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The Seal-Away™ Hemostasis Adapters are designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing the blood loss is essential.

The Daig Seal-Away™ Hemostasis Adapter is an Introducer Accessory designed to provide easy access to the vascular system while providing convenient temporary closure of a standard indwelling introducer access site during introduction of pacing leads, angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel.

The provided text describes a 510(k) summary for the Seal-Away™ Hemostasis Adapter, focusing on its substantial equivalence to a predicate device. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews in the context of typical AI/software device studies.

The document primarily states:

• Substantial Equivalence: The Seal-Away™ Hemostasis Adapter is considered substantially equivalent to the Removable Hemostasis Adapter with Sideport (K894343).
• Technological Characteristics: All technological characteristics (product design, packaging, sterilization, labeling) are substantially equivalent to the predicate device.
• Intended Use: Designed to minimize blood loss during the introduction of various catheters and electrodes into a vessel.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device assessment (AI/Software) than the 510(k) submission for a physical medical device.

Here's a breakdown of what can be inferred from the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as performance metrics. The implicit acceptance criterion is "substantial equivalence" to the predicate device.
• Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, blood loss volume, etc.) are reported in this document. The "performance" is implicitly deemed equivalent to the predicate.

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

• Not Applicable / Not Provided: This document describes a physical medical device (hemostasis adapter) and its substantial equivalence. There is no "test set" of data in the context of an AI/software algorithm. The clearance is based on comparison to an existing device, not on a clinical performance study using a data set.

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

• Not Applicable / Not Provided: Ground truth establishment by experts for a test set is relevant for AI/software devices. This document does not describe such a process. The "ground truth" for this device's clearance is its functional similarity to a previously cleared predicate device.

4. Adjudication Method for the Test Set:

• Not Applicable / Not Provided: Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations for AI/software ground truth. This is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

• No, Not Applicable: MRMC studies compare human performance with and without AI assistance. This document describes a physical medical device; no such study was conducted or is applicable.

6. If a Standalone (algorithm only without human-in-the-loop performance) study was done:

• No, Not Applicable: Standalone performance studies are for AI algorithms. This is a physical device submission.

7. The Type of Ground Truth Used:

• Predicate Device Equivalence: The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate device (K894343). The new device is simply shown to be sufficiently similar in design and intended use to warrant equivalence without new, extensive clinical trials.

8. The Sample Size for the Training Set:

• Not Applicable / Not Provided: "Training set" refers to data used to train an AI algorithm. This concept does not apply to the Seal-Away™ Hemostasis Adapter.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable / Not Provided: As there is no training set for an AI algorithm, the establishment of ground truth for it is irrelevant in this context.

In summary: The provided 510(k) summary is for a physical medical device and relies on the concept of "substantial equivalence" to a predicate device. It does not involve AI/software performance studies, and therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth, and expert reviews is not present in the document.

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