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The PediFlex™ Flexible Nail System is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow, or flexibility of the implant is required. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric and small stature patients. In pediatric patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.

The PediFlex™ Flexible Nail System includes stainless steel and titanium flexible nails, interlocking clamps, clamp screws and end caps for the application of aiding bone fracture repair and healing. All the implants are MR conditional. The system is implanted using Class II and Class I exempt surgical instruments.

The PediFlex™ flexible nails are provided in 316L stainless steel and titanium alloy (Ti-6Al-4V). The 316L stainless steel flexible nails are available in diameters ranging from 1.5 mm to 4.0 mm in increments of 0.5 mm. The titanium alloy (Ti-6Al-4V) flexible nails are available in diameters ranging from 1.5 mm to 4.5 mm in increments of 0.5 mm.

The PediFlex™ interlocking clamps are designed to hold flexible nails in place after insertion by clamping the nail and being fixed to the bone. The use of the interlocking clamps is optional. The interlocking clamps are manufactured from both 316L stainless steel and titanium alloy (Ti-6Al-4V) materials. The 316L stainless steel interlocking clamps are available in right and left configurations, in diameters of 3.0 mm, 3.5 mm and 4.0 mm which are to be used with 316L stainless steel flexible nails in diameters of 3.0 mm, 3.5 mm and 4.0 mm. The 316L stainless steel clamp screws are available in 15 mm, 25 mm, and 35 mm in length. The titanium alloy (Ti-6Al-4V) interlocking clamps are available in right and left configurations, in diameters of 3.0 mm, 3.5 mm, 4.0 mm and 4.5 mm which are to be used with titanium alloy (Ti-6Al-4V) flexible nails in diameters of 3.0 mm, 3.5 mm, 4.0 mm and 4.5 mm. The titanium alloy (Ti-6Al- 4V) clamp screws are available in 15 mm, 25 mm, and 35 mm in length. The material of the clamp must match the material of the nail and screw in the surgery.

The PediFlex™ end caps are designed to affix to the exposed nail tip to help prevent soft tissue irritation. The use of the end cap is optional. They are not a structural element and impart no additional strength to the construct. The subject end caps are manufactured in titanium alloy (Ti-6Al-4V) and are available in diameters ranging from 1.5mm to 4.5mm with 0.5mm increments which are to be used with titanium alloy (Ti-6Al-4V) flexible nails in diameters ranging from 1.5mm to 4.5mm with 0.5mm increments. The material of the end cap must match the material of the nail used in the surgery.

The flexible nails, interlocking clamps, clamp screws and end caps in PediFlex™ Flexible Nail System are offered both sterile and non-sterile. All other Class II implants and instruments of the PediFlex™ Flexible Nail System are offered non-sterile to be sterilized by the end-user.

The provided FDA 510(k) clearance letter for the PediFlex™ Flexible Nail System primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device rather than presenting a study proving that the device meets specific acceptance criteria in a clinical performance sense (like an AI/ML device would).

The information in the document highlights design verification and validation activities related to safety and functionality for a medical implant, but it does not outline acceptance criteria for a diagnostic or AI-driven system that would involve performance metrics like sensitivity, specificity, or human-in-the-loop improvements.

Therefore, for aspects related to "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample sizes for test and training sets," "expert ground truth establishment," "adjudication," "MRMC studies," "standalone performance," and "ground truth types," the provided document does not contain the necessary information to answer those questions in the context of an AI/ML device or a comparative clinical study.

The document states:

• "The subject PediFlex™ Flexible Nail System and predicate device share identical intended use, patient population, principles of operation, and all fundamental technological characteristics."
• "There are some differences... However, those differences are supported by successful testing provided in this submission. Therefore, such differences do not raise new questions of safety and effectiveness."
• "Results of the performance testing demonstrate substantially equivalent performance of the subject device as compared to the predicate."

This indicates that the "acceptance criteria" were likely related to demonstrating that the changes (sterilization, packaging, shelf life, MR conditional labeling) did not negatively impact the established safety and effectiveness of the device, rather than establishing new performance benchmarks.

