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The Jostra Suction Devices are designed to aspirate blood and other fluids from the operative field and return it to the extracorporeal circuit during open heart surgery lasting 6 hours or less.

The Jostra Suction Devices are single, sterile devices for single use only and not to be resterilized by the user. The Jostra Suction Devices are designed to aspirate blood and other fluids from the operative field and return it to the extracorporeal circuit during open-heart surgery. The suction devices include rigid, flexible and pericardial suckers.

The provided text describes a 510(k) summary for Jostra Suction Devices, focusing on establishing substantial equivalence to a predicate device. This type of regulatory submission does not typically involve the kind of detailed clinical study with acceptance criteria, sample sizes, expert ground truth, or MRMC studies that would be associated with AI/ML-based medical devices or devices requiring extensive clinical trials for efficacy.

The document primarily discusses non-clinical testing to demonstrate performance and biocompatibility. Therefore, much of the requested information regarding AI/ML study methodologies is not applicable.

Here's an analysis based on the provided text, highlighting what is present and what is absent:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for Jostra Suction Devices

The Jostra Suction Devices underwent non-clinical testing to demonstrate substantial equivalence to a predicate device (Medtronic DLP Suction Devices), rather than a clinical study with detailed acceptance criteria for a new clinical outcome.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states, "Comparative testing has demonstrated that these differences do not affect safety and effectiveness." This implies that the acceptance criteria were based on demonstrating comparable safety and effectiveness to the predicate device through these non-clinical tests.

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

• Sample Size: The document does not specify exact sample sizes for the performance or in-vitro tests conducted. It only generically mentions "performance testing" and "in-vitro testing."
• Data Provenance: The testing was non-clinical (laboratory/bench testing and in-vitro). The country of origin for the testing is not specified, but the submitter is based in Germany. The data is retrospective in the sense that it's a review of non-clinical tests performed, not a prospective clinical trial.

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

This information is not applicable to this submission. The ground truth was established through engineering and laboratory testing protocols designed to assess physical performance characteristics and biocompatibility against established standards and the characteristics of the predicate device. There was no "ground truth" established by human expert consensus in the clinical sense for this type of device.

4. Adjudication Method for the Test Set

This information is not applicable. As there were no human expert evaluations for clinical "ground truth," there was no need for an adjudication method like 2+1 or 3+1. Performance was assessed through objective measurements from non-clinical tests.

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

No, an MRMC comparative effectiveness study was not conducted for this device. This type of study is typically done for diagnostic imaging devices or AI-assisted diagnostic tools, which is not the nature of the Jostra Suction Devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The device is a physical medical instrument (suction device), not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation was based on:

• Engineering specifications and performance standards.
• Biocompatibility test results.
• Direct comparison to the Medtronic DLP Suction Devices (predicate device) specifications and known performance.
• Objective measurements from performance tests like bond strength and leakage tests, and in-vitro cellular component analysis.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML system, so there is no concept of a "training set" for an algorithm.

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

Not applicable. As there is no training set, there is no ground truth to be established for it.

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The Hollow Fiber Membrane Oxygenator Quadrox Safeline is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide and to temper blood during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

The Jostra Hollow Fiber Oxyqenator Quadrox Safeline HMO 2030 is identical to the Jostra Hollow Fiber Oxygenator Safeline Quadrox HMO 1030 in design, intended use, method of operation, components, packaging, and fundamental scientific technology. The primary difference between the two devices is that the Jostra Hollow Fiber Oxygenator Quadrox Safeline HMO 2030 contains a heat exchanger fiber made of polyurethane (instead of polyethylene) which reduces the risk of electrostatic discharge for the patient significantly.

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

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

The document does not explicitly state the sample size used for the test set beyond mentioning "In-vitro tests were performed." The data provenance is also not specified; however, given that the manufacturer is based in Germany (Jostra AG, Hirrlingen, Germany) and the submission is to the US FDA, it can be inferred that the testing would have been conducted by the manufacturer, likely in Germany, to meet international standards for device evaluation. The data is retrospective in the sense that it's based on tests conducted on the modified device to compare against an existing predicate device.

