Search Results

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