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The KLS Martin Ixos system is indicated for use in forearm fractures, osteotomies, and arthrodeses. This system is intended for adults, as well as adolescents (12-21 years) and children (2-12 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

The KLS Martin Ixos System consists of metallic plates used in conjunction with bone screws and locking pins intended for the internal fixation, alignment, stabilization, and reconstruction of the distal radius and/or ulna. Plates are manufactured from Ti-6Al-4V and are available in various shapes and dimensions. The system also includes the necessary instruments to facilitate placement of the implants. The manufacturing process, sterilization methods, materials and packaging are identical to those of the cleared predicate device, KLS Martin LINOS Wrist System (K222624).

The provided FDA 510(k) clearance letter for the KLS Martin Ixos System does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria for an AI/software device.

This document describes a metallic bone fixation appliance, not a software or AI medical device. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states "Clinical Performance Data: Not Applicable" and details mechanical performance testing (in accordance with ASTM F382) and MR compatibility testing (per various ASTM standards). These are standard tests for orthopedic implants to demonstrate their static and dynamic strength, and safety in an MRI environment.

Therefore, I cannot extract the following information as it is not present in the provided text:

• A table of acceptance criteria and the reported device performance (for AI/software).
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to predicate orthopedic implants based on:

• Same intended use/indications for use.
• Similar technological characteristics: manufactured from the same materials (Ti-6Al-4V), using the same manufacturing methods, and having similar principles of operation.
• Performance data: Non-clinical comparative static and dynamic mechanical performance testing against a secondary predicate (Stryker VariAx 2 distal radius plates) and MR compatibility testing.

In summary, the provided document is a 510(k) clearance for a physical medical device (bone plate system), not an AI/software device, and thus does not include the type of performance evaluation details (e.g., ground truth, reader studies, training data) relevant to AI/software.

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The KLS Martin Drill-Free MMF Screw is indicated for temporary stabilization of mandibular and maxillary fractures to maintain proper occlusion during surgery in adults and adolescents (age 12 and older) in whom permanent teeth have erupted.

The KLS Martin Drill-Free MMF Screw are bone-borne, self-drilling screws for maxillomandibular fixation (MMF). The screws are intended to provide stabilization of mandibular and maxillary fractures as well as maintain proper occlusion during intraoneralive bone fixation. These screws may be applied prior to or after exposure of the Drill Free MMF Screw is manufactured from stainless steel (ASTM F138) with a head designed with a hole to allow passing and securing ligature wire during the procedure and is available in threaded lengths of 2.0 x 8.0 mm - 2.0 x 12.0mm. Implants are available both sterile and non-sterile.

This document is a 510(k) Premarket Notification summary from the FDA for a medical device called the "KLS Martin Drill-Free MMF Screw". It is specifically a clearance letter and a summary of the device and its equivalence to a predicate device.

Based on the provided text, the device is a mechanical implant (a screw for bone fixation), not a software-based AI/ML medical device. Therefore, the questions related to AI/ML acceptance criteria, ground truth establishment, training data, MRMC studies, and effect sizes are not applicable to this documentation.

The document describes the non-clinical performance data used to demonstrate substantial equivalence for this mechanical device.

Here's an analysis of the provided information, focusing on the mechanical device's testing:

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

The document states that comparisons were made to a primary predicate device (KLS Martin Drill Free MMF Screw (K083432)) and reference devices. It describes the type of tests performed, but does not provide specific numerical acceptance criteria or the reported device performance metrics in a tabular format within this summary.

Types of Tests Mentioned:

• Comparative head-to-head static and dynamic bench testing: Conducted on the subject device and the primary predicate device to determine equivalent performance.
• Comparative screw testing: Performed to evaluate:
  • Torsional strength
  • Drive torque
  • Pullout strength
• Biological safety risk assessments: In compliance with ISO 10993-1:2018.
• LAL endotoxin testing: To address the presence of bacterial endotoxins and meet pyrogen limit specifications in accordance with ANSI/AAMI ST72:2019.
• Gamma sterilization process validation: In accordance with ISO 11137-1:2015 and ISO 11137-2:2015 using the VDmax25 method, and also ISO 11737-1:2018 and ISO 11737-2:2019.
• Packaging validations: Performed for the PETG blister pack with 1073B Tyvek cover in accordance with ISO 11607-1 and ASTM D7386.

Reported Device Performance (General Statement):
"Mechanical test results demonstrate that KLS Martin MMF Screw's performance is substantially equivalent to the primary predicate device."
"Biological safety risk assessments... concluded the devices are biocompatible and appropriate for their intended use."
"LAL endotoxin testing... meet pyrogen limit specifications."

