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CD Horizon™ Astute™ Spinal System: The CD Horizon™ Astute™ Spinal System is intended to provide for posterior, supplemental fixation when used with an interbody fusion cage for patients diagnosed with degenerative disc disease (DDD- defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). 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.

CD Horizon™ Fenestrated Screw Set: 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), pseudarthrosis, and/or failed previous fusion. Additionally, CD Horizon™ Fenestrated Screws may be used for immobilization 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 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™ Fenestrated Screws augmented with 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.

CD HORIZON™ Growth Rod Conversion Set: The CD Horizon™ Growth Rod Conversion Set is indicated in patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency including early-onset scoliosis. The CD Horizon™ Growth Rod Conversion Set may be used with any cleared traditional CD Horizon™ Spinal System rod construct ranging in diameter from 3.5mm to 5.5mm, with the exception of PEEK Rod constructs. The CD Horizon™ Growth Rod Conversion Set may not be used with PEEK rods, Spire™ Spinous Process Plates, or Shape Memory Alloy (SMA) Staples.

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 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, 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, 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 pedictic patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic 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. 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 (12 - 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. To achieve additional levels of fixation, 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.

GDLH™ Posterior Spinal System: The GDLH™ Posterior Spinal System, when using TSRH™ variable angle screws, is intended only for patients (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) receiving fusions using autogenous bone graft only; (c) having the device fixed or attached to the lumbar and sacral spine: and (d) having the device removed after the development of a solid fusion mass. When properly used. this system is intended to assist stabilization until a solid spinal fusion develops. Except for situations where screws are attached to the lumbar and sacral spine via a posterior surgical approach in a GDLH™ construct for the treatment of severe spondylolisthesis (Grade 4) at the L5-S1 vertebral joint, the specific indications for the GDLH™ Posterior Spinal System are the following: Degenerative disc disease (DDD - as defined by instability in the presence of one or more of the following: osteophyte formation, decrease in disc space height, endplate sclerosis, disc herniations, facet joint changes, and scarring and/or thickening of the annulus fibrosis, ligamentum flavum, or facet joint capsule). Pseudoarthrosis. Stenosis. Spondylolisthesis. Spinal deformities such as scoliosis, kyphosis, and lordosis. Fracture. Unsuccessful previous attempts at spinal fusion. Tumor resection. Nota bene: the GDLH™ Posterior Spinal System is limited to non-cervical use. TSRH™ variable angle with the GDLH™ Posterior Spinal System, are intended for sacral/iliac attachment only. GDLH™ hooks and Crosslink™ bars are intended for posterior thoracic and/or lumbar use only.

COLORADO 2™ Spinal System: When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Colorado 2™ Spinal System is indicated for one or more of the following: ( ) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (5) kyphosis, (6) spinal tumor, and/or (7) pseudarthrosis. In addition, when used as a pedicle screw fixation system, the Colorado 2™ Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5 S1) vertebral joint, (2) receiving fusions using autogenous bone graft only, (3) having the device fixed or attached to the lumbar and sacral spine (L3 and below), and (4) having the device removed after the development of a solid fusion mass. When used as a posterior, non-cervical, non-pedicle screw fixation system, the Colorado 2™ Spinal System is intended for the following indications: (1) degenerative disc disease (DDD - as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e. scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, and/or (7) tumor resection. When used as an anterolateral thoracic/lumbar system, the Colorado 2™ Spinal System is intended for the following indications: (1) DDD (as defined by back pain of discogenic origin with degeneration of the disc confirmed b patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e. scoliosis, kyhosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, and/or (7) tumor resection.

SHILLA™ Growth Guidance System: The Shilla™ Growth Guidance System is indicated for skeletally immature patients less than 10 years of age with the potential for additional spinal growth who require surgical treatment for correction and maintenance of the correction of severe, progressive, life-threatening early-onset seculiosis, which are associated with or at risk of thoracic insufficiency syndrome. The Shilla™ Growth Guidance System is intended to be removed after skeletal maturity.

