Search Results

Extracorporeal Membrane Oxygenation

The LifeSPARC System is a centrifugal blood pump system intended to assist in circulation of the patient's blood when part of an extracorporeal circuit including physiologic gas exchange of the patient's blood in adult patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. These may include:

· Failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients;

· ECMO-assisted cardiopulmonary resuscitation in adults.

Cardiopulmonary Bypass

The LifeSPARC System is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

The LifeSPARC Pump is a sterile, single-use, low prime volume centrifugal pump with an integrated motor and a single-point, pivot bearing. It is sterilized using ethylene oxide (EO) and sized to fit in the palm of the hand or to secure to the patient.

The LifeSPARC Controller provides the interface between pump and user, as well as the power and electrical signals to drive the pump. It is a microprocessor-based electromechanical pump drive system designed to operate on standard AC current (100/240 VAC, 50/60 Hz) or on internal, rechargeable batteries for intra-hospital transport.

The provided document is a 510(k) premarket notification summary for the CardiacAssist, Inc. LifeSPARC System. This submission appears to be for a software update to an already cleared device, not for a new device requiring extensive clinical trials to prove its performance against specific acceptance criteria.

The document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, as such a study would typically be conducted for a novel device or a significant change in intended use, which is not the case here.

Here's why the requested information is absent and what the document does indicate:

1. A table of acceptance criteria and the reported device performance: This is not present. The submission focuses on demonstrating "substantial equivalence" to previously cleared versions of the LifeSPARC System, specifically due to a software update. This means the performance is assumed to be equivalent to the predicate devices, rather than being re-evaluated against new, explicit acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable in the context of this submission. The testing mentioned is "Software Verification and Validation testing (including Cybersecurity)," which typically does not involve human patient data or "test sets" in the clinical sense.

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. "Ground truth" established by clinical experts is relevant for diagnostic or AI-driven devices that interpret complex data (like medical images). This device is a mechanical pump system with a controller, and its "performance" is assessed through engineering and software validation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for the reasons stated above.

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 diagnostic tool and does not involve "human readers" interpreting data with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document mentions "Software Verification and Validation testing." This type of testing evaluates the algorithm's performance in isolation (standalone), but it's in the context of a software update for a medical device's control system, not a diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. For software validation, the "ground truth" would be the expected functional behavior of the software as defined by its requirements and specifications.

8. The sample size for the training set: Not applicable. This is not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does state regarding performance and testing:

• Device Change: The submission is for an update to the software version of a currently cleared device (LifeSPARC System). All other aspects of the device are identical to the predicate and reference devices.
• Testing Performed: "Software Verification and Validation testing (including Cybersecurity) was completed for the Subject device with the new software."
• Conclusion: "Testing described in this notification demonstrates that the Subject LifeSPARC System performance is substantially equivalent to the legally marketed Predicate LifeSPARC System (K211830) and Reference device (K232132)." The document explicitly states that "no concerns regarding safety and effectiveness result from the software changes."

In essence, this FDA 510(k) clearance is based on demonstrating that the software update does not change the safety or effectiveness of the device compared to its previously cleared versions, and therefore, it is "substantially equivalent." It is not a submission for a new device requiring extensive new clinical performance data against pre-defined acceptance criteria.

Ask a specific question about this device

The ProtekDuo Veno-Venous Cannula is a single use dual lumen cannula, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in adult patients with acute requiring Veno-Venous Extracorporeal Membrane Oxygenation, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

Each ProtekDuo Veno-Venous Cannula Set includes a dual lumen cannula and an introducer. The introducer is designed to accept a standard 0.038-inch guidewire. The ProtekDuo Veno-Venous Cannula Sets are intended as single patient, single use, sterile devices.

Each ProtekDuo Veno-Venous Cannula consists of two (2) distinct lumens, each made of polyurethane with a wire-reinforced cannula body. The inner lumen is located entirely within the outer lumen forming two concentric channels.

The distal section (inner lumen/cannula) of the cannula body is the smaller diameter lumen with six (6) side holes near the distal tip opening. The proximal sections of each lumen are clear and not wire-reinforced to allow visualization of blood and to enable clamping to prevent blood flow during set-up and removal of the cannula from the extracorporeal circulatory support equipment. A non-vented barbed connector is affixed to both proximal ends (inner/distal and outer/proximal lumens) of the cannula and allow for connection of standard 3/8-inch blood circuit tubing for subsequent connection to extracorporeal circulatory support equipment. The cannula has two suture wings that can be used for securing the cannula in place to the patient. The cannulas also have printed insertion depth markings measured from the distal tip.

