(94 days)
The Synthes Curvilinear Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device. The Synthes Curvilinear Distraction System is indicated for correction of congenital deficiencies or posttraumatic defects of the mandibular body and ramus where gradual bone distraction is required.
The 2.0 mm Curvilinear Distractor is intended for use in adult and pediatric patients more than 1 year old.
The 1.3 mm Curvilinear Distractor is intended for use in pediatric patients 4 years of age and younger.
The Synthes Curvilinear Distraction System is intended for single use only.
The Synthes Curvilinear Distraction System is a family of internal distraction osteogenesis devices that gradually advance the mandible along a specific trajectory of distraction. The system features various curved and straight distractors in two sizes; the 1.3mm Curvilinear Distractor and the 2.0mm Curvilinear Distractor. The distractors accept extension arms which move the point of activation to a location that is easily accessible with the activation instrument. Synthes Curvilinear Distraction System devices are manufactured from titanium alloy and chromium cobalt alloy. Devices are supplied non-sterile and must be sterilized prior to use.
The distractor features a worm gear that is activated to move the distractor along a curved or straight track. The distractor consists of three main components: Track, Worm gear activation assembly, and Housing.
Acceptance Criteria and Device Performance Study for Synthes Curvilinear Distraction System (K121502)
This report details the acceptance criteria and the study that proves the Synthes Curvilinear Distraction System meets these criteria, based on the provided 510(k) summary (K121502).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Strength (Four Point Bend Testing) | Withstand forces applied from mastication and resist permanent deformation within the range of predicate devices. | The proposed 1.3 mm Curvilinear Distractor can withstand forces applied to it from mastication and can resist permanent deformation within the range of the predicate devices. |
| Distraction Force (Torque-Force Testing) | Generate sufficient force to overcome anatomical resistance to distraction (soft tissue resistance, callus stretching, etc.). | The proposed 1.3 mm Curvilinear Distractor can generate sufficient force to overcome the anatomical resistance to distraction... by over three times the acceptance criterion. |
| Biocompatibility | Manufactured from titanium alloy and chromium cobalt alloy, meeting respective ASTM standards and having an established history of use as a surgical implant material. | The proposed device is manufactured from titanium/titanium alloys and chromium cobalt, each of which meets the requirements of its respective ASTM standard. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a distinct "test set" in the context of clinical data for performance evaluation. The performance data is derived from non-clinical mechanical testing.
- Sample Size for Test Set: Not applicable as a clinical test set was not used. The mechanical testing involved specific test articles (Synthes Curvilinear Distraction System, specifically the 1.3 mm Curvilinear Distractor). The exact number of units tested for each mechanical test is not specified in this summary.
- Data Provenance: The data is from non-clinical mechanical testing conducted by Synthes (USA), a company located in West Chester, PA, United States of America.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. Since clinical testing was not performed and performance was evaluated through mechanical testing, there was no ground truth established by human experts for a clinical test set. The "ground truth" for the mechanical tests would be the established engineering standards and physical properties for medical devices of this type, as measured by standard laboratory equipment and procedures.
4. Adjudication Method for the Test Set
Not applicable. As stated above, clinical testing with a human-in-the-loop component was not conducted, rendering an adjudication method unnecessary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence." Therefore, no assessment of human readers' improvement with or without AI assistance was conducted.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a mechanical distraction system, not an algorithm or AI-powered system. Therefore, standalone algorithm performance is not relevant.
7. Type of Ground Truth Used for Performance Evaluation
The ground truth used for evaluating the performance of the Synthes Curvilinear Distraction System was based on:
- Established engineering standards and benchmarks for mechanical strength (four-point bend testing) to demonstrate the ability to withstand mastication forces and resist permanent deformation.
- Physiological requirements and existing clinical understanding of anatomical resistance to distraction, which served as the basis for the acceptance criterion for the torque-force testing.
- ASTM standards for material composition and biocompatibility.
8. Sample Size for the Training Set
Not applicable. There was no "training set" as this device is a mechanical system and does not involve machine learning or AI that requires training data.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there was no training set, there was no ground truth established for it.
§ 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.