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

The document does not specify the sample sizes used for the bench testing (e.g., number of screws tested for torsional strength, number of packaging units for validation). The provenance is "Non-Clinical Performance Data," implying lab testing rather than patient data. Country of origin for data is not mentioned, but the applicant and correspondent are KLS-Martin L.P. in Jacksonville, Florida, United States. These are bench tests, not clinical studies.

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. Ground truth for mechanical performance is established through physical measurements and adherence to engineering standards (e.g., ASTM, ISO). There are no "experts" in the sense of clinicians establishing ground truth from medical images for this type of device.

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

This question is not applicable as this is a mechanical device, not an AI/ML system requiring human annotation adjudication.

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 is a mechanical device, not an AI-assisted diagnostic tool. No MRMC study was performed or required.

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

This question is not applicable. This is a mechanical device.

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

For this mechanical device, the "ground truth" for performance is based on established engineering standards and physical measurements (e.g., force, torque, material properties) as defined by ASTM and ISO standards, and comparison to the predicate device's measured performance. Biosafety is determined by established biological test methods (e.g., LAL, biocompatibility assays).

8. The sample size for the training set.

This question is not applicable. This is a physical device, not an AI model that requires a training set.

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

This question is not applicable. As above, there is no AI training set for this device.

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KLS Mini Osteosynthesis System (K943347): The KLS Mini Osteosynthesis System is indicated for 1) Fractures, 3) Reconstruction procedures of the craniomaxillofial skeletal system.
KLS Chin Plate System (K943348): The KLS Chin Plate System is indicated for 1) Fractures, 3) Reconstruction procedures of the craniomaxillofacial skeletal system.
KLS-Martin Micro Osteosynthesis System (1.0MM) (K944561): The KLS-Martin Micro Osteosynthesis System (1.0MM) is used in oral-maxillo-cranio-facial surgery to stabilize fractures. The bone segments are attached to the plate with screws to prevent movement of the segments.
KLS-Martin Micro Osteosynthesis System (1.5MM) (K944565): The KLS-Martin Micro Osteosynthesis System (1.5MM) is used in oral-maxillo-cranio-facial surgery to stabilize fractures. The bone segments are attached to the plate with screws to prevent movement of the segments.
KLS Martin Centre-Drive Drill-Free Screw (K971297): The KLS Martin Centre-Drive Drill-Free Screws are in rigid internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bone fragments. The addition of the self drilling feature is the only difference between the submitted device and the predicate device referenced.
KLS-Martin Temporary Condylar Implant (K990667): The KLS-Martin Temporary Condylar Implant is only intended for temporary reconstruction of the mandibular condyle in patients who have undergone resective procedures to remove malignant or benign the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMF or treatment of temporomandibular joint disease (TMD).
KLS-Martin Mandibular/Reconstruction System II (K032442): The KLS-Martin Mandibular/Reconstruction System II is intended for use in the stabilization of mandibular fractures and mandibular reconstruction.
KLS-Martin Ortho Anchorage System (K033483): The KLS-Martin Ortho Anchorage System is intended to be surgically placed in the mouth for use an an anchor for orthodontic procedures.
KLS-Martin Ortho Anchorage System (Plates) (K040891): The KLS-Martin Ortho Anchorage System (Plates) are implants intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures in patients.
KLS Martin Rigid Fixation - Sterile (K060177): The KLS Martin Rigid Fixation - Sterile is in sterile packaging, osteosynthesis products with the following indications for use:
K051236: The RESORB-X® SF Sonotrode is only intended for use for insertion of the RESORB-X® SF pins.
K032442: The KLS Martin Mandibular/Reconstruction System II is intended for use in the stabilization of mandibular fractures and mandibular reconstruction.
K971297: The KLS Martin Centre-Drive Drill-Free screws are in rigid internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bony surface and stabilize the bone fragments. The addition of the self drilling feature is the only difference between the predicate device reference
K944565: The KLS-Martin Micro Osteosynthesis System is used in oral-maxillo-cranio-facial surgery to stabilize fractured bone segments. The bone segments are attached to the plate with screws to prevent movement of the segments.
K944561: The KLS-Martin Micro Osteosynthesis System is used in oral-maxillo-cranio-facial surgery to stabilize fractured bone segments. The bone segments are attached to the plate with screws to prevent movement of the segments.
KLS Martin Drill-Free MMF Screw (K042573): The KLS Martin Drill-Free MMF Screws is intended for use in maxilonandibular fixation of fractures of the maxilla, mandible, or both.
Drill Free MMF Screw (K083432): The Drill Free MMF Screw is intended for use in maxillomandibular fixation of fractures of the maxilla, mandible, or both.
KLS Martin L1 MMF System (K173320): The KLS Martin L1 MMF System is intended for temporary stabilization of maxillary fractures. It is designed to maintain proper occlusion during intraoperative bone healing (app. 6-8 weeks). It is indicated for the temporary treatment of maxillomandibular fixation (MMF) in adults or adolescents who have permanent teeth present (ages 12 and older).

