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DePuy Synthes VOLT™ Mini Fragment Plating System:

The VOLT™ Mini Fragment Plating System is indicated for internal fracture fixation of bones and bone fragments of the appendicular skeleton appropriate for the implant size.

The VOLT™ Mini Fragment Plating System is intended for adults and both children (2-12 years) and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by fixation.

If used in the femur, tibia, humerus, patella, or pelvis the VOLT™ Mini Fragment Plating System can only be used for non-load bearing stabilization and reduction.

DePuy Synthes VOLT™ Small Fragment Plating System:

The VOLT Small Fragment Plating System is indicated for internal fracture fixation of bones and bone fragments of the appendicular skeleton appropriate for the implant size.

The VOLT Small Fragment Plating System is intended for adults and both children (2-12 years) and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by fixation.

If used in the femur the VOLT Small Fragment Plating System can only be used for non-load bearing stabilization and reduction.

DePuy Synthes VOLT™ Mini Fragment Plating System

The DePuy Synthes VOLT™ Mini Fragment Plating System is a family of implantable devices, consisting of non-contoured, non-anatomic straight and shaped plates (Adaption, Adaption Combi, Compact Straight, Straight Condylar, Hook, T-Plate, Tine, Y-Plate and Triangle), with variable angle screw holes, and two screw types (cortex and locking screws). The system is available in three sizes; 2.0mm, 2.4mm and 2.7mm. The Triangle Plate is available in 2.4mm and 2.7mm sizes only.

The plates of this system are available in Stainless Steel and Commercially Pure Titanium, whilst the corresponding screws are available in Stainless Steel and Titanium Alloy (TAV) respectively. Plates and screws within the VOLT™ Mini Fragment Plating System are available either sterile or non-sterile and are single-use only.

DePuy Synthes VOLT™ Small Fragment Plating System

The DePuy Synthes VOLT™ Small Fragment Plating System is a family of implantable devices consisting of 3.5mm non-contoured, non-anatomic plates with variable angle screw holes. and 3.5mm locking, 3.5mm cortex, and 4.0mm cancellous screws.

The plates of this system are available in Stainless Steel and Titanium, whilst the corresponding screws are available in Stainless Steel and Titanium Alloy (TAV). Plates and screws within the VOLT™ Small Fragment Plating System are available either sterile or non-sterile and are single-use only

The provided text is a 510(k) summary for the DePuy Synthes VOLT Mini Fragment Plating System and VOLT Small Fragment Plating System. This document describes the device, its indications for use, and a comparison to predicate devices, focusing on non-clinical performance testing (mechanical and engineering analyses) to demonstrate substantial equivalence.

Crucially, this document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."

Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details), which are typically found in clinical performance studies validating AI/ML-based medical devices, is not applicable to this submission.

This 510(k) clearance is based on the devices being "substantially equivalent" to existing predicate devices, primarily demonstrated through non-clinical performance testing (mechanical simulations and analyses), rather than clinical trials or studies involving human data and AI algorithm performance.

Therefore, I cannot provide the requested information as it is not present in the provided text. The device in question is a physical orthopedic implant, not an AI/ML software device that would require such performance evaluations.

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The TRILEAP™ Plating System is indicated for fixation of bones and bone fragments of the foot and ankle in adults and adolescents (aged 12 -21 years) where the growth plates have fused.

The TRILEAP Plating System is intended for reduction, temporary fixation, fusion and stabilization of bones. The system consists of a family of implantable devices consisting of 2.0mm, 2.5mm, 3.0mm, 3.5mm and 4.0mm non-contoured and anatomic procedure specific plates, cortical screws, and variable angle locking screws available in various sizes.

This document describes the FDA's clearance of the TRILEAP Plating System, a metallic bone fixation device. The focus of the provided text is on demonstrating the substantial equivalence of this new device to existing predicate devices through non-clinical performance data, rather than on a study proving the device meets acceptance criteria for an AI/ML powered device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment methods for an AI/ML device is not applicable to this submission.

The provided text only discusses non-clinical performance data for the TRILEAP Plating System as follows:

1. A table of acceptance criteria and the reported device performance:

Summary of what's not in the document:

• Sample sized used for the test set and the data provenance: Not applicable.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method (e.g. 2+1, 3+1, none) 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: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Explanation of the Study (as described in the document):

The study was a non-clinical performance evaluation conducted to demonstrate the substantial equivalence of the TRILEAP Plating System to predicate devices. The study involved:

• Non-clinical Performance Data: The following analyses were conducted:
  • Plate Cross-Section Analysis (Bending Strength)
  • Screw Torsional Strength Analysis according to ASTM F543 via a Finite Element Analysis model
  • Screw Driving Torque according to ASTM F543
  • Screw Pull-Out via the Chapman Equation
• Acceptance Criteria Source: Screw testing utilized acceptance criteria from the FDA Guidance, "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway (December 2020)". For other tests, acceptance was implicitly based on demonstrating similarity or equivalence to the predicate devices.
• Conclusion: The results of the non-clinical performance data demonstrated that the subject devices are substantially equivalent to the predicate devices, and any differences in technological characteristics do not raise new questions of safety and effectiveness.

