(91 days)
Absorbent non adherent dressing is used as a topical dressing to cover a wound or operative site while providing absorbency.
Absorbent non adherent dressing
This document is a 510(K) Summary for a medical device called "Dukal Non Adherent Pad," submitted in 1997. It describes the device and compares it to a predicate device, the "Kendell Non Adherent Dressing."
Based on the provided information, a significant portion of the requested details about acceptance criteria, study methodologies, and performance metrics are not available in this specific 510(K) summary. This document primarily focuses on demonstrating substantial equivalence to a predicate device through material and physical property comparisons. It does not contain information typically found in studies evaluating software algorithms or complex diagnostic devices.
Here's an analysis of what can be extracted or inferred, and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance (Dukal Non Adherent Pad) |
|---|---|
| Thickness | 47 mil |
| Delnet Fracture | 5 lb/in |
| T-Peel | 700 lb/in |
| Absorptive Capacity | 38 oz/yd² |
| MD Tensile | 6 lb/in |
| Basis Weight | 5.0 oz/yd² |
| Intended Use | Absorbent non adherent dressing is used as a topical dressing to cover a wound or operative site while providing absorbency. |
Note: The acceptance criteria are implicitly defined by the "same" column, indicating that the Dukal device's performance is deemed acceptable if it matches or is substantially equivalent to the predicate device (Kendell Non Adherent Dressing) for these physical characteristics. The document doesn't explicitly state numerical acceptance thresholds before presenting the results, but rather compares directly to the predicate.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available. The document does not describe a clinical "test set" in the sense of patient data or clinical outcomes. The "tests" mentioned are for physical properties of the dressing material. No sample sizes for these material tests are provided, nor is any data provenance information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This document pertains to a medical dressing, not a diagnostic device or a device involving expert interpretation of data (like imaging). Therefore, there is no "ground truth" established by experts in the context of a diagnostic test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As there is no clinical test set requiring expert interpretation, no adjudication method is relevant or described.
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 a non-adherent wound dressing, not an AI or imaging diagnostic tool. Therefore, an MRMC study or AI-assisted human reader improvement is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the conventional sense. For this device, "ground truth" would relate to the physical and chemical properties of the dressing itself (e.g., its measured thickness, tensile strength, absorptive capacity) as determined by standard laboratory test methods. The document doesn't detail these methods, but the reported values act as the "truth" for demonstrating equivalence to the predicate. There's no clinical "ground truth" like pathology or outcomes data presented here.
8. The sample size for the training set
- Not applicable. This device is a physical medical dressing, not a machine learning model. There is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this question is irrelevant.
Summary of what is present and what is missing:
This 510(K) summary for the Dukal Non Adherent Pad is a device comparison document focused on demonstrating substantial equivalence to a predicate device based on material composition and physical characteristics. It is not a clinical study report for a diagnostic or therapeutic device involving complex performance metrics, patient data, or AI algorithms. As such, most of the detailed questions about acceptance criteria for diagnostic performance, expert review, sample sizes for clinical data, or AI model evaluation are not addressed because they are not relevant to the type of device and regulatory submission presented.
N/A