Search Results

· M.U.S.T. Fenestrated Pedicle Screw

The M.U.S.T. Fenestrated Pedicle Screw System when used without cement is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). These devices are indicated as an adjunct to fusion for all of 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 (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in conjunction with Meta+ Spine cement, the M.U.S.T. Fenestrated 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 allow for achievement of fusion. M.U.S.T. Fenestrated Pedicle Screw System augmented with Meta+ Spine cement is intended for use at spinal levels where the structural integrity of the spine is not severely compromised.

· Meta+ Spine Cement

Meta+ Spine cement, when used in conjunction with the M.U.S.T. Fenestrated 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 allow for achievement of fusion. The M.U.S.T. Fenestrated Pedicle Screw System, augmented with Meta+ Spine Cement, is for use at spinal levels where the structural integrity of the spine is not severely compromised.

The purpose of this submission is to gain the clearance for the Meta+ Spine Cement to be used in conjunction with the M.U.S.T. Fenestrated Pedicle Screw System, a Medacta M.U.S.T. Pedicle Screws System line extension including the following screws:

• A. Poly-Axial Screws with standard screw head design, Ø 5, 6 mm (Dual Diameter) and 7mm (Single Diameter)
• B. Poly-Axial Screws with large screw head design, Ø 7, 8, 9, 10 mm (Dual Diameter)
• C. Mono-Axial Screws, Ø 5, 6, 7 mm (Dual Diameter)
• D. Long Tab (LT) Poly-axial screws Ø 4.5. 5. 6. 7. 8 mm (Single Diameter).

The Meta+ Spine Cement as well as the M.U.S.T. Fenestrated Pedicle Screws are provided individually packed, sterile and single-use.

The provided text describes a 510(k) premarket notification for a medical device (Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System) and outlines the testing conducted to support its substantial equivalence to predicate devices.

However, the document focuses on demonstrating substantial equivalence through a comparison of technological characteristics and performance data against predicate devices, rather than establishing specific, quantitative acceptance criteria and proving the device meets those criteria. The "Performance Data" section lists various non-clinical tests performed, but it does not specify quantitative acceptance criteria or report specific device performance results against those criteria in a table format.

Therefore, many of the requested details about acceptance criteria, test set specifics (sample size, provenance, expert adjudication, ground truth), and training set details for an AI/ML-based device cannot be extracted from this document. This submission is for a traditional medical device (bone cement and pedicle screws), not an AI/ML diagnostic or therapeutic device. As such, concepts like "human readers improve with AI vs without AI assistance," "standalone algorithm performance," and "ground truth establishment for training" are not applicable to this type of submission.

Based on the information provided, here's what can be gathered:

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

This information is not explicitly provided in the document as quantitative acceptance criteria with reported performance values in a table. The document states "testing activities were conducted to written protocols" and lists the types of tests. It asserts that "The comparison of technological characteristics and performance data provided within the submission supports the substantial equivalence of the subject devices with respect to the predicate devices." Implied acceptance is that the device performs equivalently to the predicate devices as per the listed tests.

Summary of Tests Performed (Implied Performance Goal: Substantial Equivalence to Predicate):

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

• Sample Size: Not specified in the provided text. The document refers to "cadaver specimen and PU foam" for the bone cement injection test, but no specific number of specimens/tests is given for any of the listed tests.
• Data Provenance: Not specified. (e.g., country of origin, retrospective/prospective). This is unlikely to be relevant for non-clinical, in-vitro/ex-vivo biomechanical and material tests.

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

• Not applicable / Not specified. This document describes non-clinical performance testing of a physical medical device (bone cement and pedicle screws), not an AI/ML algorithm that requires expert annotation for ground truth. The "ground truth" for these tests would be derived from the physical properties and mechanical behavior measured against established ASTM standards and comparable predicate device data, not expert consensus on images.

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

• Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used in studies involving human readers or AI output where subjective interpretation or consensus is needed (e.g., image reading). This is not relevant to the described biomechanical and material property tests.

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 not mentioned, nor would it be relevant for this type of device. This device is a physical implant and bone cement, not an AI-assisted diagnostic tool.

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

• Not applicable. This pertains to AI/ML algorithms. No such algorithm is part of this submission.