TENOR™ Spinal System: The Tenor™ Spinal System, when used for pedicle screw fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar – first sacral (L5-S1) vertebral joint; (b) receiving fusions using autogenous bone graft only; (c) having the device fixed to the lumbar and sacral spine (levels of pedicle screw fixation may be from L3 to sacrum); and (d) having the device removed after the development of a solid fusion mass. Note: Tenor™ Plates are intended for the L5-S1 pedicle screw indication only. The Tenor™ Spinal System, when used as a posterior, non-pedicle screw fixation system, is intended for the following indications: Degenerative disc disease (DDD - as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). Pseudarthrosis. Stenosis. Spondylolisthesis. Spinal deformities such as scoliosis, kyphosis, and/or lordosis. Fracture. Tumor resection. When used for posterior non-pedicle screw fixation. the Tenor™ Spinal System is intended for thoracic, lumbar, and sacral (T1- Sacrum) fixation only.

CD HORIZON™ ASTUTE™ SPINAL SYSTEM: The CD Horizon™ Astute™ Spinal System consists of a variety of sizes of rods, as well as set screws, which are used with bone screws from the CD Horizon™ Solera™ Spinal System, to create a variety of rigidly locked configurations, with each construct being tailored to the individual case. CD Horizon™ Astute™ Spinal System implant components are fabricated from medical grade titanium alloy, tantalum, or polyetheretherketone (PEEK). Medical grade titanium, titanium alloy, or medical grade cobalt-chromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct. Only use set screws designed for use with CD Horizon™ Astute™ rods. PEEK implants may be used with titanium alloy or cobaltchromium-molybdenum alloy implants. CD Horizon™ Astute™ Spinal System rods are not to be used with Crosslink™M plates, fixed angle screws, sagittally adjusting screws, or in pediatric patients. To achieve best results, do not use CD Horizon™ Astute™ Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document.

CD HORIZON™ Growth Rod Conversion Set: The CD Horizon™ Growth Rod Conversion Set consists of a variety of inline connectors used with certain CD Horizon™ Spinal System components to create posterior pedicle screw and hook constructs intended for treatment of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The CD Horizon™ Growth Rod Conversion Set is used with CD Horizon™ Spinal System rods (ranging in diameter from 3.5mm to 5.5mm), pedicle screws, hooks, and connectors of various sizes. These implants are used to form a distinct spinal construct in growing children to correct spinal deformities in a non-fusion manner. Similar to CD Horizon™ implants used in fusion cases, these components are rigidly locked into a variety of configurations with each construct being tailor-made for the individual. As the patient grows, subsequent lengthening surgeries are performed periodically to reapply tension/distraction to the construct. These surgeries are repeated until the child has reached skeletal maturity, at which point the implants may be removed. Certain components within the CD Horizon™ Spinal System are excluded for use in pediatric patients and, therefore, are excluded for use with the CD Horizon™ Growth Rod Conversion Set. These include PEEK rods, Shape Memory Alloy Staples and Spire™ Plates. All screws used in pediatric cases are only cleared for use via a posterior approach. CD Horizon™ Growth Rod Conversion Set components are fabricated from medical grade stainless steel or titanium alloy. Compatible CD Horizon™ Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy. Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct. To achieve best results, do not use any of the CD Horizon™ Growth Rod Conversion Set implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document.

