(674 days)
The Jostra Suction Devices are designed to aspirate blood and other fluids from the operative field and return it to the extracorporeal circuit during open heart surgery lasting 6 hours or less.
The Jostra Suction Devices are single, sterile devices for single use only and not to be resterilized by the user. The Jostra Suction Devices are designed to aspirate blood and other fluids from the operative field and return it to the extracorporeal circuit during open-heart surgery. The suction devices include rigid, flexible and pericardial suckers.
The provided text describes a 510(k) summary for Jostra Suction Devices, focusing on establishing substantial equivalence to a predicate device. This type of regulatory submission does not typically involve the kind of detailed clinical study with acceptance criteria, sample sizes, expert ground truth, or MRMC studies that would be associated with AI/ML-based medical devices or devices requiring extensive clinical trials for efficacy.
The document primarily discusses non-clinical testing to demonstrate performance and biocompatibility. Therefore, much of the requested information regarding AI/ML study methodologies is not applicable.
Here's an analysis based on the provided text, highlighting what is present and what is absent:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for Jostra Suction Devices
The Jostra Suction Devices underwent non-clinical testing to demonstrate substantial equivalence to a predicate device (Medtronic DLP Suction Devices), rather than a clinical study with detailed acceptance criteria for a new clinical outcome.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate comparison) | Reported Device Performance (Jostra Suction Devices) |
|---|---|
| Intended Use: Aspirate blood and fluids from operative field and return to extracorporeal circuit during open-heart surgery lasting ≤ 6 hours. | Meets: Same intended use as the predicate device. |
| Principles of Operation: Similar design and function for aspiration. | Meets: Substantially equivalent to predicate. |
| Materials: Biocompatible materials suitable for blood contact and surgical use. | Meets: Biocompatibility testing performed. |
| Design: Rigid, flexible, and pericardial suckers for aspiration. | Meets: Devices include rigid, flexible, and pericardial suckers, similar to predicate. |
| Performance: Effective aspiration, no leakage, no adverse effects on cellular components, suitable for single-use, sterile. | Meets: Performance testing (Bond Strength, Leakage Test) and in-vitro testing (effects on cellular components) performed and demonstrated substantial equivalence. |
Note: The document states, "Comparative testing has demonstrated that these differences do not affect safety and effectiveness." This implies that the acceptance criteria were based on demonstrating comparable safety and effectiveness to the predicate device through these non-clinical tests.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for the performance or in-vitro tests conducted. It only generically mentions "performance testing" and "in-vitro testing."
- Data Provenance: The testing was non-clinical (laboratory/bench testing and in-vitro). The country of origin for the testing is not specified, but the submitter is based in Germany. The data is retrospective in the sense that it's a review of non-clinical tests performed, not a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this submission. The ground truth was established through engineering and laboratory testing protocols designed to assess physical performance characteristics and biocompatibility against established standards and the characteristics of the predicate device. There was no "ground truth" established by human expert consensus in the clinical sense for this type of device.
4. Adjudication Method for the Test Set
This information is not applicable. As there were no human expert evaluations for clinical "ground truth," there was no need for an adjudication method like 2+1 or 3+1. Performance was assessed through objective measurements from non-clinical tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not conducted for this device. This type of study is typically done for diagnostic imaging devices or AI-assisted diagnostic tools, which is not the nature of the Jostra Suction Devices.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The device is a physical medical instrument (suction device), not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation was based on:
- Engineering specifications and performance standards.
- Biocompatibility test results.
- Direct comparison to the Medtronic DLP Suction Devices (predicate device) specifications and known performance.
- Objective measurements from performance tests like bond strength and leakage tests, and in-vitro cellular component analysis.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML system, so there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth to be established for it.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).