Each introducer consists of a tube and hub. The introducer fits inside the inner lumen of the cannula during insertion of the cannula/introducer assembly. The introducer is used to advance the cannula over a guidewire and facilitate cannula placement within the target vessel. The introducer has a hub at its proximal end to manage introducer insertion and removal from the cannula. The hemostasis cap minimizes blood loss when the cannula/introducer assembly is inserted into the target vessel. The introducer body is constructed from radiopaque polyvinyl chloride material for visualization under fluoroscopy.

This document describes the premarket notification (510(k)) for the ProtekDuo Veno-Venous Cannula Sets, asserting their substantial equivalence to legally marketed predicate devices. The information provided outlines the device's technical characteristics, its intended use, and the non-clinical testing performed to demonstrate its performance.

However, the provided text does not contain specific acceptance criteria or details of a study that proves the device meets those criteria in the context of an AI/human reader performance study. The document focuses on regulatory approval (510(k) clearance) based on substantial equivalence to existing devices, primarily through non-clinical testing and an in vivo animal study. It does not mention any AI component or human reader performance evaluation.

Therefore, I cannot fulfill the request to provide information based on the input about:

• A table of acceptance criteria and reported device performance (in the context of AI/human reader performance)
• Sample sized used for the test set and data provenance (for an AI/human reader study)
• Number of experts used to establish ground truth and qualifications (for an AI/human reader study)
• Adjudication method (for an AI/human reader study)
• MRMC comparative effectiveness study, effect size
• Standalone (algorithm only) performance study
• Type of ground truth used (for an AI/human reader study)
• Sample size for the training set (for an AI)
• How ground truth for the training set was established (for an AI)

The document's "acceptance criteria" are related to regulatory conformity (e.g., biocompatibility, sterility, mechanical integrity) and "performance" refers to the device's physical and functional characteristics (e.g., flow rates, tensile strength) demonstrated through non-clinical bench testing and an animal study, not human or AI diagnostic performance.

Based on the provided document, here's what can be extracted regarding the device's acceptance criteria and proof of performance:

The acceptance criteria for the ProtekDuo Veno-Venous Cannula Sets are primarily defined by the Special Controls outlined in 21 CFR 870.4100 for Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure. The study proving the device meets these criteria is a series of non-clinical tests (bench tests) and an in vivo animal study.

1. Table of Acceptance Criteria (Special Controls) and Reported Device Performance:

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

• Test Set (Non-Clinical/Bench Testing): Specific sample sizes for each non-clinical test (e.g., number of cannulas tested for tensile strength, number of setups for pressure/flow) are not detailed in this summary. However, these would be standard engineering test sample sizes to ensure statistical validity for the specific tests performed (e.g., according to ISO standards or internal validation protocols).
• Test Set (In Vivo): The summary mentions a "14-day in vivo evaluation" in a "biologic test system." The specific number of animals used for this study is not provided in this document.
• Data Provenance: The testing appears to be conducted by the manufacturer or contract research organizations as part of their regulatory submission for the device. The country of origin for the data is implied to be related to the applicant's location (Pittsburgh, PA, USA) or its testing facilities. It is a prospective set of tests and studies specifically performed for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable as this submission is for a medical device (cannula) based on physical and biological performance, not an AI or diagnostic imaging device requiring expert reader ground truth.

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study: Not applicable.

7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is established by physical measurement standards, engineering specifications, and established biological/material compatibility protocols (e.g., ISO standards for biocompatibility, flow dynamics equations for pressure/flow).
For the in vivo animal study, the "ground truth" would be the observed physiological function and integrity of the device within the biologic system over the 14-day period.

8. The Sample Size for the Training Set: Not applicable, as this is not an AI/machine learning device.

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

Ask a specific question about this device

The LifeSPARC System is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

The LifeSPARC Pump is a sterile, single-use, low prime volume centrifugal pump with an integrated motor and a single-point, pivot bearing. It is sterilized using ethylene oxide (EO) and sized to fit in the palm of the hand or to secure to the patient.

The LifeSPARC Controller provides the interface between pump and user, as well as the power and electrical signals to drive the pump. It is a microprocessor-based electromechanical pump drive system designed to operate on standard AC current (100/240 VAC, 50/60 Hz) or on internal, rechargeable batteries for intra-hospital transport.

The provided text describes a 510(k) premarket notification for the LifeSPARC System, which is a nonroller-type blood pump used for cardiopulmonary bypass. The submission is a software update to an already cleared device, and thus the focus is on testing related to software and electromagnetic compatibility.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state numerical acceptance criteria or specific reported device performance metrics in a table format. It generally states that "Testing of the LifeSPARC Controller demonstrates that no concerns regarding safety and effectiveness result from the changes and updates to the technology; specifically, test data is provided regarding Software and Electromagnetic Compatibility." This implies the device met the necessary standards for these aspects.