However, I can extract the information relevant to the types of studies and testing performed:

1. Table of Acceptance Criteria and Reported Device Performance:

As this is a 510(k) for a physical medical device (Flexible Nail System) demonstrating substantial equivalence to a predicate, the "acceptance criteria" are not reported as specific clinical performance metrics (e.g., sensitivity, specificity, or diagnostic accuracy) like they would be for an AI/ML diagnostic. Instead, the performance data focuses on demonstrating that the manufacturing/design changes (sterilization, packaging, shelf life, MR compatibility) do not raise new questions of safety or effectiveness and that the device maintains its intended physical properties and functionality.

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

• Test Set Sample Size: Not applicable in the context of clinical performance data for an AI/ML algorithm. The studies mentioned are primarily bench testing and engineering analyses for device characteristics. Specific sample sizes for each standard (e.g., number of packages tested for sterility, number of nails tested for MR compatibility) are not detailed in this summary.
• Data Provenance: Not applicable for clinical data. The testing is laboratory and engineering-based (e.g., material testing, packaging integrity testing).

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 refers to defined engineering and material properties, not expert clinical interpretations via a consensus process.

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

• Not applicable. This is not a clinical study involving human readers or interpretations needing 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:

• No. This is a submission for a physical medical implant, not an AI/ML diagnostic or assistive device.

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

• No. This is for a physical medical implant.

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

• For the physical device, the "ground truth" for the performance data is based on established engineering standards, material specifications, and regulatory guidelines. For example:
  • Sterility: Absence of microbial growth (based on AAMI/ISO standards).
  • Packaging integrity: No breaches or failures (based on ASTM/ISO standards).
  • Material properties: Adherence to specified mechanical properties for the material (implied by type of material, though specific data is not shown).
  • MR Conditional status: Demonstrating acceptable heating, artifact, and force under specific MR conditions defined by ASTM standards.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

In summary, the provided document details the verification and validation activities for a physical medical implant (PediFlex™ Flexible Nail System) to demonstrate its safety and effectiveness under a 510(k) pathway, primarily for design and manufacturing changes. It does not provide the kind of performance data (e.g., clinical accuracy, reader studies) that would be presented for an AI/ML-driven device.

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The Pediatric Plating Platform | Hip is intended for temporary internal fixation and stabilization of proximal femur fractures and osteotomies, mal-unions and non-unions, in pediatric and small stature adults.

The Pediatric Plating Platform | Hip consists of plates, screws and connector bolts in a variety of sizes and shapes to accommodate different anatomic requirements. The Pediatric Plating Platform | Hip also includes surgical instruments.

The Pediatric Plating Platform | Hip offers a selection of plates and screws specifically designed for deformity correction and trauma of the proximal femur. Plates are offered in a variety of angles and offsets to accommodate the anatomy following planned osteotomies or fixation of traumatic fractures. The plate is fixed to the bone via the choice of beam, locking and non-locking screws to ensure stable fixation and healing. The Pediatric Plating Platform | Hip is available in infant, child and adolescent families providing a suitable range of screw and plate sizes.

The implants of the Pediatric Plating Platform | Hip are manufactured from implant grade 316LVM Stainless Steel (ASTM F138 and/or F139).

The provided FDA 510(k) clearance letter for the Pediatric Plating Platform | Hip is for a physical medical device (bone plates and screws), not an AI/Software as a Medical Device (SaMD).

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/SaMD (which typically involves metrics like sensitivity, specificity, AUC, human reader studies, etc.) is not applicable to this submission.

The FDA clearance relies on traditional medical device testing and comparisons for physical implants, such as:

• Biocompatibility: Based on the prior use of the OrthoPediatric Corp's Locking Proximal Femur System which shares the same materials, manufacturing, and cleaning processes.
• MR Safety: Evaluated using ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119, determined to be MR Conditional.
• Mechanical Performance: Included Torsional Properties, Insertion and Removal Torque, Axial Pullout Strength (per ASTM F543), and Static Compression Bending and Fatigue Compression Bending (per ASTM F384). The results demonstrated substantially equivalent mechanical performance to the predicate device.

