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The T2 Alpha Humerus Nailing System is indicated for the treatment of humerus fractures. Fractures can include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures.

The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.

The T2 Humeral Nail is intended to provide temporary stabilization of various types of fractures, malunions, and non-unions of the humerus. The nails are inserted using an open or closed technique and can be static, dynamic, or compression locked. The subject and predicate devices are indicated for use in the humerus. Types of fractures include, but are not limited to, fractures of the humeral shaft, non-unions, malalignments, pathological humeral fractures, and impending pathological fractures.

The T2 Alpha Humerus Nailing System is an intramedullary humerus fracture nailing system consisting of sterile implants (Nails, End Caps, Compression Screw, and Washer) and non-sterile indication-specific instrumentation. The Nails, End Caps, Compression Screw, and Washer are made of titanium alloy as per ASTM F136. The T2 Alpha Humerus Nailing System will be used with the existing Locking Screws and Advanced Locking Screws of the IMN Screws System.

The IMN Screws System includes bone screws (Locking Screws and Advanced Locking Screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct. All screws are sterile and made of titanium alloy (Ti6Al4V ELI) per ASTM F136.

The T2 Humeral Nail System is an intramedullary nailing system that allows antegrade and retrograde humeral nailing. The nails, end caps, compression screw, and washer are provided sterile and made of titanium alloy as per ASTM F136.

The provided FDA 510(k) clearance letter (K251400) does not concern an AI/software device. Instead, it pertains to a physical medical device: the Stryker T2 Alpha Humerus Nailing System, IMN Screws System, and T2 Nailing System, which are intramedullary fixation rods and bone screws used for treating humerus fractures.

Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/software performance metrics (e.g., accuracy, sensitivity, specificity, F1-score, expert consensus, MRMC studies) are not applicable to this submission.

The document discusses non-clinical performance testing for the physical device, focusing on mechanical properties, sterilization, packaging, and biocompatibility, to demonstrate substantial equivalence to previously cleared predicate devices.

Key points from the document regarding "performance":

• Non-Clinical Performance: This section details various engineering and material tests performed on the physical implants, such as dynamic and static bending, torsional stiffness, targeting accuracy, insertion torque, pull-out force, MRI assessment (magnetically induced displacement/torque, RF-induced heating, image artifacts), packaging tests, and biocompatibility evaluation. All these tests are standard for orthopedic implants.
• Clinical Performance: The document explicitly states: "Clinical data were not needed for the subject devices to demonstrate substantial equivalence to the predicate devices." This is a common situation for 510(k) submissions of physical devices where substantial equivalence can be demonstrated through non-clinical testing and comparison to predicates.

Since the request asks for information relevant to AI/software device performance, and this document is for a physical orthopedic device, I cannot extract the requested information (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone performance) because it is not present and not relevant to this specific biological device 510(k) submission.

In summary, there is no AI/software component in this device clearance that would require the types of performance statistics and study methodologies described in the prompt.

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The indications for use of these internal fixation devices include:

• Open and closed femoral fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures and tumor resections
• Supracondylar fractures, including those with intraarticular extension
• Fractures involving osteopenic and osteoporotic bone
• Fractures distal to a total hip prosthesis
• Periprosthetic fractures
• Nonunions and malunions

The struts of the T2 Alpha Femur Retrograde Nailing System are intended to be used only with the nails of this system; they are not to be used as stand-alone devices.

T2 Alpha Femur Retrograde Nailing System, previously cleared in K203819, consists of sterile implants (intramedullary nails in various diameter and sizes, compression screw and end caps), as well as nonsterile instruments (targeting devices).

The subject of this 510(k) submission is to introduce new devices of the T2 Alpha Femur Retrograde Nailing System. This line extension consists of anatomically pre-contoured struts and interlinking dowels designed to be used in combination with the existing nails of the T2 Alpha Femur Retrograde System for the treatment of complex fractures of the distal femur.

All struts are manufactured from Ti6Al4V ELI (Type II anodization) and are available in different sizes and left/right versions; these will be provided both non-sterile and sterile packaged. Interlinking dowels to the femoral nail are manufactured from CoCr and will be provided sterile packaged.

