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NEO Pedicle Screw System™

The NEO Pedicle Screw System™, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (scoliosis, kyphosis), tumor, pseudarthrosis, and/or failed previous fusion.

When used in conjunction with BonOs® Inject Cement, the NEO Pedicle Screw System™ is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use with 5 mm to 8 mm screw diameters at spinal levels (thoracic and lumbar T1 to L5) where the structural integrity of the spine is not severely compromised.

BonOs® Inject

BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedure.

When used in conjunction with NEO Pedicle Screw System™ BonOs® Inject is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

1. BonOs® Iniect

BonOs® Iniect is a radiopaque, iniectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. It is a twocomponent system consisting of a powder and a liguid. Methylmethacrylate polymer is the primary constituent of the powder component. Zirconium dioxide is added as radiopacifier. Methylmethacrylate monomer is the primary constituent of the liquid component. Mixing the two separate sterile components, initially an injectable paste is produced which can be transferred into a syringe and which then can be injected under slight pressure into the vertebral body. After curing of the bone cement by exothermic polymerization it stabilizes the vertebral lesions and vertebral compression fractures.

2. NEO Pedicle Screw System™

The NEO Pedicle Screw System™ has been optimized and consists of 27 pedicle and 8 iliac screws, rods and connectors which are available in different sizes. The system includes a reduced optimized trav of instruments providing options for open and MIS surgical techniques. The implants are all delivered sterile and ready to use. The relevant instruments are mainly delivered as single use, disposable and delivered sterile, just a few optional instruments are reusable and delivered non-sterile.

All the system components are made of materials compliant with ASTM and/or ISO standards. Screws and rods are made of titanium-alloy (Ti-6AI-4VELI) and comply with ISO 5832-3 or ASTM-F136. The screws are made out of a titanium alloy and delivered pre-mounted to a screw extender including a tissue dilator and sterile. The rods are made out of a titanium alloy or cobalt chrome alloy CoCrMo (ISO 5832-12, ASTM F1537) and delivered sterile, Connectors are made out of titanium alloy and delivered sterile.

The pedicle screws are offered in diameters of 4.5 – 8.0 mm and lengths of 25 - 55 mm. Illiac screws are offered in diameters of 8.0 mm and 10.0 mm and lengths of 70 – 100 mm. Three different types of rods are available: pre-bent, straight or special bent rod for S1/L5. All rods have a diameter of 5.5 mm. Pre-bent rods are offered in lengths of 35 – 100 mm, straight rods in lengths from 30 - 500 mm and the special-bent rod in either 30 or 40 mm length.

The NEO Pedicle Screw System™ provides immobilization and stabilization of spinal seqments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system can be used via an open or minimally invasive posterior approach. lliac screws shall be placed via Sacral Alar Iliac (SAI) and/or Posterior Superior Illiac Spine (PSIS) approach. The size and form of the device is adjusted to the morphology of the body and the surgical technique.

The provided text is an FDA 510(k) clearance letter and a 510(k) summary for a medical device called the "NEO Pedicle Screw System™" and "BonOs® Inject Bone Cement." This document details the administrative information, device description, indications for use, and a summary of performance data to support substantial equivalence to a predicate device.

However, the document specifies that "No clinical studies were conducted." This means that the information requested regarding acceptance criteria for a study proving device performance (especially for AI/algorithm-based devices), sample size for test and training sets, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment cannot be provided from this document.

The performance data mentioned in the document are limited to non-clinical testing, primarily focusing on mechanical performance, biological evaluation, and MRI compatibility. These types of tests are used to demonstrate that changes to the device (like new components or size extensions) do not negatively impact its existing, cleared performance characteristics, and that it is substantially equivalent to the predicate device.

Therefore, I cannot populate the requested table or answer the specific questions related to the acceptance criteria and study that proves the device meets the acceptance criteria in the context of an AI/algorithm-driven device's performance study, as this submission is for a physical orthopedic implant system, not a software or AI product requiring such a study.

Here's what can be inferred from the document regarding "acceptance criteria" and "proof" in the context of this device:

The "acceptance criteria" for the modifications introduced in this 510(k) submission are implicitly met if the device demonstrates substantial equivalence to its predicate device. This is primarily demonstrated through:

• Mechanical Performance: Meeting the requirements for pedicle screw spinal systems according to relevant ASTM and ISO standards (e.g., ASTM F1717 for dynamic compression bending). The document states: "Non-clinical performance testing demonstrate that the NEO Pedicle Screw System™ meets the requirements for Pedicle screw spinal systems according to Spinal System 510(k)s Guidance for Industry and FDA Staff Document issued on: May 3, 2004 and is substantially equivalent to its predicate devices."
• Biological Evaluation: Compliance with ISO 10993-1 series for the new components.
• MRI Compatibility: Meeting standards like ASTM F2052-15, ASTM F2182-11a, and ASTM F2119-07 (R2013).
• Functionality: Internal validation confirming new components function as intended.

