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The Proximal Tibia Plating System is intended for non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.

The Proximal Tibia Plating System consists of 3.5 mm and 4.5 mm Plates and a 3.5/4.5 mm Washer. The plates are anatomically contoured; feature a low profile, limited contact design, and are available in right and left versions. The heads of the plates include holes for K-wires or sutures, if necessary. The 3.5 mm Plates are used with 3.5 mm cortex, 4.0 mm cancellous, and 4.5 mm cannulated screws. The 4.5 mm Plates are used with 4.5 mm cortex, 6.5 mm cancellous, 7.0 mm and 7.3 mm cannulated screws. When used with the 3.5/4.5 washer, the 4.5 mm Plates can also be used with all of the screws that fit the 3.5 plates; the washer prevents the screw head from pulling through the plate holes. This device system is manufactured from stainless steel.

This document is a 510(k) premarket notification for the Synthes Proximal Tibia Plating System. As such, it does not contain details about acceptance criteria, device performance studies, or ground truth establishment typically found in clinical trial reports or validation studies for AI/ML-driven devices.

The document primarily focuses on establishing "substantial equivalence" to predicate devices, a regulatory pathway that largely relies on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed device, or, if there are differences, that those differences do not raise new questions of safety or effectiveness.

Therefore, many of the requested sections regarding acceptance criteria, study details, and ground truth are not applicable to the information provided in this 510(k) submission.

Here's an analysis of what can be extracted or inferred based on the provided text, with clear indications of what information is not present:

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

• Not Applicable / Not Provided. This document does not present specific quantitative acceptance criteria or reported performance data in the way a clinical study report would for an AI/ML device. The "performance" in a 510(k) context refers to demonstrating that the device functions as intended and is substantially equivalent to existing devices, usually through mechanical testing, biocompatibility testing (if applicable), and comparison of design features and materials. No specific performance metrics against acceptance criteria are outlined in this summary.

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 / Not Provided. This document is not about an AI/ML device that would require test sets of data. It describes a physical medical device (bone plating system).

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 / Not Provided. This concept (ground truth established by experts for a test set) is not relevant to a 510(k) submission for a bone plating system.

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

• Not Applicable / Not Provided. This concept is not relevant to a 510(k) submission for a bone plating system.

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 / Not Provided. This is not an AI-assisted device.

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

• Not Applicable / Not Provided. This is not an algorithm-only device.

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

• Not Applicable / Not Provided. For a physical implant like a bone plate, "ground truth" generally refers to design specifications, material properties, and mechanical performance data, often compared against established standards or predicate devices. This document summarizes the device and its intended use, but does not detail the specific testing methodologies or "ground truth" used in its development or substantial equivalence determination.

8. The sample size for the training set

• Not Applicable / Not Provided. This document is not about an AI/ML device that would require a training set of data.

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

• Not Applicable / Not Provided. This concept is not relevant to a 510(k) submission for a bone plating system.

Summary of Device and Regulatory Status (Based on Provided Text):

• Device Name: Synthes (USA) Proximal Tibia Plating System
• Device Classification: Class II (according to the FDA letter)
• HRS Product Code: 888.3030 (Single/multiple component metallic bone fixation appliances and accessories)
• Indications for Use: Non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.
• Predicates: Zimmer Periarticular Plating System, Synthes Narrow DCP, Howmedica Alta Plating System.
• Regulatory Determination: The FDA determined the device to be "substantially equivalent" to predicate devices marketed in interstate commerce prior to May 28, 1976, or to lawfully marketed predicate devices. This determination allows the sponsor to market the device.

In essence, this 510(k) document is a regulatory filing demonstrating that a new physical medical device is similar enough to existing, legally marketed devices that it does not require a full Premarket Approval (PMA) process, which would involve more extensive clinical data. The detailed studies and data requested for AI/ML devices are not typically part of a 510(k) submission for a mechanical implant.

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