There is no mention of:

• AI algorithm performance metrics.
• Test sets, training sets, or data provenance for AI models.
• Ground truth established by experts for AI.*
• Multi-reader multi-case (MRMC) studies for AI assistance.
• Standalone AI performance.

In summary, a table of acceptance criteria and reported device performance, sample size, expert qualifications, and adjudication methods for AI/SaMD are not part of this 510(k) submission as it is for a physical orthopedic implant, not an AI software product.

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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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The VerteGlide Spinal Growth Guidance System is indicated for skeletally immature patients less than 10 years of age with the potential for additional spinal growth who require surgical treatment for correction and maintenance of the correction of severe, progressive, life-threatening early onset deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome for the following subset of patients:

• · Patients who may require serial magnetic resonance imaging;
• · Patients with small stature:

· Patients with low body weight, compromised tissue coverage adjacent to spinal implants, or increased risk of implant associated wound healing adverse events;

• · Patients at risk for implant prominence following surgery;
• · Patients with hyperkykyphotic spinal deformities; OR.

· Patients at elevated risk of cardiac arrest/sudden death from anesthesia associated with additional spinal surgery.

The VerteGlide Spinal Growth Guidance System is intended to be removed after skeletal maturity.

The VerteGlide Navigation Compatible Instruments are intended to be used during the preparation and placement of the VerteGlide Spinal Growth Guidance System screws. The VerteGlide Navigation Compatible Instruments have the option to be used with or without Medtronic StealthStation® System. Use of VerteGlide Navigation Compatible Instruments with Medtronic StealthStation® System during spinal surgery can assist the surgeon in precisely locating anatomical structures in the VerteGlide Spinal Growth Guidance System procedures. The Medtronic StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The VerteGlide Spinal Growth Guidance System consists of longitudinal members (rods), anchors (screws), and interconnection components (cross connector and rod clamp) in a variety of sizes to accommodate differing anatomic requirements. The VerteGlide Spinal Growth Guidance System also include surgical instruments.

The VerteGlide Spinal Growth Guidance System offers a solution for early-onset scoliosis (EOS) patients with potential for additional spinal growth. Fusion screws are used at the apex of the curve to rigidly lock the rod in place, while sliding (non-fusion) screws are used above and below the apex to stabilize but allow for continued growth. A unique rod design is used to provide rigid fixation of the fusion screws and further promote sliding of the non-fusion screws. Fixation to the bone is provided using standard fusion and non-fusion pedicle screws. While the non-fusion pedicle screws are rigidly fixed to the bone, they also allow for sliding along the rod axis during normal growth without requiring separate rod lengthening procedures. The VerteGlide Spinal Growth Guidance System allows for deformity correction and minimizes repeat surgeries needed until skeletal maturity.

The components of the VerteGlide Spinal Growth Guidance System are manufactured from titanium alloy per ASTM F136, unalloyed titanium per ASTM F67, or cobalt chromium per ASTM F1537.

The provided text describes the VerteGlide Spinal Growth Guidance System, a medical device. However, it does not detail a study that proves the device meets specific acceptance criteria in the manner requested (i.e., a clinical study with performance metrics like sensitivity, specificity, or accuracy in a diagnostic context).

The document is an FDA 510(k) clearance letter and a 510(k) Summary for a spinal growth guidance system. This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria for a diagnostic or AI-driven system.

The "Performance Data" section primarily addresses biocompatibility, MR compatibility, and mechanical performance of the physical implant components. It states these aspects meet relevant ASTM and ISO standards, which serve as acceptance criteria for the hardware itself.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance, training set details) are not applicable to this type of device and submission.

