Search Results

The DePuy Synthes Reconstructive Plates 'Y' Plates are indicated for pelvic and acetabular reconstructive surgery and the reduction of fractures in the distal humerus, the clavicle, and the scapula.

The DePuy Synthes Anatomical Locking Plate System indicated to treat fractures (including but not limited to) the radius, ulna, humerus, tibia, fibula, femur.

The DePuy Synthes CABP System is a plate and screw system intended to treat fractures of the proximal humerus and distal tibia. Proximal humerus fractures include two-part greater tubercle fractures and fracture dislocations, two-part surgical neck fractures and fracture dislocations, three-part fractures or fracture dislocations, fractures in osteopenic bone, and nonunions and malunions. Distal tibia fractures include acute fractures in osteopenic bone, and nonunions and malunions.

The DePuy Synthes 3.5 mm 90° Cannulated Limited Contact Angled Blade Plates are intended for the fixation of fractures and non-unions of the proximal humerus and distal tibia.

The DePuy Synthes Large Fragment DCL is intended for fixation of various long bones, such as the humerus, femur and tibia. Also for use in fixation of osteopenic bone and fixation of non-unions or malunions.

The DePuy Synthes Large Fragment Locking Compression Plate (LCP) System - T Plate is intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. Also for use in fixation of osteopenic bone and fixation of non-unions and malunions.

The DePuy Synthes Curved Reconstruction Plate is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone as a part of the DePuy Synthes Small Fragment DCL System.

The DePuy Synthes One-Third Tubular Plate is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone as a part of the DePuy Synthes Small Fragment DCL System.

The DePuy Synthes LCP Proximal Humerus Plate is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

The DePuy Synthes Pilon Plate is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia.

DePuy Synthes TomoFix™ Osteotomy System is intended for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia and lateral distal femur, treatment of bone and joint deformities, and malalignment caused by injury or disease such as osteoarthritis.

The DePuy Synthes 3.5 mm Broad LCP & 4.5 mm LCP Distal Humerus Plates are indicated for fractures of the distal humerus.

The DePuy Synthes Clavicle Hook Plate is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

The DePuy Synthes 3.5 / 4.5mm LCP® Metaphyseal Plate is intended for the fixation of various long bones, excluding the femur. It is also for use in fixation of osteopenic bone and fixation of nonunions or malunions.

The DePuy Synthes 3.5 mm LCP Distal Humerus System is indicated for intraarticular fractures of the distal humerus, commninuted supra-condylar fractures, osteotomies, and non-unions of the distal humerus.

The DePuy Synthes LCP Proximal Humerus Plate, Long is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

The DePuy Synthes Curved Broad Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of peri-prosthetic fractures, osteopenic bone and non-unions or malunions. The DePuy Synthes Curved Condylar Plates are intended for buttressing multifragmentary distal femur fractures, including: supracondylar, intra-articular and extra-articular condylar fractures, peri-prosthetic fractures and fractures in normal or osteopenic bone, nonunions/malunions, and osteotomies of the femur.

The DePuy Synthes Low Profile Reconstruction Plates are intended for pelvic and acetabular reconstruction and fixation of fractures of the distal humerus, clavicle, and scapula.

The DePuy Synthes 3.5 mm Spring Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal fibula.

The DePuy Synthes 3.5 mm LCP Hook Plate is indicated for fractures, osteotomies and nonunions of small bones including the ulna, radius, tibia and fibula, particularly in osteopenic bone.

The DePuy Synthes 3.5 mm LCP Periarticular Proximal Humerus Plates are indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

The DePuy Synthes 3.5 mm Locking Compression Plate (LCP) System: The DePuy Synthes 3.5 mm LCP is indicated for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone for adult patients. These plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients. The DePuy Synthes 4.5 mm Locking Compression Plate (LCP) System: The DePuy Synthes 4.5 mm LCP is indicated for fixation of various long bones, such as the humerus, femur and tibia and for use in fixation of peri-prosthetic fractures, osteopenic bone and fixation of non-unions or malunions in adult patients. These plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients.

The DePuy Synthes 3.5mm Locking Attachment Plate is intended for use with DePuy Synthes LCP plates to augment the stabilization of fractures, including periprosthetic fractures and fractures in the presence of intramedullary implants, in the femur, tibia and humerus, particularly in osteopenic bone.

