(70 days)
The St. Jude Medical Transseptal Catheter Introducer Set is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
The Swartz™ Braided Transseptal Guiding Introducer set consists of a fixed compound curve, dilator, and guidewire. The fixed curve Swartz introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. The introducer features distal vent holes to facilitate aspiration and minimize cavitation, and a radiopaque tip marker to improve fluoroscopic visualization. The device is provided sterile and is intended for single-use only.
I am sorry, but the provided text does not contain the detailed information necessary to complete the requested table and answer all the questions.
Specifically, the document is a 510(k) summary for a medical device (Swartz™ Braided Transseptal Guiding Introducer) and focuses on establishing substantial equivalence to predicate devices, rather than detailing a specific study with acceptance criteria and performance metrics of the device itself.
Here's what I can extract and what's missing:
Missing Information:
- Acceptance Criteria for Device Performance: The document does not state specific performance metrics (e.g., success rates, complication rates, measurement accuracy) or their associated acceptance criteria. Instead, it refers to "mechanical testing" to demonstrate safety and effectiveness for dimensional and material differences.
- Reported Device Performance: No quantitative performance data for the Swartz™ Braided Transseptal Guiding Introducer is provided.
- Study Design Details:
- Sample size for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: This type of study is more common for diagnostic imaging devices involving human interpretation, not for an introducer catheter. The document does not mention such a study.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
- Type of ground truth used.
- Sample size for the training set (not applicable for this type of device).
- How ground truth for the training set was established (not applicable).
Information that can be inferred or is present (though not in the requested format for a performance study):
- The document implies that the "acceptance criteria" for the device's design changes were met through mechanical testing. However, no specifics of these tests or their acceptance thresholds are provided in this summary.
- The study that "proves the device meets the acceptance criteria" refers to mechanical testing that demonstrated dimensional and material differences do not adversely affect safety and effectiveness. This is not a clinical study with patient outcomes or expert reviews in the way typically required for AI/diagnostic devices.
Based on the provided text, I can only state that a direct answer to your request regarding acceptance criteria and a detailed study proving device performance (as if it were an AI diagnostic device) cannot be given.
The document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, expert information, or ground truth details.
- Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.
- Details on ground truth establishment for training sets.
The core of this 510(k) submission is about demonstrating "substantial equivalence" to legally marketed predicate devices, primarily through comparison of technological characteristics and, where differences exist, through mechanical testing to ensure safety and effectiveness. It is not a clinical performance study with defined endpoints and ground truth experts as would be expected for an AI-powered diagnostic tool.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).