CD HORIZON™ SPINAL SYSTEM: The CD Horizon™ Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, Crosslink™ Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. A subset of CD Horizon™ Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, Crosslink™ plates, and connecting components. Similar to the CD Horizon™ implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Certain components within the CD Horizon™ Spinal System are specifically excluded for use in pediatric patients. These include PEEK rods, Spire™ plates. Screws used in pediatric cases are only cleared for use via a posterior approach. All components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, and medical grade cobalt-chromium-molybdenum alloy. Certain implant components from other Medtronic spinal systems can be used with the CD Horizon™ Spinal System in non- pediatric cases. These components include TSRH™ rods, hooks, screws, plates; Crosslink™ plates, connectors, staples and washers; GDLH™ rods, hooks, connectors; Crosslink™ bar and connectors and Medtronic multi-axial rods and screws. Note that certain components are specifically designed to connect to specific rod diameters, while other components can connect to multiple rod diameters. Care should be taken so the correct components are used in the spinal construct. CD Horizon™ hooks are intended for posterior use only. CD Horizon™ staples and associated screws are intended for anterior use only. However, for patients of smaller stature and pediatric patients, CD Horizon™ 4.5mm rods and associated components may be used posteriorly. CD Horizon™ Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, medical grade cobalt- chromium-molybdenum alloy, or medical grade PEEK Optima-LT1. Certain CD Horizon™ Spinal System components may be coated with hydroxyapatite. Never use stainless steel and titanium implant components in the same construct. Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct. PEEK Optima-LT1 implants may be used with titanium or cobalt-chromium-molybdenum alloy implants. CD Horizon™ PEEK rods are not to be used in pediatric patients. PEEK rods are only to be used with the associated pedicle screws as well as interbody fusion devices in the anterior spinal column. To achieve best results, do not use CD Horizon™ Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document.

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 (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. Refer to the CD Horizon™ Spinal System package insert for information regarding those implants. Care should be taken so the correct components are used in the spinal construct. CD Horizon™ Fenestrated Screw Set implant components are fabricated from medical grade titanium and/or medical grade titanium alloy and/or medical grade cobaltchromium-molybdenum alloy. Never use stainless steel and titanium implant components in the same construct. To achieve best results, do not use CD Horizon™ Fenestrated Screw implants with components from any system other than the CD Horizon™ Spinal System.

COLORADO 2™ SPINAL System: The Colorado 2TM Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, and connecting components. Colorado 2TM implant components can be rigidly locked into a variety of configurations, with each construct being tailormade for the individual case. Colorado 2TM Spinal System implant components are fabricated from medical grade stainless steel. Alternatively, the entire system may be fabricated from medical grade titanium or titanium alloy. The titanium version of the Colorado 2TM Spinal System is used in conjunction with GDLHTM φ5.5 rods, TSRHTM Spinal System rods and TenorTM Spinal System rods. To achieve best results, do not use Colorado 2TM Spinal System implant components with components from any other system or manufacturer. Never use stainless steel and titanium implant components in the same construct.

GDLH™ POSTERIOR SPINAL SYSTEM: The GDLHTM Posterior Spinal System consists of a variety of shapes and sizes of rods, hooks, and connecting components. TSRHTM variable angle screws may also be used with the GDLHTM Posterior Spinal System. GDLHTM implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. GDLHTM Posterior Spinal System implant components are fabricated from medical grade stainless steel described by ASTM Standard F 138, Grade 2 (commonly called 316 LVM Stainless Steel) or ISO 5832-1 or ISO 5832-9. This material is not compatible with titanium, MP35NTM1 or any other alloy. Alternatively, GDLH TM Posterior Spinal System implant components are fabricated from titanium alloy (Ti-6Al-4V) such as described by ASTM F136 or ISO 5832-3. Implant components made from different metal alloys must not be used together in a construct. Medtronic expressly warrants these devices are fabricated from the foregoing material specifications. To achieve the best results, do not use GDLHTM Posterior Spinal System components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopaedic implants, none of the GDLH Posterior Spinal System components should ever be reused under any circumstances.

