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The Chase Thoracic Catheter is indicated for use during and after open-heart surgery to drain fluid from the pericardium.

The Chase Thoracic Catheter is a polyvinyl chloride tube with precut holes at the distal tip.

The provided text describes a 510(k) premarket notification for the "Chase Thoracic Catheter." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than performing extensive novel clinical studies with detailed acceptance criteria and performance metrics.

Therefore, many of the requested elements (like a table of acceptance criteria, sample sizes for test sets, expert consensus, MRMC studies, standalone performance, and training set details) are not applicable or not provided in this document, as they are typically required for de novo submissions or PMA applications for novel devices.

Here's a breakdown of the information that is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable / Not provided. The submission focuses on substantial equivalence based on material and functional comparison to a predicate device and engineering testing, not a clinical test set with patient data for performance evaluation in the way a diagnostic AI would.

• For functional and engineering tests: The sample sizes for tests like sterilization validation, package integrity, and shipping tests are not specified.

• Data Provenance: Not applicable in the context of device performance, as no clinical data or patient data is mentioned.

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

• Not applicable / Not provided. This device is a Class I thoracic catheter, and the submission is a 510(k) based on substantial equivalence. It does not involve a "ground truth" derived from expert consensus for diagnostic AI performance. The "ground truth" here is compliance with engineering standards and direct comparison of physical properties with the predicate.

4. Adjudication Method for the Test Set

• Not applicable / Not provided. No clinical test set with human readers or AI output requiring adjudication is described or performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. An MRMC study was not done. This type of study is relevant for evaluating the impact of an AI diagnostic aid on human reader performance, which is not the scope of this 510(k) for a physical medical device.

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

• No. This is a physical medical device, not an algorithm or AI. Standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is primarily:
  • Predicate Device Specifications: The "Sherwood Medical Thoracic Catheter (K760351)" serves as the primary ground truth for substantial equivalence in terms of materials, fit, form, and function.
  • Engineering Standards and Test Methods: Standards like ASTM F I 140-88 (for burst test) and National Safe Transit Ass. (for vibration and drop tests) provide the "ground truth" for physical and packaging performance.
  • Sterilization Standards: The "Overkill Method" leading to an SAL 10⁻⁶ is the ground truth for sterilization efficacy.

8. The Sample Size for the Training Set

• Not applicable / Not provided. This is a physical device, not an AI model. There is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

• Not applicable / Not provided. As there is no training set, this question is not relevant to this submission.

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