This appears to be a 510(k) clearance letter for an orthopedic implant, not an AI/Software as a Medical Device (SaMD). The document describes the "T2 Alpha Femur Retrograde Nailing System," which is a physical device used for internal fixation of femoral fractures.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert ground truth, MRMC studies, standalone performance, and training/test set provenance does not apply to this clearance document. These criteria are typically evaluated for AI/SaMD products, where algorithmic performance and human-AI interaction are critical.

The provided document details:

• Device Type: Intramedullary fixation rod (physical implant).
• Performance Data: Non-clinical bench testing (fatigue strength, cut-out performance, stiffness, shear-off, pull-out, insertion, static bending, fretting corrosion, targeting accuracy, MR assessment, packaging) and references to clinical evidence from peer-reviewed scientific literature.
• Comparison to Predicate Devices: Focuses on material, manufacturing, intended use, and mechanical performance equivalence.

No mention of AI, algorithms, or software performance evaluation is present.

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The Succession™ Ankle Fusion Nail (AFN) System is a tibiotalocalcaneal (TTC) solid fusion system that has been developed for the following indications:

• Failed ankle replacement
• Arthritis of ankle and subtalar joint
• Correcting neuromuscular imbalance of hindfoot, where bone fusion is required
• Revision of failed ankle and/or subtalar fusion
• Revision of failed Tibiotalocalcaneal (TTC) fusion
• Talar Avascular Necrosis (AVN)
• Charcot
• Trauma
• Neuroarthropathy
• Pseudoarthrosis
• Rheumatoid arthritis

The Succession™ AFN System is comprised of a set of straight 10mm, 11mm, and 12 mm diameter cannulated nails, 12.5mm diameter end caps, 5mm and 6mm diameter cortical screws, and accessory instrumentation. All implants are composed of Titanium (Ti-6Al-4V ELI) and provided to the user sterile packed with a combination of both sterile and non-sterile accessory instrumentation to assist in implantation. Each of the accessory instruments provided with the subject device contain substantially equivalent materials to the Oxford™ Ankle Fusion Nail System predicate device instrumentation, including stainless steel (ASTM F899 and ASTM F138 / ISO 5832-1) and Fluorinated Ethylene Propylene direct contacting materials.

During the procedure, following preparation of the tibial intramedullary canal (using the device accessory instrumentation) and placement of the intramedullary fixation nail, the provided 5mm screws are inserted into the medial to lateral (M/L) slots of the implant, allowing for fixation in the tibia, talus, and calcaneus. In both the talus and calcaneus, dynamic compression slots are included in the nail and are to be used with the internal and/or external methods of compression across the tibiotalar and subtalar joints. In addition, a 6mm screw is placed through the only angled posterior to anterior (P/A) slot located at the distal end of the nail implant, allowing for additional fixation between the calcaneus and talus. Following the placement of all screws, the end caps are implanted to add stability to the distal end of the nail and prevent excess bony ingrowth from occurring within the nail cannulation. Overall, the Succession™ Ankle Fusion Nail is intended to effectively fuse the tibiotalar and subtalar joints together, providing stability in the hindfoot region to facilitate tibiotalocalcaneal arthrodesis.

Based on the provided FDA 510(k) Clearance Letter, the Succession™ AFN System is an intramedullary fixation rod, and the clearance is primarily based on substantial equivalence to predicate devices. This means the device is demonstrated to be as safe and effective as a legally marketed device, not necessarily by proving it meets specific quantitative performance acceptance criteria for an AI/machine learning device.

The document provided does not contain information about an AI/ML-driven device's acceptance criteria or a study proving its performance. The "Non-Clinical and/or Clinical Tests Summary" in the document describes mechanical testing of the physical device (nails, screws, and accessories) for properties like torsional yield strength, driving torque, pullout strength, self-tapping force, cyclic fatigue, bending strength, torsional strength, and corrosion resistance.

Therefore, I cannot provide the requested information for an AI/ML device based on this document. The provided text is solely about the substantial equivalence of a physical orthopedic implant.

If this were a document about an AI/ML device, the sections you requested would typically be found in a "Performance Benchmarking" or "Clinical Study" section, detailing the AI's accuracy, sensitivity, specificity, or impact on human performance, along with the study methodology.

