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The EVOS Small Fragment Plating System is indicated for adult and adolescent (greater than 12-21 years of age) patients, as well as patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metatarsals, and clavicle.

The subject of this Traditional 510k is the EVOS Straight Proximal Humerus 7-15 hole plates (137-225mm). The EVOS Straight Proximal Humerus Plate are a line extension to the existing 3 and 5 holes EVOS Straight Proximal Humerus Plates (93-114mm). The EVOS Straight Proximal Humerus Plates were previously cleared for market via premarket notification K173293. The lengths of the subject EVOS Straight Proximal Humerus Plates are being extended to include 7-15 hole plates (137-225mm). The EVOS Straight Proximal Humerus Plates are for single use only. Similar plate lengths have been cleared on EVOS Curved Proximal Humerus 6-18 hole plates (114-246mm) via premarket notification K173293.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

Summary of Acceptance Criteria and Device Performance for EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)

Based on the provided document, the device described is a bone fixation plate, not an AI or diagnostic device. Therefore, the typical "acceptance criteria" and "device performance" metrics associated with AI-powered diagnostic tools (like sensitivity, specificity, accuracy, etc.) are not applicable here. Instead, the "acceptance criteria" for this type of medical device relate to substantial equivalence to a predicate device, demonstrated through engineering analysis, material properties, and performance testing relevant to mechanical functionality and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of an engineering analysis of a bone plate. There isn't a "test set" of patient data or images in the way an AI study would have. The "testing" refers to mechanical and material characterization of the device itself.
• Data Provenance: Not applicable. The "data" comes from engineering analysis and laboratory testing of the device, not from patient populations.

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

• Not applicable. The "ground truth" for a mechanical device is established through engineering principles, material science, and regulatory standards, not expert consensus on patient cases.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" requiring adjudication in this context.

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 for evaluating human performance, often in diagnostic tasks, with and without AI assistance. This document describes a medical implant.

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

• Not applicable. This device is a physical bone plate, not an algorithm.

7. The Type of Ground Truth Used

• For mechanical performance: The "ground truth" is based on established engineering principles, material properties, and validated computational models (finite element analysis). Compliance with validated engineering standards and comparison to a legally marketed predicate device forms the basis of performance evaluation.
• For biocompatibility: The "ground truth" is defined by established regulatory limits for endotoxins as detailed in FDA guidance and ANSI/AAMI ST72.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" for this type of medical device.

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

• Not applicable.

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