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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), 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.

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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.

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, 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 at spinal levels where the structural integrity of the spine is not severely compromised.

BonOs® Inject:
BonOs® Inject is a radiopaque, injectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. It is a two-component 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.

Neo Pedicle Screw System™:
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 - 55mm. 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 - 100mm, straight rods in lengths from 30 - 300 mm and the special-bent rod in either 30 or 40mm 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.

Since it states that there were no changes made to the existing devices BonOs® Inject (K090460) and Neo Pedicle Screw System™ (K171582) and no additional testing was required or performed for these specific devices, I am unable to extract all the requested information for acceptance criteria and study details. However, I can provide the available information regarding the additional predicate device comparison.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for the axial pullout strength, cement flow, or bolus formation tests. The data provenance is not specified (e.g., country of origin, retrospective or prospective).

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

Not applicable. The tests mentioned are mechanical and biological performance tests, not those requiring expert consensus on clinical ground truth.

4. Adjudication Method for the Test Set

Not applicable. The tests mentioned are objective performance tests.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.

6. Standalone (Algorithm Only) Performance

Not applicable, as this is a physical medical device (bone cement and screw system), not a software algorithm.

7. Type of Ground Truth Used

For the axial pullout strength and cement flow/bolus formation, the "ground truth" was established by comparison to the performance of the predicate device (Kyphon™ Xpede™ Bone Cement Medtronic HV-R™ Fenestrated Screw Cement CD Horizon™ Fenestrated Screw Set) as per established ASTM standards.
For bacterial endotoxins and pyrogen limits, established regulatory standards (Ph. Eur., USP, FDA guidance) served as the ground truth.

8. Sample Size for the Training Set

Not applicable. This document describes the substantial equivalence of a physical medical device, not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set mentioned.

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

BonOs® Inject is a radiopaque, injectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. It is a two-component 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.

This submission is for a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device rather than explicitly defining and meeting acceptance criteria through a standalone study with specific performance metrics. Therefore, the information typically requested for acceptance criteria and a study proving device performance (like sensitivity, specificity, or reader improvement with AI) is not directly available in this document.

Instead, the submission focuses on demonstrating that the new device, BonOs® Inject, is as safe and effective as the predicate device, OSTEOPAL® V, through comparative physical, chemical, and mechanical tests.

Here’s a breakdown based on the provided text, addressing your points where possible, and noting where the information is not applicable to this type of submission:

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

Since this is a 510(k) submission proving substantial equivalence, explicit "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, etc.) are not provided. Instead, the "performance" revolved around demonstrating equivalence to the predicate device in key physical, chemical, and mechanical properties.

Note: The document states, "The effectiveness and substantial equivalence of BonOs® Inject was determined by physical, chemical and mechanical comparative tests to OSTEOPAL®V and by comparing the results of the relevant data." The specific values or direct comparisons for each property are not detailed in this summary.

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

This submission does not detail a clinical "test set" in the way a diagnostic AI device would. The "tests" likely refer to bench-top laboratory tests for physical, chemical, and mechanical properties.

• Sample Size for Test Set: Not specified. The submission refers to "comparative tests" and "relevant data" but does not provide numbers for specimens or batches used in these tests.
• Data Provenance: Not specified, but the applicant is from Germany, so it's likely the tests were conducted in Germany or a related clinical setting. The device is also "successfully marketed in Europe."
• Retrospective or Prospective: Not applicable as these are not human subject studies in the traditional sense for evaluating device performance. These would be laboratory studies.

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

Not applicable. This device is a bone cement, not a diagnostic imaging device requiring expert interpretation for ground truth establishment. The "ground truth" here would be established by validated laboratory testing methods and standards for material properties.

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

Not applicable. This is not a study involving human readers or subjective assessments.

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

Not applicable. This is not a medical device involving AI or human readers for diagnostic interpretation.

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

Not applicable. This device is a medical implant (bone cement), not an algorithm.

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

The "ground truth" in this context would be the established material properties and performance characteristics of the predicate device (OSTEOPAL® V), determined through standard laboratory testing methods and industry specifications for bone cements. The new device was then tested against these established benchmarks to demonstrate equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

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