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The AMPLATZER® Sizing Balloon is intended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.

The AMPLATZER® Sizing Balloon is a 7F double lumen balloon catheter made from radiopaque nylon. The balloon is compliant and made from a very thin stretchable plastic membrane. The balloon-carrying segment is angled to 45° to the shaft providing a more or less right-angled position in relation to the atrial septum.

The acceptance criteria and study that proves the device meets the acceptance criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that these tests were "performed" but does not provide specific quantitative acceptance criteria or the results of these tests, beyond the implication that they were successfully met to establish substantial equivalence.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated for any of the performed tests (in vitro functional, biocompatibility, or animal testing).
• Data Provenance: The tests are described as "in vitro functional tests," "biocompatibility testing," and "animal testing," implying laboratory-based and animal-based studies. The country of origin is not specified but is presumably the location of AGA Medical Corporation (Golden Valley, MN, USA). The studies appear to be prospective for the purpose of demonstrating safety and performance.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

Not applicable. The document describes laboratory, in-vitro, and animal testing. There is no mention of human-expert-established ground truth for a test set in the context of diagnostic performance.

4. Adjudication Method (Test Set)

Not applicable. There is no mention of expert adjudication for a test set as the studies involve functional, biocompatibility, and animal testing.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The submission focuses on the safety and performance of the device itself, not on the improvement of human readers with or without AI assistance. The device is a physical sizing balloon, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study in the context of an algorithm's performance was not done. The device is a physical medical device (balloon catheter), not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for the tests performed would be based on:

• In vitro functional tests: Engineering and materials science standards for catheter performance (e.g., measuring inflation/deflation, material strength, leakage limits).
• Biocompatibility tests: Established ISO standards and guidelines for biological evaluation of medical devices (e.g., absence of cytotoxicity, sensitization, systemic toxicity).
• Animal testing: Physiological and pathological observations in animal models to assess safety and performance in a living system.

8. Sample Size for the Training Set

Not applicable. The document does not describe a training set for an algorithm. The "training set" concept is relevant for machine learning or AI models, which is not the nature of this medical device.

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

Not applicable, as there is no training set for an algorithm. The device's design and manufacturing processes are likely informed by established medical device development guidelines and previous knowledge, rather than a data-driven training set.

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