(82 days)
Synthes Resorbable Fixation System is intended for fractures of the craniofacial skeleton, including, but not limited to, comminuted fractures of the nasoethmoldal and infraorbilal areas, comminuted fractures of the frontal sinus wall, and midfacial fractures; and reconstructive procedures of the midface or craniofacial skeleton. Do not use in the mandible.
Synthes Resorbable Fixation System is not intended for: 1) areas with active infection; 2) patient conditions including: hinod supply limitations, insufficient quantity of quality of bone, or latent infections. This device is not designed for use in the mandible or for use in full load bearing procedures
Synthes (U.S.A.) Resorbable Fixation System contains various plates, and sercws which are made from a resorbable copolymer, 70:30 poly(L/DL-lactide). The product line consists of a small ayatem based upon 1.5 mm screws and a large system based on 2.0 mm screws.
The system is provided pre-sterilized by gamma radiation and is not intended to be resterilized by the user.
The provided document is a 510(k) summary and an FDA clearance letter for a medical device called the "Synthes (U.S.A.) Resorbable Fixation System." This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria and performance metrics for the novel device itself.
Therefore, much of the requested information regarding acceptance criteria, specific study details, sample sizes, ground truth establishment, and multi-reader multi-case studies cannot be extracted directly from this document.
However, I can provide the available information and highlight what is missing.
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present a table of acceptance criteria or specific performance metrics for the Synthes Resorbable Fixation System. The clearance is based on substantial equivalence to existing metallic and resorbable fixation systems already on the market.
| Acceptance Criteria (Not explicitly stated for new device - implied by substantial equivalence) | Reported Device Performance (Not explicitly stated for new device - implied by substantial equivalence to predicates) |
|---|---|
| Biocompatibility | Material: 70:30 poly(L/DL-lactide) resorbable copolymer. |
| Mechanical integrity (strength, degradation profile suitable for intended use) | Designed for fractures of the craniofacial skeleton and reconstructive procedures of the midface/craniofacial skeleton. Not for full load-bearing or mandible. Implied to function similarly to predicate devices K912932, K953806, K955729, K960988. |
| Sterility | Provided pre-sterilized by gamma radiation. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical study with a "test set" in the context of AI/algorithm performance. The clearance is based on a comparison to predicate devices, likely through material testing, mechanical testing, and potentially animal studies (though not detailed here) to demonstrate equivalence in performance characteristics and safety. No human clinical trial with a specific "test set" to prove device performance as an AI/algorithm is described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is not a study involving expert-established ground truth for an AI/algorithm's output.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study is not mentioned in this document. This is a clearance for a physical medical device (fixation system), not an AI diagnostic or interpretive tool that would typically undergo such a study.
6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" in the context of this 510(k) clearance is the established safety and effectiveness profile of the predicate devices. The new device is deemed substantially equivalent if it performs as safely and effectively as these already marketed devices. This would involve comparing material properties, mechanical properties, and intended use, often supported by bench testing and sometimes preclinical animal studies. There is no mention of pathology, outcomes data, or expert consensus in the typical sense of evaluating diagnostic accuracy for this type of device.
8. The Sample Size for the Training Set
No training set or training data is mentioned. This is a physical medical device, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.