(52 days)
SynOss Synthetic Bone Graft Material is intended for use in dental surgery. The products may be used in surgical procedures such as:
- Augmentation or reconstructive treatment of alveolar ridge .
- Filling of periodontal defects ●
- Filling of defects after root resection, apicocectomy, and cystectomy .
- Filling of extraction sockets to enhance preservation of the alveolar ridge .
- Elevation of maxillary sinus floor .
- Filling of periodontal defects in conjunction with products intended for Guided . Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided . Bone Regeneration
SynOss™ Synthetic Bone Graft Material is an osteoconductive calcium phosphate based bone graft material with an apatite structure similar to that of human bone. The product is supplied in granular form, and it is sterile, non-pyrogenic, and for single use only.
The provided document is a 510(k) summary for the SynOss™ Synthetic Bone Graft Material. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study that measures against specific acceptance criteria for performance.
Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth for training set) are not applicable or not available within this type of regulatory submission. The submission primarily addresses safety and effectiveness through characterization studies and biocompatibility testing, asserting equivalence to a previously approved device.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device meets biocompatibility standards as per FDA Blue Book Memorandum G95-1 and ISO 10993-1. | The device passed all selected FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices. |
| Effectiveness: Device characteristics meet design requirements for an effective bone grafting material. | "The characteristics of the SynOss Synthetic Bone Graft Material meet the design requirements for an effective bone grafting material." (This is a general statement, not specific quantitative criteria). |
| Substantial Equivalence: SynOss™ Synthetic Bone Graft Material is substantially equivalent to OsteoGuide™ Anorganic Bone Mineral Products (K043034) in terms of intended use, material structure, material characterization, form, and sizes. | "The SynOss Synthetic Bone Graft Material and its predicate have the same technological characteristics. In particular, both SynOss and its predicate are the same with respect to intended use, material structure, material characterization, form, and sizes." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document refers to "a number of tests" for safety/biocompatibility and "in vitro product characterization studies." It does not mention a "test set" in the context of clinical performance or diagnostic accuracy.
- Data Provenance: Not specified. The studies mentioned are general "in vitro and in vivo biocompatibility studies" and "in vitro product characterization studies."
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 submission does not involve expert-established ground truth for a test set of clinical images or outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set requiring adjudication is 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
- No. This is not an AI/software device. The submission describes a synthetic bone graft material.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/software device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For safety (biocompatibility): Ground truth was established by adherence to recognized standards (FDA Blue Book Memorandum G95-1 and ISO 10993-1) through specific biological tests (e.g., cytotoxicity, sensitization, irritation).
- For effectiveness/equivalence: Ground truth was established by comparing material characteristics (structure, physical properties, chemical composition) of the SynOss product to those of the predicate device (OsteoGuide™ Anorganic Bone Mineral Products).
8. The sample size for the training set
- Not Applicable. This is not an AI/software device with a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/software device with a training set.
§ 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.