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The Dukal Sterile, ABD Combine pad is used as a topical dressing to cover a wound or operative site while providing absorbency.

The Dukal Sterile, ABD Combine pad is used as a topical dressing to cover a wound or operative site while providing absorbency.

Here's an analysis of the provided text in the context of device acceptance criteria and performance, as requested.

Based on the input document, it is clear that this submission is for a medical device that is a dressing (Dukal ABD Combine pad), not an AI/ML-driven diagnostic or assistive device. Therefore, many of the requested elements for AI/ML performance evaluation (such as multi-reader multi-case studies, ground truth establishment with experts, etc.) are not applicable to this type of traditional medical device.

The document describes a 510(k) submission for a Dukal ABD Combine Pad, which is a topical dressing. The primary method of demonstrating substantial equivalence for such devices is through comparison to a predicate device, showing that it has the same technological characteristics and intended use.

Here's how the provided information fits your request:

1. Table of acceptance criteria and the reported device performance

For this type of device, "acceptance criteria" are typically defined by the characteristics of the predicate device that the new device must match or exceed to demonstrate substantial equivalence. The "reported device performance" is the measured characteristic of the new device.

The document explicitly states "same" for all quantitative characteristics, indicating that the Dukal device met these criteria by matching the predicate.

2. Sample size used for the test set and the data provenance
Not applicable for this type of device submission. This refers to clinical performance testing, which is generally not required for 510(k) clearances of dressing devices demonstrating substantial equivalence through material and physical property comparison. The "test set" here refers to physical samples of the dressing being tested for its material properties. The document does not specify the number of samples tested for each characteristic (e.g., how many pads were tested for thickness or absorptive capacity) nor the origin of these samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" established by experts is relevant for diagnostic devices interpreting complex data (e.g., medical images). For a wound dressing, the "ground truth" is typically the measured physical properties of the material and its functionality, which are objectively measured, not subject to expert interpretation in the same way.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in studies where multiple human readers or experts are interpreting results, and their opinions need to be reconciled. This is not relevant for the physical testing of material properties.

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 entire point refers to AI-assisted diagnostic tools. The Dukal ABD Combine pad is a physical wound dressing and does not involve AI or human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to AI algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" for its performance is derived from objective physical and material property measurements (e.g., thickness, tensile strength, absorptive capacity) conducted in a laboratory setting. It is not based on expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or treatment efficacy studies.

8. The sample size for the training set
Not applicable. This device is not an AI/ML model, so there is no "training set."

9. How the ground truth for the training set was established
Not applicable. As above, no AI/ML model or training set.

Summary of the Study Proving Acceptance Criteria:

The "study" proving the device meets its acceptance criteria for a 510(k) submission like this is primarily a comparison of the new device's physical and material properties to those of a legally marketed predicate device.

• Methodology: The submission presents a direct comparison table, listing several key physical and performance characteristics of the Dukal ABD Combine pad and comparing them to the "Hermitage Combine II Dressing" (predicate device).
• Proof: For each characteristic listed (Thickness, Delnet Fracture, T-Peel, Absorptive Capacity, MD Tensile, Basis weight), the Dukal device's performance is stated as "same" as the predicate device. This indicates that laboratory testing was performed on the Dukal device, and the results of those tests matched the known or established characteristics of the predicate device.
• Acceptance: The acceptance criteria were met by demonstrating that the Dukal device possessed the same technological characteristics and intended use as the predicate device, thereby establishing substantial equivalence. This type of submission relies on the principle that if a new device is substantially equivalent to a device already cleared for market, it is also safe and effective.

In essence, the "study" is the technical testing and characterization of the Dukal ABD Combine pad's physical properties which showed it was identical or sufficiently similar to the predicate device across all critical parameters. The document itself is a summary of that comparison, rather than a detailed report of the underlying tests.

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