(356 days)
GuidOss® is recommended for:
- Simultaneous use of membrane (GuidOss®) and implants : 1.
- Augmentation around implants placed in immediate extract sockets; 2.
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- Augmentation around implants placed in delayed extraction sockets;
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- Localized ridge augmentation for later implantation;
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- Alveolar ridge reconstruction for prosthetic treatment
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- Filling of bone defects after root resection, cystectomy, removal of retained teeth.
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- Guided bone regeneration in dehiscence defects; and
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- Guided tissue regeneration procedures in periodontal defects.
GuidOss® is made from pure type I collagen membrane obtained by a standardized controlled manufacturing process. The type I collagen is obtained from veterinary certified porcine and is carefully purified to avoid immunological reactions. GuidOss® membrane is manufactured by fibrillogenesis and crosslinking. The collagen fibers are self-assembled by the process of fibrillogenesis. The crosslinked collagen fibers exhibited increased mechanical strength, thermal stability and increased resistance to pepsin digestion compared to non-crosslinked collagen.
The provided document is a 510(k) summary for the medical device GuidOss®, a resorbable collagen membrane. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a dedicated study with defined metrics.
Here's an analysis of the provided information, addressing your questions where possible:
1. A table of acceptance criteria and the reported device performance
The document does not present specific quantitative acceptance criteria or reported device performance metrics in the way one would typically find for an AI/device performance study (e.g., sensitivity, specificity, AUC values against a predefined threshold). Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly defined by the intended use and the predicate devices' established performance.
| Property/Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (GuidOss®) |
|---|---|---|
| Intended Use | Same or similar to predicate devices: Used for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus; and other specified indications (simultaneous use of membrane and implants, augmentation around implants, localized ridge augmentation, alveolar ridge reconstruction, filling of bone defects, guided bone regeneration in dehiscence defects, guided tissue regeneration). | Used for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus; and all other specified indications (see pages 2-3 for full list). |
| Target Population | Human oral, periodontal | Human oral, periodontal |
| Material | Type I collagen (similar to predicates); Porcine source | Type I collagen; Purified from veterinary certified porcine skin |
| Biocompatibility | Must be biocompatible, as demonstrated by a range of tests (genotoxicity, micronucleus, intracutaneous reactivity, maximization/sensitization, pyrogen, acute systemic injection, cytotoxicity, implantation). Non-pyrogenic. | Biocompatible, demonstrated by: Genotoxicity testing, Micronucleus Test for Genetic Toxicology, Intracutaneous reactivity testing, Maximization and sensitization testing, Pyrogen testing, Acute systemic injection testing, Cytotoxicity testing, Implantation testing. Non-Pyrogenic: Yes. Confirmed product safety in accordance with ISO 10993 and FDA's "Class II Special Controls Guidance Document." |
| Performance | Periodontal Regeneration (comparable to predicate devices) | Periodontal Regeneration. Animal studies showed growth of new bone and similar resorption rates to predicate. Clinical case series resulted in defect healing and new bone formation sufficient for implant placement. |
| Sterilization | Sterile by Gamma Irradiation (similar to predicates) | Sterile by Gamma Irradiation to SAL 1 x 10⁻⁶. |
| Shelf-Life | 36 Months (similar to predicates) | 36 Months |
| Safety Efficacy | Raises no new issues of safety and efficacy compared to predicate devices. | Demonstrates substantial equivalence, expected to be safe and effective for intended uses. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "several animal studies" and "a clinical case series."
- Animal Studies: Sample size is not specified. Provenance not specified but likely conducted by the manufacturer or a contracted lab. These would be prospective.
- Clinical Case Series: Sample size is not specified. Provenance not specified. This would typically be prospective, showcasing real-world use.
The document does not detail a "test set" in the context of an AI device's validation with specific performance metrics against a ground truth.
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)
Not applicable. This device is a bone grafting material, not an AI device that requires expert adjudication of images or data for ground truth establishment. The "ground truth" for its performance would be histological evaluation of bone regeneration in animal models or clinical outcomes in human subjects, as observed by clinicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 3. This type of adjudication is typically for image-based diagnostics where human experts generate a consensus label.
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 device is a physical medical device (resorbable collagen membrane), not an AI-assisted diagnostic tool. Therefore, MRMC studies and "human readers improving with AI" are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. See point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance of the GuidOss® device, the "ground truth" would be:
- Pathology/Histology: For the animal studies, this would confirm new bone formation and resorption rates.
- Clinical Outcomes Data: For the clinical case series, this would include observations of defect healing, formation of new bone, and subsequent successful dental implant placement.
- Biocompatibility Testing Standards: Adherence to established ISO 10993 standards for confirming safety (e.g., cytotoxicity tests, implantation tests).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.