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CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an intravascular catheter placed in the vein or artery. The device may be used for the administration of blood and fluids to patients, including pediatrics and immunocompromised patients. The device may also be used with power injector procedures up to 10mL per second of contrast media and a maximum pressure of 350psi. The device incorporates a technology that will prevent fluid displacement resulting from the following: Connection of a luer; syringe plunger compression; patient vascular pressure changes, such as coughing or sneezing; and IV solution container run-dry. The CLAVE Neutron incorporates a pre-slit septum that does not reguire the use of needles and will therefore passively aid in the reduction of needlestick injuries.

The CLAVE Neutron is a normally closed, bidirectional connector that incorporates a unique silicone valve within the fluid path. The unique valve prevents fluid displacement, both positive and negative at all times, including when the device is accessed.

Here's a breakdown of the acceptance criteria and study information for the CLAVE® Neutron™ device based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally demonstrated by the CLAVE Neutron's performance being "substantially equivalent" to predicate devices, or meeting specific physical and functional benchmarks. The table below integrates information from the "Technological Characteristics and Substantial Equivalence Table" and other sections of the summary.

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

The document mentions "a variety of functional tests including microbial ingress and performance criteria" and "simulated use environment testing" as part of the "CLAVE Neutron Design Verification Report." However, specific sample sizes for these tests (e.g., number of devices tested for each functional criterion) are not provided in this summary.

• Data Provenance: The document states that the CLAVE Neutron Design Verification Report is proprietary and included in the submission. The information provided about the CLAVE and its use in pediatric/immunocompromised patients comes from two published clinical studies:
  • Bouza (2003): Randomized clinical trial. Patient population: immunocompromised, intensive care patients. Location: Department of Cardiovascular Surgery, Hospital General University of Madrid, Madrid, Spain. Outcome: reduced catheter hub and tip bacterial colonization.
  • Maragakis (2006): Clinical study. Patient population: pediatric ICU and pediatric oncology service patients. Location: John's Hopkins Hospital in Baltimore, Maryland. Outcome: observed catheter-related bloodstream infection rates.

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

• For the CLAVE Neutron's design verification tests: This information is not provided in the summary. These are laboratory-based functional and performance tests, not clinical studies requiring expert ground truth setting in the same way an imaging AI might.
• For the clinical studies referenced (Bouza 2003, Maragakis 2006): These studies evaluated clinical outcomes (bacterial colonization, bloodstream infection rates). The "ground truth" would be established by clinical diagnostic methods relevant to those outcomes, performed by healthcare professionals at the respective hospitals. The qualifications of these professionals are not explicitly detailed in this summary, beyond the fact they were conducted at medical institutions.

4. Adjudication Method for the Test Set

• For the CLAVE Neutron's design verification tests: Adjudication methods are not described in the summary. These are typically objective measurements against engineering specifications.
• For the clinical studies referenced: Standard clinical trial methodologies would have been used for data collection and outcome assessment in the Bouza (2003) and Maragakis (2006) studies. Specific adjudication methods for outcomes are not detailed in this summary.

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

• No MRMC comparative effectiveness study was mentioned or performed for the CLAVE Neutron. This device is a physical medical device (needleless connector), not an AI algorithm assisting human readers. The summary explicitly states: "There is no clinical data included in this submission." The referenced clinical studies (Bouza 2003, Maragakis 2006) are about the clinical performance of the predicate CLAVE connector, not about AI assistance.

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

• Not applicable. The CLAVE Neutron is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• For the CLAVE Neutron's design verification tests: The "ground truth" is defined by the predetermined performance criteria and product specifications outlined in the submission (e.g., specific mL/minute flow rates, psig leak pressures, lbf-in component assembly strength).
• For the referenced predicate CLAVE clinical studies (Bouza 2003, Maragakis 2006):
  • Bouza (2003): Clinical outcomes data (catheter hub and tip bacterial colonization).
  • Maragakis (2006): Clinical outcomes data (catheter-related bloodstream infection rates).

8. The Sample Size for the Training Set

• Not applicable. The CLAVE Neutron is a physical medical device and does not involve a "training set" in the context of machine learning or AI.

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

• Not applicable. As the device is not an AI algorithm, there is no training set or corresponding ground truth establishment in that sense. The device's design and manufacturing rely on engineering principles, materials science, and functional testing to meet specified performance standards.

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