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510(k) Data Aggregation
(217 days)
The Arterial Cannulae are intended to be used as perfusion cannulae to return arterial blood from the extracorporeal circuit to the patient during cardiopulmonary surgery for periods of up to six hours.
The PureFlex Arterial Cannulae intended to be used to cannulate the arterial vessels during cardiopulmonary bypass surgery.
The cannulae consist of a single-lumen wire-reinforced polymer body constructed and a distal tip. The distal tip is available in either a straight or curved shape with a collar or They are offered with or without a connector for attachment to the flange. cardiopulmonary bypass circuit.
The provided text is a 510(k) summary for the PureFlex Arterial Cannulae. It details the device's description, indications for use, technological characteristics, and non-clinical testing. However, it does not describe an AI medical device or a study involving an AI algorithm. Therefore, I cannot extract information related to acceptance criteria for an AI device, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an AI system.
The document focuses on the substantial equivalence of the PureFlex Arterial Cannulae to a predicate device (Aortic Arch Cannulae K162215) based on physical and performance characteristics, not on software or AI performance.
Below is the information regarding the medical device described in the document, based on the non-AI related testing performed.
1. A table of acceptance criteria and the reported device performance
| Test Name | Acceptance Criteria (Implicit) | Reported Device Performance Statement |
|---|---|---|
| Peak Tensile Force | Compliance with product's performance specifications and substantial equivalence to predicate devices (as per ISO 10555-1 relevant sections). | "The devices met the acceptance criteria for the following tests." |
| Structural Integrity | Compliance with product's performance specifications and substantial equivalence to predicate devices (as per ISO 10555-1 relevant sections). | "The devices met the acceptance criteria for the following tests." |
| Blood Trauma | Compliance with product's performance specifications and substantial equivalence to predicate devices (as per ISO 10555-1 relevant sections). | "The devices met the acceptance criteria for the following tests." |
| Kink Resistance | Compliance with product's performance specifications and substantial equivalence to predicate devices (as per ISO 10555-1 relevant sections). | "The devices met the acceptance criteria for the following tests." |
| Pressure Drop | Compliance with product's performance specifications and substantial equivalence to predicate devices (as per ISO 10555-1 relevant sections). | "The devices met the acceptance criteria for the following tests." |
| Leakage Under Pressure | Compliance with product's performance specifications and substantial equivalence to predicate devices (as per ISO 10555-1 relevant sections). | "The devices met the acceptance criteria for the following tests." |
| Shipping/Packaging | Compliance with product's performance specifications and substantial equivalence to predicate devices (as per ISO 10555-1 relevant sections). | "The devices met the acceptance criteria for the following tests." |
| Biocompatibility | Compliance with ISO 10993-1 and FDA's Guidance for Use of International Standard ISO 10993-1. | "Biocompatibility testing was performed in accordance with ISO 10993-1..." |
| Sterility Assurance Level | SAL of ≤10-6 | "Sterilized with ethylene oxide and have a sterility assurance level (SAL) of ≤10-6" |
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 specify sample sizes for the "in vitro testing" mentioned (Peak Tensile Force, Structural Integrity, etc.). It also does not explicitly state the provenance of data for these tests. It's safe to assume this data is collected during product development and testing activities by Sorin Group Italia, which is based in Italy.
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 applicable as the device is a medical cannulae and the testing described is engineering/performance testing, not diagnostic or clinical interpretation by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for the type of device and 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
Not applicable as this is not an AI medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable as this is not an AI medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" refers to the established performance specifications and the requirements outlined in relevant standards such as ISO 10555-1 and ISO 10993-1. For biocompatibility, it's compliance with biological safety standards. For sterility, it's achieving the specified Sterility Assurance Level.
8. The sample size for the training set
Not applicable as this is not an AI medical device.
9. How the ground truth for the training set was established
Not applicable as this is not an AI medical device.
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