(311 days)
The Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The centrifugal pump is indicated for use in cardiopulmonary bypass procedures only.
The Advanced Perfusion System 1 is a configurable heart-lung system with a distributed network architecture that allows the user to customize the number and types of system components, which can then be configured, displayed, and controlled from a central monitor. The system is designed to enable users to choose from the TCVS supplied components to define and configure a heart-lung system to meet individual institution requirements.
The provided text describes a 510(k) summary for a medical device called the "Advanced Perfusion System 1" from Terumo Cardiovascular Systems Corporation. This document concerns modifications made to a previously cleared heart-lung machine, primarily for compliance with electromagnetic compatibility standards (IEC 60601-1-2) and software updates. It does not present a study with specific acceptance criteria and reported device performance metrics in the format requested, such as sensitivity, specificity, or AUC.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (the Advanced Perfusion System 1 K022947) through performance testing related to safety and functionality, rather than a clinical efficacy study with quantitative performance measures.
Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in the available information and indicate where information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1-2 electromagnetic compatibility standard. | Third-party testing was conducted to confirm that, with the engineering modifications in place, the System 1 complies with IEC 60601-1 and IEC 60601-1-2. |
| Successful software verification and validation testing for modules with software modification since initial clearance. | Software verification and validation testing was conducted for those modules that have undergone software modification since initial clearance. All software… testing was successful. |
| Successful functionality testing for new or modified components to demonstrate performance compatibility. | Functionality testing was conducted on those new or modified components of the Advanced Perfusion System 1 to demonstrate performance compatibility. All… performance testing was successful. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified. The document refers to "third party testing," "software verification and validation testing," and "functionality testing" but does not quantify the number of units or test cases used.
- Data provenance: Not explicitly stated as retrospective or prospective data from a specific country, as this was a device modification and testing performed for regulatory submission, likely in a controlled lab environment by Terumo and a third-party testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. The testing described appears to be technical in nature (electromagnetic compatibility, software, functionality) rather than clinical validation requiring expert ground truth in the context of diagnostic interpretation.
4. Adjudication method for the test set
- This information is not provided in the document, as it's not applicable to the type of technical performance testing described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This submission is for modifications to a heart-lung machine, not an AI-powered diagnostic device, so this type of study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable as the device is a heart-lung machine, an active medical device, not a diagnostic algorithm. Performance is assessed through compliance with standards and functional testing, inherently involving the device's operational capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the performance testing described would be defined by the technical specifications and standards (e.g., IEC 60601-1-2 for electromagnetic compatibility, and internal design specifications for software and functionality). It is not clinical ground truth established by medical experts or pathology in the typical sense for an AI/diagnostic device.
8. The sample size for the training set
- This concept is not applicable to the type of device described. A heart-lung machine does not typically involve training sets in the context of machine learning or AI algorithm development.
9. How the ground truth for the training set was established
- This question is not applicable as there is no mention of a training set for this device.
§ 870.4220 Cardiopulmonary bypass heart-lung machine console.
(a)
Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.(b)
Classification. Class II (performance standards).