(204 days)
Mini-frag System
The Tyber Medical Mini-frag System is intended for fixation of fractures, nonunions, replantations, and fusions of short bones and short bone fragments including, but are not limited to, the hand, wrist, foot and ankle. The Tyber Medical Mini-frag System is not for Spinal Use.
Foot System
The Tyber Medical Foot System is Indicated for Use in fixation of short bones and short bone fragments in the foot (Phalanges and Metatasals), and long bones and long bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) for stabilization of fractures. joint fusions, osteotomies, nonunions, reconstruction of short and long bones, revision surgeries and replantations in an adult patient. The Tyber Medical Foot System is not for Spinal Use.
Long Bone Fracture System
The Tyber Medical Long Bone Fracture System is intended for osteotomies and non-unions, fixation of fractures of the clavicle, scapula, olecranon, humerus, radius, ulna, fibula.
The Tyber Medical Long Bone Fracture System is not for Spinal Use.
Ankle Fracture/Fusion System
The Tyber Medical Ankle Fracture/Fusion System is Indicated for Use in:
1). Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, corrective osteotomies, non-unions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures;
2). In intra- and extra articular fractures, medial malleolar fractures and non-unions of the metaphyseal region of the distal fibula, and calcaneus;
3). In distal tibia/fibula long bones which include the metaphyseal regions of the tibia and fibula in the ankle.
The Tyber Medical Ankle Fracture/Fusion System is not for Spinal Use.
The Tyber Medical Anatomical Plating System consists of the following categories:
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Mini-frag System
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Foot System
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Long Bone Fracture System
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Ankle Fracture/Fusion System
A brief and concise description of each system is as follows:
Mini-fraq System
The Tyber Medical Mini-frag System offers a variety of bone fragments. The system incorporates a series of standard and locking compression plates and screws of varying lengths, thicknesses, and configurations including 1). Straight Fracture Plates, 2). T-shape Fracture Plates, 3). Y-shape Fracture Plates, 4). Cloverleaf plates, 6). Straight Fusion Plates, 7). Oblique Fracture Plates, 8), Oblique Fracture Compression Plates, 9), Double Y-Shape Plates, 11. Partial Zig-Zag Plates, 12. Mesh Plates
The System will incorporate both Locking Screws and Non-Locking Screws in 2.0mm, 3.0mm and 3.5mm sizes in various lengths. All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with color anodized for sizing.
A full set of Ancillary instrumentation is available with the system. The Tyber Medical Mini-frag System is offered both sterile and nonsterile for single-use.
Foot System
The Tyber Medical Foot System consists of a variety of plates with shapes and sizes designed for internal fixation of short bone fragments of the foot. The implants are designed to provide highly anatomic and versatile options and stabilizations of short bones in the feet. The plates are available in various lengths, with straight, right and left configurations. Plate types consist of 1). TMT-1 Fusion Plates, 2). Open Wedge Plates, 3). Cuboid Plates, 5). Lateral Talar Neck Plates, 6). Akin Plates, 7). 5th Metatarsal Jones Fracture Plates, 8). 5th Metatarsal Fracture Compression Plates, 9). 5th Metatarsal Avulsion Fracture Plates, 10). Medial Talar Neck Plates, 11). Distal Medial Column Plates, 13). ORIF Standard Calcaneal Plates, 14). Rectangular Plates, 15). X -Plates, 16). Cotton Plates, 17). Dwyer Plates, 19). MTP Fusion Revision Plates, 20). Stepped Lapidus Plates, 21). Plantar TMT Plates, 22). Medial Column Plates, 24). TMT-I Medial Fusion Plates, 25). Sinus Tarsi Plates, 26). 1st 2nd Ray Lisfranc Joint Plates, 27). 2nd and 3rd Ray Lisfranc Joint Plates, 28). Navicular Cuneiform Plates, 30). Talonavicular Plates.
The system will incorporate both locking and Non-locking screws. All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with color anodized for sizing.
A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Foot System is offerile and non-sterile for single-use.