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The Phantom® Hindfoot TTC/TC Nail System is indicated for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include:

• Post-traumatic or degenerative arthritis
• Previously infected arthrosis
• Revision of failed ankle arthrodesis
• Revision of failed total ankle arthroplasty
• Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis)
• Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle
• Rheumatoid arthritis
• Osteoarthritis
• Nonunions or pseudarthrosis of hindfoot and distal tibia
• Trauma (severe or malunited tibial pilon fracture)
• Charcot foot (neuroarthropathy)
• Severe end-stage degenerative arthritis
• Instability and skeletal defects after tumor resection
• Pantalar arthrodesis
• Severe foot/ankle deformity

Phantom® Hindfoot TTC/TC Nail System is comprised of intramedullary nails, screws and accessory components. The subject Phantom® Hindfoot TTC Trauma Nails are offered in a variety of sizes and lengths to accommodate variations in patient anatomy. The Phantom® TTC/TC screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required.

I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Phantom® Hindfoot TTC/TC Nail System) and does not contain the specific information you are requesting about acceptance criteria, study details, expert qualifications, or ground truth establishment for a diagnostic or AI-based device.

This document is a regulatory approval notice that states the device is substantially equivalent to a previously cleared predicate device. It confirms the device's indications for use, its classification, and mentions that "engineering analysis is presented to provide evidence that the original testing and subsequent performance is not adversely affected by the modifications to the subject devices." However, it does not elaborate on:

1. A specific table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number or qualifications of experts used for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness study results or effect sizes.
6. Stand-alone algorithm performance (as this is not an AI/diagnostic device).
7. Type of ground truth used.
8. Training set sample size.
9. How ground truth for the training set was established.

The document discusses "performance testing" and "engineering analysis" to demonstrate substantial equivalence, but it does not detail these tests in the way you've outlined for a diagnostic or AI study. The "device" in question is a surgical implant system, not a diagnostic tool or an AI algorithm that would typically have the kind of performance metrics you are seeking.

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The GMReis Fibula Nail System is intended for fixation of fractures and osteotomies of the fibula.

The GMReis Fibula Nail System is a system of locked intramedullary nails for osteosynthesis of fibular fractures. It has multiple lengths (110mm to 180mm) and diameters (3.0mm and 3.6mm). The arrangement of the holes in the intramedullary nails allows the surgeon to block the implant in different planes. The screws have a specific profile that reduces the risk of skin prominence and have threaded locking in the nail holes. GMReis Fibula Nail System are manufactured with titanium alloy, are for single use and the devices are provided non-sterile and must be properly cleaned and sterilized before use, according to the recommendations provided in the Instructions for Use.

The provided FDA 510(k) Clearance Letter for the "GMReis Fibula Nail System" (K250559) establishes substantial equivalence based on mechanical performance data, not clinical performance or AI/software-driven insights. Therefore, many of the requested points regarding acceptance criteria, study design, ground truth establishment, and expert involvement for an AI/software-based device cannot be extracted from this document.

The clearance is for a mechanical medical device (an intramedullary fixation rod), not a software or AI device. The type of acceptance criteria and study design are fundamentally different for a mechanical device versus a software/AI device.

However, I can extract the information relevant to this specific device's clearance process from the provided document:

Acceptance Criteria and Device Performance for GMReis Fibula Nail System (K250559) - A Mechanical Device

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of devices tested, but implicitly refers to a sufficient number of samples to satisfy the requirements of the ASTM standards (ASTM F1264 for Intramedullary Fixation Rods and ASTM F543 for Metallic Medical Bone Screws). These standards outline specific testing configurations and sample numbers for mechanical characterization.
• Data Provenance: The document does not specify the country of origin of the data beyond the manufacturer being in Brazil. The data is retrospective in the sense that it's generated for a regulatory submission rather than a prospective clinical trial.

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

• Not Applicable. This is a mechanical device. "Ground truth" in the context of expert consensus or clinical outcomes is not relevant for the primary evidence of substantial equivalence for this type of device. The "ground truth" here is the physical properties demonstrated by mechanical testing, measured by calibrated equipment.

4. Adjudication method for the test set:

• Not Applicable. As this is mechanical testing to specific ASTM standards, there is no expert adjudication process in the sense of reviewing images or clinical data. The results are quantitative measurements against predefined engineering specifications.