KLS Mini Osteosynthesis System (K943347): The KLS Mini Osteosynthesis System consists of titanium non-locking plates ranging in thickness from 0.6mm - 2.5mm and titanium screws ranging in diameter from 1.5mm - 2.3mm.
KLS Chin Plate System (K943348): The KLS Chin Plate System consists of titanium plates ranging in thickness of 0.6mm and titanium screws ranging in diameter from 1.5mm - 2.3mm.
KLS-Martin Micro Osteosynthesis System (1.0mm) (K944561): The KLS-Martin Micro Osteosynthesis System is designed to aid in the alignment and stabilization of the skeletal system after a facial fracture or surgery. The bone plates, bone plates, bone screws and accessories of various shapes and sizes for use in oral-maxillo-cranio-facial surgery. The bone plates are manufactured from CP Titanium and range in thickness from 0.3mm - 0.6mm. The bone screws are manufactured from Titanium Alloy and range in diameter from 1.0mm - 1.2mm.
KLS-Martin Micro Osteosynthesis System (1.5mm) (K944565): The KLS-Martin Micro Osteosynthesis System is designed to aid in the alignment and stabilization of the skeletal system after a facial fracture or surgery. The bone plates and screws of various shapes and sizes for use in oralmaxillo-cranio-facial surgery. The bone plates are manufactured from CP Titanium and range in thickness from 0.3mm - 0.6mm. The bone screws are manufactured from Titanium Alloy and range in diameter from 1.5mm - 1.8mm.
KLS Martin Centre-Drive Drill-Free Screw (K971297): The KLS Martin Centre-Drive Drill-Free Screws are designed to eliminate the need for pre-drilled pilot holes. They are self-tapping with one step insertion. They are intended for use in rigid internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates where are contoured to fit the bone fragments. The bone fragments. The bone screws are manufactured from Titanium Alloy and range in diameter from 1.0mm - 2.0mm.
KLS-Martin Temporary Condylar Implant (K990667): The KLS-Martin Temporary Condylar Implant is a solid condylar head which attaches with fastening screws to a KLS-Martin Fracture/ Reconstruction Plate. The implant is available for left and right placement. The KLS-Martin Temporary Condy intended for temporary reconstruction of the mandibular condyle in patients who have undergone resective procedures to benign tumors requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
KLS-Martin Mandibular/Reconstruction System II (K032442): The KLS-Martin Mandibular/Reconstruction System II includes several different designs of titanium plates and screws intended for use in the stabilization and fixation of mandibular fractures and reconstruction. The plates are manufactured from either CP Titanium or Titanium Alloy and range in thickness from 1.0mm - 3.0mm. The screws are manufactured from either CP Titanium Alloy and range in diameter from 2.0mm - 3.2mm.
KLS-Martin Ortho Anchorage System (K033483): The KLS-Martin Ortho Anchorage System consists of a titanium screw designed to aid in dental movement by providing a rigid skeletal fixation point. The screw is intended to be surgically placed in the mouth for orthodontic procedures. The screws are manufactured from either CP Titanium or Titanium Alloy.
KLS-Martin Ortho Anchorage System (Plates) (K040891): The KLS-Martin Ortho Anchorage System (Plates) consists of titanium non-locking plates to aid in dental movement by providing a rigid skeletal fixation point. The plates are manufactured from either CP Titanium Alloy and are fixated with titanium screws and are utilized as an anchor for orthodontic procedures in the palatal, maxilla or mandible region.
KLS-Martin Drill-Free MMF Screw (K042573): The KLS-Martin Drill-Free MMF Screw provides temporary occlusal and fracture stabilization. These screws may be applied prior to or after exposure of the fracture. The KLS-Martin Drill-Free MMF Screw is in maxillomandibular fixation to provide stabilization of fractures of the maxilla, or both. The screws are manufactured from either CP Titanium Alloy and are provided in 2.0mm diameter with lengths ranging from 8mm - 12mm.
KLS Martin Rigid Fixation - Sterile (K060177): The KLS Martin Rigid Fixation - Sterile includes titanium plates of various shapes and thickness, titanium screws of various length and diameter, stainless steel twist drills of various length and stainless steel sonotrode tips that are provided in sterile packaging. The KLS Martin Rigid Fixation - Sterile is intended to provide KLS Martin's previously cleared osteosynthesis products in sterile packaging.
Drill Free MMF Screw (K083432): The Drill Free MMF Screw provides temporary occlusal and fracture stabilization. These screws may be applied prior to or after exposure of the fracture. The Drill Free MMF Screw is in maxillomandibular fixation to provide stabilization of fractures of the maxilla, mandible, or both. The screws are manufactured from Stainless Steel and are provided in 2.0mm diameter with lengths ranging from 8mm - 12mm.
KLS Martin L1 MMF System (K173320): The KLS Martin L1 MMF System is a bone-borne maxillomandibular fixation (MMF) system consisting of metalic archbars with sliding locking plates that attach to the dental arches with screws. The system is intended to provide temporary stabilization of mandibular and maxillary fractures as well as maintain properative bone fixation and postoperative bone healing (app. 6-8 weeks). The patient is brought into occlusion by wiring around the archbar wire hooks. The L1 MMF system plates are manufactured from CP Titanium (ASTM F67), are available in either a 7-hole siding plate configuration with two different lengths, and are 0.5mm in plate thickness. The L1 MMF system sliding locking plates are fixated with either 2.0 x 6 mm selfdrilling locking screws manufactured from Ti-6Al-4V (ASTM F136). Implants are available both sterile. The system also includes the necessary instruments to facilitate placement of the implants.

