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The AOS Small External Fixation System is intended to be used with the AOS External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures in anatomies such as the hand, wrist, forearm, foot, and ankle where soft tissue injury may preclude the use of other fracture treatments.

The AOS Small External Fixation System is intended to be non-weight bearing.

The AOS Small External Fixation System is an external fixation device comprised of rods, clamps, and threaded pins used for the management of bone fractures and reconstructive orthopedic surgery. The system is a modular system designed to provide options in frame construction, simplicity in frame components, and ease of use. The AOS Small External Fixation System is manufactured with threaded half pins and rods of 5.0mm shaft diameter, which allows for connectivity with AOS' External Fixation System (510(k) cleared: K080408) for support with bone fractures. The system is comprised of titanium and stainless steel (pin-to-rod and multi-pin) clamps, stainless steel threaded half pins and k-wires, carbon fiber connector rods, and pin caps. The AOS Small External Fixation System is a non-sterile single use fixation device.

The pin-to-rod clamps are designed to clamp to the 5.0mm carbon fiber rods and to the 2.0mm and 3.0mm stainless steel pins. The multi-pin clamps are designed to stabilize fractures using multiple pins in close proximity to each other. The multi-pin clamps can be used individually or as part of a larger construct.

The stainless steel threaded pins come in thread diameters of 2.0mm and 3.0mm with a 5.0mm shaft diameter. Thread lengths are available in 5mm increments from 10mm to 25mm long. Overall pin lengths of 55mm, 75mm, 100mm and 140mm are available. The stainless steel k-wires are provided in a 1.5mm diameter.

The connecting rods are carbon fiber composite with an diameter of 5.0mm and are in lengths of 50mm, 75mm, 100mm, 125mm, 150mm, 200mm, 250mm, and 300mm.

The surgical technique used for the AOS Small External Fixation System is a standard method used for external fixation and is the same as the technique used for the predicate devices. The instrumentation for the system consists of a wrench, two T-wrenches, a drill quide, and drills.

The provided text describes a 510(k) premarket notification for the "AOS Small External Fixation System," a medical device for stabilizing bone fractures. The document is primarily focused on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable or not available in this type of submission.

Here's a breakdown of the information that is and is not present, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the format of acceptance criteria with corresponding performance results. The submission relies on "substantial equivalence" to predicate devices, meaning its performance is considered comparable to already cleared devices based on design and intended use, rather than unique, quantitatively measured performance against specific criteria.

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

Not applicable. No specific test set to measure performance against acceptance criteria is described. The submission focuses on comparison to predicate devices, not de novo performance testing.

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

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method for the test set

Not applicable. No adjudication method for a test set is described.

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 device is a mechanical external fixation system, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant here.

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

Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No specific ground truth for performance evaluation is mentioned. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. As above, this is not an AI model.

Summary of what the document does provide regarding "acceptance criteria" and "study":

The "acceptance criteria" in this context are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices. The "study" that proves this is primarily a comparative analysis of design features, operating principles, materials, and indications for use between the new device and the predicate devices.

The crucial statement is:

"The construct of the AOS Small External Fixation System and the predicate devices are virtually identical. Since the devices are substantially equivalent in design, geometry, construction, materials of construction, and indications, it was determined that no mechanical testing was necessary to demonstrate substantial equivalence."

This indicates that the FDA accepted the argument that because the device is so similar to existing, cleared devices, specific performance testing to define new acceptance criteria and then meet them was not required in this 510(k) submission. Therefore, the "study" is effectively the documentation and argument for substantial equivalence, which was deemed sufficient by the FDA for clearance.

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