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The Stryker Neurovascular TransForm™ Occlusion Balloon Catheters (Compliant and Super Compliant) are indicated for use in the neuro and peripheral vasculature to temporarily stop or control blood flow and for balloon assisted embolization of intracranial aneurysms.

Stryker Neurovascular's TransForm Occlusion Balloon Catheters (Compliant and Super Compliant) are compliant, variable stiffness reinforced balloon catheters. The outer surface of the catheter's distal segment is coated with a lubricious hydrophilic coating designed to reduce friction. Each balloon catheter has two radiopaque markers to facilitate fluoroscopic visualization. The proximal end of the balloon catheter incorporates a strain relief and a standard luer fitting to facilitate the attachment of accessories.

Here's an analysis of the provided 510(k) summary for the TransForm™ Occlusion Balloon Catheter, detailing acceptance criteria and proof of their fulfillment.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (bench testing, shelf life, packaging, and biocompatibility). The "acceptance criteria" for this type of submission are typically that the new device meets the performance requirements for its intended use and is proven safe and effective for that use, typically demonstrated by showing it performs comparably or better than the predicate for relevant attributes.

Since specific numerical acceptance criteria (e.g., "Deflation time must be < X seconds") are not explicitly stated as pass/fail thresholds in the summary, the table below will list the types of performance characteristics assessed and imply the acceptance was demonstrated by achieving satisfactory results for these tests, thereby showing equivalency and fitness for purpose.

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

• Sample Size for Test Set: The document does not specify the exact sample sizes (N) for each individual test (e.g., how many catheters were tested for balloon fatigue, how many were submitted for biocompatibility). It only lists the types of tests performed.
• Data Provenance: All tests described are non-clinical bench and lab tests, as well as packaging and shelf life testing. This data is generated in a controlled laboratory environment, not from human or animal subjects. Therefore, concerns about country of origin, retrospective/prospective studies, and ground truth establishment from patient data are not applicable to the non-clinical testing described.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This question is not applicable to this 510(k) summary. The "ground truth" for non-clinical performance testing is established by engineering specifications, validated test methods (e.g., EN ISO standards), and internal performance requirements, not by expert consensus on clinical data. The tests measure objective physical and chemical properties of the device.

4. Adjudication Method for the Test Set:

This is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations of clinical data or images. For non-clinical bench testing, results are typically objective measurements with defined pass/fail criteria.

5. 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:

This is not applicable. The TransForm™ Occlusion Balloon Catheter is a medical device (a physical catheter), not an AI/software as a medical device (SaMD) that assists human readers in interpreting medical images. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:

This is not applicable for the same reason as point 5. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this submission's non-clinical testing is based on:

• Established engineering specifications and design requirements: These define the target performance characteristics of the device.
• Industry standards (e.g., EN ISO 10555-1, EN ISO 10555-4, EN ISO 11607-1 and -2, EN ISO 10993-1): These provide standardized test methods and accepted performance benchmarks for medical devices.
• Comparison to the predicate device: The predicate device's established performance serves as a benchmark for demonstrating substantial equivalence.

8. The Sample Size for the Training Set:

This is not applicable. This is a physical medical device, not an AI/machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

This is not applicable for the same reason as point 8.

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