(227 days)
The intended use of the Tyber Medical Anatomical Plating System is to draw two or more aligned bone fragments together to facilitate healing and is composed of the following bone plate categories:
Mini-frag/Small Bone System
The Tyber Medical Mini-Frag/Small Bone System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments including, but are not limited to, the hand, wrist, foot and ankle.
The Tyber Medical Mini-frag/Small Bone System is not for Spinal Use.
Foot System
The Tyber Medical Foot System is Indicated for Use in fixation of small bone fragments in the foot (Phalanges and Metatarsals), and medium/ large bones and medium/large bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) for stabilization of fractures, osteotomies, nonunions, malunions, reconstruction of small, medium and large 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, osteotomies, medial malleolar fractures and non-unions of the metaphyseal and diaphyseal 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 Plating System is not for Spinal Use.
The Tyber Medical Anatomical Plating System consists of the following categories:
- Mini-frag/Small Bone System
- Foot System
- Long Bone Fracture System
- Ankle Fracture/Fusion System
Mini-frag/Small Bone System: Offers a variety of plates for fixation of bone fragments, including standard and locking compression plates and screws of varying lengths, thicknesses, and configurations. Plates and screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L). Ancillary instrumentation is available. Offered sterile and non-sterile.
Foot System: Consists of a variety of plates with shapes and sizes designed for internal fixation of small bone fragments of the implants are designed to provide highly anatomic and versatile options for an array of fusions and stabilizations of small bones in the feet. Plates are available in various lengths, with straight, right and left configurations and numerous plate types. Plates and screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L). Ancillary Instrumentation is available. Offered sterile and non-sterile.
Long Bone Fracture System: Consists of a straight low contact locking plate and a 1/3 locking tubular plate. Incorporates both Cortical locking and standard Cortical Non-locking screws. Plates and screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L). Ancillary Instrumentation is available. Offered sterile and non-sterile.
Ankle Fracture/Fusion System: Designed to address a variety of indications in ankle reconstruction mid-shaft and distal tibia/fibula fixation surgery. Composed of various locking plate types. Incorporates both Cortical Locking Screws and standard Cortical Non-locking Screws in various lengths. Plates and screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L). Ancillary Instrumentation is available. Offered sterile and non-sterile.
The provided text is a 510(k) Pre-market Notification for the Tyber Medical Anatomical Plating System. This document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, technological characteristics, and indications for use, rather than presenting clinical study results for specific performance metrics of an AI/ML powered device.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: This document does not specify performance criteria in the context of an AI/ML study, nor does it report specific device performance metrics in comparison to such criteria.
- Sample size used for the test set and the data provenance: There is no mention of a test set for an AI/ML model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant as no AI/ML test set is described.
- Adjudication method for the test set: Not applicable.
- 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 an AI-powered device, so such a study would not be presented here.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
However, I can extract information related to non-clinical testing and the basis for proving substantial equivalence to acceptance criteria, which, in this context, are represented by the performance of predicate devices.
Acceptance Criteria and Study for the Tyber Medical Anatomical Plating System:
1. Table of Acceptance Criteria and the Reported Device Performance:
The "acceptance criteria" for this type of device (metallic bone fixation appliances) are primarily demonstrated through substantial equivalence to legally marketed predicate devices, meaning the new device performs similarly and is as safe and effective. The performance is assessed through non-clinical testing.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary from Nonclinical Testing) |
|---|---|
| Mechanical Performance and Fatigue Endurance (for Plates): Must demonstrate comparable mechanical properties to predicate devices according to established standards. | Testing according to ASTM F382-17, “Standard Specification and Test Method for Metallic Bone Plates,” has been completed on identified worst-case plates. The results demonstrate that the system (Tyber Medical Anatomical Plating System) is substantially equivalent to legally marketed predicates in terms of mechanical performance and fatigue endurance. |
| Mechanical Performance (for Screws): Must be comparable to predicate devices. | The proposed bone screws are comparable to the previously cleared Tyber Medical Trauma Screw System (K133842). These screws have identical major and minor thread diameters and thread profiles per size. No new worst-case scenario has been created, implying equivalent performance to previously cleared screws. |
| Biocompatibility: Materials must be biocompatible and safe for implantation. | Implicitly met by using standard materials (Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L)) that are well-established in similar predicate devices. The document states "similar in design, material, technological characteristics and indications when compared to the predicate devices." |
| Sterility: Must meet sterility requirements if offered sterile. | The system is offered "both sterile and non-sterile for single-use," which implies that appropriate sterilization validation would have been performed for the sterile versions, though details are not provided in this summary. This is a common requirement for medical devices and would be considered part of the overall acceptance criteria for safety and performance. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a numerical count of plates or screws tested. The testing involved "identified worst-case plates" and screws. This implies a representative selection, but not a large "sample size" in the context of a clinical study or AI/ML performance evaluation.
- Data Provenance: The "study" is nonclinical (laboratory bench testing) conducted according to established ASTM standards. The provenance is internal testing performed by or for Tyber Medical LLC.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as this is a nonclinical bench testing submission for a physical medical device, not an AI/ML product requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method for the test set:
This information is not applicable as this is a nonclinical bench testing submission.
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 – This section clearly states "Clinical Test Summary: n/a". The device is a bone plating system, not an AI-assisted diagnostic or treatment planning tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No – This is not an AI/ML device.
7. The type of ground truth used:
For mechanical testing, the "ground truth" is established by the specified parameters and methodologies within the ASTM F382-17 standard and the physical properties of the materials and designs under test. The comparison is against the performance of predicate devices as a benchmark for substantial equivalence.
8. The sample size for the training set:
Not applicable – This is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable – This is not an AI/ML device.
§ 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.