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3MTM Curos™ Tamper-Evident Device:

The 3M™ Curos™ Tamper-Evident Device is intended to be used as a tamper-evident cover for vascular access devices for IV access points including needleless connectors and Y-sites on IV tubing. This device provides visual indication to suspect tampering. This is not a tamper-proof device.

3MTM Curos™ Tamper-Evident Device, Large:

The 3M™ Curos™ Tamper-Evident Device, Large is intended to be used as a tamper-evident cover on vascular access device needleless connectors including Y-sites on IV tubing, and infusing connections, providing visual indication of attempts to tamper with or remove the device provides visual indication to suspect tampering. This is not a tamper-proof device.

The 3M™ Curos™ Tamper-Evident Device provides visual indication to suspect tampering with or attempted removal of the device for reasons other than delivering prescribed medical treatment. The Tamper-Evident Device can be used on any type of vascular access device to cover needleless connectors and the Y-sites on IV tubing [with or without disinfecting caps]. The device material is transparent allowing for visualization of the connector(s) inside, and the tamper-evident strap is green allowing for easy visualization and assessment. The 3M™ Curos™ Tamper-Evident Device is also provided in a larger size to accommodate larger needleless connector combinations including the Y-sites on IV tubing [with or without disinfecting caps] and infusing connections.

This document describes a 510(k) premarket notification for the 3M™ Curos™ Tamper-Evident Device, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria for AI/ML performance.

The provided document describes a physical medical device designed to indicate tampering with vascular access devices, not an AI/ML-driven diagnostic or treatment device. Therefore, the concepts and questions related to AI/ML performance metrics (such as sensitivity, specificity, AUC, human reader improvement with AI assistance, sample sizes for training/test sets, ground truth establishment by experts, etc.) are not applicable to this submission.

The document outlines bench testing and biocompatibility testing for the physical device. I will extract the information that is relevant to the physical device's performance acceptance criteria as described in the provided text.

Here's a breakdown of the information that is available, reframed to address the spirit of the request where possible, but emphasizing that this is not an AI/ML device:

Device Description and Purpose:

The 3M™ Curos™ Tamper-Evident Device is a physical cover intended to provide a visual indication of attempts to tamper with or remove vascular access devices (like needleless connectors and Y-sites on IV tubing). It is not a tamper-proof device. Its primary function is to show if it has been disturbed.

Acceptance Criteria and Reported Device Performance (Non-AI/ML)

The document details the bench testing performed to demonstrate that the device functions as intended. These tests serve as the "acceptance criteria" for the mechanical and visual integrity of the tamper-evident feature.

1. Table of Acceptance Criteria and Reported Device Performance:

Biocompatibility Testing:
The device also passed biocompatibility tests (Cytotoxicity, Sensitization, Irritation) in accordance with ISO 10993-1, categorized as a surface-contacting device with intact skin contact of permanent duration. This is another set of "acceptance criteria" for the materials used.

Information Not Applicable to This Device (as it's not an AI/ML system):

The following points from your request are not relevant to this 510(k) submission because it pertains to a physical medical device, not an AI/ML system:

• 2. Sample size used for the test set and the data provenance: Not an AI/ML test set. Bench tests are likely performed on a representative sample of manufactured devices.
• 3. Number of experts used to establish the ground truth... and qualifications: Ground truth for a physical tamper-evident device is visual observation of tampering, not expert interpretation of AI predictions.
• 4. Adjudication method: Not applicable.
• 5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This device doesn't "improve human readers" in an interpretive sense.
• 6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable, as there is no algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the tamper-evident feature is the physical state of the device (intact vs. torn/missing strap).
• 8. The sample size for the training set: Not applicable; there is no AI model to train.
• 9. How the ground truth for the training set was established: Not applicable.

In conclusion, the 3M™ Curos™ Tamper-Evident Device is a physical product whose acceptance criteria are based on its mechanical performance (visual indication of tampering, safe removal, and no leakage on the catheter after removal) and material biocompatibility. The provided document does not involve or describe an AI/ML study.

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