(59 days)
The intended use of the Tyber Medical Anatomical Plating System is to draw two or more aligned bone fragments together to facilitate healing in an adult patient and is composed of the following bone plate categories:
I. Forefoot System:
The Tyber Medical Forefoot Plating System is Indicated for Use in fixation of small bone fragments in the foot (Phalanges and Metatarsals) for stabilization of fractures, joint fusions, osteotomies, malunions, reconstruction of small bones, revision surgeries and replantations in an adult patient. The Tyber Medical Forefoot System is not for Spinal Use.
II. Mid & Hindfoot System:
The Tyber Medical Mid & Hindfoot Plating System is Indicated for Use in fixation of medium/large bones and medium/ large bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) for stabilization of fractures, joint fusions, osteotomies, nonunions, reconstruction of medium/large bones, revision surgeries and replantations in an adult patient.
The Tyber Medical Mid & Hindfoot System is not for Spinal Use.
III. Ankle Fracture System:
The Tyber Medical Ankle Fracture System is Indicated for Use in:
I). 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;
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 System is not for Spinal Use.
The Tyber Medical Anatomical Plating System consists of the following categories:
- Forefoot System
- Mid & Hindfoot System
- Ankle Fracture System
A brief and concise description of each system is as follows:
Forefoot System
The Tyber Medical Forefoot System is designed to address a variety of indications in forefoot reconstruction fixation/osteotomy surgery. The system is composed of many locking plate types which include: 1). Straight Fracture Plates, 2). T-Shaped Fracture Plates, 3). Y-Shape Fracture Plates, 4). L-Shaped Fracture Plates, 5). Cloverleaf Fracture Plates, 6). TMT 1 Medial Fusion Plates, 7). Open Wedge Fusion Plates, 8). MTP Fusion Plates, 9). MTP Fusion Revision Plates, and 10). Dorsal TMT 1 Step Fusion Plates, - in various plate lengths, Right & Left versions. The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 2.0mm, 2.5mm, 3.0mm and 3.5mm sizes in various lengths. All plates are composed of Medical Grade CP Titanium material (to ASTM F67) with an Anodized Type II surface treatment. All screws are composed of Medical Grade 6-4 Alloyed Titanium material (to ASTM F136) color anodized for sizing.
A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Forefoot System is offered both sterile and non-sterile for single-use.
Mid and Hindfoot System
The Tyber Medical Mid & Hindfoot System is designed to address a variety of indications in midfoot & hindfoot reconstruction fixation/osteotomy surgery. The system is composed of many locking plate types which include:
1). Straight Fracture/Fusion Plates, 2). T-Shaped Fracture/Fusion Plates, 3). L-Shaped Fracture/Fusion Plates, 4). Cloverleaf Fracture/Fusion Plates, 5). X-Shaped Fracture/Fusion Plates, 6). Retangular Fracture/Fusion Plates, 7). Cotton Osteotomy Plates, 8). Dwyer Step Plates, 9). Evans Osteotomy Plates, 10.) Plantar TMT Plates, 11). Distal Medial & 3 - 4 Column Plates and 11). ORIF & Standard Calcaneal Plates - in various plate lengths, Right & Left versions.
The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 3.0mm, 3.5mm and 4.0mm sizes in various lengths. All plates are composed of Medical Grade CP Titanium material (to ASTM F67) with an Anodized Type II surface treatment. All screws are composed of Medical Grade 6-4 Alloyed Titanium material (to ASTM F136) color anodized for sizing.
A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Mid and Hindfoot System is offered both sterile and non- sterile for single-use.
Ankle Fracture System
The Tyber Medical Ankle Fracture 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 many locking plate types which include:
1). Distal Fibula Plates, 2). Medial Distal Tibia Plates, 3). AnteroLateral Distal Tibia Plates, 4). Posterior Distal Tibia T-Plates, 5). Straight Low Contact Plates, and 6). Straight 1/3 Tubular Plates – in various plate shapes, lengths, Right & Left versions. The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 2.8mm, 3.0mm, 3.5mm and 4.0mm sizes in various lengths. All plates are composed of either Medical Grade CP Titanium (to ASTM F67) or 6-4 Alloyed Titanium (to ASTM F136) materials with an Anodized Type II surface treatment. All screws are composed of Medical Grade 6-4 Alloyed Titanium material (to ASTM F136) color anodized for sizing.
A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Ankle Fracture System is offered both sterile and non- sterile for single-use.
The provided document is a 510(k) Premarket Notification from the FDA for the Tyber Medical Anatomical Plating System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials as would be the case for a novel drug or high-risk medical device.
Therefore, the document does not contain acceptance criteria related to device performance in a clinical study, nor does it describe a study proving the device meets such criteria.
Instead, the submission asserts that the Tyber Medical Anatomical Plating System is "substantially equivalent" to a predicate device, the BioPro Foot Plating Systems (K162674). This substantial equivalence is based on similarities in design, material, technological characteristics, and indications for use.
Here's a breakdown of why the requested information cannot be fully provided from this document:
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Acceptance Criteria & Reported Device Performance: This document does not describe specific performance metrics (e.g., sensitivity, specificity, accuracy, etc.) for the device that would be typically established in a study. The acceptance criteria for a 510(k) submission revolve around demonstrating equivalence to a predicate, not absolute clinical performance.
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Study That Proves Device Meets Acceptance Criteria: No clinical study is described that tests the Tyber Medical Anatomical Plating System against specific performance criteria. The submission explicitly states: "Nonclinical Testing Summary: There have been no changes to the design, material, technological characteristics or indications of the plating systems since receiving clearance in K162674. Therefore, nonclinical testing is not provided in this submission. Clinical Test Summary: n/a". This indicates that no new nonclinical or clinical testing was performed for this specific 510(k) submission to demonstrate performance.
Given this context, I cannot fill out the detailed table and answer the questions pertaining to clinical study design, sample sizes, expert involvement, and ground truth establishment, as the information is not present in the provided text.
The closest information related to "acceptance criteria" is that the device is considered substantially equivalent if it has the "same in design, material, technological characteristics and indications" as the predicate device. The "study" for this type of submission is primarily the comparison analysis and documentation provided to the FDA to support the claim of substantial equivalence.
§ 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.