Clinical Performance Data: The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."

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The DePuy Synthes Variable Angle Locking Patella Plating System is indicated for the fixation and stabilization of patellar fractures in normal and osteopenic bone in skeletally mature patients.

The DePuy Synthes Variable Angle Locking Patella Plating System is comprised of single-use, sterile implants which will be placed on the lateral rim and on the anterior surface of the fractured patella to provide fixation during bone healing. The system offers both a small and a large plate to provide fixation for various patella fracture patterns. The subject plates are available sterile and are manufactured from implant grade stainless steel or titanium.

The system also consists of sterile, non-implantable templates that correspond to the implants. Templates are intended to help determine proper sizing and help predict contoured shape of the implant.

The provided text ("K210408") is a 510(k) premarket notification for a medical device: the DePuy Synthes Variable Angle Locking Patella Plating System. This type of FDA submission is for devices seeking substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning AI/ML performance metrics, sample sizes for test/training sets, expert adjudication, or MRMC studies.

The "Non-clinical performance data" section refers to:

• Mechanical testing: This is to demonstrate "substantially equivalent" performance to the predicate device under static and dynamic loading conditions. This is not a clinical study and doesn't involve "acceptance criteria" in the sense of accuracy, sensitivity, or specificity for a diagnostic or AI-driven device.
• Magnetic Resonance compatibility testing: To establish MR Conditional parameters.
• Endotoxin testing: To meet specified endotoxin requirements.

The "Clinical performance data" section explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."

In summary, the provided document does not describe the kind of study and acceptance criteria you're asking about, which are typically associated with AI/ML-driven diagnostic or image analysis devices. This document is for a mechanical orthopedic implant demonstrating substantial equivalence based on engineering and material performance, not clinical outcome or algorithmic performance.

Therefore, I cannot populate the table or answer the specific questions about AI/ML study design and performance metrics based on the provided text.

Ask a specific question about this device

The DePuy Synthes Locking Condylar Plate (LCP) System is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extraarticular condylar fractures, fractures in normal or osteopenic bone, and non-unions and malunions.

The DePuy Synthes Sacral Bar System is intended for fixation of fractures of the posterior pelvis, in areas of the posterior superior iliac spine and posterior iliac spine, for sacral fractures and fracture-dislocations of the sacro-iliac joint.

The DePuy Synthes Spiked Washer is intended for use in ligament reattachment or fixation, specifically re-adaptation of torn or avulsed ligaments.

The DePuy Synthes 4.0 mm Titanium Locking Screws are intended to be used with existing DePuy Synthes LCP® plating systems for the fixation of various long bones, such as the humerus, femur and tibia.

The DePuy Synthes 5.0/7.3 mm Cannulated Locking Screws are intended to be used with existing DePuy Synthes LCP® plating systems for the fixation of various long bones, such as the femur.

The DePuy Synthes Peri-Prosthetic Screws are intended for fixation of various long bones, such as the humerus, femur and tibia, in conjunction with DePuy Synthes Locking Plates that accept 4.0/5.0 mm locking screws. They are also for use in fixation of periprosthetic fractures, osteopenic bone, and fixation of nonunions or malunions.

The DePuy Synthes 3.5 mm Conical Screws are intended to be used with existing DePuy Synthes LCP plating systems for fixation and interfragmentary compression of various bones, such as the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia and fibula, particularly in osteopenic bone.

The DePuy Synthes Spherical Washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of large (long) bone and bone fragments. In addition, the DePuy Synthes Spherical Washers are intended to prevent the projection of the screw head, when the screw must be inserted at an acute angle (e.g., in ankle arthrodesis).

DePuy Synthes 6.5 mm Cancellous Screws are intended for use in hindfoot and midfoot fusions, subtalar fusions, calcaneal osteotomies, midfoot reconstruction, and ankle arthrodeses.

DePuy Synthes 6.5 mm Midfoot Fusion Bolt is indicated for fracture fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.