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

• Not applicable in the AI/ML sense. For the non-clinical tests performed, the "ground truth" is based on the physical and mechanical properties of the materials and devices as measured using validated test methods (e.g., ASTM standards) and compared against established performance benchmarks or predicate device specifications.

8. The sample size for the training set:

• Not applicable. There is no AI/ML algorithm requiring a training set for this device submission.

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

• Not applicable. As above, no training set for an AI/ML algorithm is involved.

Ask a specific question about this device

The Momentum® Posterior Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracolumbar and sacroiliac spine. When used as a posterior system, Momentum is intended for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudoarthrosis and failed previous fusion.

When used in conjunction with G21 V-Steady Bone Cement, the Momentum Posterior Spinal Fixation 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. Momentum Posterior Spinal Fixation System Screws augmented with G21 V-Steady Bone Cement are limited for use at spinal levels where the structural integrity of the spine is not severely compromised. Iliac screws are not intended to be used with bone cement.

In order to achieve additional levels of fixation the Momentum Posterior System can also be connected to the neon38 universal OCT spinal stabilization system via transition rods or connectors. Please refer to the neon3 Instructions for Use for a list of indications for use.

The Momentum® MIS Posterior System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracolumbar and sacroiliac spine. When used as a posterior spine system, Momentum MS is intended for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudoarthrosis and failed previous fusion.

When used in conjunction with G21 V-Steady Bone Cement, the Momentum MIS Posterior 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. Momentum MIS Posterior System Screws augmented with G21 V-Steady Bone Cement are limited for use at spinal levels where the structural integrity of the spine is not severely compromised. Iliac screws are not intended to be used with bone cement.

The Momentum® Posterior Spinal Fixation System, and Momentum® MIS Posterior Spinal Fixation System are standard pedicle screw and rod systems designed for fixation in the thoracolumbar and sacroiliac spine. There have been no major changes to the device since K191932, and K223274, respectively. The subject devices are identical to the previously cleared versions with the addition of the option to use bone cement (G21 V-Steady) with the fenestrated screws.

G21 V-Steady Bone Cement consists of a liquid and powder component. The powder component is constituted of PMMA beads shaped particles containing the initiator benzoy1 peroxide required for starting to initiate the cement curing. The radiopacifier agent, zirconium dioxide, is necessary for the cement visibility under radiographs but it does not take part of the curing process (radical polymerization). The liquid component comprises the monomer, methylmemethylmethacrylate (MMA); dimethyl-para-toluidine (DMPT) as polymerization accelerator and hydroquinone (HQ) as stabilizer to prevent polymerization of the liquid during storage. V-STEADY bone cement has an immediate development of viscosity and thus it is a high viscosity cement that maintains its properties throughout the useful working time.

While the provided text describes the regulatory clearance of a medical device (Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement), it does not contain any information regarding acceptance criteria, performance studies (other than "bone cement usability testing and screw removal testing"), or detailed clinical data typically associated with AI/ML device evaluations.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device based on indications for use, technological characteristics, and non-clinical performance (material composition, manufacturing, basic mechanical testing). It is not a clinical study report for an AI/ML diagnostic or prognostic tool.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, specifically regarding:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document states "bone cement usability testing and screw removal testing was conducted to validate the use," but no specific metrics or acceptance criteria are given.
2. Sample sized used for the test set and the data provenance: Not applicable to the type of testing described (usability and screw removal, likely biomechanical or benchtop).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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, as this is a physical medical device, not an AI/ML-driven diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not clearly defined for the "usability" and "screw removal" tests, but would likely refer to engineering specifications or validated test methods.
8. The sample size for the training set: Not applicable (no AI/ML training set).
9. How the ground truth for the training set was established: Not applicable (no AI/ML training set).

In summary, the provided document is a regulatory submission for a physical medical device (spinal fixation system with bone cement) and does not contain the characteristics of an AI/ML device study that your questions refer to.

Ask a specific question about this device

The PERLA® TL system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

• · degenerative disc disease;
• · spondylolisthesis;
• · fracture;
• · dislocation;
• scoliosis;
• · kyphosis;
• spinal tumor:
• · and failed previous fusion (pseudarthrosis).

