(205 days)
The membrane oxygenator Quadrox-i Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 7 l/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The Quadrox-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um. The device's utilization period is limited to six hours. The oxygenator is suitable for the delivery of the volatile anesthetics isoflurane and sevoflurane. The anesthetic gas is administered through the oxygenator's gas inlet by means of a suitable anesthetic gas vaporizer. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
This document is a 510(k) Pre-market Notification for a medical device called the "Quadrox-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating." This notification aims to demonstrate that the device is substantially equivalent to legally marketed predicate devices, rather than performing a traditional clinical study with acceptance criteria in the manner of a diagnostic AI device.
Therefore, many of the typical acceptance criteria and study design elements you've requested (like sample sizes for test sets, ground truth establishment, MRMC studies, effect sizes, etc.) are not applicable in this context. This is because the submission is focused on demonstrating substantial equivalence through non-clinical testing, rather than proving a specific performance metric against a defined ground truth for a diagnostic output.
However, I can extract information related to the device's performance based on the non-clinical testing presented to demonstrate this substantial equivalence.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of quantitative acceptance criteria in the sense of specific thresholds for metrics like sensitivity, specificity, or AUC as one would expect for an AI diagnostic device. Instead, it states that the device "met the requirements of" specific ISO standards. These standards themselves contain the "acceptance criteria" through their methodologies and required performance levels for device functionality.
| Acceptance Criteria (from Met Standards) | Reported Device Performance |
|---|---|
| ISO 10993-1: Biologic Evaluation of Medical Devices | The Quadrox-i Adult met the requirements of ISO 10993-1. (This implies it passed tests for biocompatibility, such as cytotoxicity, sensitization, irritation, acute systemic toxicity, etc.) |
| ISO 7199: 1996 "Cardiovascular implants and artificial organs – blood gas exchangers (oxygenators)" | The Quadrox-i Adult met the requirements of ISO 7199. (This implies it passed tests related to oxygenator performance, such as gas exchange efficiency, pressure drop, blood compatibility, and mechanical integrity relevant to its function as an oxygenator and heat exchanger.) |
| ISO 15675: 2001 "Cardiovascular implants and artificial organs – Cardiopulmonary Bypass – Arterial line blood filters" | The Quadrox-i Adult (version with integrated arterial filter) met the requirements of ISO 15675. (This implies it passed tests related to filter performance, such as particle removal efficiency, pressure drop, and blood compatibility relevant to its function in filtering air bubbles and particles.) |
| Integrity | Testing and evaluation demonstrated the device's integrity. (Specific metrics not provided, but implies structural soundness and absence of leaks/failures.) |
| Performance | Testing and evaluation demonstrated the device's performance. (Broad category, referring to its function as an oxygenator, heat exchanger, and filter as per the ISO standards.) |
| Biocompatibility | Testing and evaluation demonstrated the device's biocompatibility. (Refers to compliance with ISO 10993-1.) |
| Sterility | Testing and evaluation demonstrated the device's sterility. (Implies the device is manufactured and packaged to prevent microbial contamination.) |
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 sample sizes for "test sets" or data provenance in the way one would for a clinical study on an AI diagnostic. The testing performed was non-clinical bench testing to evaluate the device against established international standards for medical devices. Therefore, these standards dictate the number of units or test replicates required for each specific test (e.g., how many devices are needed for a particular biocompatibility test or performance test). This is not a "data set" in the computational sense, but rather physical devices subjected to laboratory conditions.
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 concept is not applicable here. Ground truth, in the context of this 510(k) submission, is established by adherence to the methodologies and specifications within the referenced ISO standards. The "experts" involved are those who designed and conducted the tests according to these standards, and those who verified the results against the standard requirements. Their qualifications would be in biomedical engineering, materials science, toxicology, and other relevant fields required to perform and interpret the specified tests. There are no "experts" evaluating images or clinical data to establish a ground truth for a diagnostic outcome.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human readers or interpretation requiring adjudication.
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 diagnostic device and no MRMC study was conducted.
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)
The "ground truth" for this submission is adherence to the performance and safety specifications outlined in recognized international standards (ISO 10993-1, ISO 7199, ISO 15675) and demonstrated through non-clinical bench testing. This is a regulatory "ground truth" rather than a clinical one.
8. The sample size for the training set
Not applicable. No training set for an algorithm was used.
9. How the ground truth for the training set was established
Not applicable. No training set for an algorithm was used.
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”