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510(k) Data Aggregation
(435 days)
The FloPump 57mL Centrifugal Pump is a device that uses a method other than revolving rollers 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 FloPump 57mL is a single use disposable centrifugal pump has an inlet that draws blood from a patient and an outlet that pushes the blood out, where it then passes through an oxygenator and back to the patient. The pump mates with the Sorin Group Stöckert Centrifugal Pump Console and rotates the internal impeller using a magnetic driver. The FloPump 57mL is a non-occlusive pump. The pump has a spinning rotor with flow channels which imparts rotary motion to the incoming blood, directing it through a spiral housing to the outflow port. The FloPump 57mL is part of the extracorporeal circuit, and is therefore in contact with the patient's blood while circulating. The FloPump 57mL does not have any other patient contact.
This document describes the FloPump 57mL Centrifugal Pump, a non-roller type blood pump intended for use in extracorporeal circuits for periods less than 6 hours.
Here's an analysis of the acceptance criteria and supporting studies as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list specific quantitative "acceptance criteria" with corresponding "reported device performance" in a structured table as might be expected for an AI/CAD device. Instead, it states that non-clinical testing was performed and the results were "Substantially equivalent to predicates" for a range of performance characteristics.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Flow curves | Substantially equivalent to predicate devices | Substantially equivalent to predicates |
| Heat generation | Substantially equivalent to predicate devices | Substantially equivalent to predicates |
| Prime volume | Substantially equivalent to predicate devices | Substantially equivalent to predicates |
| Air handling | Substantially equivalent to predicate devices | Substantially equivalent to predicates |
| Hemolysis | Substantially equivalent to predicate devices | Substantially equivalent to predicates |
| Reliability | Substantially equivalent to predicate devices | Substantially equivalent to predicates |
| Biocompatibility | Substantially equivalent to predicate devices | Substantially equivalent to predicates |
| Sterilization | Sterilization process results in a SAL of 10^-6 | The sterilization process results in a SAL of 10^-6 |
| Packaging durability | No signs of damage and functioned as intended following testing | No signs of damage and functioned as intended following testing |
| Shelf-life | No signs of damage and functioned as intended following testing | No signs of damage and functioned as intended following testing |
2. Sample Size Used for the Test Set and Data Provenance:
The provided text does not contain any information regarding sample sizes for a standalone (test set) for clinical performance, as it explicitly states that clinical testing was not required. The testing mentioned is non-clinical, likely laboratory-based or bench testing. Therefore, there's no information on data provenance (country of origin, retrospective/prospective) related to a clinical test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since no clinical testing was required or performed, there is no information on experts establishing ground truth for a clinical test set. The "ground truth" for the non-clinical tests would have been established by engineering specifications, validated test methods, and comparison against the performance of predicate devices.
4. Adjudication Method for the Test Set:
Given that no clinical testing requiring human interpretation or judgment was performed, there is no information on an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:
No MRMC comparative effectiveness study was done as clinical testing was not required for this device. This device is a mechanical pump, not an AI/CAD diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable to the FloPump 57mL Centrifugal Pump. This device is a physical, mechanical blood pump, not an algorithm or AI system. The "standalone" performance here refers to the device's functional performance on its own, which was evaluated through the non-clinical tests listed.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" was based on:
- Engineering specifications and design requirements: For parameters like priming volume, flow rates, and maximum rated pressure.
- Established test methods and standards: For sterilization (SAL of 10^-6), biocompatibility, and perhaps reliability testing.
- Performance of predicate devices: The primary method for proving substantial equivalence was demonstrating similar performance to legally marketed predicate devices for flow curves, heat generation, prime volume, air handling, hemolysis, and reliability. This implies that the accepted performance range of the predicate devices served as the "ground truth" for comparison.
8. The Sample Size for the Training Set:
Not applicable. This device is a mechanical blood pump, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As stated above, this is a mechanical device, not an AI/ML system requiring a training set.
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(345 days)
The FloPump 32mL Centrifugal Pump is a device that uses a method other than revolving rollers 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 FloPump 32mL is a single use disposable centrifugal pump has an inlet that draws blood from a patient and an outlet that pushes the blood out, where it then passes through an oxygenator and back to the patient. The pump mates with the Maquet RotaFlow console and rotates the internal impeller using a magnetic driver. The FloPump 32mL is a non-occlusive pump. The pump has a spinning rotor with flow channels which imparts rotary motion to the incoming blood, directing it through a spiral housing to the outflow port. The FloPump 32mL is part of the extracorporeal circuit, and is therefore in contact with the patient's blood while circulating. The FloPump 32mL does not have any other patient contact.
The provided text describes a medical device, the FloPump 32mL Centrifugal Pump, and its 510(k) summary for FDA clearance. However, it does not describe acceptance criteria and a study proving a device meets them in the context of an AI/algorithm-based medical device.
The information provided is for a physical medical device and primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. Therefore, I cannot extract the requested information regarding AI/algorithm performance.
Here's an analysis of why the requested information isn't present:
- No AI/Algorithm: The FloPump 32mL Centrifugal Pump is a physical device that functions to pump blood through an extracorporeal circuit. It does not employ any AI or algorithms for decision-making or analysis.
- No Diagnostic or Predictive Outputs: The device's function is mechanical (pumping blood), not diagnostic or predictive in nature. Therefore, there are no performance metrics like sensitivity, specificity, accuracy, or AUC that would be typically associated with AI/algorithm acceptance criteria.
- Focus on Substantial Equivalence: The 510(k) summary emphasizes "substantial equivalence" to predicate devices based on design, materials, specifications, and non-clinical testing (flow curves, heat generation, hemolysis, etc.).
- No Clinical Study for Performance: The document explicitly states, "Clinical testing was not required" for this device clearance. This further confirms the absence of studies designed to evaluate AI performance or human reader improvements.
Therefore, since the input document describes a physical medical device and not an AI-powered one, I cannot fulfill the request to provide acceptance criteria and study details related to AI/algorithm performance.
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