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KLS Martin Sternal Plating System (K032413): The KLS Martin Sternal Plating System is intended for use in stabilization of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.
KLS Martin Hand Plating System (K040598): The KLS Martin Hand Plating System is used for stabilization of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.
KLS Martin Sternal Talon (K051165): The KLS Martin Sternal Talon is intended for use in stabilization of anterior chest wall fractures including sternal fixation subsequent to sternal reconstructive procedures.
KLS Martin Sternal Talon & KLS Martin Sternal Plating System - Sterile (K070169): To offer KLS Martin Sternal Talon and KLS Martin Sternal Plating in sterile packaging with the following indications for use: K051165 KLS Martin Sternal Talon and K032413 KLS Martin Sternal Plating System are intended for use in stabilization of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.
Recon Talon (K122860): The KLS Martin Recon Talon is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternal reconstructive procedures.
LINOS MOH Hand Plating System (K141489): The LINOS MOH Hand Plating System is used for stabilization of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.
KLS Martin LSS Plating System (K151983): The KLS Martin LSS Plating System is to be used in conjunction with sternal closure wire for use in primary or secondary closure/repair of the sternum following sternotomy and is intended to reinforce the sternal halves and distribute wire tension.
KLS Martin Thoracic Plating System (K153482): The KLS Martin Thoracic Plating System is indicated for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies.
KLS Martin Cannulated Headless Screws (K161259): KLS Martin Cannulated Headless Screws are intended for the treatment of fractures, osteotomies, arthrodeses, and nonunions of small bones in the hand, wrist, foot, and ankle.
Level One Hand Plating System (K170124): The Level One Hand Plating System is used for stabilization of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.
KLS Martin Pure Pectus System (K221938): The KLS Martin Pure Pectus System is indicated for use in surgical procedures to repair pectus excavatum. It is indicated for use in adult and pediatric (children and adolescents) populations.
KLS Martin Level One Rib Fixation System (K222397): The KLS Martin Level One Rib Fixation System is indicated for use in the stabilization and rigid fixation of rib fractures in the chest wall including reconstructive procedures, trauma, or planned osteotomies in patients 18 years of age or older.
KLS Martin LINOS Wrist System (K222624): The KLS Martin LINOS Wrist System is indicated for use in forearm fractures, osteotomies, and arthrodeses. It is intended for adults, and 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 fixation.

