(55 days)
The indications for the Emerge Medical Periarticular and Locking Large Fragment System are as follows for the two subsystems:
The Emerge Medical Periarticular Locking Plate Set is intended for treatment of nonunions, mal unions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, periprosthetic fractures, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. The Periarticular Locking Plate Set is also intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular Condylar fractures in normal or osteopenic bone, periprosthetic fractures, and nonunions and malunions.
The Emerge Medical Locking Large Fragment Set is intended for fixation of various long bones, such as the humerus, femur, and tibia. Emerge Medical Locking Large Fragment Set is also intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau, and distal tibia. The set is also for use in fixation of periprosthetic fractures, osteopenic bone, and nonunions or malunions.
The Emerge Medical Periarticular and Locking Large Fragment System is not intended for use with active or latent infection, osteoporosis, insufficient quantity or quality of bone/soft tissue, material sensitivity (if suspected tests should be performed prior to implantation), sepsis, patients who are unwilling or incapable of following postoperative care instructions. This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The Emerge Medical Periarticular and Locking Large Fragment System consists of implants and instruments designed to be used for internal bone alignment and fixation of fractures of the tibia and femur. The system features four (4) types of plates (4.5mm Locking Proximal Tibia Plate, 4.5 Locking Condylar Plate, Locking 4.5mm Narrow and Broad Plate, Locking T-Plate), bone screws for fixation, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel (ASTM F139), and offered in various widths, lengths, and thicknesses. Plates and screws are provided non-sterile.
This document describes the regulatory submission for the Emerge Medical Periarticular and Locking Large Fragment System, primarily focusing on its substantial equivalence to predicate devices. It is not a study that evaluates a device's performance against detailed acceptance criteria in the context of an AI/human-in-the-loop system. Instead, it's a 510(k) premarket notification for a medical implant system based on mechanical testing and comparison to existing devices.
Therefore, many of the requested categories for AI/clinical study evaluation are not applicable or cannot be extracted from this document.
Here's an analysis based on the provided text, highlighting what can be extracted and what information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static four-point bending | Sufficient strength for intended use and substantial equivalence to predicate devices (implied by FEA comparison) | "Strength of the ... System is sufficient for its intended use" |
| Dynamic four-point bending | Sufficient strength for intended use and substantial equivalence to predicate devices (implied by FEA comparison) | "Strength of the ... System is sufficient for its intended use" |
| Static screw pull-out | Sufficient strength for intended use and substantial equivalence to predicate devices (implied by FEA comparison) | "Strength of the ... System is sufficient for its intended use" |
| Static torsion | Sufficient strength for intended use and substantial equivalence to predicate devices (implied by FEA comparison) | "Strength of the ... System is sufficient for its intended use" |
| Overall Mechanical Performance | Substantial equivalence to legally marketed predicate devices | "Overall technology characteristics and mechanical performance data lead to the conclusion that the ... System is substantially equivalent to the predicate device." |
Explanation of Acceptance Criteria: The acceptance criteria for this device, as presented in the document, are broadly defined as demonstrating "sufficient strength for its intended use" and, more importantly, "substantial equivalence to legally marketed predicate devices." The specific numerical thresholds or comparative tolerances are not explicitly stated in this text but would have been part of the underlying ASTM F382-99 and ASTM F543-13 standards and the FEA study.
2. Sample Size Used for the Test Set and Data Provenance
This was a Finite Element Analysis (FEA) study, not a study with a "test set" of patient data.
- Sample Size for Test Set: Not applicable in the context of human or imaging data. The "test set" refers to the worst-case plates and screws chosen for FEA simulation. The document mentions "worst-case plates and screws" but does not specify how many distinct FEA models or variations were run.
- Data Provenance: Not applicable in the context of human data. The "data" comes from FEA simulations, which are computational models based on engineering principles and material properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. Ground truth for mechanical testing via FEA does not involve human expert consensus in the way clinical AI studies do. The "truth" is established by the validated engineering principles and material science used in the FEA models and the comparison to established ASTM standards and predicate device performance.
- Qualifications of Experts: Not applicable for establishing ground truth in this context. The study was conducted by Emerge Medical and reviewed by the FDA's Division of Orthopedic Devices.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Mechanical testing and FEA results are objective measurements/simulations, not subject to human adjudication in the typical clinical study sense. Compliance with ASTM standards and comparison to predicate devices would be the "adjudication."
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission is for mechanical hardware, not an AI-assisted diagnostic or treatment planning tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: No, this is not an algorithm, so standalone performance is not applicable. The "performance data" is the mechanical strength of the physical device as simulated by FEA.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" for this engineering study is based on established mechanical engineering principles, material science (ASTM F139 medical grade stainless steel), and performance standards (ASTM F382-99, ASTM F543-13). The primary "truth" being established is the substantial equivalence to existing predicate devices already approved for market, implying their safety and effectiveness.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no "training set" in the context of an engineering analysis of a physical implant. The FEA models are built based on the device design and material properties.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. There is no "training set" or "ground truth" in the AI/clinical sense. The "ground truth" for the FEA models themselves would be the physical properties of the materials and the validated equations/algorithms within the FEA software.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.