(38 days)
The venous hardshell cardiotomy reservoir is used to collect, store and filter blood in extracorporeal circulation, in cardiopulmonary bypass operations on pediatric patients for up to 6 hours. The reservoir can also be employed postoperatively as drainage and autotransfusion reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was removed from the thorax for the volume exchange.
The Neonatal and Pediatric Venous Hardshell Cardiotomy Reservoirs with and without SOFTLINE Coating are developed for surgical procedures requiring cardiopulmonary bypass for pediatric patients. They are used as a blood buffer in the extracorporeal circuit and are used as a collecting and defoaming device for sucked blood. The device is supplied sterile and non-pryogenic.
The provided document describes a 510(k) premarket notification for a medical device modification, specifically for Neonatal and Pediatric Venous Hardshell Cardiotomy Reservoirs. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device's absolute safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval) submission.
Therefore, the document does not contain the acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device submission. The provided information details design verification tests, which are engineering-focused assessments, not clinical performance studies with acceptance criteria as typically understood in the context of AI/ML performance metrics (e.g., sensitivity, specificity).
Here's why the requested information cannot be fully provided from this document:
- Device Type: The device is a "Venous Hardshell Cardiotomy Reservoir," which is a physical medical device used in cardiopulmonary bypass operations, not an AI/ML algorithm.
- Study Type: The submission is a 510(k) for a "device modification," which relies on demonstrating substantial equivalence through non-clinical (i.e., laboratory/benchtop) design verification tests rather than clinical studies.
- Focus: The focus of the 510(k) is on the safety and performance of the modified physical components (defoamer coating, flow rates, volumes), not on the diagnostic or predictive accuracy of an algorithm.
However, I can extract the relevant information regarding the design verification tests performed, which serve a similar function to "proving the device meets acceptance criteria" within the context of hardware modifications:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical targets for each test, nor does it provide a detailed "reported device performance" table with precise quantitative results. Instead, it indicates that the tests were performed to show the modified device is "as safe and effective as the originally cleared devices" and that the "evaluation and test results do not show any kind of risk potential."
| Test Performed | Implied Acceptance Criteria (Based on "as safe and effective as originally cleared devices" and "no risk potential") | Reported Device Performance |
|---|---|---|
| Air handling | Device effectively handles air to prevent patient harm; performance is equivalent to the predicate device. | Evaluation and test results "do not show any kind of risk potential for the health or security of the patient or user." "Safe and effective for their intended use." |
| Defoaming | Device effectively removes foam from blood; performance is equivalent to the predicate device. | Evaluation and test results "do not show any kind of risk potential for the health or security of the patient or user." "Safe and effective for their intended use." |
| Break Through Volume, cardiotomy part and venous part | The volume of blood required to "break through" the defoaming mechanism meets established safety and performance thresholds, equivalent to the predicate. | Evaluation and test results "do not show any kind of risk potential for the health or security of the patient or user." "Safe and effective for their intended use." |
| Dynamic Priming Volume, cardiotomy part | The volume of blood needed to fill the cardiotomy part during dynamic operation meets established safety and performance thresholds, equivalent to the predicate. | Evaluation and test results "do not show any kind of risk potential for the health or security of the patient or user." "Safe and effective for their intended use." |
| Functional Test, cardiotomy part | The cardiotomy part operates as intended across its specified functionality, equivalent to the predicate. | Evaluation and test results "do not show any kind of risk potential for the health or security of the patient or user." "Safe and effective for their intended use." |
| BioBurden | Level of microbial contamination meets sterility requirements. | Evaluation and test results "do not show any kind of risk potential for the health or security of the patient or user." "Safe and effective for their intended use." |
| LAL | Endotoxin levels meet safety requirements. | Evaluation and test results "do not show any kind of risk potential for the health or security of the patient or user." "Safe and effective for their intended use." |
| Biocompatibility | Material compatibility with blood and tissues meets safety standards. | Evaluation and test results "do not show any kind of risk potential for the health or security of the patient or user." "Safe and effective for their intended use." |
Regarding the specific questions tailored for AI/ML device studies:
2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device. The "tests" were design verification tests (benchtop/laboratory), not clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance often comes from engineering specifications, established testing protocols, and physical measurements, rather than expert consensus on medical images or clinical outcomes.
4. Adjudication method for the test set: Not applicable. There is no mention of expert review or adjudication in the context of these engineering design verification 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 a physical device, not an AI/ML algorithm used for image interpretation or diagnosis by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the design verification tests listed, the "ground truth" would be established by predefined engineering specifications, performance standards, biological safety standards (e.g., ISO standards for biocompatibility), and comparison to the predicate device's known performance characteristics.
8. The sample size for the training set: Not applicable. This device does not involve machine learning and therefore has no training set.
9. How the ground truth for the training set was established: Not applicable. This device does not involve machine learning and therefore has no training set.
In conclusion: The provided document is for a traditional medical device modification (physical product) and uses design verification testing to demonstrate substantial equivalence, not a clinical study to establish performance metrics for an AI/ML device. Therefore, many of the requested fields are not applicable to this submission type.
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.