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 a mechanical implant device, not an AI or software product. MRMC studies are for evaluating diagnostic or interpretive AI systems with human-in-the-loop.

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

• Not Applicable. This is a mechanical implant device, not an AI algorithm.

7. The type of ground truth used:

• Quantitative Mechanical Properties: The "ground truth" for this device are the quantifiable mechanical properties (e.g., stiffness, strength, fatigue life) as determined by standardized laboratory tests (ASTM F1264 and ASTM F543).

8. The sample size for the training set:

• Not Applicable. This is a mechanical device, so there is no "training set" in the context of machine learning or AI.

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

• Not Applicable. (See point 8)

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ARIX Femur Nail System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).

ARIX Femur Nail System (Nail, Lag Screw, Interlocking Screw, Set Screw, and End Cap) is made of Titanium Alloy which meets ASTM F136. ARIX Femur Nail System is provided Sterile or Non-Sterile.

The provided text is an FDA 510(k) Clearance Letter for the ARIX Femur Nail System. This type of document is for a physical medical device (an intramedullary fixation rod), not a software or AI-powered device. Therefore, the questions regarding acceptance criteria, study details, expert involvement, and AI-specific metrics (like human improvement with AI assistance) are not applicable to the information given in this document.

For medical devices like the ARIX Femur Nail System, "acceptance criteria" are generally tied to meeting established industry standards for performance, material properties, and biocompatibility, rather than diagnostic accuracy or algorithmic performance. The "study that proves the device meets the acceptance criteria" refers to bench testing to demonstrate compliance with these standards and substantial equivalence to a predicate device.

Here's a breakdown of the information that is available based on your request, with an explanation of why other points are not applicable:

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):

This information is not provided in a 510(k) summary for bench testing. The "test set" in this context refers to the physical samples of the device components manufactured for the specified mechanical and material tests. The document does not specify the number of samples tested for each benchmark. There is no patient data involved, as no clinical studies were performed.

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

Not applicable. "Ground truth" in this context would refer to the established pass/fail criteria for mechanical and material tests, which are defined by the ASTM standards themselves. These are engineering specifications, not expert interpretations of clinical data.

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

Not applicable. This refers to methods for reconciling discordant expert opinions in clinical studies, which were not conducted.

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-powered device, and no MRMC studies or clinical studies were performed.

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

Not applicable. This is not an AI-powered device.

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

The "ground truth" for the device's performance is established by the specified ASTM (American Society for Testing and Materials) standards. These are internationally recognized engineering standards that define the methods and criteria for evaluating the mechanical properties and performance of medical implants.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable. This device does not involve machine learning or a training set.

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FitboneTM Trochanteric is indicated for limb lengthening of the femur. FitboneTM Trochanteric is indicated for adult and pediatric (greater than 12 through 21 years of age) patients.

FitboneTM Trochanteric is a fully implantable intramedullary lengthening nail and accessories. The subject Fitbone Trochanteric consists of the implantable intramedullary lengthening nail and accessories (Locking screws, Trial nails K-wire and Convenience kits). The subject device is implanted into the medullary canal of the femur and connected to the primary predicate intracutaneous Receiver (K203399) by a bipolar feed line. The external FITBONE Control Set is the same as previously cleared for the reference device Fitbone TAA (K203399) and consists of a control electronics station and transmitter. The power required for the distraction process is controlled by hermetically enclosed motor which draws the telescope apart. The electro-magnetic field sent from the Transmitter to the Receiver is converted in the Receiver into DC-Voltage to supply the motor of the subject Fitbone Trochanteric Nails with voltage, when actioned. The subject Fitbone Trochanteric Nails are available in two different diameter models (D09mm, D11mm), different lengths and lengthening capabilities. The subject nail is anchored to the bone by locking screws. The locking screws to be used with the subject nails are the same as cleared for the primary predicate Fitbone Trochanteric (K233867). Trial nails accessories are available for each variant of the Fitbone Trochanteric nails and are used to simulate the shape of the implant. The Fitbone Trochanteric nail and K-wire are provided in sterile conditions only. The trial nails are provided in non-sterile version only. The locking screws are available in both sterile and non-sterile versions. The subject Fitbone Trochanteric Nails and their accessories are made from implant grade stainless steel 1.4441 (AISI 316LVM) and Silicone Nusilmed.

