(27 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, fractures in normal or osteopenic bone and nonunions 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 wedge, 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 for 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.
This submission is being made for sterile packaging of plates and screws that comprise the OptiLock Periarticular Plating System.
The provided text is a 510(k) summary for a medical device (EBI OptiLock Periarticular Plating System). It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the indications for use. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through testing with a defined dataset, ground truth, or expert review.
Therefore, I cannot populate the requested table and sections based on the provided text. The document states:
- "The technological characteristics of the OptiLock Periarticular Plating System are the same as, or similar to the predicate devices."
- "The OptiLock Periarticular Plating System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics and principles of operation and do not present any new issues of safety or effectiveness."
This indicates that the submission relies on the similarity of its design and intended use to previously cleared devices, rather than presenting a performance study with acceptance criteria.
Response:
Based on the provided 510(k) Summary for the EBI OptiLock Periarticular Plating System, there is no information regarding specific acceptance criteria or a study that proves the device meets such criteria in terms of analytical or clinical performance.
The document is a 510(k) premarket notification that demonstrates substantial equivalence to predicate devices based on intended use, indications, technological characteristics, and principles of operation. It does not present data from a performance study with a test set, ground truth, or expert review.
Therefore, the requested information cannot be extracted from this document, and the table and sections below cannot be filled.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (e.g., Performance Threshold, Statistical Metric) | Reported Device Performance |
|---|---|
| Not provided in the document | Not provided in the document |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable, no performance study data provided.
- Data Provenance: Not applicable, no performance study data provided.
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, no ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) 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 a medical device for internal fixation (plates and screws), not an AI/software device. No MRMC study was performed or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, this is a medical device for internal fixation (plates and screws), not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable, no ground truth for a performance study is described.
8. The sample size for the training set
- Not applicable, this is a physical medical device, not a software/AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, this is a physical medical 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.