The DePuy Synthes 1.0mm, 1.5mm, 2.0mm, and 2.4mm Cortex Screws are intended for use in trauma procedures, reconstructive procedures, and general surgery of the hand, wrist, and other small bones and bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 2. 7mm Cortex Screw is intended for fractures and osteotomies of small bones and bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 2. 7mm Cortex Screw may also be used in fusion applications in adults and adolescents (12-21 years) when used with the DePuy Synthes 2.4mm/2.7mm Variable Angle LCP Forefoot/Midfoot System (K100776) and in adults and pediatric patients (2-12 years) when used with the DePuy Synthes Ti Wrist Fusion Plate (K023879). The DePuy Synthes 3.5mm and 4.0mm Cortex Screws are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 4.5mm Cortex Screw is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or mal unions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 4.0 mm Cortex Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur, fibula and the bones of the foot and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 4.5 mm Cortex Screws are intended for fixation of fractures, fusion, osteotomies, non-unions, and malunions of various long bones, such as the humerus, femur and tibia; the pelvis of the foot and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 2.4 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 4.5 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bone fragments; and the bones of the hand and foot, in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 6.5 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. These screws are also indicated for femoral neck fractures; slipped capital femoral epiphysis; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis; pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis. The DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws are intended for fixation of fractures, osteotomies, non-unions, and malunions of long bone fragments, pelvis, sacrum, and the bones of the foot in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. These screws are also indicated for slipped capital femoral epiphysis; ankle arthrodesis; and subtalar arthrodesis. The DePuy Synthes 1.5 mm Headless Compression Screws are intended for fixation of intraarticular and extra-articular fractures, avulsions, malunions, and osteotomies of small bones and small bone fragments, as well as arthrodesis of small joints in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 2.4 mm Headless Compression Screws are intended for fixation of fractures, osteotomies, non-unions, and malunions of small bone arthrodesis in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 3.0 mm Headless Compression Screws are intended for fixation of intraarticular and extra-articular fractures, non-unions, and osteotomies of small bones and small bone fragments, as well as arthrodesis of small joints in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screws are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of various bones and bone fragments including bones of the foot, humerus, femur and tibia in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 2.0 mm Quick Insertion Screws are intended for fixation of fractures, fusions, osteotomies, nonunions, and malunions of the forefoot, midfoot, and hand in patients 2 years of age and older in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes ALPS is a plate and screw system intended to treat fractures of various long bones, including the radius, ulna, humerus, tibia, fibula, and femur.

The DePuy Synthes Sterile 3.0 mm Cannulated Screw, used with the Threaded Washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist and forefoot. Specifically, it is intended for fractures of carpals and metacarpals, carpal and metacarpal arthrodesis; small fragments of the hand and wrist, and certain metatarsal phalangeal applications (in foot). The 3.0 mm Cannulated Screw, by itself is intended for fixation of small bones, such as the hand, wrist and forefoot.

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 4.0 mm locking screws feature a self-tapping tip, are solid, and have a flat head profile with rounded edges. They are available in lengths ranging from 14 mm to 62 mm. The threads just below the head of each locking screw engage with the threaded holes of the plate. The engagement of the screw to the plate shaft creates a locked fixed angle construct.

The DePuy Synthes Sacral Bar System consists of a threaded bar, washers, and nuts. The bars are fully threaded. One end of the bar has a trocar point to guide the bar through pre-drilled holes. The bars are available in lengths ranging from 120 to 260 mm, in 10 min increments. The washers that are used with this system are oval shaped and are designed to slide freely along the bars. Both rounded and straight nuts are provided with this system; the rounded nuts mate with the washers to create compression, while the straight nuts are then added to wedge against the rounded nuts to maintain compression.

The DePuy Synthes Spiked Washers are made of PEEK Optima™ LT plymer + 6% barium sulfate. There are either six or eight spikes arrayed around a center hole that will accommodate either 2.7, 3.5, 4.0, 4.5 or 6.6 mm screws.

The DePuy Synthes 4.0 mm Titanium (TI) Locking Screws feature a self-tapping tip, stardrive mechanishm, and have a flat head profile with rounded edges. They are available in lengths ranging from 14 mm to 90 mm. The threads below the head of each locking screw are designed to engage with the threaded holes of currently marketed DePuy Synthes LCP plating systems.

The DePuy Synthes 5.0/7.3 mm Cannulated Locking Screws feature self-drilling and self-tapping tips, have a flat head profile with rounded edges with a hex drive recess. They are available in additional lengths ranging from 100 – 145 mm. The threads below the head of each locking screw are designed to engage with the threaded holes of currently marketed DePuy Synthes LCP® plating systems

The DePuy Synthes Peri-Prosthetic Screws feature a self-tapping blunt tip, stardrive mechanism, and have a flat head profile with rounded edges. They are available in lengths ranging from 8 mm to 12 mm. The threads on the head of each locking screw are designed to engage with the threaded holes of currently marketed DePuy Synthes LCP® plating systems.