The DePuy Synthes 3.5 mm Curved Narrow and Broad LCP Plates are intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia and fibula, particularly in osteopenic bone for adult patients. The DePuy Synthes 4.5 mm Curved Narrow and Broad LCP Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of periprosthetic fractures, osteopenic bone, and non-unions or malunions in adult patients. The DePuy Synthes 3.5 mm and 4.5 mm Curved Narrow and Broad LCP Plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients.

The DePuy Synthes 2.7 mm / 3.5 mm VA-LCP Anterior Clavicle Plate System is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.

The DePuy Synthes 3.5 mm LCP Clavicle Plate System is indicated for fixation of fractures, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.

The DePuy Synthes Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused or in which the growth plates will not be crossed by the plate system. Specifically, Distal humerus plates are indicated for intra-articular fractures, commninuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus. Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.

The DePuy Synthes Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures. malunions and non-unions of the distal humerus. Olecranon and Proximal ulna plates are indicated for fractures, malunions and non-unions of the olecranon and proximal ulna.

The DePuy Synthes TOMOFIX Osteotomy System is intended for osteotomies, treatment of bone and joint deformities, fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia. Specifically, -The TOMOFIX Medial Proximal Tibia Plates are indicated for open- and close-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the medial proximal tibia -The TOMOFIX Lateral Proximal Tibia Plates are indicated for open- and closed-wedge osteotomies fixation of fractures. and malalignment caused by injury or disease, such as osteoarthritis, of the lateral proximal tibia -The TOMOFIX Lateral Distal Femur Plates are indicated for open- and closed-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the lateral distal femur -The TOMOFIX Medial Distal Femur Plates are indicated for closed-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the medial distal femur

The DePuy Synthes 2.4/2.7 mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long is intended for intra- and extra-articular fractures, osteotomies, nonunions and malunions of the distal radius, with or without extension into the radial diaphysis in adults and adolescents (12-21) where the growth plates have fused or will not be crossed, and the following adolescent distal radius fractures: - Intra-articular fractures exiting the epiphysis - Intra-articular fractures exiting the metaphysis - Physeal crush injuries - Any injuries which cause growth arrest to the distal radius

The 3.5 mm Reconstruction Plate is available in multiple lengths. It has a smooth underside, is notched between the screw holes and can be adjusted (contoured) in three dimensions. The screw holes are designed to provide limited bidirectional compression of the fracture via the tapered entrance of the hole, and accept 3.5 mm cortex screws. The 4.5 mm Reconstruction Plate has a smooth underside, is notched between the screw holes and can be adjusted (contoured) in three dimensions. The oval holes are designed to provide limited bidirectional compression of the fracture via the tapered entrance of the hole which allows 25° longitudinal and 7° lateral angulation of screws. It is available in multiple lengths and accepts 4.5 mm cortex and 6.5 mm cancellous screws. The 3.5 mm Curved Reconstruction Plate is available in multiple lengths. It has a smooth underside and is notched between screw holes and can be adjusted (contoured) in three dimensions. The screw holes are designed to provide limited bidirectional compression of the fracture via the tapered entrance of the hole and accept 3.5 mm cortex screws.

The Anatomical Locking Plate System utilizes a locking feature that secures the screw to the plate, enabling stable fixation to be achieved via unicortical fixation. The plates are available with and without an anatomically contoured head, in a variety of sizes. The head of the screw has a round cross section with a conical underside to fit into the plate. The underside has a tapered thread to match the design of the holes in the plate. The screws are available in thread diameters from 3 mm to 5 mm, in a variety of lengths.

The CABP is a straight plate with a blade at the head to allow for better fixation in the head of the humerus or in the distal tibia. The blade of the plate is cannulated to fit over a guide wire, allowing for the adjustment of the wire placement several times without adversely affecting the final result. There are cuts in the undersurface of the plate the surface area of the plate in contact with bone. The area of contact between the plate and the bone is decreased in an effort to reduce damage to the cortical blood supply under the plat, and resultant reduction in damage-induced porosis and remodeling of the bone near the plate undersurface. Plate undercuts also make the bending properties of the plate more uniform, which facilitate contouring. The plate has round and dynamic compression screw holes, accepts 4.5mm and 6.5 mm screws, is available in multiple blade lengths, and is manufactured from stainless steel and commercially pure titanium.

The DePuy Synthes 3.5 mm 90° Cannulated LC-ABP provides stable fracture fixation and rotational control for fractures of the proximal humerus and distal tibia. The plates feature a low profile limited contact dynamic compression plate (LC-DCP®) design and dynamic compression unit (DCU) screw holes. The blade portion of the plate is cannulated to accept a 2.0 mm guide wire. The plates are available in various sizes to accommodate varying patient anatomy.

