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510(k) Data Aggregation
(386 days)
The EVOS Wrist Plating System is indicated for adult and pediatric patients, as well as patients with osteopenic bone. It is indicated for fixation of fractures, malunions, and osteotomies involving the radius and ulna.
The subject of this premarket notification is the EVOS Wrist Spanning Plate. The proposed device has identical indications to those previously cleared Smith & Nephew EVOS Wrist Fracture Plating system K181533 i.e. primary predicate. The proposed device incorporates design features similar to those currently incorporated on previously cleared Smith& Nephew Bone Plate System TC -100 (K993106). Like their previously cleared counterparts, the proposed plate features a screw-to-plate locking feature that permits their use with the proposed and compatibility designed locking and cortex screws described in this premarket notification. It is comprised of EVOS Wrist Spanning plate 13H, 1.8mm locking pegs, 2.4 and 3.5mm locking and cortex screws.
The provided document is a 510(k) clearance letter and summary for a medical device (EVOS Wrist Spanning Plate). It outlines the regulatory approval process but does not contain the acceptance criteria or a detailed study proving the device meets acceptance criteria in the format typically used for software or AI/ML device performance studies.
The "Summary of Pre-Clinical Testing" section describes mechanical and other pre-market tests, but these are for the physical properties of the implant, not for the performance of an AI/ML algorithm.
Therefore, many of the requested details, such as sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable or not provided in this document as it pertains to an AI/ML-driven device.
However, I can extract the acceptance criteria and performance information that is present for the physical device:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bending Fatigue Test (ASTM F382): Bending performance of the subject plates should be similar or superior (higher) compared to the predicates when evaluated using a four-point bend fatigue test, identified through FEA as the worst-case scenario. | The subject plates that were tested showed similar or superior (higher) bending fatigue performance compared to the predicates. |
| Packaging Verification Testing: Product should not be damaged during shipment and should adequately maintain sterility post shipment. | The results of this testing demonstrated that the product will not be damaged during shipment and will adequately maintain sterility post shipment. |
| Bacterial Endotoxin Testing (FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72): Meet acceptable endotoxin limits. | Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the specified FDA guidance and ANSI/AAMI standard. |
| Master Biological Evaluation: (Implicit: Device must meet biological safety requirements for titanium plate implant devices). | A "Master Biological Evaluation of Titanium Plate Implant Devices" was performed. (The document implies this was successful, as clearance was granted). |
Missing or Not Applicable Information (for AI/ML performance studies):
- Sample sizes used for the test set and the data provenance: Not applicable. This device is a physical implant, not an AI/ML diagnostic tool. The "test set" here refers to physical samples of the plate.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical implant involves engineering specifications and material science, not expert interpretation of medical images/data.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is for AI/ML interpretation assistance, not physical implants.
- Standalone performance (i.e. algorithm only without human-in-the loop performance): Not applicable. This is a physical device.
- Type of ground truth used: For the physical device, ground truth is based on engineering standards, material properties, and biological safety standards.
- Sample size for the training set: Not applicable. The physical device is designed and manufactured, not "trained" in the AI/ML sense. Design validation and pre-clinical testing are analogous to "testing," but there's no "training set."
- How the ground truth for the training set was established: Not applicable.
In summary, the provided FDA document pertains to the pre-market clearance of a physical medical implant (EVOS Wrist Spanning Plate) based on its mechanical, packaging, and biological safety characteristics, rather than the performance of an AI/ML-driven device. Therefore, the questions related to AI/ML study design are not addressed.
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(59 days)
The EVOS Wrist Plating System is indicated for adult and pediatric patients with osteopenic bone. It is indicated for fixation of fractures, malunions, and osteotomies involving the radius and ulna.
Subject of this premarket notification is the EVOS Wrist Fragment Plating System. The proposed devices incorporate design features that are 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 cortex screws described in this premarket notification. Each screw hole contains five separate tabs that engage with the threads of the locking screw. The locking screws can be angled and locked up to fifteen degrees in any direction, allowing for custom, multi-directional locked plating constructs. The subject plates can be used with screws previously cleared via K161665, K132296, K993106, K162078, K140814 and K132886 and pegs subject of this premarket notification.
This document describes the submission for the EVOS Wrist Fracture Plating System and does not contain information related to software or AI/ML acceptance criteria or studies. Instead, it focuses on the substantial equivalence of a medical device (bone plating system) to previously cleared predicate devices.
Therefore, I cannot provide the requested information about acceptance criteria and studies proving the device meets those criteria, as it pertains to AI/ML devices. The document details mechanical testing, packaging verification, bacterial endotoxin testing, and biocompatibility testing for a physical implantable device, not a software algorithm.
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