(35 days)
The EBI® OptiLock® Periarticular Plating System (The System) is indicated for fixation of fractures and osteotomies involving the femur or tibia.
The System is intended for buttressing multifragment distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures in normal or osteopenic bone and non-unions and malunions.
The System is intended for the treatment of non-unions, malunions and fractures of the proximal tibia, including simple, comminuted lateral wedge, depression, medial vecomes of bicondylar, combinations of lateral wedge and depression and fractures with associated shaft fractures.
The System 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.
The System 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.
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The provided text describes the EBI® OptiLock® Periarticular Plating System, a metallic bone fixation device, and its 510(k) submission. However, it does not include detailed acceptance criteria or a study designed to prove the device meets specific performance metrics in the way a clinical trial or a deep learning AI validation study would. Instead, this document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing and engineering rationales.
Here's an analysis of the provided information in the context of your request:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The acceptance criteria for this device appear to be primarily based on demonstrating substantial equivalence to a predicate device in terms of safety and effectiveness, as per the FDA 510(k) process. The study conducted to meet these criteria was mechanical testing and engineering rationales.
Here's how to break down the information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness: As safe and effective as predicate devices for the stated indications for use. | Mechanical testing demonstrated that the Modified System conforms to its design specifications. Engineering Rationales were provided to justify not performing further testing on additional sizes. |
| Design Specifications Conformance: The device meets its internal design requirements. | Mechanical testing confirmed conformance to design specifications. |
| No New Issues of Safety or Effectiveness: Technological differences from predicate devices do not introduce new safety or effectiveness concerns. | Performance data and Engineering Analyses demonstrated that the Modified System is as safe and effective as its predicate devices, implying no new issues. |
2. Sample Size Used for the Test Set and the Data Provenance
This information is not explicitly stated in the provided document. The study described is mechanical testing, which typically uses a sample of the manufactured devices or components. The document does not specify the number of units tested. Data provenance (country of origin, retrospective/prospective) is not applicable in the context of mechanical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of submission. Mechanical testing relies on engineering standards, specifications, and physical measurements, rather than expert interpretation of medical data or images to establish a "ground truth."
4. Adjudication Method for the Test Set
This information is not applicable. Mechanical testing results are objective measurements against defined specifications, not subjective interpretations requiring 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
This information is not applicable. This submission is for a medical device (bone plating system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. As mentioned above, this is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the mechanical testing would be the established engineering specifications, material properties, and biomechanical requirements for internal fixation devices. These are typically derived from industry standards, scientific literature, and internal design requirements.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of mechanical testing for a physical device.
9. How the ground truth for the training set was established
This information is not applicable. There is no "training set" in this context.
Summary of the Kolo1098 Submission:
The Kolo1098 submission for the EBI® OptiLock® Periarticular Plating System primarily relies on demonstrating substantial equivalence to a previously marketed predicate device (EBI® Pertiarticular Plating System). The "study" that proves this substantial equivalence is comprised of:
- Mechanical Testing: Performed to show that the Modified System conforms to its design specifications.
- Engineering Rationales: Provided to explain why further testing on all additional sizes of the Modified System components was not deemed necessary.
The FDA's review concluded that "Performance data and Engineering Analyses demonstrate that the Modified System is as safe and effective as its predicate devices," thus achieving substantial equivalence and permitting the device to be marketed. This type of regulatory submission does not involve clinical trials or AI performance evaluations as would be expected for a diagnostic or AI-driven 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.