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

Not applicable. This submission concerns a device modification, focusing on material change and functional equivalence demonstrated through in-vitro tests, not diagnostic performance requiring expert interpretation of results. No expert adjudication of "ground truth" as typically understood in AI/imaging studies is relevant here.

4. Adjudication method for the test set

Not applicable. As this is not a study involving human interpretation of data for diagnostic purposes, no adjudication method was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This is not an MRMC comparative effectiveness study. This submission is for a modification to a medical device (oxygenator) and relies on in-vitro testing to show substantial equivalence to a predicate device, not on human reader performance.

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

Yes, in a way. The "performance" of the device is evaluated in a standalone manner through in-vitro tests without human intervention in the device's operation or data interpretation during the test, beyond setting up the experiment and analyzing the results. The focus is on the device's physical and functional characteristics.

7. The type of ground truth used

The "ground truth" in this context is the predicate device's established performance and safety profile (Jostra Hollow Fiber Oxygenator Safeline Quadrox HMO 1030, K992559). The new device's performance is compared against the known and accepted performance of this predicate through physical and functional equivalence demonstrated by in-vitro testing. It's about demonstrating that the modified device performs effectively identically to the previously approved one, despite a material change.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning study, so there is no concept of a "training set" for an algorithm.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

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The Jostra Single Stage Venous Return Catheters are designed to be used for the collection of venous blood from the right side of the superior and inferior vena cava during cardiopulmonary bypass surgery up to 6 hours or less.
The Jostra Single Stage Venous Return Catheters are designed to be used for the collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to 6 hours or less.

The Jostra Single Stage Venous Catheters are single, sterile devices for single use only and not to be resterilized by the user. The catheters are to be used to divert blood from the patient to the extracorporeal circuit by draining blood from the Inferior Vena Caya and the Superior Vena Cava. The catheters are made from polyvinyl chloride (PVC) and range in size from 12 Fr.- 40 Fr with a variety of tips and with or without attached connectors.

This 510(k) summary describes a traditional medical device (venous catheter), not an AI/ML powered device. As such, many of the requested categories related to AI/ML device studies are not applicable.

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

The document does not explicitly state numerical acceptance criteria. The performance testing aimed to demonstrate "substantial equivalency" to the predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for the non-clinical testing. It also does not specify the country of origin of the data or whether it was retrospective or prospective, as these tests are laboratory-based device performance tests rather than clinical studies on patient data.

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)

Not applicable. This device is a mechanical catheter and its performance is evaluated through physical and material properties testing, not through expert-reviewed data or ground truth labeling by medical professionals.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study requiring adjudication of expert opinions.

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 device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this medical device's performance is based on established engineering and materials testing standards and comparison to a legally marketed predicate device's performance characteristics.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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The Jostra Mecc System is intended for use in surgical procedures requiring extracorporeal circulation and gas exchange support for 6 hours or less.

The Jostra Mecc System is a finished, sterile device for single use only and not to be restenlized by the user. The Jostra Mecc System is an extracorporeal circuit including circulatory and gas exchange support devices for use during extracorporeal circulation lasting 6 hours or less.

This is a 510(k) premarket notification for a medical device called the "Jostra Mecc System". This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through clinical trials with defined acceptance criteria and performance metrics.

Therefore, the requested information about acceptance criteria, study details, human reader improvement with AI assistance, standalone algorithm performance, ground truth, and training set information is not applicable to this 510(k) submission.

Here's why and what can be inferred from the document:

• Acceptance Criteria and Reported Device Performance: In a 510(k), the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness. There isn't a table of specific performance metrics against pre-defined acceptance thresholds as you'd find in a clinical trial for a new therapeutic or diagnostic device. The document states: "The Jostra Mecc System is substantially equivalent to the currently marketed predicate devices for the stated intended use."