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 does not provide details on the sample size used for the test set or the data provenance. It only mentions "test data is provided regarding Software and Electromagnetic Compatibility" implying a test set was used but without specifying its characteristics.

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. Software and electromagnetic compatibility testing typically rely on engineering specifications and compliance standards rather than expert medical consensus for ground truth.

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

This information is not provided in the document. Given the nature of the testing (software and EMC), an adjudication method in the medical context (like for image interpretation) would not be applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI systems that assist human readers in tasks like image interpretation, which is not the function of the LifeSPARC System. This submission is for a software update to a mechanical blood pump, focusing on its safe and effective operation, not its diagnostic or interpretative capabilities.

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

The document implies that standalone testing was performed for the software and electromagnetic compatibility aspects of the device. The "Testing of the LifeSPARC Controller demonstrates that no concerns..." suggests the algorithm's performance was evaluated independently against predefined criteria.

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

For software testing, the ground truth would typically be the expected functional behavior and performance defined by engineering specifications and industry standards for medical device software. For Electromagnetic Compatibility, the ground truth is compliance with relevant EMC standards (e.g., IEC 60601-1-2).

8. The sample size for the training set

The document does not mention a "training set" because this is not an AI/ML-driven device in the context of learning from data. The software update is likely a deterministic program, not a model trained on a dataset.

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

As there is no mention of a training set for an AI/ML model, this question is not applicable to the information provided. The ground truth for the device's functionality would be established through its design specifications and validated through testing.

Ask a specific question about this device

The LifeSPARC System is a centrifygal blood pump system intended to assist in circulation of the patient's blood when part of an extracorporeal circuit including physiologic gas exchange of the patient's blood in adult patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. These may include:

• Failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients
• ECMO-assisted cardiopulmonary resuscitation in adults

The LifeSPARC Pump is a sterile, single-use, low prime volume centrifugal pump with an integrated motor and a single-point, pivot bearing. It is sterilized using ethylene oxide (EO) and sized to fit in the palm of the hand or to secure to the patient.

The LifeSPARC Controller provides the interface between pump and user, as well as the power and electrical signals to drive the pump. It is a microprocessor-based electromechanical pump drive system designed to operate on standard AC current (100/240 VAC, 50/60 Hz) or on internal, rechargeable batteries for intra-hospital transport.

The provided text describes the LifeSPARC System, an extracorporeal blood pump system, and its substantial equivalence determination by the FDA. The submission focuses heavily on non-clinical testing and an animal study, with a clinical evaluation based on retrospective registry data.

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 acceptance criteria are derived from the "Special Controls" outlined by the FDA. The "reported device performance" is summarized from the "Summary of Non-clinical Testing," "Animal Study," and "Clinical Evaluation" sections.

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

Animal Study (In vivo evaluation):

• Test Set Sample Size: 9 calves were supported with the LifeSPARC System. A control group of 5 calves were supported with the TandemHeart Pump.
• Data Provenance: Prospective animal study (bovine model, presumably conducted in a controlled laboratory setting). The specific country of origin is not stated but is implied by the US FDA submission process.

Clinical Evaluation:

• Test Set Sample Size: The text states, "The study is an enumerative study where all available ECMO data collected in the ELSO registry database that met the study criteria were analyzed." The exact number of patients for the LifeSPARC Pump group and the comparator group(s) is not explicitly stated in the provided text. However, it's inferred to be a large dataset given it's from the ELSO Registry.
• Data Provenance: Retrospective observational data from the Extracorporeal Life Support Organization (ELSO) Registry. The ELSO Registry is an international registry, so the data provenance would likely be multi-national, although this is not explicitly stated. The data was "observational data in a real-world setting."

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

Animal Study:

• The text describes "close monitoring of the systems identified early problems allowing repairs or pump exchange before becoming clinically significant." This implies veterinary or medical expertise for monitoring and assessing animal health.
• The assessment of "clinically significant thromboembolic or bleeding complications, vascular or myocardial injuries, adherent thrombus, or end organ damage" would typically fall under the purview of veterinary pathologists and clinicians.
• Number of experts and qualifications: Not specified.

Clinical Evaluation:

• The ground truth for the clinical outcomes (e.g., pump failure, hemolysis, thrombosis, death) would have been established by the clinicians and medical professionals managing the patients and inputting data into the ELSO Registry. The ELSO statistical group performed the analysis.
• Number of experts and qualifications: Not specified. The ELSO statistical group is mentioned for analysis ("independent statistical analysis," "propensity score analysis was performed by the ELSO group"), but not for establishing the initial ground truth.

