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The St. Jude Medical ACross™ Transseptal Access System is used both to puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left side of the heart.

The St. Jude Medical ACross™ Transseptal Access System consists of three main components; ( ) ) a radiopaque sheath, (2) a radiopaque dilator, (3) a transseptal luminal stainless steel needle (1) a factopaque sheam; (2) a factopaque on has a specially curved distal portion to with a sond stanness stool as the atrial septum. The proximal ends of each component interlock to form a handle. The product is also packaged with a compatible guidewire.

The sheath is fitted with a seal to provide hemostasis during catheter introduction and/or I the sitean is thited with a soar to provith a side-port and three-way stopcock to provide for aspiration, fluid infusion, blood sampling, and pressure monitoring. The transseptal needle aspiration, that mitasion, oroca sampling, as accommodate positioning in the cardiac contisis of a Drockenbrough style carreng for air aspiration, fluid infusion, blood sampling, and pressure monitoring.

The provided document is a 510(k) summary for the ACross™ Transseptal Access System. It describes the device, its intended use, and its comparison to predicate devices. However, this document does not contain any information about specific acceptance criteria, device performance metrics, or the details of a study that proves the device meets such criteria.

The summary states:
"Non-clinical testing of the ACross™ Transseptal Access System includes in vitro bench testing, animal preclinical, biocompatibility testing, shelf-life and packaging testing, and sterilization. The total of the testing demonstrates that the ACross™ Transseptal Access System design meets product specifications and intended uses."

This general statement indicates that testing was performed, and the device met its specifications. However, it does not provide specific details on:

1. Acceptance criteria and reported device performance: No table or description of quantitative or qualitative acceptance criteria and corresponding performance results is given.
2. Sample size, data provenance: No information on the sample sizes for any tests (bench, animal) or the origin/type of data (retrospective/prospective, country of origin).
3. Number/qualifications of experts, adjudication method: These pertain to studies involving human interpretation or expert review, which are typically not relevant for a device like a transseptal access system where performance is measured through physical properties and safety.
4. MRMC comparative effectiveness study: Not applicable, as this is a device for physical access, not an imaging or diagnostic AI tool.
5. Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an algorithm.
6. Type of ground truth: Not applicable in the traditional sense for a physical device. Performance is measured against engineering specifications and safety standards.
7. Training set sample size and ground truth establishment: Not applicable, as this device does not involve a "training set" in the context of AI or machine learning. Development would involve engineering design, prototyping, and testing against design specifications.

Conclusion:

Based on the provided 510(k) summary, it is not possible to extract the requested information regarding specific acceptance criteria, device performance data, study details, expert involvement, or ground truth establishment. The document only provides a high-level overview of the types of non-clinical testing performed, stating that the device "meets product specifications and intended uses." To obtain the detailed information you requested, one would typically need to refer to the full 510(k) submission and its accompanying technical reports, which are not included in this summary.

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