The document describes the KLS Martin Oral-Max Implants - MR Conditional, a bundled submission of various osteosynthesis systems and screws intended for use in craniomaxillofacial surgery. The purpose of this submission is to support the conditional safety and labeling modification of these devices in the magnetic resonance (MR) environment.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The acceptance criteria are implied by the non-clinical tests conducted to support MR Conditional safety, aligning with relevant ASTM standards and FDA guidance. The reported device performance is that the devices can be safely scanned under specified conditions.

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

The testing involved computational modeling and simulation (CM&S). The "test set" in this context refers to the simulated scenarios and device configurations.

• Sample Size for Test Set: "the entire portfolio of KLS Martin maxillofacial implants" was simulated. This implies that all devices grouped under "KLS Martin Oral-Max Implants - MR Conditional" were included in the simulations. The document also mentions "various in-vivo device positions and landmarks," "worst-case single and multiple devices," and simulations in "10 cm increments." This suggests a comprehensive set of simulated scenarios rather than a traditional physical sample size.
• Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective" in the same way clinical data is. The data is generated through computational modeling and simulation using MED Institute's FDA-qualified Medical Device Development Tool (MDDT) and the Duke virtual human anatomy. This is a form of prospective simulation data.

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

Not applicable in the traditional sense for this type of non-clinical, simulation-based study. The "ground truth" for the RF-induced heating simulations is derived from the established physics and engineering principles embedded in the FDA-qualified MDDT and the Duke virtual human anatomy model. The expertise lies in the development and validation of these computational tools and the interpretation of the simulation results by experts in MR safety and medical device engineering at MED Institute and the submitting company. The document does not specify the number or qualifications of individual experts validating the computational model, but implies that the MDDT itself is "FDA-qualified," indicating a level of expert review and agreement on its methodology.

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

Not applicable. Adjudication methods like "2+1" or "3+1" are typically used for consensus building among human expert readers for clinical studies, especially when establishing ground truth from image interpretation. This study is based on physical property testing and computational simulations, not human interpretation of clinical data.

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 a study involving human readers or AI-assisted diagnostic performance. It focuses on the physical safety of implants in an MR environment.

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

The RF-induced heating assessment involved "Computational modeling and simulation (CM&S) ... using MED Institute's FDA-qualified Medical Device Development Tool (MDDT) and in a clinically relevant position within the Duke virtual human anatomy." This is a standalone algorithm/model-based assessment without a human-in-the-loop for the performance evaluation itself. Human experts design the simulations, configure the models, and interpret the results, but the "performance" (temperature rise, SAR calculations) is computed by the algorithm.