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the PERLA® TL system is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

When used in conjunction with TEKTONA® HV US bone cement system, the PERLA®TL system is intended to restore the integrity of the spinal column even in the absence of fusion for a limited period of time, in patients whom life expectancy is of insufficient duration to permit achievement of fusion in advanced stage of thoracic and lumbar spine tumors. The PERLA®TL 35mm to 60mm lengths Screws augmented used with TEKTONA® HV US bone cement system are intended to be used at spinal levels where the structural integrity is not severely compromised.

TEKTONA® HV US Bone Cement is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

When used in conjunction with PERLA®TL system, TEKTONA® HV US Bone Cement 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. PERLA®TL Screws augmented with TEKTONA® HV US Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The PERLA® TL System consists of a range of screws, rods, set screws, hooks, rod connectors and cross-connectors. These connecting components can be rigidly locked to the rod in a variety of configurations to be adapted for the individual case. The PERLA® TL System is manufactured from medical grade titanium alloy and medical grade cobalt chromium conforming respectively to standards ASTM F136 and ASTM F1537.

The PERLA® TL System is identical to the previously cleared version, however this submission includes the additional option to use bone cement with the fenestrated screws.

Mendec Spine HV System (TEKTONA HV US Bone Cement) is highly viscous, radio-opaque acrylic resins (PMMA based) for percutaneous vertebroplasty or kyphoplasty. Mendec Spine HV System holds the powder and liquid components separately within a closed syringe-like device that serves as a mixing chamber. The device is packaged in unitary PVC-blister with tray, sealed with Tyvek lid, which is placed in an aluminum bag. The device is sold disposable and sterile.

The provided FDA 510(k) summary (K230774) describes a medical device, the PERLA® TL System, and its use in conjunction with TEKTONA® HV US Bone Cement. However, this document does not contain acceptance criteria or a study describing the device's performance against such criteria for the PERLA® TL System with bone cement augmentation for thoracic and lumbar spine tumors.

The document states that:

"Bone cement usability testing (Usability Testing, Cement Injection Time Testing, and Cement Flow, Bolus Formation, and Screw Removal from Bone Cement Testing) was conducted to validate the use of the Perla® TL System used with bone cement."

And:

"The non-clinical tests performed by the company included bone cement usability testing and screw removal testing was conducted to validate the use of the Perla® TL System used with bone cement."

This indicates that testing was performed, but the details required to answer your specific questions (acceptance criteria, performance results, sample size, type of ground truth, expert qualifications, etc.) are not present in this document. The provided text focuses on establishing substantial equivalence to predicate devices based on indications, design, materials, manufacturing, and performance based on these "usability" and "screw removal" tests, but it does not quantify their results or define specific acceptance criteria they met.

Therefore, I cannot provide the requested table or detailed information about the study from the given text.

In summary, the provided document lacks the specific information about acceptance criteria and detailed study results that you are requesting.

Ask a specific question about this device

The VADER® Pedicle 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, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.

When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the icotec Cement Cannula for mixing and injection of bone cements, the fenestrated VADER® pedicle screws are 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, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® pedicle screws augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The VADER® Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.

When used in conjunction with the icotec VADER® Pedicle System, G21 V-Fast and V-Steady Bone Cement are 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 thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® pedicle screws augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The VADER® Pedicle System is a posterior pedicle system manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of polyaxial pedicle screws and curved, straight, S-rods and J-rods as well as polyaxial, cannulated, fenestrated pedicle screws. The VADER® Pedicle System can be used for single or multiple level fixations in the non-cervical spine.

The provided text does not contain information about the acceptance criteria or a study proving that the device meets specific performance criteria in the context of an AI/ML device. The document is an FDA 510(k) clearance letter for a medical device, specifically the VADER® Pedicle System and G21 Cement, which are physical implants and bone cement, not an AI/ML diagnostic or therapeutic device.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The "Performance Testing Summary" section (Page 6) briefly mentions mechanical testing performed per ASTM standards (F1717, F1798, F543/F2193) and cement injection testing for the VADER® Pedicle System and G21 Cement. These are engineering performance tests for a physical device, confirming its structural integrity and functional characteristics, not clinical performance metrics for an AI/ML algorithm. The conclusion states that the device is "substantially equivalent" to predicate devices based on these mechanical tests.

