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510(k) Data Aggregation
(21 days)
AMPLATZER® Sizing Balloon II is indicated 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 II is a triple lumen balloon catheter with three (3) radiopaque marker bands located inside the balloon to allow for radiographic measurement. The center of the balloon contains a pair of marker bands 0.4mm apart (inside to inside), and one (1) marker band 15 mm proximal of that pair.
The provided document is a 510(k) summary for the AMPLATZER® Sizing Balloon II, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than proving novel efficacy through detailed acceptance criteria and a comprehensive study with specific performance metrics for a new AI device.
Therefore, the information required to populate the tables and answer the questions related to acceptance criteria, AI performance, and AI-specific ground truth methodologies is not present in the provided text. The document describes a non-clinical evaluation of a physical medical device, not a software algorithm or AI.
However, I can extract the relevant information from the document as it pertains to the device's "performance" in the context of a 510(k) submission for a physical device:
Device Performance and Acceptance Criteria (Non-AI device)
| Acceptance Criteria (Non-Clinical Tests) | Reported Device Performance (Summary) |
|---|---|
| Inflation time | Performed (Results not detailed, but deemed acceptable) |
| Deflation time | Performed (Results not detailed, but deemed acceptable) |
| Burst volume | Performed (Results not detailed, but deemed acceptable) |
| Bifurcation separation | Performed (Results not detailed, but deemed acceptable) |
| Tip separation | Performed (Results not detailed, but deemed acceptable) |
| Sidearm stopcock to tube separation | Performed (Results not detailed, but deemed acceptable) |
| Sidearm luer to tube separation | Performed (Results not detailed, but deemed acceptable) |
| Marker band placement | Performed (Results not detailed, but deemed acceptable) |
| Biological testing | Performed (Results not detailed, but deemed acceptable) |
Study Details (Based on the provided K053440 document, for a physical device)
- Sample size used for the test set and the data provenance: Not specified in the provided summary. The tests are "non-clinical" and likely involved a batch of manufactured devices, but the exact sample size for each test is not detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI device where human experts establish ground truth. The "ground truth" for these tests would be established by engineering specifications and measurements.
- Adjudication method for the test set: Not applicable. This is not an AI device.
- 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 device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the ground truth would be based on engineering specifications, physical measurements, and established testing standards for medical devices.
- The sample size for the training set: Not applicable. This is not an AI device.
- How the ground truth for the training set was established: Not applicable. This is not an AI device.
Conclusion from The Document:
The document concludes that "The AMPLATZER® Sizinq Balloon II is substantially equivalent to currently marketed balloon catheters used for temporary vessel occlusion," based on design modifications, a new supplier, and an additional catheter size, without altering the intended use or fundamental scientific technology of the predicate product. The non-clinical tests listed were performed to support this claim of substantial equivalence.
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