The provided document is an FDA 510(k) clearance letter for the FitboneTM Trochanteric, an intramedullary fixation rod used for limb lengthening. This type of device is classified as a Class II medical device. The document focuses on demonstrating substantial equivalence to a predicate device through engineering and mechanical testing, rather than clinical studies involving human efficacy data. Therefore, many of the requested elements pertaining to clinical study design, such as human reader performance, ground truth establishment for a training set, and multi-reader multi-case studies, are not applicable here.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are established through comparison to a predicate device and bench testing against recognized standards. The "performance" described primarily refers to mechanical properties.

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

• Sample Size for Test Set: The document does not specify a "sample size" in terms of patient data for a test set, as this was not a clinical study assessing patient outcomes. The testing described is bench testing (mechanical testing). For mechanical testing, samples of the physical device would be tested. The number of such samples is not explicitly stated but would typically involve multiple units for each configuration tested.
• Data Provenance: The data provenance is from bench testing conducted on the subject device, its primary predicate (K233867), and reference devices (K203399, K220234). This testing would have been done in a laboratory setting, likely at the manufacturer's facility or a third-party testing lab. The origin of the device is Italy (Orthofix S.r.l.). The data is prospective in the sense that the tests were conducted specifically for this submission to evaluate the design change.

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

Not applicable. Ground truth, in the context of this 510(k), is established through engineering specifications, material standards (e.g., ASTM F138-13), and validated mechanical testing methodologies, rather than human expert interpretation of clinical data.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring expert adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is used for diagnostic devices where human readers interpret medical images or data, and an AI would assist in that interpretation. The FitboneTM Trochanteric is an implantable intramedullary lengthening nail, not a diagnostic AI software.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The FitboneTM Trochanteric is a physical medical device, not a software algorithm or AI. Its function is mechanical distraction, controlled by an external unit, but it does not have a "standalone algorithm" performance to report in this context.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on engineering specifications, material properties, and established mechanical testing standards. The primary method for establishing substantial equivalence involves comparing these aspects to a legally marketed predicate device and demonstrating that any differences do not raise new questions of safety or effectiveness.

8. Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of AI or machine learning. The device's design and materials are based on established engineering principles and prior device history, not on learning from a dataset.

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

Not applicable, as there is no training set for this device.

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Pediatric Nailing Platform | Tibia is intended as a temporary implant for alignment, stabilization and fixation of tibias that have been surgically prepared (osteotomy) for correction of deformities or have sustained fracture due to trauma or disease. The patient population is pediatric and includes child and adolescent subgroups, and small-stature adults - such as patient with small intramedullary canals affected by skeletal dysplasias, osteogenesis imperfecta or other bone diseases. Nail lengths greater than 400mm are for skeletally mature patients.

Pediatric Nailing Platform | Femur is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity. Additional indications include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. The OrthoPediatrics' Pediatric Nailing Platform | Femur is for single use only.

Pediatric Nailing Platform | Tibia offers a selection of rigid intramedullary nails for internal stabilization of the tibia. When a tibia is broken into multiple pieces, via a traumatic fracture(s), disease, or planned osteotomy(ies), alignment and stabilization of the bone fragments is critical to ensuring successful healing. When inserted down the intramedullary canal and locked with screws both proximally and distally, a rigid metallic nail provides resistance to bending and axial loading of the bone. In cases where compression is desired to stimulate bone regeneration, a dynamization slot can be utilized. End caps may be implanted with the nail, to ease removal by protecting the proximal threads of the nail and prevent bony ingrowth, as well preventing incarceration of the nail. All implants are single use and are made of Ti-6Al-4V ELI. The Pediatric Nailing Platform | Tibia was evaluated for use in an MR Environment and were determined to be MR Conditional. The system is implanted using Class II and Class I exempt instruments.

Pediatric Nailing Platform | Femur includes 316L stainless steel nails which are intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments in small statue adults and pediatric populations. The nails have holes at each end which allow 316L stainless steel transverse screws to be installed to achieve greater stabilization. Pediatric Nailing Platform | Femur also offers end caps which are used to cap the head of the nail to prevent bony ingrowth and ease removal of the nail. The Pediatric Nailing Platform | Femur was evaluated for use in an MR Environment and were determined to be MR Conditional. The system is implanted using Class II and Class I exempt instruments.