Ask a specific question about this device

The Invictus Spinal Fixation System is intended for non-cervical posterior and anterolateral fixation in skeletally mature patients as an adjunct to fusion 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 (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Invictus Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Invictus Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach.

The Invictus Spinal Fixation System is intended to be used with autograft and/or allograft.

Invictus Core and Invictus SI.Core Screws are not intended for use with cement; all other fenestrated screws may be used with Invictus Bone Cement. When used in conjunction with Invictus Bone Cement, the Invictus Fenestrated Screws are 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. The Invictus Fenestrated Screws augmented with Invictus Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The Invictus Spinal Fixation System is thoracolumbosacral spinal fixation system designed to be implanted through a non-cervical posterior or anterolateral surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, commercially pure titanium (CP Ti Grade 2) per ASTM F67 and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Invictus System consists of a variety of shapes and sizes of screws, hooks, rods, connectors, and cross-connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic, lumbar and sacral spine.

Invictus Bone Cement is a self-hardening and ready to use polymethylmethacrylate (PMMA) bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. The cement is made of two sterile components: the polymer in powder and the liquid monomer. The liquid component is mainly composed of methacrylate. The major powder components are polymethylmethacrylate, methyl methacrylate, and zirconium dioxide. Benzoyl peroxide, which initiates polymerization, is included in the polymer powder. The powder and liquid monomer are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box.

The purpose of this submission is to expand indications for use of Invictus fenestrated screws with Invictus Bone Cement, add new fixed fenestrated pedicle screws to the Invictus Spinal Fixation System, and to expand indications of the Invictus Spinal Fixation System for non-cervical anterolateral fixation.

The provided text is a 510(k) summary for a medical device (Invictus® Bone Cement, Invictus Spinal Fixation System). It focuses on establishing substantial equivalence to legally marketed predicate devices based on non-clinical performance data.

Crucially, this document explicitly states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

Therefore, the information required to answer your request regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, ground truth types for test/training sets, training set size, and ground truth establishment for training set) is not present in the provided text.

The document indicates that substantial equivalence was determined through nonclinical testing, specifically:

• Axial Pullout Strength testing per ASTM F543
• Screw Torque Removal testing per ASTM F543
• Cadaveric testing to evaluate cement flow and bolus formation

These tests are typically related to the mechanical and physical performance of the device rather than diagnostic or prognostic accuracy requirements that would necessitate human expert input and clinical study designs.

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), 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

When used in conjunction with the icotec VADER® Pedicle System, G21 V-Fast and V-Steady Bone Cement are 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 thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® one pedicle screws 6.0 augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The VADER® Pedicle 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, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.

When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the icotec Cement Cannula for mixing and injection of bone cements, the fenestrated VADER® pedicle screws 6.0 are 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, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® pedicle screws 6.0 augmented with G21 V-Fast or V-Steady Bone Cement are limited to the use at spinal levels where the structural integrity of the spine is not severely compromised.

The VADER® Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.

The purpose if this Traditional 510(k) is to seek marketing clearance for the G21 Cement (V-Steady and V-Fast Bone Cements) to be used with the VADER® Pedicle System and to seek clearance for the VADER® Pedicle System.

V-Steady and V-Fast are polymethylmethacrylate (PMMA) based bone cements formulated to perform percutaneous vertebral augmentation procedures, such as vertebroplasty or kyphoplasty. Bone cements are self-curing systems consisting of liquid and powder components:

• The powder component is constituted of PMMA beads shaped particles containing the initiator benzoyl peroxide required for starting initiating the cement curing. The radiopacifier agent, zirconium dioxide, is necessary for the cement visibility under radiographs but it does not take part of the curing process (radical polymerization).
• The liquid component comprises the monomer, methylmethacrylate (MMA); dimethyl-para-toluidine (DMPT) as polymerization accelerator and hydroquinone (HQ) as stabilizer to prevent polymerization of the liquid during storage.

The specific content of PMMA and benzoyl peroxide is slightly different between the two cements conferring upon them specific properties. V-Steady bone cement has an immediate development of viscosity and thus it is a high viscosity cement that maintains its properties throughout the useful working time. The V-Fast has a low initial viscosity and a long working time allowing to work extremely carefully especially when a good time margin before polymerization is required. Both the liquid and powder components are supplied sterile. The sterile-filtered monomer component is supplied in an amber glass ampoule (10 ml) and comes in a blister pack sterilized by ethylene oxide. The polymer powder component is supplied in a double sterile packaging.