Table of Acceptance Criteria (Implicit for a Mechanical Device) and Reported Performance:

Regarding the specific questions about an AI/algorithm performance study:

1. Sample size for the test set and data provenance: Not applicable. No clinical or external algorithm performance test set was used.
2. Number of experts used to establish the ground truth and qualifications: Not applicable.
3. Adjudication method for the test set: Not applicable.
4. MRMC comparative effectiveness study: Not applicable.
5. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable.
6. Type of ground truth used: Not applicable. Ground truth for a physical device is often demonstrated by meeting design specifications and performance under defined test conditions (e.g., material strength and fatigue testing).
7. Sample size for the training set: Not applicable. This is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is for a traditional mechanical medical device, not an AI/ML powered one. Therefore, the specific criteria and study details requested, which are pertinent to AI/ML device evaluations, are not present in this submission. The "proof" for this device's acceptance rests on its demonstration of substantial equivalence to a predicate device through non-clinical laboratory testing.

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The NEO Pedicle Screw System™, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (scolosis, and/or lordosis), turnor, pseudarthrosis, and/ or failed previous fusion.

When used in conjunction with BonOs® Inject Cement, the NEO Pedicle Screw System™ is intented to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use with 5 mm to 8 mm screw diameters at spinal levels where the structural integrity of the spine is not severely compromised.

BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedure.

When used in conjunction with NEO Pedicle Screw System™ BonOs® Inject is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

BonOs® Inject is a radiopaque, injectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. It is a twocomponent system consisting of a powder and a liquid. Methylmethacrylate polymer is the primary constituent of the powder component. Zirconium dioxide is added as radiopacifier. Methylmethacrylate monomer is the primary constituent of the liquid component. Mixing the two separate sterile components, initially an injectable paste is produced which can be transferred into a svringe and which then can be iniected under slight pressure into the vertebral body. After curing of the bone cement by exothermic polymerization it stabilizes the vertebral lesions and vertebral compression fractures.

The NEO Pedicle Screw System™ consists of screws, rods and connectors which are available in different sizes. The system includes the relevant instruments which are mainly single use, disposable and delivered sterile, just few optional instruments are reusable and delivered non-sterile.

All the system components are made of materials compliant with ASTM and/or ISO standards. The screws are made out of a titanium alloy and delivered pre-mounted to a screw extender including a tissue dilator and sterile. The rods are made out of a titanium alloy or cobalt chrome alloy and delivered sterile. Connectors are made out of titanium allov and delivered sterile. Iliac connectors are being added in this special 510(k).

The pedicle screws are offered in diameters of 4.5 – 8.0 mm and lengths of 25 - 55 mm. Illiac screws are offered in diameters of 8.0 mm and lengths of 70 – 100 mm. Three different types of rods are available: pre-bent, straight or special bent rod for S1/L5. All rods have a diameter of 5.5 mm. Pre-bent rods are offered in lengths of 40 - 100 mm, straight rods in lengths from 30 - 500 mm and the special-bent rod in either 30 or 40 mm length.

The provided text is a 510(k) summary for the BonOs® Inject Bone Cement and NEO Pedicle Screw System™. It outlines the administrative information, device description, indications for use, and a comparison to a predicate device. However, it explicitly states, "No clinical studies were conducted," and the provided "SUMMARY OF PERFORMANCE DATA" primarily focuses on non-clinical, mechanical testing (static and dynamic testing, and axial gripping capacity in accordance with ASTM 1798), usability, biocompatibility, MRI safety, and sterilization validation.

Therefore, the document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria based on clinical outcomes or performance metrics typically seen in AI/ML device studies. It is likely that the "acceptance criteria" here refer to meeting the predicate device's performance through bench testing, rather than performance against a clinical ground truth.

Given this, I cannot fully complete the requested table and answer many of the questions as the information is not present in the provided text. I will indicate where information is missing.

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

Since this is a mechanical device and not an AI/ML diagnostic, the "acceptance criteria" and "reported performance" are typically related to engineering and material standards, not diagnostic metrics like sensitivity or specificity. The document mentions meeting requirements for pedicle screw spinal systems.

