(89 days)
Synthes chronOS is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. Specifically, for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral, maxillofacial and dental intraosseous defects including: ridge augmentation; sinus lifts; craniofacial augmentation; filling of defects of endondontic origin; filling of cystic defects; filling of extraction sites; filling of lesions of periodontal origin; repair of traumatic defects of the alveolar ridge; filling resection defects in bone tumors, cysts or other osseous defects; and substitute for autogenous or allogenic bone grafts.
Synthes chronOS is intended to be gently packed or placed into the surgical site and may be combined with autogenous blood, bone marrow or saline. chronOS resorbs and is replaced with bone during the healing process.
Synthes chronOS is a porous, osteoconductive, resorbable dental bone grafting material made from ß-Tricalcium Phosphate (TCP). chronOS features a uniform three dimensional pore structure. Pore diameters within the material range from 100 to 500 µm. chronOS is provided sterile in granules and preformed shapes (e.g. blocks, cylinders, wedges). chronOS may be packaged with a perfusion syringe that is used to mix the bone grafting material with the patient's blood, bone marrow or saline.
This document is a 510(k) summary for the Synthes (USA) chronOS™ - ß-TCP bone grafting material. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria with performance metrics.
Therefore, many of the requested sections about acceptance criteria, detailed study design, ground truth establishment, and MRMC studies cannot be extracted from the provided text. The document is a regulatory submission for premarket notification, not a clinical study report.
Here's a breakdown of what can be extracted and what information is not available:
Acceptance Criteria and Study Details for Synthes (USA) chronOS™ - ß-TCP
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated in performance metrics) | Reported Device Performance (as per equivalency claim) |
|---|---|
| Biocompatibility | Implied to be equivalent to predicate device, as it is a ß-Tricalcium Phosphate (TCP) material. |
| Porosity/Pore Size (100 to 500 µm) | Device features uniform three-dimensional pore structure with diameters ranging from 100 to 500 µm. |
| Osteoconductivity | Implied to be equivalent to predicate device (bone grafting material). |
| Resorbability | chronOS resorbs and is replaced with bone during the healing process. |
| Sterility | Provided sterile. |
| Intended Use | Intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region, including various specific applications listed. This aligns with the use of bone grafting materials. |
Reason for limited information: This document is a 510(k) summary demonstrating substantial equivalence to an already legally marketed predicate device (Interpore IP 200 Coralline Hydroxyapatite Granules and Blocks). It does not present a de novo study with specific quantitative acceptance criteria or a detailed performance study against those criteria in the way a novel device might. The "performance" is primarily shown by its similarity to the predicate and its material properties.
2. Sample Size Used for the Test Set and Data Provenance
- Not Available. The document does not describe a clinical "test set" in the context of device performance evaluation against specific metrics. It relies on a comparison to a predicate device for regulatory approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This type of expert review for ground truth is typically associated with diagnostic or image-based AI devices, not with a bone grafting material 510(k) submission based on substantial equivalence.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This type of study is not relevant for a bone grafting material submission focused on material properties and clinical equivalence rather than diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This device is a bone grafting material, not a software algorithm.
7. The Type of Ground Truth Used
- Implicitly, the "ground truth" is established by the known properties and clinical history of the predicate device (Interpore IP 200 Coralline Hydroxyapatite Granules and Blocks). The Synthes chronOS device's material composition (ß-Tricalcium Phosphate), physical characteristics (pore structure, resorbability), and intended use are presented as being substantially equivalent to the predicate, implying the predicate's established safety and effectiveness.
8. The Sample Size for the Training Set
- Not Applicable. The chronOS device is a physical medical device, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
Summary of what the document does provide:
- Device Description: A porous, osteoconductive, resorbable dental bone grafting material made from ß-Tricalcium Phosphate (TCP) with specific pore diameters and provided sterile in various forms.
- Intended Use: Extensive list of oral and maxillofacial bone defect applications.
- Predicate Device: Interpore IP 200 Coralline Hydroxyapatite Granules and Blocks.
- Equivalence Claim: Synthes chronOS is claimed to be substantially equivalent to other legally marketed Synthes devices (and by extension, the named predicate). This is the primary "proof" used for regulatory clearance.
§ 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.