(44 days)
The MODUS® Titanium Osteosynthesis System is intended for use in oral, maxillofacial surgery such as: trauma; surgical correction of dentofacial deformities; reconstructive surgery; orthognathic and craniofacial surgery. The MODUS® Sagittal Split Plate with slider is used for stabilization of mandibular bone segments after a sagittal split osteotomy.
The MODUS® System sagittal split plate with slider has a U-shaped design. It is available in two configurations, with six or eight screw holes. The plate is composed of CP Grade 1 titanium. The plate has a thickness of 0.7 mm and is available in a range of lengths of 31.65mm to 52.65 mm. The slider is 10 mm in diameter and is composed of Grade 4 CP titanium meeting ASTM F67.
The provided text is a 510(k) summary for the MODUS® Titanium Osteosynthesis System, specifically the Sagittal Split Plate and Slider. This document primarily focuses on establishing substantial equivalence to previously cleared devices rather than presenting a performance study with detailed acceptance criteria and supporting data as one would find for a novel device or AI/software-as-a-medical-device (SaMD).
Therefore, based on the provided text, a table of acceptance criteria and reported device performance, information about sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance cannot be extracted because this information is not present in the document.
The document details a predicate device comparison study, which is a different type of submission for medical devices focused on demonstrating equivalence to already cleared devices.
Here's a breakdown of what can be extracted and why other information isn't available:
1. A table of acceptance criteria and the reported device performance
- Not Applicable / Not Provided: The 510(k) summary for this device (K993862) establishes substantial equivalence based on intended use, design, and material comparison to predicate devices, not on a new performance study with specific acceptance criteria and reported numerical performance metrics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: This 510(k) is for a physical orthopedic implant. Clinical studies with test sets in the typical sense (like for diagnostic algorithms) are not described. The basis for equivalence is primarily engineering specifications and material properties compared to predicate devices.
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 / Not Provided: There is no mention of a test set requiring expert-established ground truth in this submission. This is not a diagnostic device or an AI/SaMD product.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No test set or adjudication method 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
- Not Applicable / Not Provided: This is not an AI/SaMD device. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided: This is not an AI/SaMD device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Provided: No ground truth in this context is relevant or described for this physical device submission.
8. The sample size for the training set
- Not Applicable / Not Provided: There is no training set mentioned, as this is not a machine learning device.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: No training set or ground truth for it is mentioned.
Summary of what the document DOES demonstrate:
The document demonstrates that the MODUS® Sagittal Split Plate with Slider is substantially equivalent to legally marketed predicate devices, specifically:
- MODUS® System Plates and Mesh (K946165)
- Synthes 2.0 mm Sagittal Split Plates (K981890)
- Synthes (MMFS) - Adjustable Sagittal Split Plate (K964328)
This equivalence is based on:
- Intended Use: Used for stabilization of mandibular bone segments after a sagittal split osteotomy in oral, maxillofacial surgery.
- Design: U-shaped design, available in two configurations (six or eight screw holes), 0.7 mm plate thickness, 10 mm diameter slider.
- Material: Plate composed of CP Grade 1 titanium; slider composed of Grade 4 CP titanium meeting ASTM F67.
The "study" in this context is the 510(k) submission process itself, which involves comparing the new device to predicate devices to establish substantial equivalence. It's a regulatory "study" rather than a clinical performance study with statistical endpoints. The acceptance criteria for this type of submission are met if the FDA agrees that the new device does not raise new questions of safety and effectiveness compared to the predicate device.
§ 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.