The provided FDA 510(k) clearance letter for the OrthoPediatrics Pediatric Nailing Platform (Tibia and Femur) addresses a "Special 510(k)" submission. A Special 510(k) is typically used for changes to a manufacturer's own legally marketed device where the modification does not affect the device's indications for use or its fundamental scientific technology.

Based on the document, the key changes are related to sterilization, shelf life, and packaging. The performance data section explicitly states:

"The sterility, shelf life as well as the packaging of the subject sterile devices were supported by the sterilization validation and the packaging validation which includes aging and simulated transport."

And:

"An engineering analysis has been conducted that there is no impact of sterilization or aging on the products' performance and functionality."

This context is crucial because the "study that proves the device meets the acceptance criteria" in this case is not a clinical study involving human patients, but rather non-clinical performance testing focused on the impact of these manufacturing changes.

Therefore, the requested information about AI model performance, multi-reader multi-case studies, expert consensus for ground truth, and training set details are not applicable to this specific 510(k) submission. This is not a software-driven diagnostic device; it is a physical, implantable medical device.

Here's how to interpret the request in the context of this document:

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

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

• Sample Size: The document does not specify exact sample sizes for the "sterilization validation," "packaging validation," or "engineering analysis." These are typically conducted according to recognized standards (e.g., ISO, ASTM) which dictate appropriate sample sizes for testing (e.g., for sterility, a certain number of units must pass tests; for aging, a specific number of packages are subjected to accelerated aging).
• Data Provenance: The data provenance is internal to OrthoPediatrics Corp., generated through their quality system and R&D processes as part of the 510(k) submission. It would be prospective for the specific tests conducted for this submission (e.g., packaging validation on new sterile packaging). The biocompatibility assessment references data from preceding predicate devices. The country of origin of the data is not specified beyond the company being based in Warsaw, Indiana, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of submission. Ground truth for non-clinical performance (like sterility, shelf life, packaging integrity) is established through validated testing methodologies and engineering analyses, not by expert human interpretation of medical images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for studies where human interpretation or consensus is required (e.g., clinical endpoint assessment, image reading). Here, acceptance is based on quantitative/qualitative results from engineering and validation tests meeting pre-defined specifications.

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 a physical, implantable medical device, not an AI/software-as-a-medical-device (SaMD).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not a software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this special 510(k) is the successful demonstration of:

• Sterility: Absence of viable microorganisms as per validated sterilization methods.
• Shelf Life: Maintenance of device integrity and function after accelerated and/or real-time aging.
• Packaging Integrity: Package seals and materials remain intact and protective after challenging conditions.
• Biocompatibility: Established safety profile from predicate devices and assessment of new packaging materials/processes.
• Mechanical Performance: Confirmation via engineering analysis that the changes do not degrade the device's original mechanical properties.

8. The sample size for the training set
Not applicable. This is not a machine learning/AI device.

9. How the ground truth for the training set was established
Not applicable. This is not a machine learning/AI device.

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This implant is indicated as a temporary implant to aid in the healing of long diaphysis fractures, malunions and nonunions and to prevent further fractures in femur, tibia and humerus in pediatric patients suffering from Osteogenesis Imperfecta and other pediatric bone diseases without disrupting the bone growth plate. It can be used in procedures such as bone lengthening concomitantly with external fixators in pediatric or small stature patients with limb length discrepancy.

The Fassier-Duval Telescopic IM System is a telescopic rod for use in fixation of long bone fractures. The design of the nail includes a female component (which is attached to the proximal -trochanteric- cortex of the bone) and a male component (which is attached to the distal cortex of the bone). Anchorage of the components is achieved through screw-type fixation. The naliding components that allow for extension of its length as the bone structures heal and normal patient growth occurs. The Fassier-Duval Telescopic IM System can be attached to bony structures without disrupting the bone growth plates. The device is sold both sterile and Non sterile.