Here's a breakdown of what can be extracted and what cannot:

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

2. Sample size used for the test set and the data provenance: Not applicable. This was a physical device testing, not an algorithmic performance evaluation on a patient dataset. The "test set" would refer to the physical samples tested for mechanical strength, biocompatibility, etc., the details of which are not provided in this summary.

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 be derived from physical measurements and standard testing protocols, not expert clinical interpretation of data.

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical spinal implant, not an AI or diagnostic imaging tool. The VerteGlide Navigation Compatible Instruments can be used with a Medtronic StealthStation® System, which is a navigation system, but the submission does not describe an MRMC study comparing human performance with and without this navigation assistance, nor is it the primary focus of the VerteGlide system's clearance.

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

7. The type of ground truth used:
* Biocompatibility: Conformance to ISO 10993-1 standards (chemical/biological assays).
* MR Compatibility: Physical measurements according to ASTM standards for heating, displacement, torque, and artifact generation.
* Mechanical Performance: Physical measurements (e.g., force, displacement, wear) against specified limits and comparison to predicate device performance.

8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of the Study type:
The study described is a benchtop (in vitro) and material-based performance evaluation to demonstrate that the physical components of the VerteGlide Spinal Growth Guidance System are safe and perform as intended, and are substantially equivalent to a predicate device. This includes:

• Biocompatibility testing: To ensure the materials are not harmful to the body.
• MR Compatibility testing: To determine if the device is safe for use in an MRI environment.
• Mechanical performance testing: To ensure the device components have adequate strength, durability, and functional characteristics (like sliding mechanism) under simulated physiological loads and conditions.

The conclusion states that the data supports the differences between the subject and predicate devices and that the VerteGlide Spinal Growth Guidance System is substantially equivalent. A Post Market Surveillance Study (522 Order) will be issued to address potential safety concerns related to wear debris, indicating that some long-term clinical data will be collected after market entry.

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The OrthoPediatrics Orthex External Fixation System is intended for external fixation with the following indications:

• · Stabilization of Fractures & Osteotomy
• · Rear and Mid-foot Foot Arthrodesis
• · Adult and Pediatric (greater than 2 through 21 years of age) Leg Lengthening
• · Correction of Bone Deformity in Upper & Lower Extremities
  The P&C Software is intended to be used as a component of multilateral external fixations listed above.

The OrthoPediatrics Orthex External Fixation System is an external fixator which includes typical components such as rings, partial rings, footplates, monolateral rails, and numerous hardware necessary for the construction of a frame to which tensioned wires, and half pins are attached to the bone and to the frame itself.
The components included in the external fixation system are made from various types of metal and plastic materials. Half pins and wires are manufactured from implant grade materials and are nonpyrogenic. External fixation components and implants are for single use only and not designed or sold for any use except as indicated.
The web based Orthex Point and Click (P&C) Software aids the surgeon in the use of the Orthex External Fixation System. The Point and Click (P&C) Software is only compatible with the Orthex External Fixation System. It can be accessed at www.orthex.net. The use of software is optional and is utilized with the bridging and additional necessary hardware elements of the frame.

I am sorry, but the provided text content does not contain the necessary information to answer your request about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML-based medical device.

The document is a 510(k) Premarket Notification from the FDA regarding the Orthex External Fixation System, a physical medical device. It describes:

• Device Name: Orthex External Fixation System
• Indications for Use: Stabilization of Fractures & Osteotomy, Rear and Mid-foot Foot Arthrodesis, Adult and Pediatric Leg Lengthening, Correction of Bone Deformity.
• Components: Rings, partial rings, footplates, monolateral rails, hardware, tensioned wires, half pins.
• Materials: Various types of metal and plastic.
• Software Component: "The web based Orthex Point and Click (P&C) Software aids the surgeon in the use of the Orthex External Fixation System." It explicitly states the use of software is optional.
• Performance Data: Biocompatibility assessment, mechanical performance evaluations (self-taping, insertion torque, torsional strength, static and dynamic bending), and Hydroxyapatite (HA) Coating performance and characterization evaluations. These are physical/mechanical tests, not performance metrics for an AI/ML algorithm.

