device in the AI sense.
Ask a specific question about this device
Page 1 of 1