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The T-AnastaFlo is indicated for use in preventing ischemia by the shunting and/or perfusion of blood or cardioplegic solution distal to the anastomosis site during the construction of coronary artery bypass grafts.

The T-AnastaFic is a sterile, single use, disposable shunt composed of two silicone bulbs on the distal ends of a flexible silicone tubular shaft. Another silicone tubular shaft is attached perpendicular to the middle of the shunt, ending with a perfusion port stopcock. Each T-AnastaFlo is individually packaged sterile and non-pyrogenic in a sealed, peeltype pouch.

The T-AnastaFlo device received FDA clearance (K990396) based on substantial equivalence to the Rivetti-Levinson Intraluminal Shunt (K972261). The clearance was based on demonstrating equivalence in intended use, technology, materials, and design, supported by performance testing.

Here's a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided 510(k) summary (K990396) for the T-AnastaFlo device focuses on demonstrating substantial equivalence to a predicate device. It explicitly states that the conclusion is "based upon tests performed for device flow rate, leak characteristics, and tensile strength, and upon the equivalence of materials, design and intended use for the proposed and predicate devices." However, the document does not provide the specific acceptance criteria or the numerical results of these tests, nor does it specify the predicate device's performance numbers that were used for comparison. The assumption is that the new device met performance characteristics deemed equivalent to the predicate.

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

The provided 510(k) summary does not specify:

• The exact sample sizes used for the flow rate, leak characteristics, and tensile strength tests.
• The country of origin of the data.
• Whether the data was retrospective or prospective.

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

This information is not applicable and not provided in the 510(k) summary. The T-AnastaFlo is a medical device (intraluminal shunt), not an AI or diagnostic imaging device that typically requires expert-established ground truths for performance evaluation. The evaluation was based on engineering and material performance tests.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used in clinical trials or studies involving human interpretation or subjective endpoints, which is not the primary focus of this type of device clearance (mechanical performance).

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools or imaging devices where human readers' performance is augmented by AI. The T-AnastaFlo is a mechanical surgical device.

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

This information is not applicable. The T-AnastaFlo is a physical medical device, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for its evaluation.

7. The Type of Ground Truth Used

The "ground truth" for the T-AnastaFlo's performance was established through engineering and material testing standards, comparing its physical properties (flow rate, leak characteristics, tensile strength) and material/design specifications against the predicate device. It was not based on expert consensus, pathology, or outcomes data in the traditional sense, but rather on meeting pre-defined mechanical and material specifications assumed to be safe and effective based on the predicate.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The T-AnastaFlo is not an AI-driven device, so there is no "training set."

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

This information is not applicable and not provided. As there is no training set for this device, a method for establishing its ground truth is irrelevant.

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