4. Adjudication method for the test set

Animal Study:

• The text indicates "close monitoring" and "identified early problems allowing repairs or pump exchange." This suggests continuous assessment by the study team. However, a formal adjudication method for adverse events or outcomes (e.g., blinded review by a panel) is not described.

Clinical Evaluation:

• The clinical evaluation is based on existing data from the ELSO Registry. The ground truth (patient outcomes) would have already been established by the reporting institutions.
• A formal adjudication method for the test set outcomes, beyond the standard data collection and reporting mechanisms of the ELSO Registry, is not described. The analysis by the ELSO statistical group is a statistical comparison, not an adjudication process.

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.
• The device is an extracorporeal blood pump system, not an AI-assisted diagnostic or interpretative device that involves "human readers" or "AI assistance" in the sense of image interpretation or similar tasks.
• The clinical evaluation was a comparison of the device's performance against other similar devices (other centrifugal pumps, including a predicate) using retrospective registry data, not a human-in-the-loop study.

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

• No, this concept is not directly applicable to the LifeSPARC System. This device is a mechanical pump, not an algorithm. Its performance is inherent to its physical operation and interaction with the patient's blood, not an independent algorithmic output. The "standalone" performance is its performance in the animal study and its outcomes as observed in the clinical registry data.

7. The type of ground truth used

Animal Study:

• Clinical observation and physiological measurements from the calves during the 14-day support period.
• Post-mortem analysis for "adherent thrombus, or end organ damage."

Clinical Evaluation:

• Outcomes data / Real-world patient data from the ELSO Registry. This includes clinically recorded events like "pump failure, hemolysis, thrombosis or clots in circuit component, patient death within 24 hours of stopping ECMO, and patient death at discharge," as well as "use of renal replacement therapy (RRT during ECMO, pulmonary hemorrhage, circuit change, central nervous system (CNS) hemorrhage, and CNS infarction." This data is based on reporting by treating clinicians.

8. The sample size for the training set

• The provided text relates to regulatory submission for a medical device (an extracorporeal blood pump system), not a machine learning model. Therefore, the concept of a "training set" in the context of AI/ML is not applicable.
• If interpreted as "data used to inform the device's design or prior evaluations," the text references a "currently-cleared devices" and "reference devices" (TandemHeart System, LifeSPARC System K183623), implying previous testing and clinical experience would have contributed to the device's development, but no specific "training set" size for this purpose is given.

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

• As the concept of a "training set" is not applicable in this context (not an AI/ML device), this question is moot.

Ask a specific question about this device

The TandemHeart System is a centrifugal blood pump system intended to assist in circulation of the patient's blood when part of an extracorporeal circuit including physiologic gas exchange of the patient's blood in adult patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

The TandemHeart Pump is a low priming volume centrifugal blood pump with a dual chamber design. The upper chamber provides a conduit for the flow of blood; the lower chamber provides communication with the controller, a hydrodynamic bearing, cooling of the motor and local anticoagulation.
The TandemHeart Escort Controller provides the interface between pump and user, the power and electrical signals to drive the pump, and the infusate fluid to the lower chamber of the pump. It is a microprocessor-based electromechanical pump drive and infusion system designed to operate on standard AC current (100/240 VAC, 50/60 Hz) or on internal, rechargeable batteries for intra-hospital transport. The controller contains a backup motor control unit, and backup batteries.

This document describes the acceptance criteria and the study that proves the TandemHeart Pump and Escort Controller, a centrifugal blood pump system, meets these criteria. The device is intended to assist in the circulation of a patient's blood as part of an extracorporeal circuit for adult patients with acute respiratory or cardiopulmonary failure.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the "Special Controls" outlined in the FDA's Final Order, 81 FR 7451, Feb. 12, 2016. The study compared the TandemHeart pump against "comparator pumps" (non-TandemHeart centrifugal pumps) using data from the ELSO Registry.

