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The Nextremity Solutions Stratur " Reduced Size Foot Plating System is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the foot and ankle, particularly in ostopenic bone.

The Stratum™ Reduced Size (RS) Foot Plating System is a foot and ankle plating system consisting of plate and screw implants. The plates range in length from 25.5mm and in width from 6.35mm to 18mm and feature between 2 and 10 screw holes. There is one diameter, 2.4mm, for all screw types including locking, non-locking, and MDS screws. The screws range in length from 8mm to 50mm and are provided sterile. The system also includes a sterile set of accessory instruments along with individually packaged drill guides / drill bits, screw driver shafts, threaded wire with nut, and olive wires designed for preparation of the implant site and insertion of devices into the bone. The plates, screws, instrument kits, drill guide / drill bits, screw driver shafts, threaded wire with nut, and olive wires are all packaged individually in separate sterile packaging. The plates, non-locking and locking screws are manufactured from Ti-6Al-4V ELI conforming to ASTM F136. The multi-directional locking screws are manufactured from Co-Cr-Mo conforming to ASTM F1537.

This document is a 510(k) premarket notification for the Stratum™ Reduced Size Foot Plating System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against defined acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, and training set information is not applicable or available in this document.

Here's an analysis of what can be extracted:

Acceptance Criteria and Device Performance

A formal table of acceptance criteria and reported device performance, as one would see in a detailed performance study, is not provided in this 510(k) submission.

Instead, the submission states that:

• Mechanical Testing: "The strength of the worst-case Stratum Reduced Size Foot Plating System plates and screws is substantially equivalent to predicate devices with similar indications and is adequate for their intended use."
• Bacterial Endotoxin Testing: "Endotoxin levels meet the requirement of < 20EU/device."

Study Information

The document describes non-clinical testing performed to demonstrate substantial equivalence.

1. Sample Sized used for the test set and the data provenance:

• Sample Size: Not explicitly stated as a numerical sample size. The testing was done on "worst case plate" and "worst case screws." This implies a selection of specific configurations for testing, not a large statistical sample.
• Data Provenance: Not applicable. This is mechanical and biological testing of physical devices, not clinical data or data from human subjects.

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

• Not Applicable. The ground truth for mechanical testing is established by engineering principles and adherence to ASTM standards. For bacterial endotoxin testing, it's a quantitative measurement against a defined threshold. No human experts were involved in establishing "ground truth" for these tests in the way described for AI/diagnostic studies.

3. Adjudication method for the test set:

• Not Applicable. As no human expert "ground truth" was established, no adjudication method was needed.

4. 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:

• No. This being a physical implantable device, an MRMC study comparing human readers with and without AI assistance is not relevant or described. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Stratum™ Reduced Size Foot Plating System to the predicate devices."

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

• Not Applicable. This is a hardware device, not an algorithm.

6. The type of ground truth used:

• Mechanical Performance: Adherence to ASTM F382-14 (four-point bending) and ASTM F543-13 (torque to failure, insertion performance, pull-out strength). The "ground truth" is that the device's performance meets or exceeds the mechanical properties suitable for its intended use and is "substantially equivalent" to predicate devices.
• Bacterial Endotoxin: Quantitative measurement using the LAL method, per AAMI ST72, USP 161 and USP 85, against a specified limit of < 20 EU/device.

7. The sample size for the training set:

• Not Applicable. This is not an AI/ML algorithm that requires a "training set."

8. How the ground truth for the training set was established:

• Not Applicable. Does not apply to this type of device submission.

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