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The BAXJECT II Hi-Flow Needleless Transfer Device is intended for transferring and mixing of drugs contained in two vials into a syringe.

The BAXJECT II Hi-Flow Needleless Transfer Device is a double-sided needleless transfer device designed for transferring and mixing of drugs contained in two vials into a syringe.

This is a 510(k) premarket notification for a medical device called the BAXJECT II Hi-Flow Needleless Transfer Device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specific acceptance criteria in the way a PMA (Pre-Market Approval) or a de novo submission would.

Therefore, many of the typical questions regarding acceptance criteria, study design, expert ground truth, and multi-reader multi-case studies are not directly applicable or are addressed through different means in a 510(k).

Here's an analysis of the provided information in the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission like this, the "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device, primarily through technological characteristics, performance, and intended use. There isn't a table of specific numerical performance metrics and their corresponding acceptance criteria as there would be for a novel device or a device requiring clinical efficacy data.

Instead, the submission indicates:

Study that Proves the Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as "Device verification testing of performance has been verified through functional and biocompatibility testing." This, coupled with the assertion of meeting "established standards and guidelines," forms the basis of the substantial equivalence claim. Specific details of these tests (e.g., specific protocols, results, statistical analyses) are not provided in the summary documents, as they are typically part of the more extensive 510(k) submission.

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

This document does not specify a "test set" in the context of a clinical study or a labeled dataset for AI. The verification testing mentioned (functional and biocompatibility) would have involved a sample of the manufactured devices. The specific sample sizes for these engineering and lab tests are not detailed in this summary. The data provenance is internal to Baxter Healthcare Corporation, based on their testing.

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

Not applicable for this type of submission. Ground truth, in the context of clinical expert consensus, is not relevant for demonstrating substantial equivalence for a needleless transfer device. The "ground truth" here is compliance with engineering standards and performance specifications.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for establishing expert ground truth for medical image interpretation or similar tasks. This device's evaluation is based on engineering and performance testing.

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 device is not an AI-powered diagnostic or assistive tool for human readers. It's a physical medical device for drug transfer.

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

Not applicable. This submission is not for an algorithm or AI system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for this device's evaluation would be defined by:

• Engineering Specifications and Standards: The device's performance (e.g., flow rate, sealing integrity, absence of leakage, material compatibility) meeting predetermined technical specifications and industry standards.
• Biocompatibility Standards: The materials used in the device meeting established biocompatibility requirements to ensure safety for patient contact.
• Sterilization Standards: The device meeting sterility assurance levels.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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