• Pump Failure: -0.7% (95% CI -1.4%, 0.1%) (TandemHeart had 0.2% vs. 0.8% for comparator)
• Hemolysis: -3.6% (95% CI -14.2%, 7.2%) (TandemHeart had 8.4% vs. 11.9% for comparator, but not statistically significant)
• Thrombosis/Clots in Circuit Component: -2.2% (95% CI -4.8%, 0.4%) (TandemHeart had 1.5% vs. 3.8% for comparator)

The confidence intervals for these treatment effects generally covered 0%, indicating no statistically significant difference in these outcomes between the TandemHeart pump and comparator pumps in the primary analysis. The analysis concluded that the TandemHeart Pump is substantially equivalent to other pumps. |

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

• Sample Size:
  • Weighted Propensity Score Analysis (January 2016-October 2020):
    • TandemHeart pump: 165 adult ECMO runs
    • Comparator pumps: 3525 adult ECMO runs
  • TandemHeart Pump and Comparator Pumps Analysis (January 2016-January 2019):
    • TandemHeart pump: 79 runs (38 VA mode, 32 VV mode, 79 All modes)
    • Other Centrifugal Pumps: 9801 runs (5214 VA mode, 3905 VV mode, 9801 All modes)
• Data Provenance: The data was extracted from the Extracorporeal Life Support Organization (ELSO) Registry. This registry collects data on ECMO runs globally. While the document mentions "All United States extracorporeal membrane oxygenation (ECMO) runs" for the second analysis, the first analysis does not explicitly state a geographical restriction, implying it might be broader given the ELSO's global nature. The data is retrospective, as it was extracted from an existing database of past clinical events.

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

The propensity score analysis was conducted by the statistical group at ELSO in consultation with clinical experts in the field of ECLS. The exact number of experts is not specified. Their qualifications are described as "clinical experts in the field of ECLS."

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method for the data within the ELSO registry. The data is reported directly from the registry. It's implied that the ELSO registry data itself serves as the "ground truth," which is collected and coded by the reporting institutions. The "clinical experts in the field of ECLS" were involved in guiding the analysis based on specific health risks, rather than adjudicating individual cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance?

This is not an MRMC comparative effectiveness study in the context of human readers being assisted by AI. This study compares the performance of two different medical devices (TandemHeart pump vs. other centrifugal pumps) directly, rather than evaluating human performance with or without AI assistance. Therefore, there is no information on the effect size of human reader improvement with AI assistance.

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

This is not a study of a standalone algorithm's performance. The study evaluates the performance of the TandemHeart pump, a physical medical device, in a real-world clinical setting using retrospective registry data.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used is primarily outcomes data recorded in the ELSO Registry. This includes clinical outcomes such as pump failure, hemolysis, thrombosis/clots in circuit component, patient death, CNS hemorrhage, renal replacement therapy, pulmonary hemorrhage, and circuit change. These are documented complications and events observed during ECMO runs.

8. The Sample Size for the Training Set

No specific training set is mentioned as this is a device comparison study utilizing retrospective clinical registry data, not an AI model development study that typically involves distinct training and test sets. The entire ELSO dataset used in the analysis serves as the "test set" for the device's performance comparison.

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

As no specific AI training set is described in the document, there is no information on how its "ground truth" would have been established.

Ask a specific question about this device

The LifeSPARC System is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

The LifeSPARC Pump is a sterile, single-use, low prime volume centrifygal pump with an integrated motor and a single-point, pivot bearing. It is sterilized using ethylene oxide (EO) and sized to fit in the palm of the hand or to secure to the patient.

The LifeSPARC Controller provides the interface between pump and user, as well as the power and electrical signals to drive the pump. It is a microprocessor-based electromechanical pump drive system designed to operate on standard AC current (100/240 VAC, 50/60 Hz) or on internal, rechargeable batteries for intra-hospital transport.

This document is a 510(k) summary for the LifeSPARC System, a non-roller-type blood pump used for cardiopulmonary bypass. It compares the LifeSPARC System to its predicate device, the TandemHeart System (K110493).

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state sample sizes for specific tests. It refers to "test data," "pressure-flow test data," and "testing of the LifeSPARC Controller," implying that these tests were conducted by the manufacturer as part of the device development and validation. The data provenance is internal to CardiacAssist, Inc. (dba TandemLife) and is prospective testing performed on the LifeSPARC System to demonstrate its equivalence to the predicate.

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

This information is not provided in the document. For non-clinical validation studies of medical devices like blood pumps, ground truth is typically established through recognized engineering standards, established test methodologies, and comparison to the performance of a legally marketed predicate device rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of the non-clinical testing (e.g., pressure-flow, hemolysis, electrical safety), an adjudication method as typically used in clinical trials with human readers/assessors would not be applicable. The "adjudication" is essentially the direct measurement and comparison of performance parameters against established benchmarks or predicate device data.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation where human readers are involved. The LifeSPARC System is a physical medical device (blood pump), and its performance is evaluated through engineering and biocompatibility testing.

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

The concept of "standalone performance" typically applies to AI algorithms. The LifeSPARC System is a physical device with some software components in its controller. The testing described (e.g., pressure-flow, hemolysis, electrical safety) evaluates the device's inherent performance. The "updated software/user interface technology" of the controller was tested for safety and effectiveness, but this isn't analogous to standalone AI algorithm performance.