• Study That Proves the Device Meets Acceptance Criteria: The "study" here is a comparison to a predicate device, not a typical clinical trial. The document explicitly states: "All devices have previous 510(K) market clearance, have the same intended use, and have been validated for assembly into an extracorporeal circuit." This implies bench testing and possibly animal studies pertinent to the predicate device's clearance, but no specific study details are provided for the Jostra Mecc System in this summary.

• Sample Size for Test Set and Data Provenance: Not applicable. The submission relies on equivalence.

• Number of Experts and Qualifications: Not applicable. Ground truth establishment by experts is not described for this type of submission.

• Adjudication Method: Not applicable.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating diagnostic performance, often with human readers. This device is an extracorporeal circuit.

• Standalone (Algorithm Only) Performance: Not applicable. This is a physical medical device, not an AI/algorithm-based diagnostic tool.

• Type of Ground Truth Used: Not applicable in the context of demonstrating performance against a ground truth. The "ground truth" for a 510(k) of this nature is that the predicate device is safe and effective when used as intended.

• Sample Size for the Training Set: Not applicable. This is not a machine learning device.

• How the Ground Truth for the Training Set Was Established: Not applicable.

Summary of Relevant Information from the Document:

While the direct answers to your questions are "not applicable" due to the nature of a 510(k) submission for this device, here's what the document does provide:

1. Predicate Device: Bentley Duraflo Treated Extracorporeal Circuit
2. Comparison Basis: The Jostra Mecc System provides the same components as the Bentley Duraflo system, assembled to the manufacturer's specifications. All components of both systems have previous 510(k) market clearance, have the same intended use, and have been validated for assembly into an extracorporeal circuit.
3. Intended Use: For use in surgical procedures requiring extracorporeal circulation and gas exchange support for 6 hours or less.
4. Conclusion: The FDA determined that the Jostra Mecc System is substantially equivalent to the predicate devices.

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The Jostra Vent Catheters are used to drain blood or fluid from the left ventricle during cardiopulmonary bypass surgery up to 6 hours or less.

The Jostra Vent Catheters are sterile devices for single use only and are not to be resterilized by the user. They are designed for use in venting the left ventricle during cardiopulmonary bypass surgery. The catheter is inserted into the left ventricle via the pulmonary vein, cardiac auricle or cardiac apex. The catheters are made of polyvinyl chloride and are available in a variety of sizes. They are also available in a variety of configurations (straight or bent tip, with or without wire reinforcement, with or without an integrated stylet, with or without a vacuum valve, malleable and non malleable). The catheters range from 8 to 18 French and are offered in lengths from 23 to 40 cm.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Jostra Vent Catheter:

The provided 510(k) summary for the Jostra Vent Catheter (K022022) focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific quantitative acceptance criteria or detailing a comprehensive study with the elements typically found in AI/ML device submissions.

Therefore, the requested information elements related to AI/ML device studies (such as sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI) are not applicable to this traditional medical device submission.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are implicitly derived from the performance and characteristics of the legally marketed predicate devices. The study's goal was to demonstrate "substantial equivalence" of the Jostra Vent Catheters to these predicates, meaning its performance, safety, and effectiveness are comparable.

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

• Sample Size: The document mentions "Performance testing of the smallest and largest models" and "in-vitro testing." It does not specify the exact number of units tested for each parameter (kink stability, leak, tensile strength) or the specific number of in-vitro samples.
• Data Provenance: Not specified. Given it's a submission by a German company (Jostra AG) to the US FDA, the testing likely occurred at the manufacturer's facilities or a contract lab, but the country of origin of the data itself is not detailed. The testing is non-clinical/bench testing, not patient data, so "retrospective or prospective" is not applicable in the typical sense.