SHILLA™ Growth Guidance System: The Shilla™ Growth Guidance System consists of stainless steel components used to form a distinct spinal construct in growing children. The Shilla™ Growth Guidance System set screw provides attachment of a spinal pedicle screw to a spinal rod. Unlike a typical set screw, which rigidly locks the vertical rod inside the connector housing to the pedicle screw, the Shilla™ Growth Guidance System set screw captures the rod within the screw housing, but does not fix it rigidly to the pedicle screw. The Shilla™ Growth Guidance System consists of a construct that includes 4.5mm or 5.5mm diameter rods, fixed angle and multi-axial screws, and CrosslinkTM plates. Additionally, the construct may be supplemented with sublaminar wire. Shilla™ Growth Guidance System implants are provided non-sterile. Shilla™ Growth Guidance System implants are not to be used with implants from other systems. Never use stainless steel and titanium implant components in the same construct.

TENOR™ SPINAL SYSTEM: The Tenor™ Spinal System consists of a variety of shapes and sizes of rods, screws, bolts, clamps, connectors, plates, cross-connectors, washers, and nuts. The Tenor™ Spinal System may be used with GDLH™ 5.5mm rods, TSRHTM hooks and connectors, TSRH™ Low Profile Crosslink™ plates, CD Horizon™ Low Profile Multispan™ Crosslink™ plates, and/or Multi-axial Low Profile Multi-span™ Crosslink™ plates for attachment to the posterior thoracic and lumbar spine. All screws/bolts in this system are 5.5mm in diameter or larger. Implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Tenor™ Spinal System implants are fabricated from medical grade titanium alloy. Alternatively, the entire system may be manufactured from medical grade stainless steel. Never use stainless steel and titanium implant components in the same construct. To achieve best results, do not use Tenor™ Spinal System implants with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document.

This document, K221646, describes an MRI update for several Medtronic ThoracoLumboSacral Anterior & Posterior Spinal Fixation Systems. The stated intention of the submission is to harmonize language in certain sections (Visual Inspection, Packaging, Cleaning & Sterilization, Cleaning & Decontamination, and Sterilization) across all 8 package inserts, claiming these changes do not impact related specifications and therefore require no further verification or validation testing.

The performance data provided focuses entirely on MRI safety testing, indicating that the device's main "performance" in this context is its MRI compatibility rather than clinical effectiveness for spinal fixation.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly mentioned for the MRI testing samples. Typically, these tests involve a representative number of device components or assemblies, but the exact count is not provided.
• Data Provenance: Not specified. It's likely these tests were conducted in a laboratory setting, not necessarily involving human or animal data. The origin of the testing facility (country) is not provided. The study is prospective in the sense that the testing was performed specifically for this submission to demonstrate MRI compatibility.

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)

• This document describes physical product testing (MRI compatibility), not a clinical study involving human interpretation where "ground truth" would be established by experts. Therefore, this information is not applicable. The ground truth is determined by the objective measurements performed during the standardized engineering tests (ASTM standards).

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

• This document describes physical product testing, not a clinical study requiring adjudication of expert opinions. Therefore, this information is 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

• No MRMC comparative effectiveness study was done. This submission focuses on the MRI compatibility of spinal implants, not diagnostic performance with or without AI assistance. Therefore, this information is not applicable.

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

• No standalone algorithm performance study was done. This submission is for spinal implants, not AI algorithms. Therefore, this information is not applicable.

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

• For the MRI safety testing, the "ground truth" is established by the physical phenomena and measurements defined by the ASTM standards (e.g., magnetic field strength, temperature measurements, image artifact measurements). It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• This submission describes physical product testing, not the development or training of an AI algorithm. Therefore, this information is not applicable.

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

• This submission describes physical product testing, not the development or training of an AI algorithm. Therefore, this information is not applicable.

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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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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 (e.g. fracture or dislocation), spinal stenosis, curvatures (e.g. scoliosis, kyphosis), pseudarthrosis, and/or failed previous fusion. Additionally, CD Horizon™ Fenestrated Screws may be used for immobilization 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 Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Coment, 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 with Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

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 (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. Please see Section IV for the complete Indications for Use.

