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The SentreHeart Occlusion Balloon Catheter is intended for temporary occlusion of large vessels in applications such as arteriography, preoperative occlusion, and emergency controlled hemorrhage procedures.

The Occlusion Balloon Catheter consists of a catheter shaft with two independent lumens upon which an expandable balloon material is bonded. The "Guide Wire" lumen extends the length of the catheter and is used for placement of guide wires and injection of contrast for angiographic visualization. The "Balloon" lumen is used to inflate and deflate the balloon. Radiopaque markers at the location of the balloon provide fluoroscopic visualization of balloon placement. The outer diameter of the catheter shaft is coated with a hydrophilic polymer that reduces friction during manipulation in the vessel.

The provided text describes a 510(k) summary for the SentreHeart Occlusion Balloon Catheter. However, it does not contain specific details about acceptance criteria for performance, device performance data through a study, sample sizes for testing, ground truth establishment, or human-in-the-loop studies.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states that functional testing and biocompatibility testing were performed but does not quantify the acceptance criteria or the results against those criteria. It relies on a general statement of "safe and effective" and "biocompatible."

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

Missing Information: The document does not mention any specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The "functional testing" is broadly mentioned without any details.

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

Missing Information: Since no specific test set or clinical study is detailed, there is no mention of experts or how ground truth would have been established. This device is a catheter, not an AI/diagnostic imaging device where expert interpretation is typically a primary ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Missing Information: No information provided.

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

Missing Information: This is not applicable to a device like an "Occlusion Balloon Catheter." MRMC studies are typically for diagnostic imaging devices where human interpretation is involved. This is a medical device for temporary occlusion, not a diagnostic tool assisted by AI.

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

Missing Information: This is not applicable. The device is a physical catheter, not an algorithm.

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

Missing Information: For a medical device like this, "ground truth" would typically relate to the physical and mechanical properties of the device (e.g., balloon inflation pressure, burst pressure, material strength, biocompatibility results) and its ability to achieve its intended function (occlusion) in relevant models (in vitro, animal, or human studies, though clinical efficacy data isn't detailed here for the 510(k)). The document only generally refers to "functional testing."

8. The sample size for the training set

Missing Information: Not applicable. This is not an AI/machine learning device that requires a training set.

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

Missing Information: Not applicable.

Summary of the Study Mentioned in the Document:

The document briefly mentions:

• "Functional testing": Conducted to support substantial equivalence and demonstrate safety and effectiveness.
• "Biocompatibility testing": Conducted for the materials used in the catheter.

Key takeaway: This 510(k) summary is for a medical device (a catheter), not a software or AI-based diagnostic tool. Therefore, many of the requested categories (like ground truth from experts, MRMC studies, training sets, algorithms) are not applicable. The document itself provides a very high-level summary of testing without specific quantitative performance data or detailed study designs. It relies on the concept of "substantial equivalence" to predicate devices rather than novel, extensive performance studies with detailed acceptance criteria for statistical clinical endpoints.

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