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

• Not Applicable. This device is a mechanical medical device (catheter), not an AI/ML diagnostic tool. There is no concept of "ground truth" established by experts for its performance tests (kink stability, leak, tensile strength). These are objective engineering measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. As above, this is not an AI/ML diagnostic or image-based device requiring expert adjudication. The tests performed are objective, measurable physical properties.

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 a component used in surgery; it does not involve "human readers" or "AI assistance."

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable / Objective Measurement. For the performance tests (kink stability, leak, tensile strength), the "ground truth" or reference is based on established engineering standards and the performance of the predicate devices, measured objectively. For biocompatibility, it refers to standard biological response evaluations.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. This is not an AI/ML device that requires a training set or ground truth for such.

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The Jostra Antegrade Cardioplegia Cannulas are intended to be used to infuse blood and/or cardioplegia solution to the patient's myocardium, antegrade, via the aortic root, during cardiopulmonary bypass for 6 hours or less.

The Jostra Antegrade Cardioplegia Cannulas are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to infuse blood or cardioplegia solution antegrade via the aortic root during extracorporeal circulation. The cannulas are made from polyurethane (PUR) in sizes 7 Fr., 9Fr., and 11 Fr., with or without vent lines and with an optional needle safety system.

The provided document describes a 510(k) premarket notification for the "Jostra Antegrade Cardioplegia Cannula" (K020515). This application demonstrates substantial equivalence to a predicate device, focusing on performance and biocompatibility. However, it does not describe an AI device or a study that establishes acceptance criteria for such a device.

The information requested in the prompt (acceptance criteria for AI, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) is specific to studies evaluating Artificial Intelligence or machine learning systems. The provided text is for a medical device (a cannula), not a software algorithm or AI.

Therefore, I cannot fulfill the request as the input document does not contain information about an AI device or a study demonstrating its performance.

This document pertains to a medical device (cannula) and not an AI or machine learning system. Therefore, the requested information regarding acceptance criteria and studies for an AI device, including details like sample sizes for test/training sets, expert qualifications, MRMC studies, and standalone performance, is not applicable and cannot be extracted from the provided text.

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The Jostra Retrograde Cardioplegia Cannulas are designed to infuse blood or cardioplegia arrest solution to the myocardial tissue retrograde via the coronary sinus during cardiopulmonary bypass up to 6 hours or less.

The Jostra Retrograde Cardioplegia Cannulas are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to infuse blood or cardioplegia arrest solution retrograde via the coronary sinus during extracorporeal circulation. The cannulas are made from polyvinyl chloride (PVC) in size 14 Fr. with a variety of balloons, with or without pressure monitoring lines and a choice of stiff or flexible stylets.

The provided text describes a 510(k) summary for the Jostra Retrograde Cardioplegia Cannula, which is a medical device. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone performance metrics typical of a novel AI device.

Therefore, many of the requested categories for AI/algorithm-based studies (like expert consensus, sample sizes for training/test sets, MRMC studies, ground truth establishment methods) are not applicable to this type of device submission. The acceptance criteria here are based on standard engineering and biocompatibility tests to show the device functions safely and effectively, similar to the predicate.

Here's the information that can be extracted and a clear indication of what is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the provided text. The testing mentioned refers to device engineering and material performance rather than a clinical "test set" of patient data.
• Data Provenance: Not applicable in the context of clinical data. The tests are non-clinical, likely performed in a lab setting.

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

• Number of Experts: Not applicable. Ground truth as typically understood for AI/diagnostic devices (e.g., expert consensus on medical images) is not relevant for this engineering-focused device submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable.

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

• MRMC Study: No, an MRMC study was not done. This type of study is typically for diagnostic devices where human readers interpret patient data (e.g., medical images) with and without AI assistance. This device is a surgical cannula, not a diagnostic tool that involves human interpretation of results.
• Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable, as no MRMC study was conducted.

