(136 days)
The Geistlich Wound Matrix 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)
The device is an animal-sourced, acellular wound dressing that is derived from porcine tissue. The porcine tissue undergoes processing to remove proteins and inactivate viruses. The device is intended for use in the management of wounds. The Geistlich Wound Matrix is terminally sterilized in its packaging.
The device has a thickness of 2.5-5mm and is offered in 3 sizes: 15 mm x 20 mm; 20 mm x 30 mm; and 30 mm x 40 mm. The device can be trimmed as needed.
The device is intended to be used by licensed surgeons and will be supplied sterile for single one time use.
This document is a 510(k) Premarket Notification from the FDA regarding the Geistlich Wound Matrix. It primarily establishes substantial equivalence to a predicate device and does not involve AI/ML performance data or a detailed clinical study with ground truth establishment in the way your request implies.
Therefore, many of the requested criteria cannot be directly extracted from this document, as they are not relevant to a 510(k) submission for a non-AI/ML device like a wound matrix. The document focuses on material composition, indications for use, and comparison to legally marketed predicate devices to assure safety and effectiveness.
Here's an attempt to address your points based on the provided document, noting where information is not applicable (N/A) or not provided:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present quantitative acceptance criteria or performance metrics for a device in the way an AI/ML product would. The "acceptance criteria" here implicitly revolve around demonstrating substantial equivalence to a legally marketed predicate device, primarily through comparison of:
- Indications for Use: The subject device's indications must be the same as or a subset of the predicate device.
- Technological Characteristics: Key characteristics (material, design, sterilization, etc.) must be similar, and any differences must not raise new questions of safety or effectiveness.
- Performance Data (implicit): For this type of device, performance data (e.g., biocompatibility) is often derived from the established safety profile of the material or similar devices, rather than a clinical trial with specific performance endpoints.
| Acceptance Criteria Category | Reported Device Performance (from document) |
|---|---|
| Indications for Use | Geistlich Wound Matrix is intended for management of partial/full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds, and trauma skin wounds. |
(Deemed substantially equivalent to predicate, with the predicate having two additional indications which were excluded by the subject device, not raising new questions of safety/effectiveness). |
| Technological Similarity | Derived from porcine connective tissue, acellular, non-crosslinked, mostly collagen Type 1, bilayer (2.5-5mm thickness), terminally sterilized.
(Found similar to Miromatrix Wound Matrix (porcine liver, acellular, non-crosslinked, collagen Type 1, sterile) despite differences in tissue source, single vs. bilayer, and thickness, with these differences not raising new safety/effectiveness questions. Identical to MUCOGRAFT reference device). |
| Biocompatibility | "Because the material of the subject device is identical to the reference device (K102531), the existing biocompatibility, sterilization, and shelf life information fully applies."
(Implies the device meets biocompatibility standards established for the reference device, which is considered sufficient for equivalence). |
| Sterilization | Terminally sterilized in its packaging.
(Existing sterilization information from the reference device (K102531) fully applies, implying it meets standards). |
| Shelf Life | N/A - Not explicitly stated, but "existing...shelf life information fully applies" from the reference device (K102531). |
2. Sample Size for the Test Set and Data Provenance
- This document states: "Bench, animal, and clinical data are not necessary to support the substantial equivalence of a wound dressing."
- Therefore, there is no "test set" in the context of an algorithmic performance evaluation.
- The data provenance, in this case, would refer to the existing safety and effectiveness profile of the predicate device and the "reference device" (Geistlich MUCOGRAFT® Collagen Matrix, K102531), which the subject device is stated to be identical to in material and design. No new clinical or animal studies were conducted for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- N/A. No ground truth establishment by experts for a test set was performed as part of this 510(k) submission. The FDA's review process involves their own experts, but not in the context of creating a dataset for device evaluation in the way you describe.
4. Adjudication Method for the Test Set
- N/A. No test set was used in this manner.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
- N/A. This is a non-AI medical device (wound matrix). MRMC studies are not relevant to its evaluation for substantial equivalence.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- N/A. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- N/A. For this particular 510(k) submission, the "ground truth" for demonstrating safety and effectiveness relies on the established performance and safety profiles of the legally marketed predicate device (Miromatrix Wound Matrix, K140510) and the reference device (Geistlich MUCOGRAFT® Collagen Matrix, K102531), to which the subject device is claimed to be substantially equivalent or identical. The basis for approval is that the new device is as safe and effective as a device already on the market, rather than meeting absolute performance criteria against an independent "ground truth" dataset.
8. The Sample Size for the Training Set
- N/A. No training set was used, as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
- N/A. No training set was used.
N/A