(30 days)
The Geistlich Derma-Gide™ is intended for the management of wounds including:
· partial and full thickness wounds
- · pressure ulcers
- venous ulcers
- · diabetic ulcers
- · chronic vascular ulcers
- · surgical wounds (donor sites/grafts, post Moh's surgery, post laser surgery, podiatric, wound dehiscence)
- · trauma skin wounds (abrasions, laceration, second degree burns, skin tears)
Geistlich Derma-Gide™ is an acellular advanced wound care device. The Geistlich Derma-Gide™ is derived from porcine tissue (mostly collagen Type 1) and is processed using proprietary technologies to remove bacteria and inactivate viruses. Geistlich Derma-Gide"" features a bilayer structure. The upper dense compact collagen layer protects the wound and the open healing process. This structure has a smooth texture with appropriate pull out strength properties to allow suturing. The second lower layer consists of a thick, porous spongeous collagen scaffold.
This document is a 510(k) Premarket Notification from the FDA for a medical device called Geistlich Derma-Gide™. It is an equivalence claim to an existing device, adding new sizes and shapes. Therefore, it does not contain a study to prove acceptance criteria for a new device's performance.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable. This document is for a special 510(k) submission, indicating minor changes to an already cleared device. The "acceptance criteria" here relate to demonstrating substantial equivalence to a predicate device, rather than performance criteria for a novel device. The document explicitly states: "New performance testing was not necessary to support the additional sizes/shapes or the updates to the IFU."
| Criterion | Reported Performance |
|---|---|
| Indications for Use | Identical to Predicate |
| Device Description | Identical to Predicate (except for added sizes/shapes) |
| Material | Identical to Predicate (Porcine) |
| Thickness | Identical to Predicate (2.5 - 5 mm) |
| Sterility | Identical to Predicate (Gamma-sterilized) |
| Single Use | Identical to Predicate (Yes) |
| Biocompatibility | Existing information from K171842 applies |
| Sterilization Assurance Level | Existing information from K171842 applies |
| Shelf Life | Existing information from K171842 applies |
| Safety and Effectiveness Issues | No new questions of safety or effectiveness raised by additional sizes/shapes or IFU updates (Claimed) |
2. Sample size used for the test set and the data provenance:
Not applicable. No new performance testing with a "test set" was conducted for this submission. The basis for equivalence relies on the predicate device's existing data and the argument that the changes (new sizes/shapes) do not alter the fundamental characteristics or performance of the device.
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. No new test set requiring expert-established ground truth was part of this submission. The evaluation is focused on regulatory equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. See point 3.
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 wound dressing, not an AI-powered diagnostic tool. The submission does not involve AI or human reader performance studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the context of new device performance testing. The "ground truth" for this submission is the established safety and effectiveness of the predicate device (Geistlich Wound Matrix, K171842), based on its original clearance. The current submission argues that the new sizes and shapes maintain this established safety and effectiveness.
8. The sample size for the training set:
Not applicable. No machine learning or AI models are involved.
9. How the ground truth for the training set was established:
Not applicable. See point 8.
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