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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

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.

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Synthes chronOS™ is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Synthes chronOS™ is indicated for use in the treatment of bony defects created surgically or through traumatic injury.

Synthes chronOS™ is intended to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement into the bony void, chronOS™ resorbs and is replaced with bone during the healing process.

Synthes chronOS™ is a porous, osteoconductive, resorbable bone void filler made from β-Tricalcium Phosphate (TCP). Synthes chronOS™ is resorbed and replaced by new bone during the healing process. The pore structure of chronOS™ provides a matrix for the ingrowth of bone. chronOS™ is provided sterile in a double sterile pack. It is available in various forms including granules, blocks, wedges and cylinders.

Synthes chronOS™ may be packaged with a perfusion syringe that is used to mix the bone void filler with the patient's blood components and/or bone marrow.

This document is a 510(k) summary for the Synthes chronOS™ bone void filler. It describes the device, its intended use, and its substantial equivalence to a predicate device.

Crucially, this document does not contain information on acceptance criteria or a study proving device performance against such criteria.

The 510(k) process is a premarket notification to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device. This typically involves showing that the new device has the same intended use and the same technological characteristics as the predicate, or if it has different technological characteristics, that these do not raise new questions of safety and effectiveness and that the device is as safe and effective as the predicate.

Therefore, the requested information cannot be extracted from the provided text.

Here's why and what might be found in a different type of submission or document:

• Acceptance Criteria and Reported Device Performance: These are typically established during device development and verified through design validation studies, which could include clinical trials, animal studies, or bench testing. A 510(k) summary generally refers to these studies if they were used to demonstrate substantial equivalence, but it doesn't usually present the raw data, acceptance criteria, or detailed results in this format. The 510(k) focuses on comparison to a predicate, not necessarily detailed performance metrics against predefined criteria in the same way a PMA (Premarket Approval) might.
• Study Details (Sample Size, Data Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone): These are all elements of a detailed study report. While studies would have been conducted to support the safety and effectiveness claims, the 510(k) summary is a high-level overview for regulatory purposes.
• Training Set Sample Size and Ground Truth: This information would be relevant for machine learning-based devices, which this particular product (a bone void filler) is not.

To find the requested information, one would typically need to consult:

• Clinical Study Reports: If clinical studies were conducted to support the 510(k) (which is less common for "substantially equivalent" devices unless significant new technological characteristics are present), these reports would contain the details.
• Design Validation Documentation: Internal company documents detailing the testing and validation performed.
• PMA Submissions: Devices requiring a PMA go through a more rigorous review process, and their submissions contain extensive data on safety and effectiveness, including detailed acceptance criteria and study results.
• Summary of Safety and Effectiveness Data (SSED): For PMA-approved devices, the FDA publishes these summaries, which detail the studies and findings.

In summary, the provided text does not contain the information requested about acceptance criteria and detailed study performance.

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Synthes chronOS is intended for the repair or filling of craniofacial defects and craniotomy cuts with a surface area no larger than 25 cm². It is also indicated for the restoration or augmentation of bony contours of the craniofacial skeleton, including the fronto-orbital, malar and mental areas. Synthes chronOS is intended to be gently packed or placed into the site. chronOS resorbs and is replaced with bone during the healing process.

Synthes chronOS is a porous, osteoconductive, resorbable bone void filler made from β-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 void filler with the patient's blood components.

This document describes a 510(k) premarket notification for the "Synthes (USA) chronOSTM" device. This is a regulatory submission for a medical device to demonstrate that it is substantially equivalent to a legally marketed predicate device. This type of submission generally does not include detailed studies on device performance against specific acceptance criteria in the way a PMA (Premarket Approval) submission would.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone studies, and ground truth establishment for a medical device algorithm or AI system is not applicable to this document.

This document focuses on:

• Device Description: Synthes chronOS is a porous, osteoconductive, resorbable bone void filler made from β-Tricalcium Phosphate (TCP), with specific pore diameters.
• Intended Use: Repair or filling of craniofacial defects and craniotomy cuts (surface area no larger than 25 cm²), and restoration/augmentation of bony contours of the craniofacial skeleton.
• Substantial Equivalence: The primary "proof" in a 510(k) is demonstrating substantial equivalence to a predicate device, not necessarily meeting a new set of performance acceptance criteria through a clinical study. The predicate devices mentioned are Norian Cranial Repair System (CRS) Bone Cement and Etex α-BSM™ Bone Substitute Material for Cranioplasty.

In summary, this document does not contain the kind of performance study data you would find for an AI/algorithm-based device to establish its acceptance criteria and prove it meets them. The "study" here is the regulatory comparison to a predicate device to establish substantial equivalence.

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