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The TM Plating System is intended to bridge or otherwise stabilize bone fragments to facilitate healing. It is composed of the following indication categories:

I. TM Plating System - Complete Articular
The TM Plating system is indicated for the treatment of nonunions, osteotomies, and fractures of the femur and tibia. This includes simple, comminuted, lateral wedge, bicondylar combination of lateral wedge and depression, diaphyseal, epiphyseal, extra- and intra-articular fractures, periprosthetic, and fractures with associated shaft fractures.

II. TM Plating System - Partial Articular
The partial articular (also called buttress or anti-glide) proximal tibia plates are indication and reduction of proximal tibia fragments and treatment of partial articular fractures of the proximal tibia (AO/OTA Fracture Classifications Type B). The partial articular straight plates are indication and reduction of long bone fragments and partial articular fractures of the distal and proximal tibia (AO/OTA Fracture Classifications Type B), and for fracture fixation of the fibula.

The system presented in this 510(k) submission consists of various bone plates, locking screws, and instruments. The TM Plating System consists of the following indication categories:

Tyber Medical Anatomical Plating System

1. Complete Articular (All OA/OTA fracture classification types)
2. Partial Articular (OA/OTA fracture classification type B)

A description of each category is provided below:

Tm Plating System – Complete Articular
The TM System is designed to address a variety of indications for long bones of the tibia and femur. The system is composed of a Straight Plate and a Lateral Proximal Tibia Plate.

TM Plating System - Partial Articular
The Partial Articular plates of TM Plating System are designed to address specific indications for long bones of the tibia and fibula. These buttress (anti-glide) plates are designed for stabilization of bone fragments, and are intended to treat OA/OTA fracture classification type B fractures only.

The system will incorporate variable angle locking and non-locking screws in various lengths and diameters.

All plates and screws are composed of Ti-6Al-4V ELI (ASTM F136).

A full set of Ancillary Instrumentation is available with the system. The instruments are not specific to the system.

The TM Plating System plates are offered nnly. The screws offered in this system have already been cleared in K222465 and are offered in both sterile and non-sterile.

The provided document is a 510(k) premarket notification letter from the FDA for the "TM Plating System." This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device. The document describes the device, its intended use, and its technological comparison to predicate devices, focusing on mechanical testing. Crucially, this document states: "No clinical testing was performed." This means that the device was not evaluated through a study involving human subjects or real-world clinical data to prove its performance in meeting specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study findings, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable or cannot be extracted from this document, as they were not part of the substantial equivalence determination process for this device.

Here's a breakdown of the information that can be extracted, and what cannot:

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

• Acceptance Criteria: Not explicitly stated in terms of clinical performance or diagnostic accuracy, as no clinical testing was performed. The device's "performance" was assessed through mechanical testing.
• Reported Device Performance: The document states: "The mechanical testing for the subject devices were performance with the FDA currently-recognized version of ASTM F382 for metallic bone plates." This implies that the device met the requirements of ASTM F382 for metallic bone plates, but specific numerical results or acceptance thresholds for this standard are not provided. The conclusion is that "The TM Plating System is substantially equivalent to the predicate devices in material, basic design features, intended use, operation and performance."

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

• Sample Size for Test Set: Not applicable. No clinical test set. Mechanical testing would involve a sample of the physical devices, not a test set of data.
• Data Provenance: Not applicable. No clinical data was used.

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 clinical test set requiring expert-established ground truth.

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

• Not applicable. No clinical test set requiring adjudication.

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

• No. The document explicitly states "No clinical testing was performed." This device is a bone plating system, not an AI-assisted diagnostic tool, so an MRMC study is not relevant to its type.

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

• No. This device is a physical bone plating system, not an algorithm.

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

• Not applicable. No clinical ground truth was established as no clinical testing was performed. For mechanical testing, the "ground truth" would be the specifications and requirements of ASTM F382.