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

For the non-clinical tests:

• Magnetically induced displacement force, torque, and image artifacts: The "ground truth" is based on the physical properties of the materials and device designs, measured or calculated according to established ASTM standards (F2052-21, F2213-17, F2119-07).
• RF-induced heating: The "ground truth" for the simulations is derived from the established electromagnetic physics and thermal dynamics principles implemented in the FDA-qualified Medical Device Development Tool (MDDT) and applied to the Duke virtual human anatomy model. The MDDT's qualification process by the FDA implicitly establishes the reliability of its results as a form of "ground truth" for simulation-based assessments.

8. The sample size for the training set

Not applicable. This is a non-clinical study for MR safety assessment, not a machine learning model requiring a training set in the typical sense. The "training" for the MDDT is its initial validation and qualification against known physical phenomena and experimental data, which is a separate process from this submission.

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

Not applicable, as there is no training set for a machine learning model in this context. The "ground truth" for qualifying the simulation tool (MDDT) would have been established through extensive validation against experimental measurements and recognized physical theories.

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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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The KLS Martin CranioXpand Spring system is indicated for use in the treatment of cranial conditions such as craniosynostosis and congental deficiencies in which osteotomies and gradual bone distraction are indicated for the infant pediatric subpopulation (29 days of age). The CranioXpand implants are implantable single-use products intended for temporary stabilization of the bony cranial roof during and after surgery. This device is intended to be removed after bone consolidation.

The KLS Martin CranioXpand Spring System consists of implantable spring distractors and supporting instruments intended for temporary stabilization and distraction of the bony cranial roof during and after surgery through distraction osteogenesis. The CranioXpand Springs are offered in various sizes. The spring features include rounded atraumatic contours to ensure optimal embedding in soft tissue with curved ends to ensure the devices can securely anchor in the bone. Two springs are provided as part of the CranioXpand system for anterior and posterior placement on the osteotomies. The springs are removed after adequate bone formation or after the bone consolidation phase is complete. These devices are typically left in the implanted location for 3 - 6 months before explantation. The CranioXpand Instruments are accessories used to facilitate spring size selection, and spring insertion and positioning.

The provided text is a 510(k) Premarket Notification from the FDA, specifically concerning the KLS-Martin L.P. CranioXpand device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets clinical performance acceptance criteria through the types of studies you've queried (e.g., MRMC studies, standalone AI performance, expert ground truth adjudication).

The CranioXpand device is a physical implant (spring system) used for cranial conditions in pediatric patients, not an AI or software-based diagnostic tool. Therefore, the types of studies and acceptance criteria you've asked about, which are common for AI-driven image analysis or diagnostic devices, are not applicable to the information contained within this 510(k) submission.

The "studies" conducted for this device are non-clinical performance bench testing and biocompatibility testing, designed to show that the CranioXpand is as safe and effective as its predicate device.

However, I can extract the information relevant to their acceptance criteria and performance studies for this type of medical device:

Here's a breakdown based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the CranioXpand device, as reported in this 510(k), are focused on bench testing to demonstrate performance equivalence to the predicate device and biocompatibility.

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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 LINOS Wrist System consists of metallic plates used in conjunction with bone screws and locking pins intended for the internal fixation, alignment, stabilization, reconstructive 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.

This document is a 510(k) summary for the KLS Martin LINOS Wrist System. It outlines the device's characteristics, intended use, and compares it to legally marketed predicate devices to demonstrate substantial equivalence.

Here's an analysis of the provided text in relation to acceptance criteria and study proving device performance:

Crucially, this document does not describe an AI/ML medical device. It describes a traditional Class II orthopedic implant (metallic bone fixation appliance). Therefore, many of the typical acceptance criteria and study aspects for AI/ML devices (like MRMC studies, ground truth establishment for algorithms, training/test set sizes for algorithms, expert adjudication methods for AI performance, etc.) are not applicable to this submission.

The acceptance criteria and study described here are for the mechanical and biocompatibility performance of a physical medical device.

Acceptance Criteria and Device Performance (for a physical orthopedic implant)

Since this is a physical medical device and not an AI/ML algorithm, the "acceptance criteria" table below reflects the types of performance metrics that would be relevant for such a device, and how its performance is typically proven.

Study Information (as applicable to a non-AI/ML medical device 510(k))

Since the provided document is a 510(k) summary for a physical orthopedic implant, not an AI/ML device, many of the requested points below (especially those related to AI/ML specific studies like MRMC or standalone algorithm performance) are not applicable or are addressed by the foundational regulatory framework for traditional medical devices.