The DePuy Synthes 3.5 mm Conical Screws are self-tapping, have a stardrive or hex drive recess, and are manufactured from stainless steel and titanium. The 3.5 mm conical screws are available in various lengths ranging from 40-95 mm.

The DePuy Synthes Spherical Washers are round or oval in design with a slotted center hole which allows for screw angulation up to 70 degrees. They are used with 4.5 - 7.3 mm diameter screws and manufactured from Stainless Steel and Titanium.

The DePuy Synthes 6.5 mm Cancellous Screws incorporate a fully threaded shaft, 4.0 mm core diameter, and have a flat head profile with rounded edges. They are available in lengths ranging from 60 mm to 130 mm in both Stainless Steel and Titanium Alloy. The screws are provided STERILE and NON STERILE.

The DePuy Synthes 6.5 mm Midfoot Fusion Bolt is a solid metallic fixation bolt which is intended to be used in procedures involving the foot and ankle. The DePuy Synthes 6.5 mm Midfoot Fusion Bolt is partially threaded on both ends and will be available in versions composed of implant quality stainless steel and titanium alloy.

The DePuy Synthes Cortical Screws have self-tapping features, stardrive, or cruciform head recesses, and are manufactured from stainless steel, commercially pure titanium, and/or titanium alloy. Cortex screws are offered both sterile and non sterile and are available in various lengths. Screws may be used independently or with any DePuy Synthes plate which accepts 1.0 mm, 1.3 mm, 2.0 mm, 2.4 mm, 2.7 mm, 4.0 mm, and 4.5 mm cortex screws. The screws, when used in pediatric applications, may be used independently or with compatible Synthes plates which are also indicated for pediatric populations.

The DePuy Synthes Cortex, Cannulated, and Headless Compression Screws are metallic bone screws manufactured from Stainless Steel (ASTM F138), Commercially Pure Titanium (ASTM F67), and/or Titanium Alloy (ASTM F1295). The screws are available in multiple lengths and diameters, and are intended to be used as stand-alone bone screws for internal bone fixation of fractures, fusions, osteotomies, non-unions, and malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation. The DePuy Synthes Cannulated and Headless Compression screws are cannulated for use with guidewires for precise placement in bone with the exception of the 1.5 mm Headless Compression Screw, which is a solid screw and therefore does not allow for instrumentation with a guide wire. The Headless Compression Screws feature threaded heads that allow for purchase in the near cortex of bone during and after implantation, potentially reducing complications associated with countersinking of traditional cortex or cannulated screws.

The DePuy Synthes 2.0 mm Quick Insertion Screws (QI Screws) are twist-off style screws comprised of a screw and post which are intended to separate at a predefined location (the breakpoint) as the screw is implanted into bone. The screws are offered with an external thread diameter of 2.0 mm and in lengths ranging from 11 mm to 18 mm to accommodate varying patient anatomy and fracture patterns in the foot and hand. The screws are made of a titanium alloy (Ti-6Al-7Nb) in accordance with ASTM F1295.

The DePuy Synthes ALPS is a plate and screw system intended to treat fractures of various long bones, including (but not limited to) the radius, ulna, humerus, tibia, fibula and femur. The ALPS utilizes a locking feature that secures the screw to the plate, enabling stable fixation to be achieved via unicortical or bicortical fixation. The locking feature consists of conical shaped, threaded screw holes in the plate that correspond wi th the conical-shaped, threaded head of the screw.

The 3.0 mm Cannulated Screw has a 3.0 mm thread diameter and a 4.0 mm head diameter. It is available in short and long thread lengths ranging from 10 mm to 40 mm. It features selfdrillinglself-tapping flutes and cancellous threads for use in cancellous bone. The screw is used in conjunction with a guide wire for precise placement in bone. The Threaded Washer has a 5.5 mm thread diameter and is 3.0 mm in length. It features exterior threads for bone purcbase in the near cortex and is cylindrically shaped to allow passage of the 3.0 mm Cannulated Screw. The washer serves to provide a buttress in the near cortex for which the screw head can compress against.

The DePuy Synthes Cannulated Angle Blade Plate 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 to reduce the surface area of the plate in contact with bone. The plate accepts 4.5 mm and 6.5 mm screws. he Cannulated Angle Blade Plate System is manufactured from stainless steel or commercially pure titanium.

