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The Micro Therapeutics, Inc. Occlusion Balloon Catheter is designed for use in blood vessels where temporary occlusion is desired. The MTI Occlusion Balloon Catheter offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow.

The Equinox™ Occlusion Balloon Catheter is a single lumen balloon catheter with a maximum outer diameter of 2.8F tapering to 2.2F at the distal tip. The distal end of the catheter has a non-detachable low inflation pressure compliant balloon. The catheter is designed to track over the MTI SilverSpeed™ 0.010" guidewire, and requires insertion of the guidewire to occlude the catheter shaft lumen to allow inflation of the balloon. Two platinum markers provide angiographic visualization of the balloon length and facilitate intravascular placement of the balloon prior to inflation. The catheter shaft is hydrophilically coated to assist catheter advancement within the vasculature. The Equinox catheter is supplied sterile for single use as a system which includes the required SilverSpeed .010" Guidewire and a rotating hemostatic valve.

The Equinox™ Occlusion Balloon Catheter (K990487) did not present specific acceptance criteria in the provided 510(k) summary. Instead, it relied on demonstrating conformance to established international standards for medical devices and establishing substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample size used for the test set and the data provenance:
   The document does not specify exact sample sizes for the performance and biocompatibility testing. The data provenance is not explicitly mentioned in terms of country of origin or retrospective/prospective nature, but the testing was conducted by the manufacturer, Micro Therapeutics, Inc.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not applicable and not provided in the 510(k) summary. The testing conducted was for device performance and biocompatibility, not clinical efficacy or diagnostic accuracy requiring expert interpretation of results.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This information is not applicable and not provided. The testing involves standardized engineering and laboratory evaluations against predefined performance parameters, not subjective clinical assessments.

4. 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:
   No MRMC comparative effectiveness study was done. This an occlusion balloon catheter, not an AI-powered diagnostic device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   No standalone algorithm performance study was done. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The "ground truth" for the performance testing was adherence to the specifications outlined in ISO 10555 (e.g., dimensional tolerances, tensile strength values, balloon inflation pressures). For biocompatibility, the ground truth was conformance to ISO 10993-1, which involves specific biological endpoints (e.g., cytotoxicity, irritation).

7. The sample size for the training set:
   This information is not applicable as there is no training set in the context of this device. The device is a physical medical instrument, not a learned algorithm.

8. How the ground truth for the training set was established:
   This information is not applicable as there is no training set for this device.

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