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

   • Test Set (for mechanical testing): The document states "Comparative head-to-head static and dynamic bench testing was conducted on the subject and predicate...". It doesn't specify the exact sample size (N number of implants tested), but standard mechanical testing for medical devices typically involves a statistically robust number of samples to demonstrate equivalence or superiority according to relevant ISO/ASTM standards.
   • Data Provenance: The studies are bench tests conducted in a laboratory setting, not on patient data. Thus, "country of origin of the data" or "retrospective/prospective" clinical study design are not relevant in this context. The "data" are mechanical test results.

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

   • Not Applicable. For a physical implant device proving mechanical performance, "ground truth" is established by adherence to recognized engineering standards (ASTM, ISO) for material properties, mechanical strength, and biocompatibility. Experts involved would be engineers, material scientists, and toxicologists conducting the tests and interpreting results against these standards, not clinicians establishing "ground truth" on patient images or outcomes.

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

   • Not Applicable. This concept is critical for establishing ground truth in clinical data, especially for AI/ML devices where reader variability exists. For mechanical bench testing, results are objective measurements against defined criteria and standards; adjudication of "readings" is not relevant.

4. 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 a type of study specifically for evaluating the performance of AI/ML diagnostic or prognostic tools when used by human readers (e.g., radiologists interpreting images). The KLS Martin LINOS Wrist System is a surgical implant; it does not involve diagnostic image interpretation or AI assistance for human readers.
   • The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence." This reinforces that the evaluation was based on non-clinical (bench) testing.

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

   • Not Applicable. Again, this pertains to an AI/ML algorithm's performance. The device is a physical implant.

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

   • For this physical medical device, "ground truth" for proving substantial equivalence relies on:
     • Standardized Mechanical Test Results: Comparing the device's measured mechanical properties (strength, torque, pullout) to those of the predicate device, as defined by ASTM and ISO standards.
     • Biocompatibility Standards (ISO 10993-1:2018): Ensuring the materials meet safety criteria for biological interaction.
     • Sterilization Standards (ISO 11137, ISO 17665): Demonstrating the effectiveness of the sterilization process.
     • Packaging Standards (ISO 11607, ASTM D4169): Verifying package integrity and shelf life.

7. The sample size for the training set:

   • Not Applicable. This concept is for AI/ML models. This device does not use a training set.

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

   • Not Applicable. This concept is for AI/ML models. This device does not use a training set.

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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.

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 F136) 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

The provided text describes a 510(k) premarket notification for the KLS Martin Level One Rib Fixation System. It focuses on establishing substantial equivalence to predicate devices based on non-clinical performance data and discussions of intended use and technological characteristics.

However, the provided document DOES NOT contain information regarding a study involving AI/algorithm performance for a diagnostic or AI-assisted device. Therefore, I cannot extract the specific details requested in your prompt regarding acceptance criteria and performance studies for an AI device.

The document primarily addresses the substantial equivalence of a physical medical device (rib fixation system) based on mechanical and biological safety testing, rather than a diagnostic or AI-driven system.

Therefore, many of the requested points, such as "table of acceptance criteria and the reported device performance" (for an AI device), "sample size used for the test set and the data provenance," "number of experts used to establish the ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how the ground truth for the training set was established," are not applicable to the content provided.

The non-clinical performance data mentioned refers to:

• Comparative head-to-head bench testing: To determine if the subject device performs equivalently to or better than the primary predicate device in pull-out system testing.
• Comparison to a reference device (Synthes MatrixRIB Fixation System): For pull-out system testing.
• Biological safety risk assessments: In compliance with ISO 10993-1:2018, concluding the devices are biocompatible.

The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence." This further confirms that no human-in-the-loop or standalone diagnostic performance studies were conducted or reported in this 510(k) summary.

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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.

The KLS Martin LP Pure Pectus system consists of metallic implants comprised of straight and angled pectus bars and connector bars that provide support to the thoracic cavity undergoing repair for pectus excavatum. The implants are provided non-sterile 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 Pure Pectus System is a metallic implant system designed for surgical repair of pectus excavatum in both adult and pediatric populations. The submission K221938 received FDA clearance. Given the information provided, here's a detailed breakdown of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission and not a standalone algorithm, the "acceptance criteria" are not reported as specific performance metrics like sensitivity, specificity, or AUC, as would be the case for an AI/ML device. Instead, the acceptance criteria are related to mechanical and biological performance designed to demonstrate substantial equivalence to an existing predicate device.