This document describes the FDA's clearance of several DePuy Synthes trauma screws and plates as "MR Conditional" devices. The clearance is based on non-clinical testing demonstrating their safety in an MR environment, not on clinical performance or diagnostic accuracy. Therefore, the questions related to clinical study design (sample size, ground truth, expert adjudication, MRMC studies, standalone performance) are not applicable in this context.

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

1. Table of acceptance criteria and the reported device performance

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

Not applicable. The study was non-clinical (in-vitro) testing of the devices' physical properties in an MR environment, not a test set using human data.

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

Not applicable. The "ground truth" here is adherence to specific ASTM standards for MR safety, which are technical measurements rather than expert human interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This was non-clinical testing against engineering standards.

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 submission is for the MR Conditional status of medical implants, not for an AI diagnostic device.

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

Not applicable. This submission is for the MR Conditional status of medical implants, not for an AI diagnostic device.

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

The ground truth used was compliance with established ASTM (American Society for Testing and Materials) standards for evaluating the MR safety of medical implants. These standards involve specific experimental setups and measurement methodologies to assess:

• Magnetically induced displacement force (ASTM F2052-14)
• Magnetically induced torque (ASTM F2213-06)
• Radiofrequency (RF) heating (ASTM F2182-11a)
• Image artifacts (ASTM F2119-07)

8. The sample size for the training set

Not applicable. This was non-clinical testing of physical devices. No training set for an algorithm was involved.

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

Not applicable. No training set for an algorithm was involved.

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OrthoPediatrics PediFoot Deformity Correction System is intended for fixation of fractures, nonunions, replantations, and fusions of small bone fragments. Examples include, but are not limited to, the hand, wrist, foot, and ankle.

The OrthoPediatrics PediFoot Deformity Correction System is a plate and screw system intended for the use in fracture fixation, osteotomies, and arthrodesis, primarily in the foot. The subject plates system will offer five different plate options – compression/neutral plates, reconstruction plates, wedge plates, clover plates and angle iron plates in various sizes to accommodate patient anatomy. All plates will be sized to allow their use in children and small statured adults. The plates are designed to accept the subject Ø2.7mm or Ø3.5mm cortical and/or variable angle locking screws. All subject plates and screws are manufactured from medical grade 316L stainless steel per ASTM F138 or ASTM F139. All instruments are manufactured from stainless steel per ASTM F899, cobalt chrome per ASTM F562, silicone, propylux, polyphenylsulfone, or aluminum per ASTM B209, B211, or B221.

This document describes the premarket notification (510(k)) for the OrthoPediatrics PediFoot Deformity Correction System. The primary purpose of this 510(k) is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove clinical superiority or specific performance metrics against a predefined acceptance criterion in the context of an AI/ML device.

Therefore, many of the requested elements for an AI/ML device's acceptance criteria and study design are not applicable to this traditional medical device submission. This submission focuses on engineering and material equivalence, along with mechanical testing.

Here's an attempt to address the prompts given the available information, highlighting what is missing or not applicable:

Overview of Device and Submission Type:

The OrthoPediatrics PediFoot Deformity Correction System is a plate and screw system intended for fracture fixation, osteotomies, nonunions, replantations, and fusions of small bone fragments, primarily in the foot, hand, wrist, and ankle. This is a traditional orthopedic implant device, not an Artificial Intelligence/Machine Learning (AI/ML) powered device. Its 510(k) submission focused on demonstrating substantial equivalence to predicate devices through technical characteristics (materials, design, function, sterilization) and non-clinical mechanical testing, rather than clinical efficacy or diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

• Torque to Failure (screws)
• Driving Torque (screws)
• Axial Pullout (screws)
• Bone Plate Bend Strength
• Variable Angle Screw/Plate Interface Performance (bending strength, push out strength) | Demonstrated Substantial Equivalence:
• Testing demonstrated the subject device's mechanical properties (torque to failure, driving torque, axial pullout, bone plate bend strength, variable angle screw/plate interface performance) are equivalent to or better than the predicate devices (Synthes Modular Foot System K001941 and Synthes 2.4mm/2.7mm Variable Angle (VA)-LCP Forefoot/Midfoot System K100776). Specific numerical results for "acceptance" vs. "performance" are not provided in this summary but were likely part of the detailed submission. |
  | Material Compatibility:
• Biocompatibility
• ASTM standards compliance (for materials) | Demonstrated Compatibility:
• Plates and screws manufactured from medical grade 316L stainless steel per ASTM F138 or ASTM F139, identical to predicate materials.
• Biocompatibility assessment completed (details not in summary). |
  | MR Environment Compatibility:
• MRI safety (if applicable) | MR Conditional:
• Evaluated for use in an MR Environment and determined to be MR Conditional. |

Note: For this type of device (traditional orthopedic implant), "acceptance criteria" are typically rooted in demonstrating that the new device performs at least as safely and effectively as predicates with respect to mechanical properties, material properties, and intended use. Specific quantitative thresholds for "acceptance" are generally not disclosed in the 510(k) summary but are part of the full submission's engineering reports.