The Large Fragment DCL system consists of limited-contact profile plates in broad and narrow sizes, which include combination dynamic compression/locking screw holes. The plates accept 4.5 mm cortex, 6.5 mm cancellous, 4.5 mm cannulated, 7.0 mm cannulated, and 5.0 mm locking screws. This device is manufactured in either stainless steel or titanium.

The DePuy Synthes Locking Compression Plate (LCP) System - T Plate is a buttress plate and screw system. The primary feature of the plate is round holes combined with locking screw holes. The locking screws form a locked, fixed angle construct with the plate, while the standard screws facilitate reduction and create compression between the plate and bone. The plates accept 4.5 mm cortex, 6.5 mm cancellous, 4.5 mm cannulated, 7.0 mm cannulated, 7.3 mm cannulated, 4.0 mm and 5.0 mm locking screws.

The DePuy Synthes Curved Reconstruction Plate line extension is a pre-curved version of the currently marketed Straight Locking Reconstruction Plate. Both of these plates will be included as part of the DePuy Synthes Small Fragment DCL System. Both the curved and straight plates have the same intended use and there is no change in safety or efficacy.

The DePuy Synthes One-Third Tubular DCL Plate line extension is a threaded version of the currently marketed Synthes Third Tubular Plate. The threaded plates will accept locking screws and therefore can be included as part of the Small Fragment DCL System. The new plates have the same intended use as other plates in the system and there is no change in safety or efficacy.

The DePuy Synthes LCP Proximal Humerus Plates are designed to match the anatomy of the proximal humerus. These plates can be applied to either the right or left humerus. The proximal portion of each plate has threaded holes that accept 3.5 mm or 2.7 mm screws. The distal portion of the plate has combination holes that allow the option of using 3.5 mm locking or cortex screws, or 4.0 mm cancellous screws to accomplish plate fixation. These plates will be offered as an addition to the DePuy Synthes Small Fragment LCP (formerly DCL) System.

The DePuy Synthes Pilon Plate is a metal plate that offers screw to plate locking designed for various fracture modes of the distal end of the tibia.

The TomoFix™ Osteotomy System consists of five different titanium plates with locking and combination holes. There are two plates (left and right) for the lateral distal femur, 2 plates (left and right) for the lateral proximal tibia, and 1 plate for the medial proximal tibia.

The DePuy Synthes 3.5 mm Broad LCP & 4.5 mm Broad LCP Distal Humerus Plates are contoured to match the anatomy of the distal humerus with a limited contact low profile design. The plate has dynamic compression holes combined with locking holes which accept 3.5 & 4.5 mm cortex, 3.5 & 4.5 mm self-tapping cortex, 3.5 mm shaft, 3.5,4.0, & 5.0 mm locking, and 4.0 mm cancellous screws. The plates are available in various lengths.

The DePuy Synthes Clavicle Hook Plate is an anatomically designed L-shaped plate featuring a distal joint bridging hook with a rounded end. The shaft of the plate contains either dynamic compression screw holes or LCP plate holes. The plates accept 3.5 mm cortex, 4.0 mm cancellous and 3.5 mm locking screws (LCP Clavicle Hook Plate only).

The DePuy Synthes 3.5 / 4.5 mm LCP® Metaphyseal Plates are contourable to match the anatomy, have a limited contact design, and are tapered at the plate head. The 3.5 / 4.5 mm metaphyseal plates feature combination dynamic compression / locking screws holes (combi-holes). The plates in this system accept 3.5 / 4.5 mm cortex, 3.5, 4.0, & 5.0 mm locking, and 4.0 mm or 6.5 mm cancellous screws. The plate also has a 2.0 mm hole for preliminary fixation with k-wires.

The DePuy Synthes 3.5 mm LCP Distal Humerus System consists of medial and posterolateral distal humerus plates of various lengths and 2.7 mm locking screws. The plates are pre-contoured to match the anatomy of the distal humerus with a limited contact low profile design. The plate features locking compression holes and conical locking holes which accept 2.4, 3.5, & 4.0 mm cortex screws, 2.4, 2.7 & 3.5 mm locking screws, and 4.0 mm cancellous screws. The System will be available in Stainless Steel and Titanium.

The DePuy Synthes LCP Proximal Humerus Plates, long are pre-contoured to match the anatomy of the proximal humerus with a limited contact low profile design. The plate features locking holes and combination locking and compression holes which accept 2.7, 3.5, & 4.0 mm cortex screws, 3.5 mm locking screws, and 4.0 mm cancellous screws. The System will be available in Stainless Steel and Titanium. These plates will be offered as an addition to the DePuy Synthes Small Fragment LCP (formerly DCL) System.

