(89 days)
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
- Complete Articular (All OA/OTA fracture classification types)
- 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.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.