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

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm, so the concept of "standalone performance" in this context is not relevant. The device itself is "standalone" in that it performs its intended function without requiring an AI algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the non-clinical tests, the "ground truth" would be established by validated engineering standards, specifications, and test methods (e.g., known flow rates, material strength properties, biological compatibility standards). This is implicitly assumed rather than explicitly stated.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not use a "training set" in the sense of machine learning algorithms.

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

• Ground Truth for Training Set: Not applicable.

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The Jostra Two-Stage Venous Cannulas are designed to be used as perfusion cannulae to divert venous blood from the patient during surgery requiring extracorporeal circulation for up to 6 hours.

The Jostra Two-Stage Venous Cannulas are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to divert blood from the patient to the extracorporeal circuit by draining blood simultaneously from the Right atrium and the Inferior vena cava. The cannulae are made from polyvinyl chloride (PVC) and range in size from 32Fr./40Fr. to 36Fr./51Fr. with a variety of tips and with or without attached connectors.

This document describes the 510(k) submission for the Jostra Dual-stage Venous Cannulae (K013944), a medical device used in cardiopulmonary bypass surgery. The submission focuses on demonstrating substantial equivalence to a predicate device, the Medtronic DLP Two-Stage Venous Cannulae.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the nature of the tests performed to demonstrate "substantial equivalence" to the predicate device. The goal is to show comparable performance. The document does not explicitly state numerical acceptance criteria for each test but rather describes the types of tests conducted and their stated outcome.

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

The document does not specify the exact sample sizes used for each of the performance tests (Flow-Pressure curves, Kink Resistance, Bond Strength, Leakage Test, and in-vitro cellular effects). The data provenance is likely from laboratory testing conducted by the manufacturer, Jostra AG, in Germany. The tests are described as in-vitro and performance testing, implying a controlled laboratory setting rather than human or animal studies. The data is retrospective in the sense that it was collected as part of the device development and verification process to support the 510(k) submission.

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

Since this is a submission for a physical medical device (venous cannulae) and the tests are in-vitro performance and biocompatibility studies, there is no "ground truth" in the traditional sense established by human experts in the way it would be for an AI/algorithm-based diagnostic device. The "ground truth" for compliance with acceptance criteria is based on objective measurements and established industry standards for device performance and safety, as evaluated by engineers and technical specialists.

4. Adjudication Method for the Test Set

Not applicable. This is not an imaging or diagnostic device that requires expert adjudication of results. The performance of the device is assessed through objective physical and biological tests.

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 done. This type of study is typically performed for diagnostic devices or AI algorithms where human interpretation is involved. The Jostra Dual-stage Venous Cannulae is a physical medical device.

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

Not applicable. This device is not an algorithm or AI system. Its performance is inherent in its physical and material properties.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective, measurable physical and biological parameters established through engineering and laboratory testing. This includes:

• Physical measurements (e.g., flow rates, pressure resistance, bond strength).
• Mechanical properties (e.g., kink resistance).
• Biocompatibility assessments (e.g., in-vitro effects on cellular components).
• Comparison to the established performance characteristics of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The device is a physical product.

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

Not applicable. There is no training set for a physical medical device of this nature.

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The Jostra Flowprobe FP-32E is indicated for use as a flow measuring device to be used as an electromagnetic blood flow transducer as a direct product replacement for the BioMedicus flowprobe DP-38 in extracorporeal circuits for up to 6 hours.

The Jostra Flowprobe FP-32E is a single, sterile device for single use only and not to be re-sterilized by the user. The flowprobe is made from polycarbonate and is available in a 3/8" size.

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Jostra Flowprobe FP-32E:

Device Name: Jostra Flowprobe FP-32E

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text does not explicitly state numerical acceptance criteria for specific performance metrics. Instead, it indicates that "performance testing was performed to demonstrate substantial equivalency to the predicate device."

