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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.

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The VK100® Percutaneous Vertebral Augmentation System is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (haemangioma), or malignant lesions (metastatic cancers, myeloma).

Like the predicate devices. VK100® is provided as a two-component system with barium sulfate as a radiopacifier. VK100® is a polydimethylsiloxane material. The VK100® System consists of a cartridge containing the two VK100® material components and a dispensing system which blends the two components for injection into the injured vertebrae. The material cures in situ to form a non-resorbable polymer.

The VK100® material is supplied in a pre-filled cartridge:

The 2-cylinder cartridge keeps each component separate until administration, when both components are extruded through a mix element, which blends the mixture at a 1:1 ratio.

Each dose (cartridge of VK100® material) consists of:

• Reinforced Dimethyl Methylvinyl Siloxanes ●
• . Barium Sulfate powder
• Methylhydrogensiloxane Crosslinker
• . Platinum catalyst,

The provided text describes a medical device, the VK100® Percutaneous Vertebral Augmentation System, and its submission for FDA clearance. The information focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study specifically designed to prove all acceptance criteria.

However, based on the provided text, we can extract details related to safety and performance, particularly concerning extravasation.

Here is an attempt to answer your questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state a table of "acceptance criteria" for the VK100® in the conventional sense (e.g., "extravasation rate must be less than X%"). Instead, it compares the VK100®'s performance to predicate devices, implying that acceptable performance is at least equivalent to or better than currently marketed devices.

Therefore, the "acceptance criterion" derived from the clinical study section is an implied comparison to the extravasation rates of predicate PMMA cements.

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

• Sample Size for Test Set: 124 subjects
• Data Provenance: The study population included a "consecutive series of 124 subjects." The text does not explicitly state the country of origin or if it was retrospective or prospective. Given the description, it likely refers to a retrospective review of existing clinical data, described as a "radiographic evaluation of existing clinical data."

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

• Number of Experts: An "independent review" was performed, implying at least one expert, but the exact number is not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The text only mentions an "independent review" of radiographic images.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Comparative Effectiveness Study: No. The device described, VK100®, is a percutaneous vertebral augmentation system (bone cement), not an AI diagnostic tool. Therefore, an MRMC study related to human reading with or without AI assistance is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance Study: Not applicable. The VK100® is a medical device (bone cement), not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the clinical study was based on radiographic evaluation by an independent reviewer(s) to identify extravasation and migration of the VK100® material. The "primary safety measure" was the "incidence or lack thereof of pulmonary emboli," which would be clinical outcomes data, but the evaluation itself was image-based.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The VK100® is a physical medical device, not an AI model that requires a training set. The clinical study described is a performance evaluation of the device in human subjects.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this device type.

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