(29 days)
The EBI® Periarticular Plating System is indicated for fixation of fractures and osteotomies involving the femur or tibia. The System consists of the following plate configurations:
Distal Femoral Plate
The Distal Femoral Plate is intended for buttressing multifragment distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures in normal or osteopenic bone and nonunions and malunions.
Proximal Lateral Tibial Plate
The Proximal Lateral Tibial Plate is intended for the treatment of non-unions, malunions and fractures of the proximal tibia, including simple, comminuted lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression and fractures with associated shaft fractures.
Proximal Medial Tibial Plate
The Proximal Medial Tibial Plate is intended to buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, medial split fractures with associated depressions and split of depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibial shaft.
Distal Tibia Plate
The Distal Tibial Plate is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.
The EBI Periarticular Plating System is an internal fixation device used to provide surgeons with bone plates that are capable of using locking screws for better rigidity and non-locking screws for compression. Compression slots are also available for non-locking screws to compress two bone fragments. The shapes of the plates are pre-contoured to the shape of the bone and the holes on the plate are threaded in such a way as to permit surgeons a choice of locking or non-locking screws. Instruments allow minimum incision during surgery.
The provided text is a 510(k) Summary for the EBI® Periarticular Plating System, which is an internal fixation device. This type of document is a premarket notification to the FDA for medical devices that are substantially equivalent to a legally marketed predicate device.
The document does not describe any acceptance criteria or a study that proves the device meets acceptance criteria in the context of device performance metrics often seen with AI/software-based devices (e.g., accuracy, sensitivity, specificity).
Instead, the core of this 510(k) submission is to demonstrate substantial equivalence to existing predicate devices based on intended use, materials, and function. This means the acceptable "performance" is that it functions safely and effectively similarly to devices already on the market, by using similar materials and having a similar intended use.
Therefore, many of the requested items in your prompt are not applicable to this type of traditional medical device submission.
Here's a breakdown based on the information provided and what is implied by a 510(k) for an internal fixation device:
1. Table of Acceptance Criteria and Reported Device Performance:
There are no specified "acceptance criteria" in terms of performance metrics (like accuracy or sensitivity) for this type of hardware device. The acceptance is based on demonstrating substantial equivalence to predicate devices in terms of:
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device "Performance" (Comparison to Predicate) |
|---|---|
| Intended Use Equivalence: | The EBI® Periarticular Plating System is intended for fixation of fractures and osteotomies (distal femur, proximal lateral/medial tibia, distal tibia). This matches the intended use of the predicate devices. |
| Material Equivalence: | Manufactured from titanium alloy as per ASTM F136-02. This is a commonly accepted biocompatible material for internal fixation and is substantially equivalent to materials used in predicate devices. |
| Function Equivalence: | Internal fixation device using bone plates capable of using locking and non-locking screws for rigidity and compression. Pre-contoured plates to bone shape with threaded holes for screw choice. Instruments allow minimum incision. This functional description is substantially equivalent to the predicate devices. "There are no significant differences between the EBI® Periarticular Plating System and other currently marketed internal fixation systems." |
| Safety and Effectiveness: | Implied by substantial equivalence to legally marketed predicate devices that have established safety and effectiveness profiles. No new safety concerns are raised. |
2. Sample Size Used for the Test Set and the Data Provenance:
Not applicable. This is a mechanical device, not a diagnostic or AI device that would typically have a "test set" of data for performance evaluation in the way you're asking. The evaluation is primarily based on engineering principles, materials science, and comparison to existing devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable. No "ground truth" establishment in the context of data labeling is mentioned or expected for this type of device submission.
4. Adjudication Method for the Test Set:
Not applicable. No "test set" or adjudication method 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. This is not an AI/software device, and therefore, no MRMC study or AI assistance is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical, implantable medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No "ground truth" in this sense. The closest concept is the established clinical performance and safety history of the predicate devices, which serve as the benchmark for substantial equivalence.
8. The Sample Size for the Training Set:
Not applicable. No "training set" is mentioned or expected for this type of device.
9. How the Ground Truth for the Training Set was Established:
Not applicable. No "ground truth" for a training set.
In summary:
The provided document is a 510(k) premarket notification for a traditional, physical medical device (internal fixation system). The "acceptance criteria" and "study" described are focused on demonstrating substantial equivalence to already approved predicate devices, rather than establishing de novo performance metrics with clinical data sets, as would be the case for AI-based or novel diagnostic devices. The acceptance is based on the FDA's review and determination that the device is as safe and effective as a legally marketed device.
§ 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.