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The EVOS Small Fragment Plating System is indicated for adult and pediatric 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, acctabulum, metacarpals, metatarsals, and clavicle.

The subject of this special premarket notification is a modification in the manufacturing process for select EVOS Small Fragment Straight Plates that were previously cleared via K162078. Also subject to this special premarket notification is the addition of EVOS 3.5mm Locking Hole Inserts and EVOS 3.5mm Washers and Double Washers. The subject devices are intended to be used with existing Smith & Nephew implants and instruments that have been previously cleared for market for use with the EVOS Small Fragment Plating System.

This document is a 510(k) premarket notification for the EVOS Small Fragment Plating System. The focus of the changes discussed in this submission is on manufacturing process modifications and the addition of new components (locking hole inserts and washers), rather than providing a detailed study that proves the device meets specific performance acceptance criteria in a clinical setting.

Therefore, the requested information cannot be fully provided as the document does not contain details about:

• A specific clinical study proving device performance against acceptance criteria.
• Sample sizes for test sets, data provenance, number of experts, adjudication methods, or MRMC studies.
• Standalone algorithm performance.
• Specific ground truth types or training set details.

However, based on the provided text, here is what can be inferred about the pre-clinical engineering testing and its acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance (Pre-clinical Engineering Testing)

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated for each test, but referred to as "worst-case designs" for plate fatigue testing.
• Data Provenance: This is pre-clinical engineering testing, not clinical data from patients or a specific country. It's a lab-based study to assess mechanical properties and biocompatibility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable as this is pre-clinical mechanical and biological testing, not a study involving human expert interpretation of data like images.

4. Adjudication method for the test set

• Not applicable for pre-clinical mechanical and biological testing.

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 not an AI/imaging device.

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

• Not applicable. This is not an AI/imaging device.

7. The type of ground truth used

• For the plate and locking hole insert bending fatigue tests, the "ground truth" would be established by the physical testing methods themselves (e.g., measuring force, displacement, cycles to failure) against predefined engineering specifications derived from predicate devices and industry standards.
• For bacterial endotoxin levels, the ground truth is established by the LAL (Limulus Amebocyte Lysate) method, which is a standard assay for endotoxin detection.

8. The sample size for the training set

• Not applicable. This is pre-clinical testing, not a machine learning model.

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

• Not applicable. This is pre-clinical testing, not a machine learning model.

In summary: The provided document is a 510(k) submission focusing on demonstrating substantial equivalence through engineering rationales and pre-clinical mechanical and biological testing. It does not include information about clinical studies with human subjects or AI performance, which are the typical contexts for many of the questions asked. The "acceptance criteria" here refer to engineering performance benchmarks.

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