(422 days)
Vitala™ Resorbable Natural Collagen Membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for:
- Simultaneous use with implants;
- Augmentation around implants placed in immediate extraction sockets;
- Augmentation around implants placed in delayed extraction sockets;
- Localized ridge augmentation for later implantation;
- Alveolar ridge reconstruction for prosthetic treatment;
- Alveolar ridge preservation consequent to tooth extraction;
- Filling of bone defects after root resection, cystectomy, removal of retained teeth;
- Over the window in lateral window sinus elevation procedures;
- Furcation defects in multi-rooted teeth;
- Treatment of recession defects, together with coronally positioned flap;
- In implants with vertical bone loss due to infection, only with satisfactory debridement and implant surface disinfection;
- Guided bone regeneration in dehiscence defects; and
- Guided tissue regeneration in periodontal defects.
Vitala™ Resorbable Natural Collagen Membrane is a natural collagen membrane sourced from veterinary certified pigs. Vitala™ Resorbable Natural Collagen Membrane, minimally manipulated without further cross-linking, is sterilized in a double tray package configuration via E-beam irradiation.
The provided text describes a 510(k) premarket notification for a medical device called "Vitala™ Resorbable Natural Collagen Membrane." This submission is focused on demonstrating substantial equivalence to predicate devices, not on a new clinical study to prove adherence to specific acceptance criteria. Therefore, most of the requested information about acceptance criteria, test sets, expert adjudication, and study designs (MRMC, standalone) is not present in this document.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not present specific quantitative acceptance criteria or performance metrics in the way a clinical study or performance testing report would. Instead, it relies on comparison to predicate devices, arguing "substantial equivalence" based on similar properties and characteristics.
The table implicitly shows "acceptance" of the Vitala™ device by demonstrating similarities to established predicate devices across various attributes. The acceptance is that the device is "substantially equivalent" to the predicates, meaning it performs as safely and effectively.
| Property | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (Vitala™) |
|---|---|---|
| Models/Sizes | Similar to predicate devices | 13mm x 25mm, 15mm x 20mm, 20mm x 30mm, 30mm x 40mm, 40mm x 50mm |
| Intended Use | Similar to predicate devices | Wide range of GBR/GTR applications, extensively listed and overlapping with predicates. |
| Basic Design | Incorporates same basic design as predicates | Yes |
| Operating Principle | Utilizes the same operating principle as predicates | Cell-occlusive, Implantable, Resorbable, Hemostatic |
| Materials | Incorporates similar materials to predicates | Yes, porcine collagen |
| Sterilization Process | Identical to predicates | Irradiation |
| Biocompatibility | Biocompatible | Yes |
| Non-pyrogenicity | Non-pyrogenic | Yes |
2. Sample size used for the test set and the data provenance
No test set data is provided in this 510(k) submission. The document relies on a comparison table to predicate devices. For 510(k) submissions, in vitro testing or existing biocompatibility data for the material may be submitted, but often detailed clinical study sample sizes are not required if substantial equivalence can be shown through other means (e.g., comparison of materials, manufacturing processes, and indications for use). This document does not detail any specific studies with sample sizes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No test set requiring expert ground truth establishment is described.
4. Adjudication method for the test set
Not applicable. No test set described.
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 collagen membrane, not an AI or imaging device. There is no mention of MRMC studies or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a collagen membrane, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this 510(k) submission is effectively the established safety and efficacy of the predicate devices as determined by their previous regulatory clearances and real-world performance. The new device demonstrates "substantial equivalence" to these established benchmarks.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
§ 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.