The KLS Martin Sternal Plating System consists of titanium plates ranging in thickness from 1.0mm – 3.0mm and screws ranging in diameter from 2.3mm – 3.2mm.
The KLS Martin Hand Plating System consists of titanium plates ranging in thickness from 0.6mm – 3.0mm and screws ranging in diameter from 1.0mm – 2.7mm.
The KLS Martin Sternal Talon is a two-piece with various foot depths and lengths that utilizes a ratcheted locking system. Each piece of the device is placed on opposing sides of the sternum and is designed to interlock providing a stabilized fixation thus allowing for various sternal widths. The device has a three-position screw which allows the ratchet to open, close and lock. In an emergency situation, the device can be reopened by turning the screw to the open position. A second emergency re-entry is provided by cut points adjacent to the screw. The KLS Martin Sternal Talon is manufactured from titanium alloy (Ti-6Al-4V).
The KLS Martin Sternal Talon (K051165) is a two-piece with various foot depths and lengths that utilizes a ratcheted locking system. Each piece of the device is placed on opposing sides of the sternum and is designed to interlock providing a stabilized fixation thus allowing for various sternal widths. The device has a three-position screw which allows the ratchet to open, close and lock. In an emergency situation, the device can be reopened by turning the screw to the open position. A second emergency re-entry is provided by cut points adjacent to the KLS Martin Sternal Talon is manufactured from titanium alloy (T-6Al-4V). The KLS Martin Sternal Plating System (K032413) consists of titanium plates rom 1.0mm – 3.0mm and screws ranging in diameter from 2.3mm - 3.2mm. The screws are used to affix the plates to the sternum. Plate an elongated midsection to facilitate quick re-entry in subsequent thoracic procedures.
The KLS Martin Recon Talon is a two-piece clamping device, which has on either end an attached plate. Plate thickness ranges from 1.0mm to 3.0mm and screw diameter ranges from 2.2mm. The two-piece clamping device utilizes a ratcheted locking system. Each piece of the device is affixed to opposing sides of the sternum and interlocks to provide stablized fixation. The device has a threeposition screw, allowing the ratchet to open, close, and lock. In an emergency situation the device can be reopened by turning the screw to the open position. Secondary emergency re-entry is provided by cut points adjacent to the screw.
The LINOS MOH Hand Plating System consists of titanium plates ranging in thickness from 0.6mm – 3.0mm and screws ranging in diameter from 1.0mm – 2.7mm. Plate features include a low profile with anqulated-locking threaded screws are either locking or non-locking.
The KLS Martin LSS Plating System includes plates and screws that are in conjunction with stainless steel suture wire for midline sternal closure. The LSS plates, when applied, are used to reinforce the sternal halves and mitigate the chance of sternal wire pulling through bone. The plates are manufactured from PEEK and offered in one size. The thickness from 2.1 mm – 2.5 mm (minimum – maximum dimensions) and are fixated using 2.3mm titanium screws. Once the sternum is reapproximated, the midline is closed using circumferentially wrapped stainless steel suture wires. Emergent re-entry is accomplished by cutting the stainless steel suture wire.
The KLS Martin Thoracic Plating System includes metallic plates and screws that provide rigid fixation to fractures, and can be used for reconstructive procedures in the thoracic anatomy. The implants are available non-sterile in multiple shapes and sizes. Plates are manufactured from CP Titanium (ASTM F67:2013) and range in thickness from 1.0 – 3.0mm. Screws are manufactured from Ti-6Al-4V (ASTM F1362013) and range in diameter from 2.3 – 3.2mm with lengths from 7 – 17mm.
The KLS Martin Cannulated Headless Screws (CHS) system is comprised of headless cannulated screws intended for bone fixation in the treatment of fractures, non-unions, osteotomies, or to aid in small joint fusions of the hand, wrist, foot, and ankle. Bone fixation is achieved by proximal and distal threads designed with different pitches that, when inserted into the bone, cause compression of the bone fragments for bone reduction, stability, and healing. Cannulation of the user to inow the user to insert the screw over the guide wire for proper placement prior to compression. The CHS system offers screws in various diameters, overall lengths, and thread lengths to accommodate different sizes and types of bone reduction, such as scaphoid fractures and non-unions. The screws are self drilling and self-tapping to eliminate the need for do implantation. All screws are manufactured from Ti-6Al-4V (ASTM F136:2013).
The Level One (L1) Hand Plating System includes metallic plates, washers, and screws intended for small bone fixation. Plates are precontoured to accommodate patient anatomy, available in various shapes and range in thickness from 0.6mm - 3.0mm and are compatible with the standard and multidirectional locking screws offered in the system. Screws are self tapping, available in a standard or multidirectional locking configuration and range in diameter from 1.0mm - 2.7mm with lengths from 2mm - 32mm. Standard screws may be used alone or in conjunction with the washers or plates for small fragment osteosynthesis. Implants are manufactured from CP Titanium (ASTM F67) or Ti-6Al-4V (ASTM F136).
The KLS Martin LP Pure Pectus system consists of metallic implants comprised of straight and angled pers that provide support to the thoracic cavity undergoing repair for pectus excavatum. The implants are in multiple sizes and are manufactured using tradition methods. Pectus bars are manufactured from CP Titanium. Connector bars are manufactured from Ti-6Al-4V. The system also instruments to facilitate placement of the implants.
The KLS Martin Level One Rib Fixation System is comprised of PEEK plates and titanium locking screws intended to provide rigid fixation of bone in the thoracic anatomy. The PEEK plates are pre-contoured to accommodate patient anatomy and are offered in plate thicknesses of 2 mm - 3 mm. The PEEK plates are compatible with the Ti-6Al-4V (ASTM Fl 36) 2.3 mm x 7 mm multidirectional locking screws offered in the system. The plates are manufactured from PEEK (ASTM F2026). The system includes the necessary instrumentation to facilitate implantation.
The KLS Martin LINOS Wrist System consists of metallic plates used in conjunction with bone screws and locking pins intended for the internal fixation, alignment, stabilization, and/or corrective osteotomies of the distal radius and/or ulna. Plates are manufactured from Ti-6Al-4V or CP Titanium. Plates are pre-contoured to accommodate patient anatomy and are available in various shapes and dimensions. The system also includes the necessary instruments to facilitate placement of the implants.

The provided text discusses the KLS Martin Orthopedic Implants - MR Conditional device and the studies conducted to support its conditional safety in a Magnetic Resonance (MR) environment.

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

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The text does not specify a "test set" in the traditional sense of a clinical or observational study with a certain number of patients or cases. Instead, the performance evaluation is based on non-clinical testing and computational modeling and simulation (CM&S) of the devices themselves.

• Sample size for non-clinical testing: The text refers to "the entire portfolio of KLS Martin thoracic and hand osteosynthesis implants." While not a specific number, it implies a comprehensive evaluation of the range of devices.
• Data provenance: The studies are non-clinical, done ex-vivo (for some tests) and through simulation. The computational modeling utilized "MED Institute's FDA-qualified Medical Development Tool (MDDT) and in a clinically relevant position within the Duke virtual human anatomy." This suggests the data is generated through established scientific methods rather than patient data from a specific country or retrospective/prospective collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable in the context of this submission. The "ground truth" for non-clinical testing and simulation is defined by the physical properties of the materials, the established testing standards (ASTM), and the validated computational models. There were no human experts establishing ground truth for evaluating the device's MR compatibility in the way radiology images would be reviewed.

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

This question is not applicable as there was no human adjudication of a clinical test set. The evaluation relies on standardized testing protocols and validated computational models.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. This submission is for the MR Conditional labeling of orthopedic implants, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

A "standalone" performance in the context of an algorithm is not applicable here. The computational modeling and simulation for RF-induced heating could be considered a form of "algorithm only" evaluation for a specific physical property of the device, but it is not an AI diagnostic algorithm. It's a scientific modeling approach to predict a physical outcome.

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

The ground truth for the non-clinical tests and simulations is based on:

• Physical properties and behavior of materials according to established scientific principles.
• Standardized test methods defined by ASTM (e.g., ASTM F2052-21, ASTM F2213-17, ASTM F2119-07, ASTM F2182-19e2).
• FDA-qualified Medical Development Tool (MDDT) for computational modeling, implying its results are considered reliable and accurate.

8. The sample size for the training set

This question is not applicable as there is no mention of a "training set" in the context of artificial intelligence or machine learning. The studies described are non-clinical hardware tests and physics-based simulations, not data-driven AI model training.

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

This question is not applicable for the same reasons as #8.

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