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

• Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients" because this was bench testing on physical devices, not a clinical trial or algorithm evaluation with data. The sample size would refer to the number of bars tested for each mechanical test (static and dynamic bending). While not specified, these types of tests typically involve a statistically significant number of samples per variant (e.g., 5-10 samples per size/configuration for fatigue, 3-5 for static).
• Data Provenance: The data provenance is from non-clinical "bench testing" conducted by the manufacturer, KLS Martin L.P. This is not patient data; it's laboratory test data.

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

Not applicable. For this type of submission (mechanical and biocompatibility testing for a medical device), "ground truth" is not established by human experts in the way it would be for an AI diagnostic algorithm. Ground truth is established by validated laboratory testing procedures and international standards.

4. Adjudication Method for the Test Set

Not applicable. This was not an expert review/adjudication of clinical images or patient cases. The "adjudication" in this context is the comparison of test results against pre-defined acceptance criteria per established test protocols and 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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic tools that assist human readers in interpreting medical images or data. The KLS Martin Pure Pectus System is a metallic implant; its evaluation focused on its physical and biological performance, not its interpretive capabilities.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance evaluation was not done. This is also not relevant for an implantable medical device. Standalone performance is assessed for algorithms that provide diagnostic or prognostic outputs without human oversight.

7. The Type of Ground Truth Used

For the mechanical testing, the "ground truth" is the measured physical properties and performance of the subject device compared against the measured physical properties and performance of the predicate device, with both tested under standardized conditions. The benchmark for "ground truth" for biocompatibility is conformance to ISO 10993-1:2018 standards.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable. This device is not an AI/ML algorithm that requires a "training set" or ground truth for training.

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KLS Martin IPS Distraction includes devices intended as bone stabilizers and lengthening (and or transport) devices for correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, alveolar ridge, palate, and symphysis) and mid-face bones that require gradual distraction in adults, adolescents, children and infants weighing more than 2.5 kg.

KLS Martin IPS Distraction System is comprised of patient-specific models, guides and distraction footplates used in conjunction with previously cleared distractor bodies and metallic bone screws for internal fixation and reconstruction of maxillofacial / midface and mandibular bones. The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization of the device. The physician only provides input for model manipulation and interactive feedback by viewing digital models of planned outputs that are modified by trained KLS Martin personnel during the planning session. For each design iteration, verification is performed by virtually fitting the generated device model over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit.

Implants are provided sterile or non-sterile, range in thickness from 0.6 - 10 mm, and are manufactured using additive or traditional (subtractive) methods from either CP Titanium (ASTM F67) or Ti-6A1-4V (ASTM F136) materials. These patient-specific devices are fixated with previously cleared KLS Martin screws.

This document describes the 510(k) summary for the KLS Martin IPS Distraction device. It provides information regarding the device's indications for use, technological characteristics, and a comparison to predicate and reference devices to support a claim of substantial equivalence.

Based on the provided text, the device in question is a medical implant (bone plates) designed for cranial and facial bone distraction. Therefore, the acceptance criteria and study proving its performance will relate to its mechanical properties, biocompatibility, sterilization, software validation, and clinical safety and effectiveness for its intended patient population.

Here's an analysis of the provided text to extract the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it describes various tests performed and their outcomes in narrative form to demonstrate substantial equivalence. I will infer the "acceptance criteria" from the types of tests conducted and the "reported device performance" from the stated results.

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

• Mechanical Testing (Weld Strength): The document does not specify the exact sample size for the weld strength test. It states "A direct comparison weld strength test was performed," implying sufficient samples for a comparative analysis, but no number is given.
• Biocompatibility, Sterilization, Pyrogenicity: These tests leveraged data from a previously cleared device (K191028). No new sample sizes are explicitly mentioned for these, as the substantial equivalence hinges on the similarity to the already-tested reference device. If new samples were tested for verification, their numbers are not stated.
• Software V&V: No specific sample size (e.g., number of cases or simulations) is mentioned for software testing. It refers to "all software requirements and specifications" and "on-site user acceptance testing."
• Clinical Performance (Pediatric): 5 clinical studies were analyzed to support the pediatric indications. The document lists the studies, but does not state how many patients were in the "test set" for the KLS Martin device specifically. These appear to be literature reviews, not new clinical trials conducted for this device clearance.
  • Data Provenance: The provenance of the data for the 5 analyzed clinical studies is implied to be from published literature ("Based on published literature findings"). Specific country of origin is not mentioned, nor is whether the studies were retrospective or prospective, though typical clinical trials are prospective, and reviews can be of either.

