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The AOS Proximal Humeral Plate is indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.

The AOS Proximal Humeral Plate is an internal fixation device for the fixation of fractures of the humeral head and is intended as a load sharing device which may be removed once the fracture has healed.

The plate is manufactured in multiple lengths with the overall length of the plate ranging from 97mm to 236mm. The proximal portion has eight 135° angled holes to accept 4.0mm locking screw. The distal portion has 3, 5, 8, 11 and 14 hole configurations which will accept a 4.0mm locking screw or a 3.5mm cortical screw. There are three associated screws for the AOS Proximal Humeral Plate; the 4.0mm fully threaded locking screws, the 4.0mm partially threaded locking screw and the 3.5mm cortical screw. The AOS Proximal Humeral Plates and screws are manufactured from titanium alloy.

The overall length of the AOS Proximal Humeral Plate ranges from 97mm to 236mm while the proximal portion is consistent for all plates at 48mm. The proximal portion of the plate contains 8 threaded holes that accept the 4.0mm partially threaded cancellous locking screw. The proximal portion of the plate also contains six suture holes and a 2.0mm hole for positioning.

The distal shaft of the plate is manufactured in 3, 5, 8, 11 and 14 hole configurations with the first hole being a slot. These threaded holes are staggered through the length of the plate and accept a 4.0mm fully threaded cancellous locking screw or the 3.5mm cortical screw.

The provided document is a 510(k) premarket notification for a medical device called the "AOS Proximal Humeral Plate." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a new clinical study. Therefore, the information requested about acceptance criteria, study details, and performance metrics for the device itself (like AI performance) is not directly present in this document, as it outlines a comparison to a predicate device.

Specifically, the document states: "The AOS Proximal Humeral Plate and the predicate Synthes (USA) Proximal Humeral Plate have the same indication for use, similar design geometry and are manufactured from similar material. Therefore, mechanical testing to support Substantial Equivalence was not necessary." This means the assessment was primarily based on design and material similarity to an already approved device, rather than new performance testing.

Here's an attempt to answer the questions based on the information provided, highlighting what is not applicable:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as this is a substantial equivalence submission relying on similarity to a predicate device. The "acceptance criteria" here is that the device is substantially equivalent to the predicate.
• Reported Device Performance: Not reported in terms of specific numeric performance metrics, as direct performance testing was deemed unnecessary due to substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This is not a study that involved a test set with patient data. It's a regulatory submission based on comparison to an existing device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No ground truth was established by experts for a test set in this context. The "ground truth" for substantial equivalence is the predicate device and its established safety and effectiveness.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No test set requiring adjudication was used.

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 a medical device for internal fixation, not an imaging device or AI-assisted diagnostic tool.

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

• Not applicable. This is a physical orthopedic implant, not an algorithm.

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

• The "ground truth" in the context of a 510(k) submission for substantial equivalence is the safety and effectiveness profile of the predicate device. This profile is established through its own prior approvals, clinical use, and potentially pre-market or post-market studies of the predicate. No new ground truth, in the sense of expert consensus, pathology, or outcomes data for the AOS Proximal Humeral Plate, was generated for this submission.

8. The sample size for the training set

• Not applicable. There was no training set for a study described in this document.

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

• Not applicable. There was no training set for a study described in this document.

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