(92 days)
Ossix™-PLUS biodegradable collagen membrane is 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 procedures.
- In implants with vertical bone loss due to infection, only in cases where . satisfactory debridment 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
Ossix-Plus is a resorbable dental membrane made from ribose cross-linked porcine collagen. The membrane provides a barrier that guides bone regeneration, segregates tissue layers, or supports periodontal tissue regeneration. Barrier membranes are placed over bony or periodontal defects to prevent the population by cells from the gingival connective tissue and epithelium. This segregation of tissues by the membrane creates a cavity into which bone forming cells migrate and leads to new bone formation, as well as allowing cementum with inserting periodontal fibers to reform on exposed roots. The regeneration of lost periodontal structures (bone, periodontal ligament, and connective tissue attachment) around teeth is known as guided tissue regeneration ("GTR").
Because Ossix-Plus is a collagen membrane of animal origin, the device resorbs over time (within approximately 8 months based on animal model data). A second surgical procedure to remove the membrane is not required.
The ColBar LifeScience Ltd.'s Ossix™-Plus is a resorbable dental membrane intended for guided bone regeneration (GBR) and guided tissue regeneration (GTR). The device's acceptance criteria and the study proving it meets these criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence: The device must function as a resorbable barrier membrane in guided bone regeneration for a specified set of oral applications. | ColBar conducted animal model alveolar defect testing. The conducted tests demonstrated that Ossix-Plus functions as a resorbable barrier membrane in guided bone regeneration. This was shown for the following oral applications: 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 procedures, In implants with vertical bone loss due to infection (given satisfactory debridement and implant surface disinfection achieved). |
| Resorption Time: The device should resorb over a clinically acceptable period, avoiding the need for a second surgical procedure for removal. | Based on animal model data, the device is reported to resorb within approximately 8 months. This fulfills the requirement that a second surgical procedure for membrane removal is not required. |
| Similar Intended Uses & Indications: The device must have intended uses and indications that are the same as or similar to legally marketed predicate devices. | Ossix-Plus has the same intended uses and similar indications as its predicate devices (ColBar LifeScience Ltd. - Bio-Bar and Geistlich Pharma's Bio-Gide Resorbable Bilayer Membrane). |
| Similar Technological Characteristics & Principles of Operation: The device must share similar technological characteristics and principles of operation with its predicate devices. | The device possesses similar technological characteristics and principles of operation as its predicate devices. It is a resorbable dental membrane made from ribose cross-linked porcine collagen, providing a barrier that guides bone regeneration. |
| Safety and Effectiveness Equivalence: The device must be as safe and effective as its predicate devices, with no new safety or effectiveness issues raised by any technological differences. | Ossix-Plus is deemed as safe and effective as the Ossix™ and Bio-Gide. The manufacturer states that "The minor technological differences between the Ossix-Plus and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Ossix-Plus is as safe and effective as predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document states that "ColBar conducted animal model alveolar defect testing." The exact sample size of animals used for this testing is not specified in the document.
The data provenance is retrospective, as the testing was conducted by ColBar as part of its premarket notification, and the results are presented as past findings. The "country of origin of the data" is not explicitly stated beyond ColBar LifeScience Ltd. being located in Herzliya, Israel.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not specify the number of experts used to establish a ground truth or their qualifications. The testing was described as "animal model alveolar defect testing."
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the test set, as no human assessment of results and subsequent adjudication of discrepancies is mentioned. The study focused on animal model testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The document describes animal model testing to demonstrate the device's function as a resorbable barrier membrane, not a comparison of human reader performance with and without AI assistance.
6. Standalone Performance (Algorithm Only)
This device is a physical medical device (resorbable dental barrier membrane), not an algorithm or AI software. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable to this product.
7. Type of Ground Truth Used
The ground truth used was based on animal model outcomes. The document states that "The conducted tests demonstrated that Ossix-Plus functions as a resorbable barrier membrane in guided bone regeneration." This implies that the effectiveness of the regeneration and barrier function were assessed using established scientific methods in the animal model.
8. Sample Size for the Training Set
The concept of a "training set" typically applies to machine learning models. As Ossix™-Plus is a physical medical device and not an AI or algorithm, the idea of a training set is not applicable. The data presented is from performance testing.
9. How the Ground Truth for the Training Set Was Established
As stated above, the concept of a "training set" is not applicable to this device. The performance data was established through "animal model alveolar defect testing."
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.