(95 days)
GBR Configurations: To aid in bone regeneration and augmentation in oral surgery for: Extraction socket site preservation; Immediate implant placement at time of extraction or delayed placement when additional bone regeneration is desire; Ridge augmentation; Sinus elevation; Stable barrier for the containment of bone grafting materials. GTR Configurations: To aid in the regeneration and integration of periodontal tissue components. For use as an adjunct in periodontal surgical treatment to supplement the reparative process following scaling and root planning for: Class II furcations; intrabony defects; recession type defects.
The GUIDOR® Bioresorbable Matrix Barrier is a two-layered (sandwich) structure with spacers between the layers that provide stability to the matrix and maintain an adequate space to aid in tissue regeneration and prevention of epithelial downgrowth. The GUIDOR® Matrix is bioresorbable to allow for singlestep surgery, eliminating the need for a second surgery to remove the matrix.
- Acceptance Criteria and Reported Device Performance:
| Feature/Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | The device should have the same intended use, similar indications, technological characteristics, and principles of operation as legally marketed predicate devices. It must be as safe and effective as the predicate devices. | The GUIDOR® Bioresorbable Matrix Barrier is stated to have the "same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices." It is concluded to be "as safe and effective as the predicate devices," thereby demonstrating substantial equivalence. |
| Technological Characteristics | Should be similar to predicate devices, specifically regarding its two-layered (sandwich) structure, inclusion of spacers, and being bioresorbable. The material composition (synthetic) should also be comparable to relevant predicates. | The device is described as a "two-layered (sandwich) structure with spacers" and is "bioresorbable." It shares "the same technical characteristics and operating principles as the Guidor™ predicate (K912724)" and is "composed of synthetic materials similar to the Guidor™ predicate (K912724), Inion GTR Biodegradable Membrane System (K033074), and Resolut® Adapt LT Regenerative Membrane (K051267) predicates." It is also designed to be sterile. |
| Material Properties | Biocompatible and sterile for its intended use. | "Results of biocompatibility and sterility testing conclude that the GUIDOR® Bioresorbable Matrix Barrier is biologically safe for its intended use." |
| Clinical Efficacy | Should aid in bone regeneration and augmentation for specific GBR configurations and aid in regeneration and integration of periodontal tissue components for specific GTR configurations, similar to established performance of predicate devices. | "Results from retrospective clinical data and human studies reported in the literature for both synthetic resorbable membranes and resorbable collagen membranes support that the GUIDOR® Bioresorbable Matrix Barrier is substantially equivalent to those of the previously accepted and clinically successfully used bioresorbable membranes for similar indications." |
Study Information:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not explicitly state a specific "test set" sample size or its country of origin.
- The clinical evidence provided is based on "retrospective clinical data and human studies reported in the literature." This suggests the data is retrospective, but the origin country is not specified.
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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. The study relies on "retrospective clinical data and human studies reported in the literature" rather than a specific expert-adjudicated test set for this 510(k) submission. No information is provided about the number or qualifications of experts involved in the original studies forming the literature review.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No explicit adjudication method is mentioned for a test set. The submission relies on a literature review.
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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 bioresorbable matrix barrier, not an AI or imaging diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is implicitly derived from the established clinical outcomes and efficacy reported in the existing "retrospective clinical data and human studies reported in the literature" for both synthetic resorbable membranes and resorbable collagen membranes. This effectively means outcomes data from previously conducted clinical studies.
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The sample size for the training set:
- Not applicable. This submission does not describe an AI/machine learning model with a distinct "training set." The evidence for substantial equivalence is based on existing published clinical literature.
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How the ground truth for the training set was established:
- Not applicable, as there is no described training set for an algorithm in this submission.
§ 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.