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

Not applicable. The performance data described is based on non-clinical (bench) testing, not a clinical test set.

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)

Not applicable. No clinical ground truth was established as "No clinical studies were conducted."

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

Not applicable. No clinical test set or adjudication was performed.

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 document does not mention any MRMC study. The device is a physical pedicle screw system and bone cement, not an AI diagnostic tool.

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

Not applicable. The device is a physical pedicle screw system and bone cement, not an algorithm.

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

Not applicable. No clinical ground truth was established as "No clinical studies were conducted." The closest equivalent to "ground truth" here would be the established engineering standards (ASTM and ISO) and the performance of the predicate device.

8. The sample size for the training set

Not applicable. The device is a physical pedicle screw system and bone cement, not an AI/ML model that requires a training set.

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

Not applicable. No training set was used.

Ask a specific question about this device

The NEO Pedicle Screw System™, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (scolosis, and/or lordosis), tumor, pseudarthrosis, and/ or failed previous fusion.

When used in conjunction with BonOs® Inject Cement, the NEO Pedicle Screw System™ is intented to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use with 5 mm to 8 mm screw diameters at spinal levels where the structural integrity of the spine is not severely compromised.

BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedure.

When used in conjunction with NEO Pedicle Screw System™ BonOs® Inject is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

BonOs® Inject is a radiopaque, injectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. It is a twocomponent system consisting of a powder and a liquid. Methylmethacrylate polymer is the primary constituent of the powder component. Zirconium dioxide is added as radiopacifier. Methylmethacrylate monomer is the primary constituent of the liquid component. Mixing the two separate sterile components, initially an injectable paste is produced which can be transferred into a syringe and which then can be injected under slight pressure into the vertebral body. After curing of the bone cement by exothermic polymerization it stabilizes the vertebral lesions and vertebral compression fractures.

The NEO Pedicle Screw System™ consists of screws, rods and connectors which are available in different sizes. The system includes the relevant instruments which are mainly single use, disposable and delivered sterile, just few optional instruments are reusable and delivered non-sterile.

All the system components are made of materials compliant with ASTM and/or ISO standards. The screws are made out of a titanium alloy and delivered pre-mounted to a screw extender including a tissue dilator and sterile. The rods are made out of a titanium alloy or cobalt chrome allov and delivered sterile. Connectors are made out of titanium allov and delivered sterile.

The pedicle screws are offered in diameters of 4.5 – 8.0 mm and lengths of 25 - 55 mm. Illiac screws are offered in diameters of 8.0 mm and lengths of 70 – 100 mm. Three different types of rods are available: pre-bent, straight or special bent rod for S1/L5. All rods have a diameter of 5.5 mm. Pre-bent rods are offered in lengths of 40 – 100 mm, straight rods in lengths from 30 - 500 mm and the special-bent rod in either 30 or 40 mm length.

The provided text describes a 510(k) premarket notification for the BonOs Inject Bone Cement and NEO Pedicle Screw System. It does not contain information regarding acceptance criteria, device performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or training set details. The submission focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and non-clinical performance testing.

Therefore, I cannot provide the requested information based on the given text. The document refers to:

• Non-clinical performance testing: Static compression bending, dynamic compression bending, static torsion (per ASTM F1717), and axial gripping capacity (per ASTM 1798).
• Biocompatibility testing.
• MRI safety and compatibility evaluation.
• Sterilization cycle validation: In accordance with ISO 11137-2.
• Bacterial endotoxin testing: Per ANSI/AAMI ST72:2011 using the LAL pyrogen testing.
• Usability testing.

However, it explicitly states: "No clinical studies were conducted." This means there is no clinical data from patients or human readers to determine performance metrics against acceptance criteria like sensitivity, specificity, or accuracy in a diagnostic context. This document pertains to a medical device where performance is assessed through mechanical and material properties, not through AI or diagnostic imaging.

Ask a specific question about this device

The NEO Pedicle Screw System™ is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, non-cervical firation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, tumor, pseudarthrosis, and/or failed previous fusion.

The NEO Pedicle Screw System™ consists of pedicle screws and connecting rods which differ in length and diameter. The system includes the relevant instruments which are single use, disposable and delivered sterile. All components and instruments are sterilized by gamma irradiation.

The screws are offered in diameters of 5.0 - 7.0 mm and lengths of 35 - 55 mm. Three different types of rods are available: pre-bent, straight or special bent rod for S1/L5. All rods have a diameter of 5.5 mm. Pre-bent rods are offered in lengths of 40 - 100 mm, straight rods in lengths from 30 - 300 mm and the special-bent rod in either 30 or 40 mm length. All spinal implant components are made of titanium alloy (Ti6Al4V Eli) in accordance with ASTM F136. The screws are color coded for better identification of the different diameters. The screws are double threaded, cannulated, fenestrated and selftapping.

