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3 M Th Tegaderm™ CHG Chlorhexidine Gluconate I. V. Port Dressing can be used to cover and protect catheter sites and to secure devices to skin. Common applications include securing and covering intravascular catheters and percutaneous devices.

3MTM Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing is used to cover and protect vascular access sites and to secure devices to the skin. The Chlorhexidine Gluconate I.V. Port Dressing is a two part system consisting of a bordered, transparent film cover dressing with an adhesive free window and an antimicrobial CHG Gel Device. The Chlorhexidine Gluconate I.V. Port Dressing is breathable and transparent, allowing continuous site observation. The cover dressing provides an effective barrier against external contamination including fluids (waterproof), hacteria, and yeast. The CHG gel pad device consists of an integrated gel pad containing 2% w/w Chlorhexidine Gluconate (CHG), an antiseptic agent with broad spectrum antimicrobial and antifungal activity. The gel absorbs fluid.

The 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing is a medical device used to cover and protect vascular access sites and secure devices to the skin. This submission is a 510(k) premarket notification, which means the manufacturer seeks to demonstrate the device is substantially equivalent to a predicate device already legally marketed. Therefore, the "acceptance criteria" are typically related to proving this substantial equivalence, rather than setting specific performance targets against a disease state or clinical endpoint.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" generally refer to demonstrating that the new device is as safe and effective as a predicate device. This is primarily done through comparative data, including non-clinical (bench) testing. The text does not provide a table with quantitative acceptance criteria for specific performance metrics (e.g., a specific log reduction in bacteria counts, or a certain peel strength). Instead, the acceptance criteria are implicitly met by demonstrating sameness or similarity to the predicate device in key characteristics.

Study Proving Acceptance Criteria:

The study proving the device meets the (implied) acceptance criteria is a non-clinical (bench) testing study. The text explicitly states: "Bench testing was collected to demonstrate substantial equivalence for this submission."

The document also mentions "In vitro testing (time kill and zone of inhibition) demonstrates that the gel pad in the device has an antimicrobial effect against a variety gram-positive and gram-negative bacteria and yeast." This in vitro testing is a component of the non-clinical performance data.

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

• Sample Size: The document does not specify the sample size for the bench testing or in vitro tests.
• Data Provenance: The data is "non-clinical performance data" and "in vitro testing." It is not clinical data from human subjects. Therefore, concerns about country of origin or retrospective/prospective nature are not directly applicable in the same way as clinical trials. It's safe to assume these were laboratory tests conducted by the manufacturer (3M Company).

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

Not applicable. For a 510(k) based on non-clinical data, the "ground truth" is typically established by the results of the bench and in vitro tests themselves, often adhering to recognized standards or established testing methodologies. There would not be "experts" in the sense of clinical reviewers establishing ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are common in clinical trials or studies where human interpretation of data is crucial. For bench testing, the results are typically determined by laboratory measurements and experimental procedures, not by a panel of adjudicators.

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 an I.V. port dressing, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not applicable. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for demonstrating substantial equivalence and device performance was derived from:

• Bench testing: Measuring physical properties, barrier effectiveness, and other relevant characteristics.
• In vitro testing: Demonstrating antimicrobial and antifungal activity against specific microorganisms using laboratory assays (time kill and zone of inhibition).

These tests act as the "ground truth" to show the device functions as intended and is comparable to the predicate.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, not for physical product development and testing in this context.

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

Not applicable, as there is no "training set" in the context of this device.

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