The DePuy Synthes LCP® Curved Plates have a slight curve to better match the anatomy of the bone. The plates have a limited contact profile design and includes combination dynamic compression/locking screw holes.

The DePuy Synthes 3.5 mm Low Profile Reconstruction Plates consist of straight, curved, and J-shaped plates. The shape and profile of these plates are designed to minimize soft tissue irritation and minimize the need for intraoperative contouring. However, when intraoperative contouring is required for a precise fit with the bone, the plate design allows for simple and uniform bending.

The DePuy Synthes 3.5mm Spring Plate is a variation of the DePuy Synthes one-third tubular plate with collar which utilizes two sharp spikes at the bottom surface and a pre-bent convex shape to aid in the reduction of small bone fragments while conforming to bony uneven surfaces. The plate incorporates a 1 - 10 hole design in lengths ranging from 19.5mm - 132mm and accepts either 3.5mm cortex or pelvic screws. In addition the plates are manufactured from Stainless Steel and Commercially Pure Titanium and provided STERILE and NON STERILE.

The DePuy Synthes 3.5 mm LCP Hook Plate is a low-profile, precontoured bone fixation plate intended for the treatment of fractures, osteotomies, and non-unions in small bones. The plates feature a preformed dual hook on one end and are available in stainless steel and titanium.

The DePuy Synthes 3.5 mm LCP Periarticular Proximal Humerus Plates are low-profile, precontoured bone fixation plates intended for the treatment of fractures of the humerus. The plates are offered sterile and non-sterile and are available in stainless steel and titanium.

The DePuy Synthes 3.5 mm and 4.5 mm LCP Plates with Expanded Indications consist on.5 mm LCP plates, 4.5 rom Narrow LCP Plates, 4.5 mm Broad LCP plates and 4.5 mm Curved Broad LCP Plates for fracture fixation in adults and pediatric patients. These plates accept locking, cortex and cancellous screws.

The DePuy Synthes 3.5mm Locking Attachment Plates are low-profile, pre-contoured plates which are intended to be used with existing Synthes to stabilize fractures. The plates are available in stainless steel and titanium.

The DePuy Synthes Curved Narrow and Broad LCP Plates are available in stainless steel and titanium, and consist of limited-contact profile plates in 3.5 mm and 4.5mm narrow and broad sizes. The plates feature Dynamic Compression Plate (DCP) holes combined with locking screw holes. The 3.5mm plates accept 3.5mm cortex and locking screws and 4.0 mm cancellous screws, and the 4.5mm plates accept 4.5 mm cortex screws, 4.0mm and 5.0mm locking screws, 4.5 mm cannulated screws, 5.0 mm periprosthetic screws, and 6.5 mm cancellous screws.

The DePuy Synthes 2.7 mm / 3.5 mm VA-LCP Anterior Clavicle Plate System consists of plates of various lengths and variable angle screws that provide the flexibility to lock screws in trajectories that can diverge from the central axis of the plate hole. The system features medial and lateral plates that are pre-contoured to match the anatomy of the clavicle and a limited contact, low profile design. The plate with lateral extension features Variable Angle (VA) Locking holes and Dynamic Compression Plate (DCP) holes. The medial plate features Dynamic Compression Plate (DCP) holes combined with VA locking screw holes.

The DePuy Synthes 3.5 mm LCP Clavicle Plate System consists of metallic plates and screws that offer screw to plate locking designed for various fracture modes of the clavicle.

The DePuy Synthes Variable Angle LCP Elbow System contains plates intended to treat fractures of the distal humerus and proximal ulna. A variety of plate configurations are included in the system to allow for fixation of multiple fracture patterns. Specifically, the system includes several plate configurations for fixation of the distal humerus which are intended to be used in a two-plate construct where plates are positioned medially and laterally. Additionally, the system includes plates for fixation of the olecranon and proximal ulna. In its entirety, the following plate types are included in the system: - -Medial Distal Humerus Plate - -Lateral Distal Humerus Plate - -Olecranon Plate - -Proximal Olecranon Plate Extra-articular Proximal Ulna Plate The system accepts existing conical and locking screws as well as new metaphyseal screws, and allows for both dynamic compression and locking through Combi holes. The plates are universally designed for both left and right use and will be offered in both stainless steel and titanium.

