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The NIPRO Needleless Transfer Device is a sterile device for the aseptic transfer of solutions from container to container or reconstituting medications.

The Nipro Needleless Transfer Device with or without 20mm vial closure adapters is a sterile, single-use needleless liquid transfer device with the intent of transferring sterile water from its vial into an evacuated vial containing lyophilized product requiring reconstitution.

This device consists of a single piece injection molded main body with 2 capped spikes on both ends. The device is provided with and without 2 adapters used for setting at the mouth of the solution bottle in order to stabilize the container at the time of mixture.

The device is sterile, single-use only, latex-free, non-toxic and non-pyrogenic.

The NIPRO Needleless Transfer Device is a sterile, single-use needleless liquid transfer device intended for transferring sterile water from a vial into an evacuated vial containing lyophilized product for reconstitution, or for aseptic transfer of solutions between containers.

Here's an analysis of the provided information regarding its acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document primarily focuses on non-clinical tests to establish substantial equivalence rather than specific performance metrics against pre-defined numerical acceptance criteria for a "device." Instead, the criteria are related to the successful execution of various tests aligning with known good manufacturing practices and device functionality.

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

The document does not explicitly state the sample sizes for each non-clinical test (Dimensional, Mechanical, Operational, Chemical, Biocompatibility). These tests are typically conducted on a representative sample of finished product. The data provenance is presumed to be from tests performed by the manufacturer (Nipro Medical Corporation) in support of their 510(k) submission. No information on country of origin of data or whether tests were retrospective or prospective is provided.

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

This information is not applicable and therefore not provided in the document. For non-clinical device testing, "ground truth" is typically established by engineering specifications, regulatory standards, and validated test methods, not by expert consensus in the same way it would be for diagnostic AI.

4. Adjudication Method for the Test Set:

Not applicable. The non-clinical tests described do not involve human adjudication in the context of interpreting results in a consensus approach. Test results are compared against pre-defined specifications or predicate device performance.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (especially those involving AI or human interpretation) to assess clinician performance with and without AI assistance. The NIPRO Needleless Transfer Device is a mechanical medical device, not a diagnostic tool requiring human interpretation or AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

No, a standalone (algorithm only) performance assessment was not done. This is not relevant for a mechanical medical device.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical tests was established by:

• Engineering Specifications: Designed parameters and tolerances for the device.
• Regulatory Standards: Applicable standards for safety, performance, and biocompatibility of medical devices (e.g., ISO standards, FDA guidance documents).
• Predicate Device Performance: The established performance characteristics of the legally marketed predicate device (K972117: MSI Transflow) served as a benchmark for comparison to demonstrate substantial equivalence.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms.

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

Not applicable. There is no training set for this type of medical device.

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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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