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

• Sample Size for Test Set: Not specified in the provided summary. Mechanical testing typically involves a number of samples (e.g., 5-10 per test condition) to establish statistical significance for engineering properties.
• Data Provenance: The data is from non-clinical (bench) testing performed by the manufacturer, OrthoPediatrics, Corp. This is not patient data; it's laboratory test data.

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

• Not Applicable: This is a mechanical device submission, not an AI/ML diagnostic or prognostic tool. "Ground truth" in the context of expert consensus on patient data (e.g., radiologists interpreting images) is not relevant to demonstrating substantial equivalence for an orthopedic implant. Ground truth for mechanical testing is established by the test methods and equipment calibration.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are used for reconciling expert opinions on clinical data, which is not relevant here. Mechanical test results are objective measurements.

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

• No: An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is an orthopedic implant, not a diagnostic imaging tool.

6. If a Standalone (Algorithm Only) Performance Was Done

• Not Applicable: This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• Engineering Specifications and Mechanical Test Standards: The "ground truth" for this device's performance demonstration lies in meeting established mechanical performance standards (e.g., ASTM F543, F382) and demonstrating comparable or superior performance to the predicate devices in these tests. The properties measured (e.g., torque, bend strength, pullout force) are the "ground truth" for the device's mechanical integrity.

8. The Sample Size for the Training Set

• Not Applicable: This device does not involve training data as it is not an AI/ML algorithm.

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

• Not Applicable: No training set or associated ground truth for an AI/ML algorithm development.

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The Piccolo Composite foot and ankle plates are indicated for fixation of osteotomies, fusions, fractures, nonunions, malunions and replantations of small bone fragments in adult and adolescent (12 - 21 years) patients, including the foot and ankle, and including in osteopenic bone.

The Lapidus plates are indicated for fusion and arthrodesis of the 1st tarsometatarsal joint (Lapidus Fusions).

The Piccolo Composite Lapidus Plate System comprises implants (plates and screws), and a set of instruments.

The plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), and are marked with a tantalum thread, to provide for their visualization under fluoroscopy.

The screws are made of titanium alloy. Both non-locking and locking 2.7mm screws are available, in various lengths. Cannulated Lag Screws are also provided.

This document is a 510(k) premarket notification for the "Piccolo Composite® Plate System" and primarily focuses on establishing substantial equivalence to predicate devices, rather than an AI/ML device study. Therefore, most of the requested information regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance is not applicable to this submission.

However, I can extract the relevant performance criteria and summary from the document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable. This document describes the mechanical testing and material compatibility of an orthopedic plate system, not an AI device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not expert consensus.

4. Adjudication method for the test set: Not applicable.

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, as this is not an AI device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.

7. The type of ground truth used:

• Mechanical Performance: Established through standardized engineering tests (ASTM F 382) for static and dynamic bending. The "ground truth" here is the measured mechanical properties of the device and its predicate devices.
• Biocompatibility: Established through bacterial endotoxin testing.

8. The sample size for the training set: Not applicable, as this is not an AI device.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI device.

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The DePuy Synthes Variable Angle Locking Hand System is intended for fracture fixation of the hand and other small bones and small bone fragments, in adults and adolescents (12-21) particularly in osteopenic bone.
System indications include the following:

• Open reduction and internal fixation of fractures, mal-unions, and non-unions
• Following excision of benign bone tumors
• Replantations and reconstructions
• Arthrodeses of joints involving small bones
• Osteotomies, including deformity correction such as rotation, lengthening, shortening
• Pathological fractures, including impending pathologic fractures

The DePuy Synthes Variable Angle Locking Hand System consists of metallic plates and screws that offer screw-to-plate locking designed for various fracture modes of the hand. Generally, the system consists of plates, screws, and instruments which feature variable angle locking technology. The plates contained in the DePuy Synthes Variable Angle Locking Hand System are offered in a range of configurations to accommodate patient anatomy and surgical need. The plates are designed to accept existing 1.5mm cortex screws (K090047), previously cleared 1.5mm Locking Screws at the nominal angle only (K090047), and new 1.5mm VA Locking Screws. The new 1.5mm VA Locking Screws feature existing variable angle locking technology (K100776, K120689, K110354), and are designed to fit in the 1.5mm holes of the subject plates.