This document describes the Fassier-Duval Telescopic IM System, an intramedullary fixation rod. The 510(k) submission, K241983, primarily focuses on updating the intended use of the device to include other pediatric bone diseases beyond Osteogenesis Imperfecta and providing MR safety labeling information. The device itself is substantially equivalent to previously cleared predicate devices, with no design changes.

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

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

The submission does not explicitly state quantitative acceptance criteria in a table format. Instead, it relies on the concept of substantial equivalence to predicate devices and adherence to recognized standards for MR safety. The "acceptance criteria" are implicitly met by demonstrating that the device is as safe and effective as its predicates and is MR Conditional according to established ASTM standards.

The intended uses are similar, all for deformity correction and fracture fixation.

The subject device also shares technological characteristics (design, materials, principle of operation) with its predicates. The only difference is the expanded intended use to include "other pediatric bone diseases" which is covered by the predicate Simple Locking Intramedullary (SLIM) System (K192710).

The submission states, "The information provided above supports that the Fassier-Duval Telescopic IM System is as safe and effective as the predicate devices." |
| Safety and Effectiveness for Expanded Intended Use (Other Pediatric Bone Diseases): | The submission states: "The successful usage of the subject device pertaining to [the new intended use] is supported by the already available clinical literature. The clinical literature data provided in this submission support the amended intended use and do not raise different questions for safety and effectiveness." |
| MR Safety (MR Conditional): The device should be safe for use in an MR environment and meet relevant safety standards. | The implants were evaluated in an MR environment and determined to be MR Conditional. This evaluation was based on FDA-recognized standards:

• ASTM F2119-07: Evaluation of MR Image Artifacts from Passive Implants.
• ASTM F2052-14: Measurement of Magnetically Induced Displacement Force.
• ASTM F2213-06: Measurement of Magnetically Induced Torque.
• ASTM F2182-11a: Measurement of Radio Frequency Induced Heating. |

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

The submission does not mention a specific test set or sample size in the traditional sense of a clinical trial or a formal device performance study with a 'test set' of patients or data.

For the MR safety evaluation, the "test set" would be the physical Fassier-Duval Telescopic IM System implants themselves, tested under specific MR conditions defined by the ASTM standards. The provenance of these tests is implied to be within controlled laboratory environments according to the specified ASTM test methods. No patient data is involved in this part.

For the expanded intended use, the submission refers to "already available clinical literature." This suggests a retrospective review of published studies involving similar devices or the predicate device in similar patient populations. No specific sample size or direct patient data provenance (e.g., country of origin) for a new test set is provided in this document.

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)

Given the nature of the submission (substantial equivalence and MR safety testing), there is no mention of experts establishing a ground truth for a test set in the context of diagnostic or clinical accuracy. The "ground truth" for MR safety is established by the rigorous parameters and results of the ASTM standard tests. For the expanded intended use, the "ground truth" of safety and effectiveness for "other pediatric bone diseases" is inferred from the collective body of existing clinical literature, which would have involved the consensus of medical professionals who authored those studies. Specific details on the number or qualifications of these authors/experts are not detailed in this 510(k) summary.

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

Since there is no formal clinical test set or diagnostic study described, there is no adjudication method mentioned. The MR safety testing follows standardized protocols, and the interpretation of results is based on these engineering standards rather than expert adjudication of clinical outcomes. The clinical literature review for the expanded intended use would have encompassed existing conclusions from individual studies, but no new adjudication process is described here.

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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor is it applicable. This device is an intramedullary fixation rod, a physical implant, not an AI-assisted diagnostic tool. Therefore, direct comparison of human reader performance with or without AI assistance is irrelevant to this submission.

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

Not applicable. This is a physical medical device, not a software algorithm.

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

• For MR Safety: The ground truth is based on the objective measurements and criteria defined by the ASTM international standards (e.g., specific deflection, torque, temperature rise limits). These are engineering standards designed to ensure material and device safety in an MR environment.
• For Expanded Intended Use: The ground truth relies on outcomes data and expert consensus reported in "already available clinical literature" concerning the use of similar telescopic intramedullary systems in patients with various pediatric bone diseases. This is a literature-based justification rather than a directly generated new ground truth.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device as it is not an AI/ML algorithm or a diagnostic tool that requires machine learning training.

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

Not applicable. As there is no training set, there is no ground truth established for it.

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