The sterilization process is ethylene oxide and it has been properly validated. Preparation and application procedures of the subject devices are detailed within the labeling as Mixing Phase, Waiting Phase, Application Phase, Setting/Hardening Phase.

The VADER® Pedicle System is a posterior pedicle system manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of polyaxial pedicle screws and curved, straight and J-rods as well as polyaxial, cannulated, fenestrated pedicle screws. The VADER® Pedicle System can be used for single or multiple level fixations in the non-cervical spine.

This document is a 510(k) Premarket Notification from the FDA, which outlines the substantial equivalence of medical devices (G21 Cement and VADER® Pedicle System) to already legally marketed devices. It primarily focuses on the device's intended use, description, and performance testing summaries for mechanical and material properties, rather than AI/algorithm-based diagnostic or prognostic performance.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" related to AI/algorithm performance (e.g., sample size for test set, expert consensus for ground truth, MRMC studies, standalone algorithm performance) is not applicable to this document.

The acceptance criteria and performance studies detailed in this 510(k) summary are for the physical and mechanical properties of the bone cement and pedicle screw system.

Here's a breakdown of the relevant information from the document that loosely relates to your request, but is specific to the mechanical device, not an AI:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "table" for acceptance criteria as one would expect for an AI algorithm. Instead, it lists the types of performance testing conducted, implying that the acceptance criteria are adherence to the specific ASTM standards and demonstration of substantial equivalence to predicate devices. The reported performance is that the devices met these standards and were found substantially equivalent.

Note: The document states "The results of the performed tests demonstrate that the VADER® Pedicle System is substantially equivalent to legally marketed predicate devices." This is the reported performance against the implied acceptance criteria of meeting or exceeding the predicate device's performance based on these standards.

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

• Sample Size: Not explicitly stated for each test. For mechanical testing (ASTM standards), the sample size would typically be a specific number of devices/implants per test as required by the standard. This is not "data" in the sense of patient data.
• Data Provenance: Not applicable in the context of patient data. The "data" comes from in vitro mechanical and material testing conducted by the manufacturer (icotec ag) in Switzerland. The "clinical data" mentioned is not detailed, but for a 510(k), it often refers to references to existing literature or limited clinical use data, not necessarily new prospective studies for the 510(k) itself unless specified.

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

• Not applicable. Ground truth as typically understood for AI-based diagnostic/prognostic devices (e.g., radiological interpretation) is not relevant here. The "ground truth" for these tests comes from objective physical measurements and adherence to engineering standards.

4. Adjudication method for the test set:

• Not applicable. This is not a human interpretation task.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• Not applicable. This is for mechanical device performance, not AI assistance for human readers.

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

• Not applicable. This is a PMMA bone cement and pedicle screw system, not an algorithm.

7. The type of ground truth used:

• For mechanical tests: Objective physical measurements against established ASTM standard specifications.
• For biocompatibility: Adherence to relevant biocompatibility standards.
• For "Clinical Data": Details are not provided, but it likely refers to existing literature/clinical experience with similar devices or limited clinical data demonstrating safety and performance.

8. The sample size for the training set:

• Not applicable. This document is not about an AI/ML algorithm.

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

• Not applicable. This document is not about an AI/ML algorithm.

In summary: The provided document is a 510(k) clearance for a mechanical medical device (bone cement and pedicle screws). The "acceptance criteria" and "proof" relate to standard engineering, material, and biocompatibility testing, demonstrating substantial equivalence to predicate devices, rather than the performance metrics and study designs typically associated with AI/ML-based medical devices.

Ask a specific question about this device

When used without cement, CD Horizon™ Fenestrated Screws (with or without Sextant™ or Longitude™ instrumentation) are intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD- defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tumor and/or trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), pseudarthrosis, and/or failed previous fusion.

Additionally, CD Horizon™ Fenestrated Screws may be used for immobilization and stabilization when used for trauma (e.g., fracture or dislocation) with the usage of bone graft material left to the surgeon's discretion.

When used in conjunction with Kyphon™ HV-R™ Bone Cement or Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screws are 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, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD Horizon™ Fenestrated Screws augmented with Kyphon™ HV-R™ Bone Cement or Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - 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 (i.e. scoliosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion.

