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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

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.

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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.

Not Found

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

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.

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