There is no mention of:

• AI/ML algorithms or their performance.
• Acceptance criteria for an AI/ML model (e.g., sensitivity, specificity, AUC).
• Test sets for AI/ML models (sample size, data provenance).
• Ground truth establishment by experts for imaging.
• Multi-reader multi-case (MRMC) studies.
• Standalone algorithm performance.
• Training sets for AI/ML models or their ground truth establishment.

Therefore, I cannot extract the information required to populate the table or answer the specific questions about the AI/ML study.

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The RESPONSE™ Rib and Pelvic System is indicated for skeletally immature patients with severe, progressive spinal deformities such as congenital scoliosis, neuromuscular scoliosis, syndromic scoliosis and/or three-dimensional deformity of the thorax associated with or at risk of Thoracic Insufficiency Syndrome (TIS).

The RESPONSE™ Rib and Pelvic System consists of longitudinal members (rods), anchors (saddles, hooks, and screws), interconnection components (rod-to-rod and anchor-to-rod connectors) in a variety of sizes to accommodate differing anatomic requirements. The implants in the system can be assembled in a number of different configurations to accommodate the wide variety of anatomical deformities encountered by the clinician. The RESPONSE™ Rib and Pelvic System also includes surgical instruments. All implants and instruments in the system are provided non-sterile. The RESPONSE™ Rib and Pelvic System mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow. The subject devices are attached perpendicularly to the child's rib, thoracic vertebra, sacrum, ilium and pelvis. This mechanically stabilizes the chest wall and spine and enlarges the thorax to improve respiration and lung growth. Once the subject devices are in place, its design allows for expansion, anatomic distraction, and replacement of component parts through less invasive surgery. The components of the RESPONSE™ Rib and Pelvic System are manufactured from titanium alloy per ASTM F136, unalloyed titanium per ASTM F67, or cobalt chromium per ASTM F1537.

The provided text details the FDA clearance for the OrthoPediatrics Corp. RESPONSE™ Rib and Pelvic System. However, this document does not describe an AI/ML device or its associated studies.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical and biocompatibility testing performed for the physically implanted medical device, not a software-based AI/ML diagnostic or prognostic tool.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance related to a software AI/ML device.
• Sample size used for a test set (in the context of AI/ML).
• Data provenance for AI/ML.
• Number of experts or their qualifications for ground truth in AI/ML.
• Adjudication method for AI/ML.
• MRMC comparative effectiveness study for AI/ML.
• Stand-alone performance for an AI/ML algorithm.
• Type of ground truth (clinical outcomes, pathology, expert consensus) for AI/ML.
• Sample size for training set for AI/ML.
• How ground truth for training set was established for AI/ML.

The document states:

• Performance Data (Section VII):
  • "The Biocompatibility assessment and testing for the RESPONSE™ Rib and Pelvic System were performed in conformance with ISO 10993-1."
  • "The implants of RESPONSE™ Rib and Pelvic System were evaluated for use in an MR Environment using ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119, and were determined to be MR Conditional and will be labeled as such."
  • "Mechanical performance evaluations included construct static and dynamic compression testing based on ASTM F1717; axial and torsional grip testing per ASTM F1798; and screw torsional strength, insertion torque, and removal torque testing per ASTM F543; and engineering analysis."
  • "Results of the mechanical testing/analysis demonstrate substantially equivalent mechanical performance of the subject device as compared to the predicate."

This indicates that the acceptance criteria were based on established ASTM and ISO standards for mechanical performance and biocompatibility of implantable devices, and the device met these engineering and material standards to demonstrate substantial equivalence to predicate devices. It is a physical product, not a software algorithm.

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The Pediatric Nailing Platform | Tibia is intended as a temporary implant for alignment, stabilization of tibias that have been surgically prepared (osteotomy) for correction of deformities or have sustained frauma or disease. The patient population is pediatric, including 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.

The 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-6A1-4V ELI. The system is implanted using Class II and Class I exempt instruments. All implants and instruments in the system are provided non-sterile.

