Search Results

The provided 510(k) summary (K984214) describes a Temporary Occlusion Balloon Catheter and outlines performance testing done to establish substantial equivalence to predicate devices.

This is not an AI/ML device. The performance testing described is for a physical medical device. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample sizes for test and training sets, number of experts for ground truth, adjudication methods, MRMC studies) are not applicable.

Here's an analysis based on the information provided, focusing on what is relevant for a non-AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Benchmarks (Implied)	Reported Device Performance
In-vitro Testing:
Tip linear stiffness similar to predicates	Performs similar to predicate devices
Catheter kink resistance similar to predicates	Performs similar to predicate devices
Catheter preparation time similar to predicates	Performs similar to predicate devices
Balloon inflation/deflation times similar to predicates	Performs similar to predicate devices
Deflatability similar to predicates	Performs similar to predicate devices
Animal Study Testing:
Device works as intended (temporary occlusion of blood vessels)	Device works as intended
Biocompatibility:
All appropriate biocompatibility tests passed	All appropriate biocompatibility tests were successfully performed on the materials used

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated for in-vitro tests (e.g., number of catheters tested for stiffness, kink resistance). For animal studies, the number of animals used is not specified.
Data Provenance: Not applicable in terms of country of origin or retrospective/prospective data as this pertains to physical device performance testing rather than clinical data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth for a physical device's performance is established through direct measurements and observations during in-vitro and animal testing, not typically through expert consensus on medical images or clinical outcomes.

4. Adjudication method for the test set

Not applicable. Adjudication methods are typically used when interpreting ambiguous clinical data or images, which is not the primary focus of this device's performance evaluation.

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

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

In-vitro testing: Physical measurements and functional performance observations.
Animal study testing: Direct observation of device function (temporary vessel occlusion) and potential biological response in a living model. Biocompatibility results would be based on laboratory testing against established standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Ask a Question

Ask a specific question about this device

Page 1 of 1