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

• Mechanical, Biocompatibility, Sterilization, Pyrogenicity, Software V&V: The document does not mention the use of external "experts" to establish ground truth for these non-clinical performance tests. These are typically assessed against pre-defined engineering and biological standards by internal or contract testing labs.
• Clinical Performance (Pediatric): The "ground truth" for the pediatric clinical performance is based on "published literature findings" and risk assessments performed based on FDA guidance. There is no mention of a specific number of experts used to establish a new ground truth for this 510(k) submission's test set. The experts are implicitly the authors of the peer-reviewed clinical literature analyzed and the regulatory/clinical affairs personnel conducting the risk assessment. Qualifications of these implied experts are not detailed in this document.

4. Adjudication Method for the Test Set

• No adjudication method (e.g., 2+1, 3+1) is described for any of the tests, as these are technical performance tests or literature reviews, not studies involving human interpretation of medical images or data requiring reader consensus.

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 MRMC comparative effectiveness study was mentioned or performed. This device is a passive implantable device, not an AI-assisted diagnostic tool.

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

• This question is not applicable. The device is a surgical implant, not a software algorithm. The software mentioned (for planning and design) is a tool for manufacturing patient-specific implants, not a diagnostic algorithm in itself that would have standalone performance.

7. The Type of Ground Truth Used

• Mechanical Testing: Ground truth is implicitly defined by engineering standards for tensile strength and material properties.
• Biocompatibility: Ground truth is established by the accepted international standard ISO 10993 series.
• Sterilization: Ground truth is defined by the accepted international standard ISO 17665-1:2006 and a target SAL of 10^-6.
• Pyrogenicity: Ground truth is defined by AAMI ANSI ST72:2019 and USP allowed limits for endotoxins.
• Software V&V: Ground truth is established by pre-defined software requirements, specifications, and risk assessment outcomes.
• Clinical Performance (Pediatric): Ground truth for the safety and effectiveness in pediatric applications is based on peer-reviewed clinical literature and FDA guidance on pediatric medical devices, interpreted through a risk assessment. This is a form of outcomes data and expert consensus derived from previous studies, rather than a new "ground truth" adjudicated for this submission.

8. The Sample Size for the Training Set

• This question is not applicable to an implantable device like KLS Martin IPS Distraction. "Training set" usually refers to data used to train a machine learning algorithm.
• For the patient-specific design, the "training" data is the individual patient's CT scan. Each device's design is unique to the patient's anatomy. The "training" for the process comes from accumulated experience, validated software, and adherence to design specifications described in the section about patient-specific manufacturing.

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

• This question is not applicable for the reasons stated above. For the individual patient design process, the "ground truth" (the patient's anatomy for which the device is being designed) is established directly from the patient's CT scan data. The "virtual planning" involves interactions between the physician and trained KLS Martin personnel to refine the design, with "verification" performed by virtually fitting the generated device model over a 3D model of the patient's anatomy to ensure adequate fit.

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KLS Martin Individual Patient Solutions (IPS) is intended as a pre-operative software tool for simulating / evaluating surgical treatment options as a software and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The is processed by the IPS software and the result is an output data file that may then be provided as digital models or used as input in an additive manufacturing portion of the system that produces physical outputs including implants, anatomical models, guides, splints, and case reports for use in maxillofacial, midface, & mandibular surgery.

KLS Martin Individual Patient Solutions (IPS) implant devices are intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in children (2 years of age), adolescents (12 years of age - 21 years of age), and adults.

KLS Martin Individual Patient Solutions (IPS) is comprised of a collection of software and associated additive manufacturing equipment intended to produce various outputs to support reconstructive and orthognathic surgeries. The system processes the medical images to produce various patient-specific physical and/or digital output devices which include implants, anatomical models, guides, splints, and case reports.

Patient-specific metallic bone plates are used in conjunction with metallic bone screws for internal fixation of maxillofacial, midface, and mandibular bones. The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician provides input for model manipulation and interactive feedback by viewing digital models of planned outputs that are modified by trained KLS Martin engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated output device over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit.

Implants are provided non-sterile and are manufactured using traditional (subtractive) or additive manufacturing methods from either CP Titanium (ASTM F67) or Ti-6AI-4V (ASTM F136). These patient-specific devices are fixated with previously cleared KLS Martin screws.

Here's a summary of the acceptance criteria and study information for the KLS Martin Individual Patient Solutions device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the KLS Martin Individual Patient Solutions device primarily revolve around demonstrating substantial equivalence to predicate devices and ensuring the safety and effectiveness of the device, particularly for the expanded pediatric population and new specifications. The performance is assessed through various non-clinical tests and a review of clinical literature.

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