This document pertains to the 510(k) premarket notification for a medical device called the "NEO Pedicle Screw System™." This submission is for a Class II medical device, and as such, it focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than proving a totally new level of device performance through extensive clinical trials.

Therefore, the information typically sought regarding acceptance criteria and studies proving the device meets those criteria (especially in the context of device performance metrics like accuracy, sensitivity, specificity, or human-AI reader performance improvements) is not present in this type of regulatory submission.

Here's why and what information IS available:

1. Nature of the Device: The NEO Pedicle Screw System™ is an orthopedic implant (pedicle screws and rods) used for spinal fixation. Its primary function is mechanical support. Unlike diagnostic AI software, its performance is not measured by diagnostic accuracy or an effect size on human reader improvement.
2. Regulatory Pathway (510(k)): The 510(k) pathway for Class II devices primarily requires demonstration of "substantial equivalence" to a predicate device already on the market. This is achieved by showing that the new device has:
   • The same intended use as the predicate.
   • The same technological characteristics as the predicate, OR
   • Different technological characteristics, but these do not raise new questions of safety and effectiveness, AND the device is as safe and effective as the predicate.
3. Focus of Testing: The testing detailed in this document is primarily non-clinical and focuses on:
   • Material properties: Biocompatibility (ISO 10993-1), chemical analysis.
   • Mechanical performance: Static and dynamic axial compression, static torsion (in accordance with ASTM F1717), showing comparability to other marketed systems.
   • Sterilization: Validation (ISO 11137-2), pyrogenicity.
   • Packaging: Shelf life (ISO 11607-1), transport studies.
   • MRI Compatibility: Magnetic field interactions, heating, artifacts (ASTM F2052-15, F2182-11a, F2119-07).
   • Usability: WetLab study with orthopedic surgeons.

Therefore, I cannot provide the requested information about acceptance criteria for AI performance, MRMC studies, or specific effect sizes, as this device is a mechanical implant and not an AI/diagnostic software.

However, I can extract the information relevant to the types of studies conducted for this specific device:

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

For this device, the "acceptance criteria" are not based on diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they are based on meeting established standards for mechanical performance, biocompatibility, sterility, and durability, demonstrating "comparability" and "substantial equivalence" to predicate devices. The document implies that the device met these standards, as it received 510(k) clearance.

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

• Sample Size for Test Set: Not applicable in the context of diagnostic AI. For mechanical and biological testing, sample sizes are dictated by the specific ASTM/ISO standards referenced (e.g., number of test specimens for mechanical strength, number of samples for sterility validation), but these specifics are not provided in this summary. Data provenance is implied to be from the manufacturer's own internal testing and external certified labs commissioned by the manufacturer. It is not clinical data (retrospective or prospective) in the sense of patient data.

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 device. "Ground truth" in the context of AI diagnostic performance relies on expert consensus or biopsy/pathology. Here, the "truth" for mechanical performance is defined by adherence to engineering standards (ASTM, ISO), and human experts (orthopedic surgeons) were involved in a "WetLab study" for usability, but not to establish "ground truth" for a diagnostic test.

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

• Not applicable. This refers to methods for consolidating expert opinions in diagnostic studies, which is not relevant 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. An MRMC study is for evaluating human performance with and without AI assistance for diagnostic tasks. This device is a surgical implant, not a diagnostic AI.

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

• Not applicable. This refers to the performance of an AI algorithm alone.

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

• For this device, "ground truth" is established by:
  • Engineering standards and specifications: For mechanical strength (ASTM F1717), sterility (ISO 11137-2), biocompatibility (ISO 10993-1), MRI compatibility (ASTM F2052-15, F2182-11a, F2119-07), and packaging (ISO 11607-1).
  • Functional verification: For the monoaxial mode and overall usability (WetLab confirmation by surgeons).
  • Published scientific literature: Used for clinical evaluation to demonstrate equivalence to predicate devices, as "Clinical studies were not required."

8. The sample size for the training set:

• Not applicable. This term is relevant for machine learning models.

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

• Not applicable. This term is relevant for machine learning models.

In summary, the provided document describes a regulatory submission for a physical medical device (spinal implant) through the 510(k) pathway. The evidence presented focuses on ensuring the device is safe and effective as a mechanical and biological component, rather than as a diagnostic tool or AI algorithm.

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