This FDA 510(k) summary does not contain information about acceptance criteria or a study proving device performance as typically understood for AI/ML-driven devices. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and standard performance testing.

Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth for an AI/ML device is not applicable or cannot be extracted from this document.

However, I can extract the following relevant information:

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

The document does not provide specific quantitative acceptance criteria or reported device performance in the context of an AI/ML study. It refers to:

2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

None of the above information can be extracted from the provided document. The document describes a traditional medical device (intramedullary nail) rather than an AI/ML-driven device. The performance data mentioned refers to biocompatibility, MR safety, and mechanical testing against recognized standards (ASTM F1264 and ASTM F543) to demonstrate the physical properties and safety of the implant, not to the performance of an algorithm or its impact on human readers.

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The RESPONSE 4.5/5.0 and 5.5/6.0 Spine Systems and the RESPONSE 5.5/6.0 Cannulated Screw System are intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of dicogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), turnor, pseudarthrosis, and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the RESPONSE 4.5/6.0 Spine System and the RESPONSE 5.5/6.0 Cannulated Screw System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis, neuromuscular scoliosis, and congental scoliosis. The RESPONSE 4.5/5.0 Spine Systems and the RESPONSE 5.5/6.0 Cannulated Screw System are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The RESPONSE 5.5/6.0 Cannulated Screw System is a cannulated screw spinal implant system consisting of anchors (screws) that attach to the longitudinal members (rods) and interconnection components (connectors) previously cleared in the RESPONSE 5.5/6.0 Spine System see K193100. Pedicle screws are placed in the spine that attach to rods that allow immobilization and stabilization of the spine. The RESPONSE 5.5/6.0 Cannulated Screws are cannulated screws that are passed over a guidewire to achieve insertion. The RESPONSE 5.5/6.0 Cannulated Screws are available in a 6mm to 9mm diameter range by 40mm to 100mm lengths. All implant components are manufactured from titanium alloy, cobalt chrome, and commercially pure titanium. All components are supplied non-sterile. The screws, which have a Ø1.750 mm cannulation, are available in the following diameters and lengths: Ø6.0 - 40-80mm Ø6.5 - 40-90mm Ø7.0 - 40-100mm Ø8.0 - 40-100mm Ø9.0 - 40-100mm. All screws are double lead with a 2.750 mm thread pitch which is identical to the predicate screws. For the subject screws, the minor diameter, neck diameter and thread runout length were increased and the hexalobe feature and root radius were modified from the predicate pedicle screw design to accommodate the cannulation. The subject drivers are cannulated with features to interface with the screw hexalobe.

The provided text is a 510(k) summary for the OrthoPediatrics RESPONSE 5.5/6.0 Cannulated Screw System, a medical device for spinal fixation. This document primarily focuses on demonstrating substantial equivalence to a predicate device through material and mechanical testing. It does not describe a study involving human readers or AI performance in diagnostic or clinical tasks.

Therefore, the requested information regarding AI performance, human reader studies, ground truth establishment for AI, and related metrics cannot be extracted from this document, as it is not relevant to the type of device review described.

Below is the information that can be extracted, primarily related to the mechanical performance testing of the device for its substantial equivalence determination.

Acceptance Criteria and Reported Device Performance

The document describes various performance tests conducted to support substantial equivalence. The acceptance criteria themselves are not explicitly detailed as numerical thresholds in this summary, but rather implied as meeting the standards set by the predicate device and relevant ASTM standards. The "reported device performance" is that the device "supports the differences between the subject and predicate devices" and "is substantially equivalent."

Information Not Applicable to this Device/Study:

• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This is a mechanical device, and the "tests" refer to laboratory-based mechanical and material performance evaluations, not diagnostic image analysis or clinical data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for mechanical testing is defined by engineering specifications and material properties, assessed in a lab, not by expert human interpretation.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept is relevant for clinical or diagnostic studies involving human assessment, not for mechanical testing.
• 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. There is no AI component in this device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no AI component.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical tests, the ground truth is based on physical scientific principles, engineering standards (ASTM), and direct measurement of material and structural performance, not expert consensus or clinical pathology.
• The sample size for the training set: Not applicable. Pertains to AI model development.
• How the ground truth for the training set was established: Not applicable. Pertains to AI model development.