7. The Type of Ground Truth Used:

The ground truth for the device's performance is established by:

• Engineering Standards and Benchmarks: For parameters like electrical safety, electromagnetic compatibility, and sterilization.
• Predicate Device Performance Data: For key performance characteristics directly comparable to the predicate TandemHeart System, such as pressure-flow characteristics and hemolysis rates. The predicate device's performance serves as the benchmark for "substantial equivalence."
• Biocompatibility Standards: To ensure the materials in contact with blood are safe.

8. The Sample Size for the Training Set:

This information is not applicable. The LifeSPARC System is a hardware device with embedded software; it is not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for such a system would involve its design, engineering, and manufacturing processes.

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

This information is not applicable as there is no "training set" in the context of AI/ML for this device. The development and validation of the device rely on established engineering principles, regulatory standards, and comparison to the predicate device.

Ask a specific question about this device

The ProtekDuo Mini Veno-Venous Cannula Set is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures.

The ProtekDuo Mini Veno-Venous Cannula Set consists of two components: a 31 Fr. Dual Lumen Veno-Venous Cannula and a 15.5 Fr. Introducer is designed to accept a standard 0.038 inch guidewire. The ProtekDuo Mini Veno-Venous Cannula Set is intended as a single patient, single use, sterile device.

The ProtekDuo Mini Veno-Venous Cannula (Figure 5-1) consists of two distinct lumens with a wire-reinforced cannula body. The inner lumen is located entirely within the outer lumen forming two concentric channels.

The distal section (inner lumen/cannula) of the cannula body has six side holes near the distal tip opening. The proximal sections of each lumen are clear and not wire-reinforced to allow visualization of blood and to enable clamping to prevent blood flow during setup and removal of the cannula from the extracorporeal circulatory support equipment (see Figure 5-1). A non-vented barbed connector is affixed to both proximal ends (inner/distal and outer/proximal lumens) of the cannula and allow for connection of standard 3/8 inch blood circuit tubing for subsequent connection to extracorporeal circulatory support equipment.

The introducer (Figure 5-2) consists of a tube with a luer hub. The introducer fits inside the inner lumen of the cannula during insertion of the cannula/introducer assembly. The introducer is used to advance the cannula over a guidewire and facilitate cannula placement within the target vessel. The introducer has a luer hub at its proximal end to manage introducer insertion and removal from the cannula. The luer hub can also enable contrast injection, if necessary, to facilitate placement and final positioning of the cannula within the target vessel. The hemostasis cap minimizes blood loss when the cannula/introducer assembly is inserted into the target vessel. The introducer body is constructed from radiopaque material for visualization under fluoroscopy.

Here's a summary of the acceptance criteria and the study that proves the ProtekDuo Mini Veno-Venous Cannula Set meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes (number of devices, repeats per test, etc.) for the non-clinical tests conducted. The data provenance is also not explicitly stated in terms of country of origin or retrospective/prospective nature, but these are bench-top non-clinical tests.

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

Not applicable. This is a non-clinical device performance study, not a study involving human interpretation of data where expert ground truth would be required.

4. Adjudication Method for the Test Set:

Not applicable. This is a non-clinical device performance study.

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

No, an MRMC comparative effectiveness study was not done. This is a non-clinical device performance study.

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 AI algorithm. The performance described is for the device itself.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" or reference was based on established engineering principles, design specifications, and direct measurement of the device's physical properties and performance against predetermined criteria (often derived from the predicate device's performance or industry standards).

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable. This is a physical medical device.

Ask a specific question about this device

The Protek Venous Dilator Sets are intended for single use by a trained physician to assist in vessel cannulation.

The Protek Venous Dilator Sets are comprised of vascular dilators with diameters of 14, 18, 22 and 26 Fr. outer diameter. There are two distinct kits, one intended for insertion of cannula smaller than 26 Fr. which includes the 14, 18, and 22 Fr. dilators and one intended for the insertion of cannula larger than 26 Fr. which also includes the 26 Fr. dilator. The Dilators are designed to accept a standard 0.038 inch guidewire. The Protek Venous Dilator Sets are intended as a single patient, single use, sterile device.

Each dilator consists of a tube with a hub. The dilators fit over a guidewire during insertion. The dilators are used to prepare the target vessel for the safe introduction of a large bore cannula. The dilator body is constructed from radiopaque material for visualization under nuoroscopy.