With the exception of DDD, the CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 - S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.

In order to achieve additional levels of fixation, the CD Horizon™ Spinal System rods may be connected to the Vertex™ Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of the Vertex™ indications of use.

Kyphon™ HV-R™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathological fracture may include a symptomatic vertebral body microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

When used in conjunction with CD Horizon™ Fenestrated Screws, Kyphon™ HV-RTM Bone Cement 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, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD Horizon™ Fenestrated Screws augmented with Kyphon™ HV-RTM Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation™ System, which 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 a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Reusable Instruments are also compatible with the IPC™ Powerease™ System. Do not implant the instruments.

IPC™ System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures. The IPC™ Powerease™ System is indicated for drilling, tapping and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods. Do not implant the instruments.

CD Horizon™ Fenestrated Screw Set: The CD Horizon™ Fenestrated Screw Set consists of a variety of cannulated screws. These screws contain a series of fenestrations which allows polymethylmethacrylate (PMMA) bone cement (Kyphon™ HV-R™ Bone Cement or Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement) to be injected into the treated site. This cement is used to augment screw fixation into the pedicle in patients whose life expectancy is of insufficient duration to permit achievement of fusion. These implants may also serve as traditional pedicle screws when used without bone cement in patients. CD Horizon™ Fenestrated Screws are specifically designed to connect to appropriate rods and associated connecting components contained within the CD Horizon™ Spinal System. CD Horizon™ Fenestrated Screw Set implant components are fabricated from medical grade titanium and/or medical grade titanium alloy and/or medical grade cobalt-chromiummolybdenum alloy.

CD Horizon™ Spinal System: The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for various spinal conditions. The system includes titanium, cobalt chrome, and stainless steel implants, as well as PEEK rods and the Spire™ plate. The system can be used with autograft and/or allograft.

Kyphon™ HV-R™ Bone Cement: Kyphon™ HV-R™ Bone Cement is a polymethylmethacrylate (PMMA) that contains approximately 30% barium sulfate. It is designed for delivery in a highly viscous state. It is provided sterile in two components: 20 grams of powder and nine grams of liquid. The powder contains methylmethacrylatestyrene co-polymer, barium sulfate, and benzoyl peroxide. The liquid contains methylmethacrylate (monomer), hydroquinone and N, N dimethyl-p-toluidine.

Medtronic Navigated Reusable Instruments for use with StealthStation™ and IPC™ Powerease™ Systems: Medtronic Navigated Reusable Instruments are spine preparation instruments made of high grade stainless steel. They are designed for use with the StealthStation™ Image Guidance System to track the instruments in the surgical field. They are also compatible with Medtronic's IPC™ Powerease™ System.

Medtronic Reusable Instruments for use with the IPC™ Powerease™ System: The Medtronic Reusable Instruments compatible with Medtronic's IPC™ Powerease™ System are spine preparation instruments, manufactured from materials commonly used in orthopedic procedures. They can be connected to the Powerease™ Driver or used manually and are compatible with various Medtronic spinal implant systems.

The provided text does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of AI/ML or diagnostic performance.

The document is a 510(k) summary for several medical devices: CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, and Kyphon™ HV-R™ Bone Cement. It primarily focuses on demonstrating substantial equivalence to predicate devices through design descriptions, indications for use, and a general statement about performance data.

Here's why the requested information cannot be extracted:

• No AI/ML Component: The devices described are spinal implants and bone cement, along with surgical instruments. There is no mention of any artificial intelligence or machine learning component.
• No Diagnostic Performance Data: The document discusses the mechanical and material equivalence of the devices to existing ones, and their indications for use in surgical procedures. It does not contain any data related to diagnostic performance metrics like sensitivity, specificity, AUC, or F1 score.
• No Clinical Study for Performance Metrics (as requested): While "performance data" is mentioned (Section VI), it refers to mechanical testing (ASTM F1798 and ASTM F1717) for spinal systems, not clinical trials or studies to evaluate diagnostic accuracy or AI model performance. It states that these mechanical tests "met the pre-determined acceptance criteria," but these criteria are for physical properties, not diagnostic accuracy.