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The OrthoPediatrics Orthex External Fixation System is intended for external fixation with the following indications:

• Stabilization of Fractures & Osteotomy
• Rear and Mid-foot Foot Arthrodesis
• Adult and Pediatric Leg Lengthening
• Correction of Bone Deformity in Upper & Lower Extremities

The P&C Software is intended to be used as a component of multilateral external fixations listed above.

The OrthoPediatrics Orthex External Fixation System is an external fixator which includes typical components such as rings, partial rings, footplates, monolateral rails, and numerous hardware necessary for the construction of a frame to which tensioned wires and half pins are attached to the bone and to the frame itself. The system has an optional software to assist the user in adjusting the hexapod.

The components included in external fixation systems are made from various types of metal and plastic materials. Half pins and wires are manufactured from implant grade materials and are non-pyrogenic. External fixation components and implants are for single use only and not designed or sold for any use except as indicated.

The web-based Orthex Point and Click (P&C) Software aids the surgeon in the use of the Orthex External Fixation System. The software is optional to use. The Orthex Point and Click (P&C) Software does not control any hardware (such as rings, struts, wires, half pins) directly. The Point and Click (P&C) Software is only compatible with the Orthex External Fixation System. It can be accessed at www.orthex.net. The Pre-Operative planning function of the software aids the surgeon in pre-operative deformity analysis which includes determining where an osteotomy will be made, visualizing corrections, and planning for hexapod construction by positioning rings and calculating the initial strut lengths in preparation for frame application. The Post-Operative planning function of the software aids the surgeon in producing a strut length schedule to achieve the desired correction. The patient or caregiver manually adjusts the struts according to the strut length schedule.

This document is a 510(k) Premarket Notification from the FDA regarding the OrthoPediatrics Orthex External Fixation System. It grants clearance for the device based on its substantial equivalence to a predicate device.

The prompt requires information about acceptance criteria and a study that proves the device meets them, specifically for a software component ("P&C Software"). However, this document primarily discusses the hardware aspects and the software's role as an optional component. It states that the key updates to the software relate to adding a pre-operative planning function, changing schedule output formatting, and improving X-ray page functionality. The most significant software-related change mentioned is the re-addition of the "Rear and Mid-foot Foot Arthrodesis" indication to the software, as the software now includes the necessary modules and icons.

Crucially, this document does not describe any specific clinical study demonstrating accuracy or clinical effectiveness for the software. Instead, it relies on:

• Substantial Equivalence: The primary argument is that the device (hardware and updated software) is substantially equivalent to a previously cleared predicate device.
• Verification and Validation (V&V) Testing: It broadly states, "The safety and effectiveness of all the updates made to the software since its initial clearance have been successfully verified and validated. The software documentation including the verification and validation testing support that the subject software has met applicable design requirements established based on their intended use."

Given this, I cannot provide detailed answers to many of the sub-questions as they pertain to clinical or performance studies that are not described in this document. The V&V testing mentioned is typically internal engineering testing, not a comparative effectiveness study with human readers or standalone performance data in the way implied by the questions.

Therefore, the following table and explanations reflect what can be inferred or directly stated from the provided text, and where information is not present.

Acceptance Criteria and Device Performance (Based on available information)

• Pre-operative planning function
• Changing schedule outputs formatting
• Improved X-Ray pages' functionality
• Inclusion of foot and ankle modules/icons to support "Rear and Mid-foot Foot Arthrodesis" indication. |
  | Safety (Hardware, MR Environment) (Explicitly for hardware) | "The Orthex External Fixation System is MR unsafe" due to ferromagnetic materials. |
  | Substantial Equivalence (Overall regulatory criterion) | "The Orthex External Fixation System is as safe and effective as the predicate device." |

Study Details (As much as can be gleaned from the document):

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

   • Not specified. The document mentions "verification and validation testing" but does not detail a test set in terms of patient data or clinical cases. This testing is likely internal engineering and functional testing of the software itself and its algorithms, rather than a clinical study with a patient data test set.

