(132 days)
The OSTEOMED ICON Modular Locking Fixation System is indicated for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction.
The OSTEOMED ICON Modular Locking Fixation System implants and drills are intended for single use onlv.
The OSTEOMED ICON Modular Locking Fixation System is comprised of plates, screws and instrumentation utilized in the fixation of maxillofacial and mandibular fractures. The screw and plate interface allows up to 20 degrees of angulation within screw placement. The plating system allows for the use of locking standard screws, locking Auto-Drive™ screws, standard non-locking screws, safety screws and Auto-Drive™ screws, as needed.
The system features three modular blocks.
- . The 1.6mm Midface System consists of 1.6mm locking standard screws with lengths ranging from 3mm to 14mm, 1.6mm locking Auto-Drive™ screws with lengths ranging from 4mm to 8mm and 1.9mm safety screws with lengths ranging from 3mm to 1.6mm midface plates range in thicknesses of 0.6mm to 0.8mm.
- . The 2.0mm Midface/Mandible System consists of 2.0mm locking standard screws with lengths 4mm to 18mm, 2.0mm locking Auto-Drive™ screws with lengths of 4mm to 8mm, and 2.3mm safety screws with lengths ranging from 4mm to 24mm. The midface plates range in thicknesses of 0.6mm to 0.8mm and the mandible plates range in thicknesses of 1.0mm to 1.5mm.
- The 2.8mm Mandible System consists of 2.0mm locking standard screws with lengths 6mm to 22mm, 2.4mm locking Auto-Drive™ screws with lengths of 6mm to 8mm, and 2.7mm safety screws with lengths ranging from 6mm to 22mm. The fracture plates range in thicknesses of 1.0mm to 1.5mm and the reconstruction plates range in thicknesses of 2.0mm to 2.8mm.
The instruments include drill bits, plate bending pliers, plate holding forceps, plate cutters, drill guides, cannulae, taps, countersinks, and screwdrivers to facilitate the placement of screws and modification of plates.
The document describes the OsteoMed ICON Modular Locking Fixation System, which is indicated for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction, and orthognathic reconstruction. The device is being compared to its predicate device, the OsteoMed Modular Locking Fixation System (K080694).
Here's an analysis of the provided information, addressing your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable format with specific thresholds. Instead, it describes a "verification evaluation" to ensure the new device meets "required mechanical strength criteria" that are equivalent to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical strength criteria for intended use (equivalent to predicate device K080694) | The OsteoMed ICON Modular Locking Fixation System 2.8mm plates were compared to the OsteoMed 2.5mm Modular Locking Fixation System plates (K080694). The ICON Modular Locking Fixation System plates underwent verification evaluation to ensure that the design features met the required mechanical strength criteria for their intended use. "Performance equivalence was shown through the verification comparison to the predicate devices." |
| Design similarity to predicate device | "A design, dimensional, and performance comparison was performed to establish substantial equivalence to the legally marketed predicate devices listed in this summary." |
| Material similarity to predicate device | The ICON system uses Titanium Alloy (ASTM F-136) for screws and plates (or commercially pure Titanium (ASTM F-67) for plates), and various grades of stainless steel, anodized aluminum, and/or medical grade plastic for instrumentation. These are stated to be "the same materials used in the manufacture of the predicate devices." |
| Biocompatibility | The materials used are stated to be "biocompatible." |
| Sterilization | "The basis of substantial equivalence...is based on the similarities in design, technology, material, function, sterilization, and intended use." (Implies sterilization method is similar and acceptable.) |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "The OsteoMed ICON Modular Locking Fixation System 2.8mm plates were compared to the OsteoMed 2.5mm Modular Locking Fixation System plates, K080694."
- Sample Size for Test Set: The exact sample size (number of plates/screws tested) for the "verification evaluation" is not specified in the provided text. It only mentions the 2.8mm plates of the ICON system being compared to the 2.5mm plates of the predicate device.
- Data Provenance: The study described is a non-clinical performance evaluation (mechanical testing), not a clinical study involving human data. Therefore, data provenance in terms of country of origin or retrospective/prospective does not apply in the typical sense. It's an internal engineering verification study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study is a non-clinical mechanical performance evaluation, not a study requiring expert interpretation or ground truth establishment in a clinical context.
4. Adjudication Method for the Test Set
This information is not applicable as the study is a non-clinical mechanical performance evaluation.
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
This information is not applicable. This document describes a medical device (bone fixation system), not an AI/software device that involves human readers or AI assistance. The study is a non-clinical mechanical performance evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This document describes a medical device (bone fixation system), not an AI/software device. The study is a non-clinical mechanical performance evaluation.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established mechanical strength criteria for the intended use of bone fixation plates. This "ground truth" is derived from engineering principles and standards relevant to the type of device and its intended application. The device's performance was compared against these criteria and the performance of the predicate device.
8. The Sample Size for the Training Set
This information is not applicable. This describes a mechanical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable. As in point 8, this is a mechanical device, not a machine learning model.
§ 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.