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510(k) Data Aggregation
(304 days)
JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS
The Jostra Single Stage Venous Return Catheters are designed to be used for the collection of venous blood from the right side of the superior and inferior vena cava during cardiopulmonary bypass surgery up to 6 hours or less.
The Jostra Single Stage Venous Return Catheters are designed to be used for the collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to 6 hours or less.
The Jostra Single Stage Venous Catheters are single, sterile devices for single use only and not to be resterilized by the user. The catheters are to be used to divert blood from the patient to the extracorporeal circuit by draining blood from the Inferior Vena Caya and the Superior Vena Cava. The catheters are made from polyvinyl chloride (PVC) and range in size from 12 Fr.- 40 Fr with a variety of tips and with or without attached connectors.
This 510(k) summary describes a traditional medical device (venous catheter), not an AI/ML powered device. As such, many of the requested categories related to AI/ML device studies are not applicable.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria. The performance testing aimed to demonstrate "substantial equivalency" to the predicate device.
| Test Category | Acceptance Criteria (explicitly stated) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Not explicitly stated (implied safe) | Performed, demonstrated substantial equivalency |
| Flow-Pressure curves | Not explicitly stated (implied comparable to predicate) | Performed, demonstrated substantial equivalency |
| Kink Resistance | Not explicitly stated (implied comparable to predicate) | Performed, demonstrated substantial equivalency |
| Bond Strength | Not explicitly stated (implied comparable to predicate) | Performed, demonstrated substantial equivalency |
| Leakage Test | Not explicitly stated (implied no leakage) | Performed, demonstrated substantial equivalency |
| Effects on Cellular Components | Not explicitly stated (implied no adverse effects) | In-vitro testing performed, demonstrated substantial equivalency |
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 the sample sizes used for the non-clinical testing. It also does not specify the country of origin of the data or whether it was retrospective or prospective, as these tests are laboratory-based device performance tests rather than clinical studies on patient data.
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)
Not applicable. This device is a mechanical catheter and its performance is evaluated through physical and material properties testing, not through expert-reviewed data or ground truth labeling by medical professionals.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of expert opinions.
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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this medical device's performance is based on established engineering and materials testing standards and comparison to a legally marketed predicate device's performance characteristics.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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