The provided document is a 510(k) premarket notification letter and supporting documentation for the Protek Venous Dilator Sets. It focuses on demonstrating substantial equivalence to a predicate device for a medical dilator. This type of document does not include information related to acceptance criteria, study details, expert involvement, or statistical analysis typically found in an FDA submission for AI/ML-driven devices or diagnostic tools.

Therefore, I cannot provide the requested information for this specific document because it describes a physical medical device (dilator) and not a device that relies on AI/ML or requires a complex validation study with acceptance criteria related to diagnostic performance.

The document details non-clinical testing for the dilator, such as:

• Tensile Strength: "Pull test with objective acceptance criteria." Conclusion: "All test articles met acceptance criteria. Mechanical integrity is more than adequate for the intended application."
• Deflection Test: "Compliance measurement with side-by-side comparison to similar sized predicate devices." Conclusion: "The Protek Venous Dilators are all more compliant than similarly sized predicate devices, as designed."
• Biocompatibility: "Testing per ISO-10993 for an external communicating device in contact with circulating blood for limited duration less than 24 hours." Conclusion: "All tests passed."

This is the extent of the "acceptance criteria" and "study" information available in this document. It does not fit the format of an AI/ML-driven diagnostic study.

Ask a specific question about this device

The TandemHeart Veno-Venous Cannula Set is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures.

The TandemHeart Veno-Venous Cannula Set consists of two components: a 29 Fr. Dual lumen Veno-Venous Cannula and a 13 Fr. Introducer. The Introducer is designed to accept a standard 0.038 inch guidewire. The TandemHeart Veno-Venous Cannula Set is intended as a single patient, single use, sterile device.

The TandemHeart Veno-Venous Cannula (Figure 1) consists of two distinct lumens with a wire-reinforced cannula body. The inner lumen is located entirely within the outer lumen forming two concentric channels.

The distal section (inner lumen/cannula) of the cannula body has six side holes near the distal tip opening. The proximal sections of each lumen are clear and not wire-reinforced to allow visualization of blood and to enable clamping to prevent blood flow during setup and removal of the cannula from the extracorporeal circulatory support equipment (see Figure 1). A non-vented barbed connector is affixed to both proximal ends (inner/distal and outer/proximal lumens) of the cannula and allow for connection of standard 3/8 inch blood circuit tubing for subsequent connection to extracorporeal circulatory support equipment. The cannula has printed insertion depth markings every 10 centimeters from 10 to 30 cm followed by every 2 centimeters for the remainder of the insert-able length, measured from the distal end. The cannula also has a suture wing that can be used for securing the cannula in place to the patient.

The introducer (Figure 2) consists of a tube with a hub. The introducer fits inside the inner lumen of the cannula during insertion of the cannula/introducer assembly. The introducer is used to advance the cannula over a guidewire and facilitate cannula placement within the target vessel. The introducer has a hub at its proximal end to manage introducer insertion and removal from the cannula. The hemostasis cap minimizes blood loss when the cannula/introducer assembly is inserted into the target vessel. The introducer body is constructed from radiopaque material for visualization under fluoroscopy.

The provided document is a 510(k) summary for the TandemHeart Veno-Venous Cannula Set. This type of regulatory submission is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving efficacy or performance against specific clinical acceptance criteria in the manner requested.

Therefore, the document does not contain the requested information about acceptance criteria, a human clinical study, or AI performance metrics.

Here's what can be extracted from the document regarding the device's evaluation, and why it doesn't align with the request:

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

• This information is not present. The document discusses general performance testing but does not detail specific acceptance criteria or quantitative performance tables.

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 describes "non-clinical performance testing" using "in-vitro system capacity testing and flow vs. pressure drop (HQ)." This indicates it was not a human clinical study and therefore has no human "test set" in the sense of a patient cohort. The "sample size" would refer to the number of devices or experimental setups, which is not specified.
• Data provenance (country, retrospective/prospective) is not applicable as it's not a clinical study.

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

• This is not applicable as there was no human clinical "test set" requiring expert ground truth establishment.

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

• This is not applicable as there was no human clinical "test set" and thus no adjudication of clinical outcomes.

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:

• This device is a medical cannula, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI performance metrics are not applicable.

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

• This is not applicable as the device is not an algorithm or AI system.

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

• For the non-clinical performance testing, the "ground truth" would be established by engineering and chemical principles, likely against a set of predetermined engineering specifications for flow rate, pressure drop, flexibility, strength, biocompatibility, etc. These specific "ground truths" and their methods are not detailed in the summary.

8. The sample size for the training set:

• Not applicable as there is no AI component or machine learning "training set."

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

• Not applicable as there is no AI component or machine learning "training set."

