Search Results

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.

(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.

Ask a specific question about this device

OSSIX® VOLUMAX is a resorbable collagen membrane intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for:

• Ridge augmentation for later implant insertions.
• Simultaneous ridge augmentation and implant insertions.
• Ridge augmentation around implants inserted in delayed extraction sites.
• Ridge augmentation around implants inserted in immediate extraction sites.
• Alveolar ridge preservation consequent to tooth (teeth) extraction(s).
• Over the window in lateral window sinus elevation procedure.
• In implants with vertical bone loss due to infection, only in cases where satisfactory debridement and implant surface disinfection can be achieved.
• In intra bony defects around teeth.
• For treatment of recession defects, together with coronally positioned flap.
• In furcation defects in multi rooted teeth.
• Localized gingival augmentation.

OSSIX® VOLUMAX is a biodegradable and biocompatible collagen membrane intended for use during the process of guided tissue and bone regeneration. The collagen is derived from veterinary certified pigs and is purified and cross-linked using ribose. OSSIX® VOLUMAX is packed in a double blister and an outer cardboard box and is sterilized by ethylene oxide. Due to its porous and fibered microstructure, the membrane readily absorbs fluids, adheres to the surrounding tissues and provides a barrier that guides bone and tissue regeneration. Available in sizes: 10x12.5 mm, 15x25 mm, 25x30 mm and 10x40 mm. Intended for use by dental surgeons.

This document is a 510(k) Pre-market Notification for the OSSIX® VOLUMAX resorbable collagen membrane. It aims to demonstrate substantial equivalence to a predicate device, OSSIX® PLUS. The information provided primarily focuses on the comparison between the new device and its predicate.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of "acceptance criteria" for performance metrics in the way a typical efficacy study might. Instead, it compares the technological characteristics of the OSSIX® VOLUMAX (subject device) with the OSSIX® PLUS (predicate device) and demonstrates that performance is either substantially equivalent or superior in relevant aspects. The underlying acceptance criterion for the subject device is to perform at least as well as the predicate device for demonstrating substantial equivalence.

Here's a table based on the comparison provided:

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Non-clinical (In Vitro) Tests: The document lists various in vitro tests (heavy metals, endotoxins, collagenase resistance, tensile strength, etc.). It does not specify sample sizes for each of these in vitro tests, but implies standard laboratory testing was conducted to characterize the material.
• In Vivo Animal Study:
  • Sample Size: 19 animals (Beagle dogs).
  • Data Provenance: Not explicitly stated, but typically these studies are conducted in a controlled laboratory setting by the manufacturer or a contract research organization. It is a prospective animal study.
• Biocompatibility: Leveraged from previous submission of the predicate device. For the individual pyrogenicity test, sample size for rabbits is not mentioned but usually involves a small number of animals (e.g., 3-8).

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)

This 510(k) submission is for a medical device (collagen membrane) and relies on non-clinical (in vitro and animal) studies, along with a comparison to a predicate device, rather than a clinical study requiring expert ground truth for interpretation of human patient data. Therefore, the concept of "experts establishing ground truth for a test set" in the context of diagnostic performance (e.g., radiologists interpreting images) is not applicable here.

The "experts" involved would be the scientists and veterinarians conducting the animal study, the laboratory personnel performing the in vitro tests, and the regulatory experts overseeing the submission. Their qualifications are implied by adherence to recognized standards like ISO and USP.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used in clinical studies where multiple human readers independently interpret data (e.g., images) and discrepancies need to be resolved. This submission relies on objective physical, chemical, and biological measurements from laboratory and animal studies.

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 is a medical device (collagen membrane), not an AI diagnostic algorithm. Therefore, an MRMC study related to AI assistance is not relevant.

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

Not applicable. As noted above, this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the studies performed primarily consists of:

• In vitro studies: Objective measurements against established scientific and engineering principles and recognized standards (e.g., tensile strength, chemical composition, porosity).
• Biocompatibility: Adherence to recognized ISO standards (ISO 10993 series) and specific tests like the Rabbit Pyrogen Test (USP ). The "ground truth" here is the biological response (or lack thereof) confirming safety.
• In vivo animal study: Histological analysis, evaluation of degradation, and assessment of tissue response and performance in the defect model, performed by veterinary pathologists and researchers. The "ground truth" is the observed biological outcome in the animal model.
• Predicate comparison: The ground truth for substantial equivalence is that the new device is as safe and effective as the legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable.

Ask a specific question about this device