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Clave Neutral-Displacement Connectors (MicroClave™/ NanoClave™/ Clave™Neutron) are intended for the aspiration, injection, or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. Clave Connectors may be used with power injectors at a maximum pressure of 400 psi and a maximum flow rate of 10ml/sec. Clave Connectors will prevent microbial ingress for seven (7) days.

Clave Neutral-Displacement Connectors are needlefree, bi-directional connectors that utilize a pre-slit septum which prevents microbial ingress when in the un-activated state and allows access to the fluid path when activated with an ISO 80369-7 compliant male luer. The septum offers neutral displacement of fluid during connection or disconnection of a male luer and self-seals upon disconnection to prevent fluid loss or air ingress. The Neutron incorporates additional technology that will prevent fluid displacement resulting from syringe plunger compression; patient vascular pressure changes, such as coughing or sneezing; and IV solution container run-dry. The Clave Family of Connectors do not require a cap but may be used with disinfecting caps containing 70% isopropyl alcohol.

The provided text is a 510(k) clearance letter and summary for the Clave™ Neutral-Displacement Needlefree Connectors. This document describes a medical device, not an AI/ML algorithm. Therefore, many of the requested fields related to AI/ML device performance (e.g., effect size of human readers with AI vs. without AI, ground truth for training set, number of experts for ground truth) are not applicable.

However, the document does describe the device's acceptance criteria and the studies performed to demonstrate equivalence and support new claims.

Here's the information extracted from the document:

1. A table of acceptance criteria and the reported device performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device and supporting new claims through non-clinical performance data and a retrospective clinical study.

Acceptance Criteria and Device Performance (Based on "Summary of Non-Clinical Testing" and "Performance Data: Non-Clinical Testing Summary")

2. Sample size used for the test set and the data provenance

• Non-Clinical Testing: The document does not specify the exact sample sizes for each non-clinical test (e.g., ISO 8536-4, ANSI/AAMI CN27). It states that "The subject device has been evaluated for the prevention of microbial ingress for a worst-case simulated use protocol of seven (7) days" and mentions conformance to various standards, which implicitly include testing of multiple units.
• Clinical Testing (CMS study):
  • Sample Size: Not explicitly stated as a "sample size" in the context of device testing. This was a retrospective study that analyzed 2019 CMS data. The study "analyzed 2019 CMS data" to compare hospitals using Clave connectors to those not using them.
  • Data Provenance:
    • Country of Origin: United States (CMS data).
    • Retrospective or Prospective: Retrospective.
    • Specifics: "analyzed 2019 CMS data," "adjusting for Hospital characteristics," "acute-care Hospitals which utilized the Clave Family of Connectors... had a statistically significant lower relative risk... when compared to acute-care Hospitals that did not utilize Clave Connectors."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This information is for AI/ML devices. The 510(k) is for a physical medical device (needlefree connector). Ground truth for the clinical study (bloodstream infection rates) would have been established through hospital records and CMS reporting, not by human experts adjudicating images or cases for AI training/testing.

4. Adjudication method for the test set

• Not Applicable. This information is typically for AI/ML devices involving human reviewer consensus. The clinical study used pre-existing CMS data on bloodstream infections.

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 is not an AI/ML device. The clinical study was a comparison of hospital outcomes based on device usage, not human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is not an AI/ML device.

7. The type of ground truth used

• Non-Clinical Testing: Ground truth is established by the specifications and measurement techniques defined in the referenced industry standards (e.g., ISO, ANSI/AAMI, USP). Performance is measured against these established parameters.
• Clinical Testing: The ground truth for the clinical claim (bloodstream infection reduction) was based on outcomes data from official government reporting (CMS data) regarding bloodstream infection rates (CLABSI) and bloodstream infection-associated mortality in acute-care hospitals.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device. There is no "training set."

9. How the ground truth for the training set was established

• Not Applicable. This is not an AI/ML device.

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