Summary of what is available from the document:

The document states that "Non-clinical performance testing was conducted to demonstrate substantial equivalence of flow characteristics between the TandemHeart Veno-Venous Cannula and the predicate, Medtronic Avalon Elite." It also mentions "Flexibility, strength, biocompatibility, in-vitro hemolysis, leak testing, sterilization, and shelf life" were addressed.

The conclusion drawn from this testing was that "Based on the performance test results and data from the predicate devices, the TandemHeart Veno-Venous Cannula was found to meet established design input requirements and thus to be substantially equivalent to the predicate Avalon Elite Dual Lumen Veno-Venous Cannula."

In conclusion, this document describes the regulatory clearance of a physical medical device (a cannula) based on substantial equivalence to predicate devices, primarily through non-clinical, in-vitro testing. It does not involve AI, human clinical trials with specific acceptance criteria as you've outlined, or ground truth established by medical experts for a diagnostic task.

Ask a specific question about this device

The 15 French TandemHeart Arterial Cannula Set (15 Fr. THAC) is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The cannula introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.

The 15 French TandemHeart Femoral Arterial Cannula Set consists of two components, as shown in Figure 1: a 15 Fr. Femoral Arterial Cannula and a 10 Fr. Introducer. The device is intended to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal circulatory support equipment. The product is intended to be single patient, single use, sterile device.

The cannula has multiple side holes in addition to the tip opening for unimpeded flow of blood at the distal end and a vented barbed fitting at the proximal end to enable the connection of 3/8" tubing. Radiopaque markers are embedded at the distal tip of the cannula, and the cannula body is wire-reinforced for visualization under fluoroscopy. Insertion depth markings have been incorporated in the cannula body working length from 5 to 17 cm measured from the distal tip.

The cannula includes a suture wing to provide a means for securing the cannula to the patient and a stop component to minimize cannula insertion depth beyond its working length. Printing on the proximal region of the cannula indicates the area where a clamp should be applied if needed during the set-up or removal process.

The 10 Fr. introducer is provided to facilitate placement of the arterial cannula, within the target vessel, and is designed with a tapered distal tip. The introducer proximal end contains a luer hub to aid in the removal of the introducer body is also constructed of a radiopaque material for visualization under fluoroscopy.

The introducer includes a hemostasis cap that provides the interface between the cannula proximal connector and introducer body. The hemostasis cap aids in minimizing blood loss during the insertion of the cannula/introducer assembly into the target vessel.

This submission K133293 describes a medical device, the 15 French TandemHeart Femoral Arterial Cannula Set, and its substantial equivalence to predicate devices, but it does not include a study that defines or demonstrates acceptance criteria in the manner requested (e.g., using performance metrics like sensitivity, specificity, or accuracy based on human-AI comparison).

The document details non-clinical performance testing conducted to show substantial equivalence for a physical medical device (cannula), not a diagnostic algorithm or AI-powered system that would typically have acceptance criteria presented as performance metrics against ground truth.

Therefore, for your specified questions, I can only provide information based on the type of testing described in the document, which focuses on physical and functional characteristics of the cannula.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

The document states that "All performance tests were conducted on both the 15 French TandemHeart Femoral Arterial Cannula Set and the applicable control device... Based on the performance test results, the TandemHeart Femoral Arterial Cannula Set was found to meet the established design input requirements as well as to perform comparably to the predicate devices."

The acceptance criteria are implicitly defined by "established design input requirements" and "perform comparably to the predicate devices." No numerical targets or specific performance metrics are provided in the document for these tests, nor are the detailed results.

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

• Sample Size for Test Set: Not specified in the document. The testing involved "in-vitro" (laboratory) conditions not patient data.
• Data Provenance: In-vitro non-clinical testing. Not applicable for country of origin or retrospective/prospective as it's not clinical data.

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

This is not applicable as the "ground truth" for this type of device (cannula) is based on engineering specifications and physical performance measurements (e.g., flow rate, kink resistance, leak proofing) in a laboratory setting, not expert clinical interpretation of data.

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

Not applicable. This concept applies to expert consensus on clinical findings, not to in-vitro engineering tests.

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 for AI-powered diagnostic devices, not a physical medical device like a cannula.

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

Not applicable. This is for AI-powered diagnostic devices, not a physical medical device.

7. The type of ground truth used:

The "ground truth" (or reference standard) would be the established engineering specifications for flow rates, material properties, and mechanical integrity tests (e.g., kink resistance, hemolysis limits, leak limits).

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/machine learning device. The device design and manufacturing processes are developed based on engineering principles and prior device experience, not a data training set.

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

Not applicable. There is no "training set" or corresponding ground truth as this is not an AI/machine learning device.

Ask a specific question about this device