The provided text is a 510(k) premarket notification for a medical device (DePuy Synthes Variable Angle Locking Hand System). This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical study data with acceptance criteria for device performance as would be seen in a PMA or De Novo submission.

Therefore, the document does not contain information typically found in acceptance criteria and study reports for software/AI devices (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, effect sizes, standalone performance, training set details).

However, it does describe the non-clinical testing performed to demonstrate the substantial equivalence of the mechanical aspects of the device.

Here's an analysis of what information is available in the provided text, structured to address your request as much as possible given the limitations of the document:

Acceptance Criteria and Study to Prove Device Performance

This 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices through non-clinical mechanical testing rather than clinical performance metrics with specific acceptance criteria typically associated with software or AI devices. The information below reflects the mechanical performance testing mentioned.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for the non-clinical tests in the format of a table, nor does it provide the quantitative results of these tests. Instead, it lists the types of tests performed to support the device's performance and substantial equivalence to predicates.

2. Sample Size and Data Provenance

• Sample Size for Test Set: Not specified for the mechanical tests. For non-clinical mechanical testing, sample sizes are typically determined by relevant ASTM standards or internal validation protocols, often involving a small number of representative samples.
• Data Provenance: The tests are non-clinical (laboratory-based) and conducted by the manufacturer (DePuy Synthes). Country of origin is implied to be within the manufacturer's operational locations (e.g., USA, as the submitting entity is Synthes USA). The data is by nature "prospective" in the sense that the tests were designed and executed to evaluate this specific device configuration.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a mechanical implant, not an AI/software device requiring expert interpretation for ground truth establishment. The "ground truth" for mechanical testing is established by the physical properties of the materials and designs under standardized test conditions.

4. Adjudication Method

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for clinical image interpretation or diagnostic decisions, not for mechanical testing of orthopedic implants.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a mechanical orthopedic implant, not an imaging device or AI diagnostic tool that would typically involve human readers.

6. Standalone Performance

The "standalone performance" in this context refers to the device's mechanical performance in laboratory settings, independent of human interaction during the test itself. The non-clinical tests (Dynamic Fatigue, Torsional, Pullout, Insertion Torque, FEA) evaluate the device in this standalone capacity.

7. Type of Ground Truth Used

For the mechanical tests, the "ground truth" is defined by:

• Standard ASTM methodologies: (e.g., ASTM F543 for screw properties).
• Engineering principles and material properties: Used in Finite Element Analysis.
• Physical measurements under controlled laboratory conditions.

This differs significantly from a "ground truth" for a diagnostic medical device which would involve expert consensus, pathology, or outcomes data.

8. Sample Size for Training Set

Not applicable. This is a mechanical device, not an AI/machine learning algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm involved in the primary function or evaluation of this mechanical device.

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The Synthes 2.7/3.5mm Variable Angle LCP Ankle Trauma System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused, and particularly in osteopenic bone. Specifically,

• Anterolateral Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia.
• Medial and Anteromedial Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
• Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and
• Lateral Distal Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.

The Synthes Anterolateral Distal Tibia Plates are intended to treat fractures of the distal tibia. These plates can be used with a new screw configuration, 3.5mm VA Locking Screws. The Anterolateral Distal Tibia Plates and 3.5mm VA Locking Screws will be offered in both stainless steel and titanium alloy (TAN), and in both sterile and non-sterile configurations. The Anterolateral Distal Tibia Plates will be offered in left and right configurations. The system accepts existing cortical screws, locking screws, dynamic locking screws, and metaphyseal screws (K100776, K063049, K112583, K000684, K111230, K120070, K110592, and K043185) as well as new 3.5mm VA Locking Screws, and allows for both dynamic compression and locking through Combi holes.

This is a 510(k) premarket notification for a medical device, specifically the Synthes 2.7/3.5mm Variable Angle LCP Ankle Trauma System - Anterolateral Distal Tibia Plates.

This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than providing clinical safety and efficacy data. Therefore, the information you're requesting regarding acceptance criteria, study details, expert review, and ground truth establishment, which are typical for studies validating AI/ML diagnostic devices, are not present in this document. This submission focuses on engineering analysis and comparison to existing, already approved devices.

Here's why your specific questions cannot be answered from this document:

• This is not an AI/ML device. The device is a physical bone fixation system (plates and screws). Therefore, concepts like "device performance" in terms of classification metrics (sensitivity, specificity), "test sets," "training sets," "ground truth" (in the context of expert consensus or pathology for diagnostic accuracy), or "MRMC studies" are not applicable.
• 510(k) is about substantial equivalence. The primary way this device met its acceptance criteria was by demonstrating that it is "at least as strong as" and has similar indications, design, materials, and performance characteristics as previously cleared predicate devices.

