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The Edwards Balloon Catheter is indicated for balloon aortic valvuloplasty.

The Edwards Balloon Catheter, is used for balloon aortic valvuloplasty. The device consists of a nylon balloon, a thermoplastic elastomer (Polyether block amide) multidurometer braided shaft with 130cm working length, platinum/iridium radio-detectable markers, and a polycarbonate y-connector that consists of a balloon inflation port and guidewire lumen. The effective length of the balloon is 4cm and is offered in 16mm, 20mm, 23mm and 25mm diameters. The balloon catheter is supplied sterilized by ethylene oxide for single use.

The provided text is a 510(k) summary for the Edwards Balloon Catheter, intended for balloon aortic valvuloplasty. It details non-clinical testing performed to demonstrate performance. However, the document does not contain the specific acceptance criteria or a dedicated study explicitly proving the device meets these criteria in the format requested.

The summary describes general non-clinical testing and refers to a "Summary of Clinical Data" that involved a literature review, complaint analyses, and a review of post-market experience, as well as an IDE study (G030069) with a predicate device. This suggests that the clinical evidence for substantial equivalence was derived from existing data and comparisons rather than a new standalone clinical study with the specific Edwards Balloon Catheter.

Therefore, many of the requested fields cannot be filled directly from the provided text.

Here is an attempt to address the request based on the available information, noting where information is not present:

Acceptance Criteria and Device Performance Study for Edwards Balloon Catheter

The provided 510(k) summary for the Edwards Balloon Catheter does not explicitly state quantitative acceptance criteria or a dedicated clinical study designed to demonstrate the device meets those criteria. Instead, it relies on non-clinical performance testing, a literature review, complaint analyses, and a review of post-market experience, along with referencing the pivotal IDE study (G030069) conducted with a predicate device (RetroFlex Balloon Catheter). The underlying assumption is that if the non-clinical performance matches predicate devices and clinical history supports safety and effectiveness, then the device is substantially equivalent.

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative "acceptance criteria" for demonstrating substantial equivalence for clinical performance are not delineated in the provided summary, a direct table cannot be constructed. The summary lists various non-clinical tests performed, and implicitly, the device passed these tests to demonstrate manufacturing quality and basic functionality.

Note: The "Acceptance Criteria" listed above are inferred as "met specifications" since no specific values are provided in the summary. The "Reported Device Performance" simply states that the tests were completed and presumably met the internal requirements for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Clinical Test Set: No specific clinical "test set" in the context of a prospective study for the Edwards Balloon Catheter is described. The "clinical assessment" relied on:
  • Literature Review: Provenance unspecified.
  • Complaint Analyses: For the Edwards Transfemoral Balloon Catheter and RetroFlex Balloon Catheter. Provenance is likely from post-market surveillance data, potentially global, but not specified.
  • Review of Post-Market Experience: With the Edwards Transfemoral Balloon Catheter. Provenance is likely from post-market surveillance data, potentially global, but not specified.
  • Pivotal IDE Study (G030069) with RetroFlex Balloon Catheter: This was a study for a predicate device. The sample size and provenance for this specific study are not detailed in the provided 510(k) summary, but it would have been prospective clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the summary, as there was no standalone clinical study described for the Edwards Balloon Catheter that would involve experts establishing ground truth for efficacy or safety endpoints. The clinical assessment relies on aggregated literature, complaint data, and a predicate device's IDE study.

4. Adjudication Method for the Test Set

This information is not provided as there was no standalone clinical study for the Edwards Balloon Catheter involving a test set that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was reported. The device is a physical medical device (balloon catheter) and not an imaging or diagnostic AI system, so an MRMC study comparing human readers with and without AI assistance would not be applicable here.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

• Not applicable. This device is a physical, invasive medical device used for a therapeutic procedure, not an algorithm or AI system. Its performance inherently involves human interaction (a surgeon or interventional cardiologist).

7. Type of Ground Truth Used

Given the context of a medical device 510(k) for a balloon catheter, "ground truth" would typically refer to clinical outcomes (e.g., successful valvuloplasty, adverse event rates, hemodynamic improvements). However, for the Edwards Balloon Catheter, the summary indicates that substantial equivalence was demonstrated through:

• Non-clinical testing: Demonstrating that the physical device functions as intended and meets design specifications (e.g., burst pressure, inflation/deflation time).
• Clinical assessment by proxy: Relying on the established safety and effectiveness of predicate devices (including the pivotal IDE G030069 for the RetroFlex Balloon Catheter), literature, and post-market surveillance data. The "ground truth" for the predicate device's IDE study would have been defined clinical outcomes (e.g., patient survival, complication rates, hemodynamic improvements assessed by objective measures) relevant to balloon aortic valvuloplasty.

8. Sample Size for the Training Set

• Not applicable/Not provided. This is not an AI/algorithm-based device that would typically have a "training set" in the computational sense. The "training" for the design and manufacturing of the device would come from engineering principles, predicate device experience, and manufacturing processes.

9. How the Ground Truth for the Training Set Was Established

• Not applicable/Not provided. As stated above, this is not an AI/algorithm-based device. For the predicate device's IDE study, the ground truth would have been established through standard clinical trial methodologies, including patient enrollment, clinical follow-up, and objective measurements of outcomes.

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