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The EVOS Large Fragment Plating System is indicated for adult patients. It is indicated for fixation of long bone fractures.

Subject of this premarket notification is an extension of the EVOS Large Fragment Plating System, the Peri-Prosthetic Plates, Blunt Tip Screws and Cable Accessories. The proposed devices incorporate design features similar to those currently incorporated on previously cleared Smith & Nephew bone plate and screw systems. Like their previously cleared counterparts. the proposed plates feature a screw-to-plate locking feature that permits their use with the previously cleared and compatibility designed locking and non-locking screws described in this premarket notification. EVOS Large Fragment Per-Prosthetic Plates are available in a variety of plate designs for specific anatomical areas. These plate designs have a combination of 3.5mm and 4.5mm holes. Plate designs may include threaded holes, non-threaded holes, and variable-angle locking holes. Blunt Tip Screws are available in 4.5mm diameter and are identical to the EVOS 4.5mm Cortex Locking Screws described in K201918 with the exception of the blunt tip. Cable Accessories include 3.5mm and 4.5mm cable saddles and 3.5mm cable post.

The provided text describes a 510(k) premarket notification for the "EVOS Large Fragment Plating System Peri-Prosthetic" by Smith & Nephew, Inc. This submission focuses on establishing substantial equivalence to previously cleared predicate devices, primarily through engineering and mechanical testing. As such, the information typically found in clinical studies involving acceptance criteria for device performance in terms of clinical outcomes, human reader improvement, or stand-alone AI performance is not applicable or present.

Here's the breakdown of the information requested, based on the provided document:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) for a metallic bone fixation system, "acceptance criteria" and "device performance" are primarily evaluated through mechanical and pre-clinical testing, ensuring the new device performs similarly or superiorly to predicate devices. Clinical performance metrics like sensitivity, specificity, or accuracy (common for AI/diagnostic devices) are not relevant here.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily discusses pre-clinical and mechanical testing. For mechanical fatigue testing, "worst case plate designs identified through FEA" were used. The sample sizes for these tests (e.g., number of plates or constructs tested) are not specified in the provided text. Data provenance (country of origin, retrospective/prospective) is not applicable or stated for this type of testing.

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)

This is not applicable to the type of device and submission described. Ground truth established by medical experts (like radiologists for imaging devices) is not relevant for a substantial equivalence claim based on mechanical performance of bone plates.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies in expert opinions, which isn't the focus of this pre-clinical mechanical evaluation.

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. An MRMC study is relevant for diagnostic imaging devices, especially those involving AI assistance, to assess the impact of AI on human reader performance. This device is a surgical implant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. "Standalone performance" refers to the performance of an AI algorithm without human intervention, again, relevant for diagnostic AI devices, not surgical implants.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the mechanical testing, the "ground truth" would be established by engineering standards and validated testing methodologies. For example:

• Mechanical Strength: Defined by industry standards (e.g., ASTM, ISO) for bone plates, or by direct comparison to the mechanical properties of predicate devices under equivalent loading conditions. The "ground truth" is that the device must meet or exceed these established engineering performance benchmarks.
• Biocompatibility: Established by adherence to ISO 10993 series standards.
• Sterility: Established by microbiology standards and endotoxin limits.

8. The sample size for the training set

Not applicable. "Training set" refers to data used to train an AI algorithm. This device is a metallic bone fixation system, not an AI/software device requiring a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no AI training set for this device.

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The EVOS Large Fragment Plating System is indicated for adult patients. It is indicated for fixation of long bone fractures.

Subject of this premarket notification is the EVOS Large Fragment Plating System. The proposed devices incorporate design features similar to those currently incorporated on previously cleared Smith & Nephew bone plate and screw systems. Like their previously cleared counterparts, the proposed plates feature a screw-to-plate locking feature that permits their use with the proposed and compatibility designed locking and non-locking screws described in this premarket notification. It is comprised of a variety of locking and non-locking 4.5mm straight plates, 3.5mm and 4.5mm anatomical plates as well as previously cleared 3.5mm locking and non-locking screws and new 4.5mm locking and non-locking screws, 5.7mm cannulated locking screws, 6.5mm locking and nonlocking screws, and 6.7mm high-torque (osteopenia) screws.

The provided text describes the EVOS Large Fragment Plating System, a medical device for bone fracture fixation. The document details the pre-clinical testing conducted to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes Used for the Test Set and Data Provenance:

• The document does not explicitly state specific sample sizes for each mechanical test. Instead, it refers to evaluating "worst case plate designs" identified through Finite Element Analysis (FEA). While FEA itself is a computational method, the subsequent mechanical testing would involve a physical sample size. This information is a major gap in the provided text.
• The data provenance is pre-clinical testing, meaning it was conducted in a laboratory setting, not on human subjects. There is no information regarding country of origin of the data provided in the FDA letter.
• The testing is retrospective in the sense that it compares the new device to existing predicate devices already on the market.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• This information is not applicable as the studies described are pre-clinical mechanical and material tests, not clinical studies involving human patients or expert interpretation of medical images. "Ground truth" in this context refers to established engineering standards (e.g., ASTM F543) and performance characteristics of predicate devices against which the new device's performance is measured.

4. Adjudication Method for the Test Set:

• This information is not applicable for pre-clinical mechanical and material testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical trials involving human subjects where multiple experts evaluate outcomes or images.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI-assisted clinical decision support tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. The EVOS Plating System is a surgical implant, not a diagnostic or AI-driven tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• No, this is not applicable. The device is an orthopedic implant, not a software algorithm.

7. The Type of Ground Truth Used:

• For the mechanical and material tests, the "ground truth" used for comparison falls into these categories:
  • Predicate Device Performance: The primary ground truth is the established performance characteristics of the legally marketed predicate devices (e.g., Smith & Nephew Locking Bone Plate System (PERI-LOC)).
  • Standardized Performance Criteria: For screws, specific FDA Guidance documents (e.g., "FDA Guidance for Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway") and international standards (e.g., ASTM F543, ANSI/AAMI ST72) serve as ground truth for acceptance.

8. The Sample Size for the Training Set:

• This information is not applicable. There is no "training set" in the context of mechanical pre-clinical testing for a surgical implant. Training sets are used in machine learning and AI development. The Finite Element Analysis (FEA) performed could be considered a form of "computational modeling" that informs the physical testing, but it's not a "training set" in the AI sense.

9. How the Ground Truth for the Training Set Was Established:

• This information is not applicable as there is no "training set." The performance targets for the device were established based on the characteristics of predicate devices and relevant industry/regulatory standards.

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