However, I can extract information related to the device and its "proof" of meeting requirements based on the document provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Regarding the other points, as explained, they are not applicable or not provided in this 510(k) submission for a physical implantable device:

2. Sample size used for the test set and the data provenance: Not applicable. Performance was demonstrated through engineering analysis and fatigue testing, not a "test set" of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" was established by experts for a diagnostic assessment.
4. Adjudication method for the test set: Not applicable.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: Not applicable. The "ground truth" equivalent here would be established engineering standards for strength and fatigue, against which the device was tested.
8. The sample size for the training set: Not applicable. No "training set" for an algorithm.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) relied on demonstrating substantial equivalence through a comparison of indications, design, materials, and engineering performance (mechanical strength) to already approved predicate devices. It did not involve clinical studies or expert evaluations of diagnostic accuracy as would be the case for AI/ML diagnostic software.

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The Synthes 1.0mm, 1.5mm, 2.0mm, and 2.4mm Cortex Screws are intended for use in trauma procedures, reconstructive procedures, and general surgery of the hand, wrist, and other small bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The Synthes 2.7mm Cortex Screw is intended for fractures and osteotomies of small bones and bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The Synthes 2.7mm Cortex Screw may also be used in fusion applications in adults and adolescents (12-21years) when used with the Synthes 2.4mm/2.7mm Variable Angle LCP Forefoot/Midfoot System (K100776) and in adults and pediatric patients (2-12 years) when used with the Synthes Ti Wrist Fusion Plate (K023879).

The Synthes 3.5mm and 4.0mm Cortex Screws are intended for fixation of fractures. osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The Synthes 4.5mm Cortex Screw is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

Screws have self-tapping features, stardrive, hexdrive, or cruciform head recesses, and are manufactured from stainless steel, commercially pure titanium, and/or titanium alloy. Cortex screws are offered both sterile and non sterile and are available in various lengths. Screws may be used independently or with any Synthes plate which accepts 1.0mm, 1.3mm, 2.0mm, 2.4mm, 2.7mm, 3.5mm, 4.0mm, and 4.5mm cortex screws. The subject screws, when used in pediatric applications, may be used independently or with compatible Synthes plates which are also indicated for pediatric populations.

The provided text describes Synthes Cortical Screws and their intended uses, focusing on expanding indications for pediatric populations. The study primarily relies on demonstrating substantial equivalence to predicate devices and does NOT involve an AI device. Therefore, many of the questions related to AI-specific studies, such as sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance, are not applicable.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail table format for the device as a whole. Instead, it details the basis for substantial equivalence to existing predicate devices.

• Torsional strength
• Insertion torque
• Axial pullout
• Bending strength
  (The document states these calculations "additionally support substantial equivalence" and that screw length has "no bearing on the cortical screws' performance or technical function," implying comparable performance to predicates) |

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

• Not applicable (N/A) for an AI device. This submission concerns physical medical devices (screws). The "test set" in this context refers to the in-vitro mechanical testing conducted, not a dataset for an algorithm.
• Data Provenance: The document mentions "Published, clinical literature" to support pediatric use and "calculations comparing torsional strength, insertion torque, axial pullout, and bending strength" for mechanical properties. The specific details of these studies (e.g., number of screws tested, exact literature cited, countries of origin) are not provided in this summary. These would typically be detailed in a more comprehensive 510(k) submission.

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

• N/A for an AI device. Ground truth for an AI algorithm is typically established by human experts reviewing data. For this device, "ground truth" relates to the performance characteristics of the screws, established through engineering tests and scientific literature.

4. Adjudication method for the test set:

• N/A for an AI device. Adjudication methods like "2+1" or "3+1" are used to establish consensus among multiple human reviewers for AI algorithm ground truth. This is not relevant for a physical device 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 is not an AI device. Therefore, no MRMC comparative effectiveness study was conducted with human readers assisted by AI.

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

• No. This is not an AI device.

7. The type of ground truth used:

• For the expanded pediatric indications: Published clinical literature on the use of similar Synthes Cortex Screws.
• For mechanical properties: Engineering calculations and in-vitro mechanical testing data (torsional strength, insertion torque, axial pullout, bending strength). Comparison against predicate device specifications or established industry standards would serve as the "ground truth" for demonstrating equivalence.

8. The sample size for the training set:

• N/A. This is not an AI device, so there is no "training set."

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

• N/A. As there is no training set for an AI algorithm, no ground truth was established for it.

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