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

• Sample Size: Not specified. The document only states that "Performance testing included" various types of tests.
• Data Provenance: Not specified, but the submission is from Jostra AG, Germany, so the testing was likely conducted in Germany or by a third-party testing facility. The study is non-clinical (bench testing), not involving human subjects.

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

Not applicable. This was a non-clinical, bench testing study. Ground truth was established through engineering and performance measurements against established standards or the predicate device's performance.

4. Adjudication Method for the Test Set:

Not applicable. This was a non-clinical, bench testing study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, this was not applicable or done. The study was non-clinical (bench testing) and did not involve human readers or cases.

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

Not applicable. This device is a physical flow probe, not an AI algorithm. Its performance is inherent to its design and function, not dependent on human interpretation or AI.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical testing was based on:

• Engineering specifications and design requirements.
• The established performance characteristics of the predicate device (Medtronic-BioMedicus DP-38 Bio-Probe).
• Industry standards for functional, pressure, electrical safety, and biocompatibility testing for medical devices.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical flow probe and does not involve AI or machine learning that would require a training set.

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

Not applicable, as there is no training set for this device.

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The Jostra Arterial Cannulae (adults) are designed to be used as perfusion cannulae during extracorporeal circulation during cardiopulmonary bypass up to 6 hours or less.

The Jostra Adult Arterial Cannulae are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to return arterial blood to the patient via the antic root or other large artery during extracorporeal circulation. to the cannulae are made from polyvinyl chloride (PVC) and range in size from 20fr. to 24fr. with a variety of tips, with or without attached connectors. The cannulas are specifically designed for use on patients requiring more than 3L/Min. of blood flow.

The Jostra Adult Arterial Cannulae is a medical device designed for use in cardiopulmonary bypass procedures. The device's acceptance criteria and performance were assessed through a non-clinical testing study to demonstrate substantial equivalence to a predicate device, the Medtronic DLP Adult Arterial Cannulae.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

The document does not specify the exact sample sizes used for each individual performance test (Flow-Pressure curves, Kink Resistance, Bond Strength, Leakage Test, and in-vitro testing for cellular effects). The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given it is a premarket notification for a new device, the testing would typically be prospective, carried out by the manufacturer.

3. Number of Experts and Qualifications:

Not applicable. This was a non-clinical performance and biocompatibility study, not a clinical study involving expert judgment for ground truth.

4. Adjudication Method:

Not applicable. Adjudication methods are typically relevant for clinical studies involving multiple reviewers; this was non-clinical testing.

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

No MRMC comparative effectiveness study was mentioned. The study focused on technical performance and biocompatibility rather than human reader performance with or without AI assistance.

6. Standalone Performance Study:

Yes, a standalone study of the device's performance was done. The non-clinical testing evaluated the device's physical properties and biocompatibility as a standalone entity. There is no mention of human-in-the-loop performance since the device is a physical cannula, not an AI or imaging diagnostic tool.

7. Type of Ground Truth Used:

The "ground truth" for this type of device is established through engineering and biological standards. For example:

• Performance Tests: The ground truth for flow-pressure curves, kink resistance, bond strength, and leakage tests would be established by validated engineering specifications and industry standards for cardiopulmonary bypass cannulae. The "truth" is whether the device meets these pre-defined physical and functional requirements.
• Biocompatibility: The ground truth is compliance with relevant biological safety standards (e.g., ISO 10993 series) and demonstration that the device material does not cause adverse biological reactions or affect cellular components.

8. Sample Size for the Training Set:

Not applicable. This device is a physical medical instrument, not an AI/machine learning model, so there is no "training set" in that context. The testing involved samples of the manufactured device.

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

Not applicable, as there is no training set for this type of device. The "ground truth" for evaluating the performance and biocompatibility of the Jostra Adult Arterial Cannulae was based on established engineering principles, industry standards, and biological safety guidelines for similar medical devices. The predicate device (Medtronic DLP Adult Arterial Cannulae) also served as a benchmark for comparison.

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