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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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The PICCGuard device is indicated for use as a tamper evident enclosure for the catheter and Luer hub with needleless connector attached on medical devices such as PICC lines and other central line catheter ports.

The PICCGuard is a two-piece plastic housing with locking barb that inserts through a hole in the bottom housing. After inserting the shaft of the catheter and Luer hub with needleless connector attached, the two halves slide together, and the barb is pushed through the hole in the bottom housing. Once the barb is inserted, the housing is locked. When a healthcare provider needs intravenous access, medical scissors can be used to disconnect the lid from the locked portion. The PICCGuard is then removed giving access to the needleless connector, and the health care provider can administer medications per normal routine.

The provided text is a 510(k) summary for the PICCGuard device. It describes the device, its intended use, and compares it to predicate devices. However, this document primarily discusses nonclinical performance testing related to biocompatibility and basic functional tests. It does not describe a study that proves the device meets acceptance criteria related to its primary indication as a tamper-evident enclosure in the context of improving human reader performance or a standalone algorithm performance.

Specifically, there is no mention of a device that uses an AI algorithm or requires human "readers" or experts to establish ground truth in the way described in the prompt's questions (e.g., related to image interpretation). The PICCGuard is a physical device intended to demonstrate tampering, not an AI-powered diagnostic or interpretive tool.

Therefore, many of the requested details about acceptance criteria and studies (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI models) are not applicable to the information provided in this 510(k) summary.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document includes a "Functional Testing Results Summary Table" that aligns with this request for specific functional aspects of the physical device.

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

• Sample Size for Functional Tests: The document states "All samples Passed" for the functional tests. However, the number of samples tested is not explicitly stated.
• Data Provenance: Not specified, but given the nature of a physical device functional test, it would likely be laboratory-based and not involve patient data or geographical provenance in the typical sense for AI/diagnostic devices.

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

• Not Applicable. This device is a physical tamper-evident enclosure, not a diagnostic tool requiring expert interpretation or ground truth establishment in a clinical sense. The "ground truth" for its functional performance is based on direct observation of physical characteristics (breaking, no leakage, ease of cutting).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• None. Not applicable, as there's no subjective interpretation or complex data requiring adjudication.

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. This is not an AI device or a diagnostic device. No MRMC study was conducted.

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

• No. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the functional tests, the "ground truth" was the direct physical demonstration of the device's characteristics:
  • Tamper evidence: Visual confirmation of breaking near the locking tab.
  • No leakage: Visual confirmation after assembly/disassembly/flush cycles.
  • Ease of cutting: Confirmation that medical scissors can easily cut the tabs.

8. The sample size for the training set:

• Not Applicable. This device is not an AI model, so there is no "training set."

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

• Not Applicable. As there is no AI model or training set, this question is irrelevant.

Additional Information from the Document:

• Clinical Studies: "No clinical studies were conducted."
• Biocompatibility Testing: The document lists several ISO 10993 standards and provides a summary table for biocompatibility tests (cytotoxicity, irritation, skin sensitization), all concluding that the Test Article meets acceptance criteria. These are standard tests for medical devices that contact the body.
• Intended Use/Indications: The device is "indicated for use as a tamper evident enclosure for the catheter and Luer hub with needleless connector attached on medical devices such as PICC lines and other central line catheter ports."
• Comparison to Predicate Devices: The document focuses on comparing the PICCGuard's regulatory class, classification name, product code, review panel division, intended use, use environment, and patient population to predicate devices. The key difference highlighted is the PICCGuard's role as an accessory providing a tamper-evident feature, which is not the primary function of the direct predicate (a PICC catheter). A reference predicate (a tamper-evident cap) is mentioned for its similar tamper-evident claim.

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