(311 days)
Cova™MAX is intended for use in oral surgical procedures as a resorbable membrane material for use in:
-Simultaneous use of GBR-membrane (Guided Bone Regeneration) and 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;
-Filling of bone defects after root resection, cystectomy and removal of retained teeth;
-Guided bone regeneration in dehiscence defects;
-Guided tissue regeneration procedures in periodontal and recession defects.
Cova™MAX is a resorbable acellular membrane for guided tissue and bone regeneration in dental applications. Cova™MAX membranes are manufactured using a standardized, controlled process. Each Cova™MAX membrane is fabricated solely from Type I collagen extracted from veterinary certified pig tendon. Porcine tendon is known to be one of the purest sources of Type I collagen that can be readily obtained and processed in commercial quantities. It is packaged in a double package and sterilized by gamma irradiation.
Cova™MAX membranes serve as a barrier to guide the healing process between anatomic plans of tissues. It has been designed in accordance with the accepted principles or guided bone regeneration (GBR) as a wound healing material post surgery. They are designed to be resorbable, non inflammatory and biocompatible for uses in clinical periodontics.
The Cova™MAX membrane is completely resorbable within a timeframe compatible with the healing process. When wetted, the membrane is conformable, elastic and easy to handle. It can be used alone or, if needed, it can be sutured in place. Cova™MAX is provided in rectangular sheets of 15 x 25 mm, 20 x 30 mm and 30 x 40 mm. Furthermore, the device can be easily trimmed or shaped to the appropriate size, without tearing or fragmenting, to fit the periodontal defect or zone to be treated.
The provided text does not contain detailed acceptance criteria and a study specifically designed to prove the device meets those criteria for the Cova™MAX Resorbable Collagen Membrane. Instead, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a dedicated study.
In the context of a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating that the device has similar characteristics and performance to legally marketed predicate devices, and that any differences do not raise new questions of safety or efficacy. The "study" proving this largely relies on comparisons, some preclinical (animal) data, and a review of existing literature.
Here's an analysis based on the provided text, structured to answer your questions as best as possible given the available information:
Acceptance Criteria and Device Performance (Implicit Basis of Substantial Equivalence)
| Acceptance Criteria (Implicit from Predicate Comparison) | Reported Device Performance (Cova™MAX) |
|---|---|
| Origin: Porcine | Porcine (Type I collagen from veterinary certified pig tendon) |
| Intended Use: For guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus | Intended for use in oral surgical procedures as a resorbable membrane material for specific GBR/GTR applications (listed in document) |
| Device Characteristics: Membrane-like, Easy to manipulate, Flexible, Implantable, Wettable, Smooth | Membrane-like, Easy to manipulate, Flexible, Implantable, Wettable, Smooth |
| Biocompatibility: Established (non-cytotoxic, non-pyrogenic, non-irritating, non-sensitizing) | Established (non-cytotoxic, non-pyrogenic, non-irritating, non-sensitizing; confirmed by studies) |
| Non-pyrogenic: Yes | Yes |
| Resorbable: Yes (within a timeframe compatible with healing process) | Yes (completely resorbable within a timeframe compatible with the healing process; 13-week estimate from rat study, clinical estimate by clinician needed) |
| Suturable: Yes | Yes |
| Reusable: Single-use device | Single-use device |
| Shelf-Life: Comparable to predicates (36 months for predicates, Cova™MAX 18 months) | 18 months (Acknowledged as similar enough not to raise new safety/efficacy concerns) |
| Sterilization Method: Gamma irradiation | Gamma irradiation |
| Packaging: Double-peel packages | Double-peel packages |
| Safety: No new issues of safety raised | All biocompatibility studies demonstrated no new safety issues. |
| Effectiveness: No new issues of efficacy raised; effective as a barrier to aid in wound healing | Animal model studies and human literature support effectiveness as a barrier to aid in wound healing. |
Study Information (Based on 510(k) Summary)
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the traditional sense of a clinical trial test set. The "test set" for substantial equivalence relied on:
- Biocompatibility studies (number of samples/animals/tests not specified). Provenance not specified, but typically conducted by certified labs.
- Animal Data: Literature review of "numerous materials" including predicates across various animal models. The document refers to "a rat implantation study" for the 13-week resorption claim, but no specific sample size is given for Cova™MAX studies. The provenance is implied to be existing literature and an internal rat study.
- Clinical Data: Literature review of "human studies" consistent with animal studies. No specific clinical study using Cova™MAX is presented. Provenance is existing literature.
- Data Provenance: Primarily literature review (animal and human studies on guided bone regeneration and similar membranes), and internal biocompatibility tests and a rat implantation study for Cova™MAX. The origin of the literature is not specified, but general "clinical practice of periodontics" is mentioned.
- Test Set Sample Size: Not applicable in the traditional sense of a clinical trial test set. The "test set" for substantial equivalence relied on:
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as there was no specific "test set" with ground truth established by a panel of experts for Cova™MAX in this summary. The ground truth for the effectiveness claims comes from the established scientific literature on Guided Bone Regeneration (GBR) and similar resorbable membranes, which implicitly relies on the consensus and findings of experts in the dental and periodontal fields over time.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There was no specific test set requiring adjudication in this 510(k) summary.
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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 device is a resorbable collagen membrane, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For safety, ground truth was established through standard biocompatibility tests (cytotoxicity, irritation, systemic toxicity, genotoxicity, pyrogenicity, implantation/absorption, sub-chronic/chronic toxicity, hemolysis) and compliance with animal tissue sourcing and viral inactivation standards.
- For effectiveness, the ground truth is derived from the established scientific understanding and clinical acceptance of Guided Bone Regeneration (GBR) and Guided Tissue Regeneration (GTR) using resorbable barrier membranes, as documented in animal model studies and human clinical literature. This is a form of expert consensus and accumulated outcomes data from past research and clinical practice.
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The sample size for the training set:
- Not applicable for a physical device in the context of a 510(k) submission showing substantial equivalence. There isn't a "training set" in the sense of machine learning. The "training" for the device design and manufacturing would implicitly come from general scientific knowledge, material science, and the characteristics of existing predicate devices.
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How the ground truth for the training set was established:
- Not applicable for the same reasons as point 7. The "ground truth" for developing Cova™MAX was the established scientific and clinical understanding of what constitutes a safe and effective resorbable collagen membrane for GBR/GTR, based on decades of research and predicate device performance.
§ 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.