The DePuy Synthes Variable Angle LCP Elbow System contains posterolateral and medial plates intended to treat fractures of the distal humerus. The plates are used together in a two-plate, 90° construct and accept existing screws. New 2.7mm Metaphyseal Screws are also compatible with the System.

The DePuy Synthes TOMOFIX Osteotomy System consists of five different titanium plate families with locking and combination locking/compression holes. This system features plates designed to provide stable fixation of osteotomies of the distal femur and proximal tibia. The DePuy Synthes TOMOFIX Medial Distal Femur Plates are part of the DePuy Synthes TOMOFIX Osteotomy System used for closed wedge femoral osteotomies. The subject plates are anatomically contoured to fit the medial distal femur, are available in right and left versions, as well as sterile and non-sterile.

The DePuy Synthes 2.4/2.7mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long will be available in stainless steel and titanium. The head of the plate will remain the same as the existing 2.4mm VA-LCP Two-Column Volar Distal Radius Plate (K102694) and will therefore allow the use of the existing guide block for these plates. The DePuy Synthes 2.4/2.7mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long will come in 3 different lengths (7 shaft holes, 10 shaft holes and 13 shaft holes). To accommodate different patient anatomy, the plate with 7 shaft holes will be available with three different plate head widths (Standard, Narrow and Wide). The 10 shaft hole and the 13 shaft hole plate will only be released with the Standard plate head width and additionally they feature a curvature in the shaft. All plates will feature left- and right-specific designs and will be offered in sterile packed only. The DePuy Synthes 2.4/2.7mm VA-LCP Two-Column Volar Distal Radius Plates, Extra-Long are designed to accept existing 2.4mm Variable Angle Locking Screws, 2.4mm Cortex Screws, 2.4mm Locking Screws, 1.8mm VA Buttress Pins and 1.8mm Locking Buttress Pins in the plate head holes. In the plate shaft, existing 2.4mm Cortex Screws, 2.7mm Cortex Screws, 2.4mm Variable Angle Locking Screws, 2.7mm Variable Angle Locking Screws, 2.4mm Locking Screws, and 2.7mm Locking Screws can be inserted.

The provided text describes several DePuy Synthes Trauma Orthopedic Plates and Screws that have received FDA 510(k) clearance (K180310) for "MR Conditional" labeling. The primary study presented for proving the device meets acceptance criteria is a series of non-clinical tests to assess the device's compatibility with the Magnetic Resonance (MR) environment.

Here's an organized breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria for "MR Conditional" labeling are based on established ASTM (American Society for Testing and Materials) standards. The reported device performance is that the devices meet these standards.

Explanation: For each device covered under this 510(k) submission, the document explicitly states: "Non-clinical testing is provided to support the conditional safety of the [Device Name] in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy." This indicates that the devices met the requirements of these ASTM standards, thus satisfying the acceptance criteria for MR Conditional labeling.

2. Sample Size Used for the Test Set and Data Provenance:

The document primarily refers to non-clinical testing. This type of testing typically involves physical device samples rather than human or animal subjects for evaluating MR compatibility. The document does not specify a numerical sample size for the devices tested for MR compatibility. The provenance is implied to be through laboratory testing under controlled conditions as per ASTM standards. There is no mention of country of origin of data in this context.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. For non-clinical testing of MR compatibility, the "ground truth" is typically established by the specifications of the ASTM standards themselves, interpreted and performed by testing engineers or technicians with expertise in medical device testing and MR safety. No specific number or qualifications of such experts are mentioned.

4. Adjudication Method for the Test Set:

This information is not provided in the document. As the testing is non-clinical and based on quantitative ASTM standards, a human adjudication method (like 2+1, 3+1) is typically not applicable. The results would be objectively evaluated against the pass/fail criteria defined by the ASTM standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a MRMC comparative effectiveness study was not done. The submission focuses on the "MR Conditional" status of the orthopedic plates and screws, which relates to their physical properties in an MR environment, not their diagnostic performance or how they impact human reader interpretation. Therefore, there is no mention of an effect size for human readers with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. The device is a physical orthopedic implant (plates and screws), not an algorithm or an AI-powered diagnostic tool. Therefore, there is no "standalone performance" of an algorithm.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical MR compatibility testing is based on established testing standards (ASTM F2052-14, ASTM F2213-06, ASTM F2182-11a, and ASTM F2119-07). These standards define the methods and acceptance criteria for classifying a device as "MR Conditional."

8. The Sample Size for the Training Set:

Not applicable. As the tests are non-clinical, there is no "training set" in the context of machine learning or AI models. The testing involves physical samples under controlled conditions.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set was used.

Ask a specific question about this device