Therefore, since the device is a physical medical implant/instrument and not an AI/ML diagnostic software, the requested information elements (acceptance criteria table related to diagnostic performance, sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, training set ground truth) are not applicable to this document.

Ask a specific question about this device

VertaPlex® HV High Viscosity Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacroplasty or sacroplasty. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

When used in conjunction with ES2® Augmentable Spinal System, Vertaplex® HV High Viscosity Radiopaque Bone Cement 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. Vertaplex® HV High Viscosity Radiopaque Bone Cement and the ES2® Augmentable Spinal System are for use together at spinal levels where the structural integrity of the spine is not severely compromised.

When used without cement, the ES2® Augmentable Spinal System is intended for posterior, non-cervical fixation as an adjunct to fusion 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, tumor and/or trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, or lordosis), pseudarthrosis, and/or failed previous fusion.

When used in conjunction with the Vertaplex® HV High Viscosity Radiopaque Bone Cement, the ES2® Augmentable Spinal 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. ES2® Augmentable Spinal System augmented with the Vertaplex® HV High Viscosity Radiopaque Bone Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.

VertaPlex® HV High Viscosity Radiopaque Bone Cement is bone cement comprised of a liquid component and powder component which when mixed together polymerize to form a hardened acrylic polymer. The mixture is in an injectable state for a period of time before it cures to form a hardened structure, capable of long-term load support and bone augmentation in the treatment of symptomatic osteoporotic vertebral compression fractures.

The powder component of VertaPlex® HV High Viscosity Radiopaque Bone Cement is Ethylene Oxide (EO) sterilized and is packaged in a polyethylene/foil pouch while the liquid monomer is aseptically filled into an amber glass ampoule which is EO sterilized. The device contains the following components: Polymer powder, Monomer liquid and Barium Sulfate. Accessories to the subject cement device are compatible Stryker cement mixers such the Stryker Autoplex System and the Stryker PCD System.

ES2® Augmentable Spinal System is a gamma sterilized, titanium implantable screw with fenestrations and blocker designed as a stabilization solution for the aging spine. The subject system (screw and blocker) has been developed to provide improved anchorage of pedicle screws with and without Vertaplex® HV High Viscosity Radiopaque Bone Cement during pedicle screw augmentation in vertebrae with reduced bone quality as compared to pedicle screw augmentation in healthy bone.

The provided text is a 510(k) summary for the Stryker Vertaplex® HV High Viscosity Radiopaque Bone Cement and ES2® Augmentable Spinal System. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing and comparison of technological characteristics, rather than presenting a study proving a device meets specific acceptance criteria based on its performance in a clinical or analytical setting.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types is largely not present in this type of FDA submission.

Here's what can be extracted and inferred based on the provided document:

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

The document states: "The subject devices were tested and met all respective acceptance criteria as specified per the individual test report." and "The acceptance criteria for the subject device were similar to the acceptance criteria for the Stryker predicate device." However, the specific acceptance criteria and detailed performance metrics are not provided 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)

The document primarily refers to "Bench" testing and "cadaver validation."

• Sample Size: Not specified for any particular test.
• Data Provenance: Implied to be in-house testing by Stryker Instruments, likely in the USA given the company's address. The testing is non-clinical.

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. The "tests" mentioned are physical/mechanical bench tests and cadaver validation, not diagnostic or clinical assessments requiring expert ground truth for interpretation.

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

Not applicable, as no expert-based ground truth establishment or adjudication is described.

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 was not done. This device is a bone cement and a spinal system, not an AI-powered diagnostic tool. The document explicitly states: "No clinical testing was deemed necessary for this 510(k)." It does mention a "clinical literature review" to support safety and effectiveness of PMMA bone cement with augmentable pedicle screws, but this is a review of existing literature, not a new comparative effectiveness study.

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

Not applicable. This device is not an algorithm.

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

For the non-clinical bench testing, the "ground truth" would be the established engineering and materials science standards (e.g., ASTM F1798-12, ASTM F1717-12, ANSI/AAMI ST72:2011(R2016), ISO 11137-2:2013, ASTM F1980, ISO 11607) that define acceptable performance for device characteristics like static strength, pullout force, sterility assurance, endotoxin limits, and shelf life.

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. This is not an AI/ML device.

Ask a specific question about this device