Long Bone Fracture System
The Tyber Medical Long Bone Fracture System consists of a straight low contact locking plate and a 1/3 locking tubular plate. The system will incorporate both Cortical locking and standard Cortical Non-locking screws. All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws are composed of Ti-6Al-4V ELL (ASTM F136) or Stainless Steel (316L) with color anodized for sizing.
A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Long Bone Fracture System is offered both sterile and non-sterile for single-use.
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 is composed of various locking plate types which include 1). Posterior Tibia Plate, 2). Fibula Plate, 3). Medial Tibia Plate, 5). Anterolateral Tibia Plate, 7). Medial Malleolus Plate, 7). Medial Malleolus Plate, 8). Fibula Hook Plate, Straight, 9). Fibula Hook Plate, Anatomic, 10). Anterior TT Plate, 12). Anterolateral TT Plate, 13). Lateral TT Plate, 14). Lateral TTC Plate, 15). Posterior TTC Plate, 17). Posteromedial Tibia Plate, 17). Posteromedial Tibia Plate, 19). Posterior Fibular Plate.
The System will incorporate both Locking Screws and Non-locking Screws in various lengths. All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with color anodized for sizing.
A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Ankle Fracture/Fusion System is offered both sterile and non-sterile for single-use.
This document is a 510(k) premarket notification for the Tyber Medical Anatomical Plating System. It's important to note that this document is for a medical device (bone fixation appliance), not a software or AI-driven diagnostic device. Therefore, the questions related to AI/algorithm performance metrics (such as sensitivity, specificity, MRMC studies, ground truth establishment for training data, etc.) are not applicable to this type of submission.
The acceptance criteria for a device like this primarily revolve around mechanical performance, material compatibility, and safety, demonstrated through non-clinical testing, and substantial equivalence to a legally marketed predicate device.
Here's an attempt to answer the questions based on the provided text, while explicitly stating when a question is not applicable:
1. A table of acceptance criteria and the reported device performance
Since this is a mechanical medical device and not a diagnostic algorithm, the "acceptance criteria" are not reported in terms of diagnostic performance metrics like accuracy, sensitivity, or specificity. Instead, they relate to mechanical integrity and safety. The document states a comprehensive evaluation of all plates and screws was performed to ensure no "worse case" was introduced, and MR Conditional testing was conducted.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Mechanical Performance | Comprehensive engineering analysis comparing new plates and screws to predicate devices. No new "worse case" introduced. (Implies mechanical equivalence and safety). |
| Material Compatibility | Composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L). (Implies biocompatibility and established material properties). |
| MR Compatibility | MR Conditional. |
- Magnetically induced displacement force (ASTM F2052) - Passed
- Magnetically induced torque (ASTM F2213) - Passed
- MR image artifact (ASTM F2119) - Passed
- Radio frequency induced heating (ASTM F2182) - Passed |
| Sterilization | Offered both sterile and non-sterile for single-use. (Implies meeting sterilization validation standards, though not explicitly detailed here). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This question is not applicable. This submission concerns a physical medical device (bone fixation system), not a data-driven diagnostic tool or AI algorithm. There is no "test set" of data in the sense of medical images or patient records. The testing performed is non-clinical (engineering analysis, material testing, MR testing).
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 question is not applicable. "Ground truth" in the context of diagnostic algorithms refers to definitively proven disease states or findings. For this device, "ground truth" relates to the physical and mechanical properties of the implants, which are established through engineering standards and testing, not expert consensus on medical images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable. There is no "adjudication method" involved as there is no diagnostic or interpretive element requiring human readers/experts to resolve discrepancies in a dataset.
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 question is not applicable. MRMC studies are used for evaluating diagnostic imaging systems and AI algorithms. This device is a surgical implant, not a diagnostic tool, and there is no AI component.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by engineering standards, material specifications (e.g., ASTM F136 for Ti-6Al-4V ELI), and validated test methodologies for mechanical properties, material properties, and MR compatibility (e.g., ASTM F2052, F2213, F2119, F2182).
8. The sample size for the training set
This question is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This question is not applicable. As there is no training set, there is no ground truth established for one.
§ 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.