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The Tyber Medical Mini-Frag System is indicated for fixation of fractures, osteotomies, non-unions, malunions, replantations, and fusion of short bones and small fragments of bone including, but not limited to, the hand, wrist, foot, and ankle. The Mini-Frag System is also intended for reduction and stabilization of non-load bearing long bone fragments.

The Tyber Medical Mini-Frag System is not for spinal use.

Ankle Fracture/Fusion System

The Tyber Medical Ankle Fracture/Fusion System is indicated for use in:

· Fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular
fractures, corrective osteotomies, non-unions, intra- and extra-articular and distal tibia fractures with a shaft extension, and malleolar fractures;

· In intra- and extra-articular fractures, osteotomies, medial malleolar fractures and non-unions of the metaphyseal and diaphyseal region of the distal fibula, and calcaneus;

In distal tibia/fibula long bones which include the metaphyseal region of the tibia and fibula in the ankle.
The Tyber Medical Ankle Fracture/Fusion System is not for spinal use.

Device Description

The Tyber Medical Anatomical Plating System consists of this submission, with a brief description of each system below:

Tyber Medical Mini-Frag System
Tyber Medical Ankle Fracture/Fusion System

Mini-Frag System

The Tyber Medical Mini-Frag System offers a variety of plating options for the fixation of bone fragments. The system incorporates plates of various lengths, thicknesses, and configurations. The system also incorporates standard (non-locking) and locking screws of varying lengths and diameters. The system incorporates optional bone screw washers for non-locking screws at a range of sizes. Additionally, specialized trays are available specific to the Tyber Medical Mini-Frag System. Other ancillary instrumentation is available that is not specific to the Tyber Medical Mini-Frag System.

The plates subject to this submission are composed of Ti-6Al-4V ELI (ASTM F136) with an anodized Type Il surface treatment. The screws and bone screw washers are composed of Ti-6Al-4V ELI (ASTM F136) with color anodizing for sizing.

The subject devices are offered non-sterile.

Ankle Fracture/Fusion System

The Tyber Medical Ankle Fracture/Fusion System is designed to address a variety of indications in ankle reconstruction mid-shaft and distal tibia/fibula fixation surgery. The system incorporates plates of varying lengths, thicknesses, and configurations. The system also incorporates standard (non-locking screws of varying lengths and diameters. The system incorporates optional bone screw washers for non-locking screws at a range of sizes. Additionally, specialized drill guides and trays are available specific to the Tyber Medical Ankle Fracture/Fusion System. Other ancillary instrumentation is not specific to the Tyber Medical Ankle Fracture/Fusion System.

AI/ML Overview

This FDA 510(k) summary describes a submission for the Tyber Medical Anatomical Plating System, which is a line extension to a previously cleared device. As such, the focus of the submission is to demonstrate substantial equivalence to the predicate devices rather than proving the device meets novel acceptance criteria through a new clinical study.

Therefore, the information typically found in a study proving acceptance criteria (like sample size, ground truth establishment, MRMC studies, etc.) is not applicable in this case. The submission relies on non-clinical testing and comparison to predicate devices.

Here's the breakdown based on your request, highlighting what is and isn't applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a line extension of an existing device, the "acceptance criteria" are primarily related to demonstrating equivalence to the predicate devices for the specified indications for use and technological characteristics. The performance is assessed through non-clinical testing.

Acceptance Criterion (Demonstrating Equivalence)	Reported Device Performance (Non-Clinical Testing)
Indications for Use: Must be the same as the predicate devices.	Met: The subject device (Tyber Medical Anatomical Plating System - line extension) has the same indications for use as the predicate device(s). This is explicitly stated in the "Indications for Use Comparison" section: "The indications for use are the same for both the subject and predicate device(s)."
Intended Use: Must be the same as the predicate devices.	Met: The subject device has the same intended use as the predicate device(s).
Material: Must be the same or comparable, with performance demonstrated if different.	Met: Plates are composed of Ti-6Al-4V ELI (ASTM F136) with an anodized Type II surface treatment. Screws and bone screw washers are composed of Ti-6Al-4V ELI (ASTM F136) with color anodizing. These materials are characteristic of orthopedic implants and are the same as or comparable to those in the predicate devices, as implied by the statement: "The Tyber Medical Anatomical Plating System are substantially equivalent to the previously cleared Tyber Medical Anatomical Plating System in regards to... material."
Design and Operational Principles: Must be similar to the predicate devices, with performance demonstrated if there are differences.	Met: The line extension includes "additional plates, trays, and instrumentation to the Tyber Medical Anatomical Plating System." The submission states: "The additional plates, screws, and accessory instrumentation have similar technological characteristics as the previously cleared predicate devices." It also states: "The additional plates and screws were compared using analysis to the predicate devices in K222465. The submitted comprehensive evaluation of the subject plates and screws shows that no new worst case is being introduced in this line extension."
Biocompatibility: (Implicitly met by using established materials)	Met: Although not explicitly detailed in the summary, titanium alloys (Ti-6Al-4V ELI) are well-established biocompatible materials for orthopedic implants.
Mechanical Performance: (Implicitly met by comparison and analysis to predicate devices)	Met: "The additional plates and screws were compared using analysis to the predicate devices in K222465. The submitted comprehensive evaluation of the subject plates and screws shows that no new worst case is being introduced in this line extension." This implies that the mechanical properties of the new components are within acceptable ranges established by the predicate device.
MR Safety: Must be characterized if the device could be exposed to MR environments.	Met: An MR assessment was performed in accordance with ASTM F2052 (magnetically induced displacement force), ASTM F2213 (magnetically induced torque), ASTM F2182 (RF-induced heating), and ASTM F2119 (image artifacts). The device is deemed MR Conditional.
Sterilization: (Implicitly addressed for non-sterile devices)	Met: The subject devices are "offered non-sterile," indicating the sterilization methods are not a new concern but rather an established state for the device.

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

Not Applicable. This submission relies on non-clinical testing and comparison to predicate devices. There is no "test set" of patient data in the context of a clinical study for this 510(k) line extension. The "test set" would refer to the components (plates, screws) that underwent mechanical and MR testing.

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

Not Applicable. There is no "ground truth" establishment by experts in the context of a clinical study for this 510(k) line extension. The ground truth for mechanical behavior comes from engineering principles, ASTM standards, and the performance characteristics of the legally marketed predicate devices.

4. Adjudication method for the test set

Not Applicable. As there is no clinical "test set" involving human interpretation or subjective assessment, no adjudication method 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 device is a metallic bone fixation system (plates and screws), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI assistance are not relevant.

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

Not Applicable. This device is a metallic bone fixation system, not an algorithm or AI.

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

Engineering Standards and Predicate Device Performance: The "ground truth" for this device's performance is established by reference to recognized ASTM International standards for mechanical testing and MR compatibility (e.g., ASTM F136 for material, ASTM F2052, F2213, F2182, F2119 for MR safety) and the established safety and effectiveness of the legally marketed predicate devices. The comprehensive evaluation showed "no new worst case is being introduced."

8. The sample size for the training set

Not Applicable. This submission is for a medical device (bone plates and screws), not an AI algorithm. There is no "training set."

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

Not Applicable. As there is no AI algorithm or training set, this question is not relevant.

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K Number

K233017

Device Name

TM Plating System

Manufacturer

Tyber Medical, LLC.

Date Cleared

2023-12-20

(89 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K222465,K222381,K210837

Intended Use

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.

Device Description

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.

AI/ML Overview

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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