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510(k) Data Aggregation
(69 days)
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.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Mechanical Strength & Durability: Maintain structural integrity and function under simulated physiological loads, demonstrating equivalence or superiority to predicate devices in fatigue. | Fatigue Performance: "Results of the testing determined that the subject plates performed similar or superior to the predicate plates tested, when evaluated under the same conditions." |
| Material Biocompatibility: Materials used must be biocompatible. | Biocompatibility Testing: "EVOS Large Fragment Fracture Plating System Biocompatibility Testing" (Completed, implies met criteria) |
| Sterility: Device must be sterile and maintain sterility until use. | Bacterial Endotoxin Testing: "Completed and met the acceptable endotoxin limits as stated in the FDA Guidance..." |
| MRI Safety & Compatibility: Device must not pose a safety risk or significantly interfere with MRI procedures. | MRI Compatibility Testing: "Conducted as per the FDA's guidance 'Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment', December 11, 2014." (Completed, implies met criteria) |
| Packaging Integrity: Packaging must protect the device and maintain sterility during transport and storage. | Packaging Verification Testing: "Conducted for the proposed packaging configurations and the results of this testing demonstrated that the product will not be damaged during shipment and will adequately maintain sterility post shipment." |
| Design Equivalence/Similarity: Design features (screw-to-plate locking, hole types, screw dimensions) should be similar to predicate devices. | Technological Characteristics: "The proposed devices are substantially equivalent to legally marketed predicates with respect to intended use, indications, and performance characteristics." "The holes are identical to those used in the EVOS Large Fragment Plates cleared via K201918. The subject screws feature a hex drive and are identical to existing Smith & Nephew predicate screws with respect to threadform and major and minor diameter." |
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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