2. 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):

   • Not specified. Ground truth establishment, if any, for software function would likely be based on engineering specifications or perhaps orthopedic surgical principles, not necessarily expert adjudication of clinical cases as would be done for an AI diagnostic device.

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

   • Not specified. This pertains to clinical studies often involving AI, which is not detailed here.

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:

   • No such study is described. The document indicates the software "aids the surgeon" and "is optional to use." It explicitly states, "The P&C Software is intended to be used as a component of multilateral external fixations listed above," implying an assistive role. However, no MRMC study or data on human reader improvement with or without AI assistance is provided.

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

   • No standalone performance study is explicitly described in terms of clinical accuracy. The "verification and validation testing" would represent internal standalone performance assessments against design requirements, but not typically a stated accuracy metric like AUC or sensitivity/specificity for a diagnostic AI. The software's role is assistive, not a standalone diagnostic.

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

   • Not explicitly stated for a clinical ground truth. For the software's functionality, ground truth would be based on engineering specifications, mathematical models for hexapod adjustments, and established orthopedic principles for deformity correction and planning.

7. The sample size for the training set:

   • Not applicable / Not specified. This device's software is described as tool-based (calculating strut lengths, pre-operative planning) rather than a machine learning model that requires a "training set" in the conventional sense of deep learning or AI. It seems to be based on deterministic algorithms.

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

   • Not applicable / Not specified. As it does not appear to be an AI/ML model with a "training set," this question is not relevant based on the information provided. Its "ground truth" would be the mathematical correctness of its calculations and the accurate representation of orthopedic planning principles.

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Pediatric Nailing Platform | Femur is used for pediatric and small stature as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunion; 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; 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 | 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 are provided as child nails and adolescent nails. The child nails are available in diameters of 7, 8 and 9 mm with a length of 200 to 420 mm depending on the diameter. The adolescent nails are available in diameters of 9, 10, 11, 12 mm with a length of 280 to 500 mm depending on the diameter. The nails have holes at each end which allow 316L stainless steel transverse screws to be installed to achieve greater stabilization. The screws are available in 3.8, 4.0, 4.5 and 5.0 mm in diameter and 15-120 mm in length depending on the diameter. The end caps 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 Pediatric Nailing Platform | Femur system is implanted using class I exempt instruments.

The subject implants under this submission in the Pediatric Nailing Platform | Femur are for single use only and will be provided non-sterile. The class II and class I exempt instruments can be single use or reusable and they are also provided non-sterile. All class II instruments have been cleared under K172583. The devices must be sterilized by the end user before use.

The provided text is a 510(k) summary for a medical device (Pediatric Nailing Platform | Femur) submitted to the FDA. It does not contain any information about acceptance criteria, device performance in a clinical study, sample sizes for test or training sets, expert qualifications, or ground truth establishment relevant to an AI/ML device.

The document describes a traditional 510(k) submission for an intramedullary fixation rod, which is a physical implant, not a software or AI/ML device. The "Performance Data" section refers to verification testing (e.g., Torsional Performance & Driving Torque, Axial Pullout, Bending Strength, Full Construct) conducted to demonstrate that new physical components (longer adolescent nails, longer screws, new end caps) meet design input requirements and are substantially equivalent to a previously cleared predicate device. It also mentions an evaluation for use in an MR Environment.

Therefore, based solely on the provided text, I cannot answer the questions regarding acceptance criteria, device performance metrics (like accuracy, sensitivity, specificity), sample sizes for AI/ML testing, expert ground truth establishment, or MRMC studies because this type of information is not relevant to the review of a physical implant device like the one described here.

To answer your prompt, I would need a document related to the FDA clearance of an AI/ML-based medical device.

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