8. The sample size for the training set

• Not applicable. No training set as no clinical algorithm or AI was developed.

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

• Not applicable. No training set and therefore no ground truth for it.

In summary: The K233017 submission for the "TM Plating System" relies on demonstrating substantial equivalence to predicate devices through mechanical testing according to ASTM F382, rather than through clinical studies involving human subjects or AI performance evaluations. Therefore, the requested information pertaining to clinical studies, acceptance criteria for such studies, and ground truth establishment is not available in this document.

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Wright's EVOLVE® TRIAD™ Plating System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, radius and ulna.

The ORTHOLOC™ Mini polyaxial locking screws are intended for use with Wright's plates manufactured from implant grade stainless steel that accept ORTHOLOC™ Mini polyaxial locking screws.

The EVOLVE® TRIAD™ Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device, including the clavicle, scapula, long bones (ulna, radius and humerus) and small bones (metacarpals, metatarsals, and phalanges).

The EVOLVE® TRIAD™ Plating System consists of 9 plates, each belonging to 1 of 3 general categories-radial head, radial neck, and coronoid-based on the contouring of each plate. The radial head and radial neck plates feature poly-axial locking screw holes, the coronoid plates feature non-locking screw holes only.

All EVOLVE® TRIAD™ plates are made from Stainless Steel. The radial head and radial neck plates accept the 2.0mm ORTHOLOC™ Mini polyaxial locking screws and the 2.0mm EVOLVE® TRIAD™ non-locking bone screws. The coronoid plates accept the 2.0mm EVOLVE® TRIAD™ non-locking bone screws.

This document describes a 510(k) premarket notification for the "EVOLVE® TRIAD™ Plating System and EVOLVE® TRIAD™ Bone Screws". This is a medical device for bone fixation, and the application aims to demonstrate "substantial equivalence" to existing legally marketed predicate devices, rather than proving novel clinical effectiveness through new clinical trials. Therefore, the "study" referred to in the prompt is a non-clinical, comparative engineering study, not a clinical trial in the traditional sense of human subjects.

Here's a breakdown of the requested information based on the provided text:

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

Note: The document states the new device "can be expected to perform at least as well as" the predicate devices. Specific quantitative acceptance thresholds (e.g., minimum torque values, maximum displacement) are not provided in this summary, but would have been part of the detailed predicate comparison within the full Premarket Notification.

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

• Sample Size: The document does not specify the exact number of plates or screws tested. It refers to "worst-case plate analysis" and "screw and construct" testing, which implies a representative sample was used for each test type.
• Data Provenance: The data is from non-clinical bench testing conducted by the manufacturer, Wright Medical Technology, Inc., located in Arlington, TN, USA. This is prospective testing performed specifically for the 510(k) submission.

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)

This is not applicable for this type of device submission. The "ground truth" for demonstrating substantial equivalence of a bone fixation system is established through engineering principles and standardized mechanical testing as outlined by relevant ASTM or ISO standards, not expert clinical consensus on images or pathology. The "experts" involved would be the engineers and quality control personnel at Wright Medical Technology, Inc., who designed and conducted the tests.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or diagnostic results where human agreement is required to establish a "ground truth." For non-clinical bench testing, the results are objectively measured and compared against established engineering criteria or predicate device performance. The "adjudication" is inherent in the objective measurement and analysis of the mechanical tests performed.

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

This is not applicable. An MRMC study is relevant for diagnostic imaging devices involving human interpretation. This submission is for an orthopedic implant and does not involve AI or human "readers" interpreting cases.

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

This is not applicable. This device is a passive orthopedic implant, not an algorithm or AI system.

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

The "ground truth" is based on objective engineering measurements from mechanical bench tests (e.g., torque to failure, pull-out strength). These measurements are then compared against the performance of legally marketed predicate devices to establish substantial equivalence.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

This is not applicable. As there is no training set, there is no ground truth to establish for one.

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