CD Horizon™ Fenestrated Screws are specifically designed to connect to appropriate rods and associated connecting components contained within the CD Horizon™ Spinal System. Refer to the CD Horizon™ Spinal System package insert for information regarding those implants. Care should be taken so the correct components are used in the spinal construct. 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. Never use stainless steel and titanium implant components in the same construct.

To achieve best results, do not use CD Horizon™ Fenestrated Screw implants with components from any system other than the CD Horizon™ Spinal System. As with all orthopedic and neurosurgical implants, CD Horizon™ Fenestrated Screw implants should never be reused under any circumstances.

The provided text describes a 510(k) premarket notification for a medical device, the CD Horizon™ Fenestrated Screw Set, and its substantial equivalence to predicate devices. However, the document does not contain information related to an AI/ML-driven device, acceptance criteria for such a device, or any study proving an AI/ML device meets specific performance criteria.

The focus of this 510(k) is an expansion of the indications for use for an existing medical implant (spinal screws) to include trauma treatment with optional bone graft material,
and states that no changes were made to the existing devices, nor were any new components added to the system. Therefore, it explicitly states: "no additional testing was required or performed."

As such, I cannot extract the requested information regarding acceptance criteria and a study proving an AI/ML device meets these criteria from the provided text. The document describes a traditional medical device approval process, not an AI/ML product validation.

Therefore, I must state that the information requested regarding AI/ML device acceptance criteria and performance study details is not present in the provided document.

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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), pseudarthrosis, and/or failed previous fusion.

When used in conjunction with Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Coment, 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™ Fenestrated Screws augmented with Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

Kyphon™ Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions 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 arrsing from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathological fracture may include a symptomatic 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™ Xpede™ 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™ Xpede™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

When used in conjunction with CD Horizon™ Fenestrated Screws, Medtronic HV-R™ Fenestrated Screw 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. Medronic HV-R™ Fenestrated Screw Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.

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 (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 with non-compromised bone quality. 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 allov.

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

Medtronic HV-RTM Fenestrated Screw Cement is a polymethylmethacrylate (PMMA) that contains approximately 30% barium sulfate. It is designed for delivery in a highly viscous state. Medtronic HV-RTM Fenestrated Screw Cement is provided sterile in two components: 20 grams of powder and nine grams of liquid. The powder contains methylmethacrylate-styrene co-polymer, barium sulfate, and benzovl peroxide. The liguid contains methylmethacrylate (monomer), hydroquinone and N. N dimethyl-p-toluidine.

This FDA 510(k) summary does not contain any information regarding clinical performance studies, AI algorithms, or human-in-the-loop performance.

The document is a premarket notification for medical devices (bone cement and fenestrated screws), not an AI/ML-driven diagnostic device. The application focuses on demonstrating substantial equivalence to previously cleared predicate devices based on technological characteristics and existing performance data for those predicates.

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies, as these types of studies were not conducted or reported in this submission for these specific medical devices.

The document explicitly states:

"Medtronic believes that testing is not warranted for the subject devices as they do not present a new worst case when compared to the predicate devices. All existing predicate data previously provided in the predicate 510(k)s are still applicable."

This indicates that the submission relies on the performance data of the predicate devices rather than new performance studies for the subject devices themselves.

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When used without cement, the 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 (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.

When used in conjunction with Medtronic HV-R™ Fenestrated Screw Bone Cement or Kyphon™ XPEDE™ Bone Cement, the CD HORIZON™ 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. CD HORIZON™ Fenestrated Screws augmented with either Medtronic HV-R™ Fenestrated Screw Bone Cement or Kyphon™ XPEDE™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

KYPHON™ Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions 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 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™ Xpede™ 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. CD HORIZON™ Fenestrated Screws augmented with KYPHON™ Xpede™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

Kyphon Xpede™ Bone Cement is self-curing PMMA based (high viscosity, radiopaque) bone cement. Kyphon Xpede™ Bone Cement is provided sterile in two components: 20 grams of powder and nine grams of liquid. The powder contains methylmethacrylate-styrene co-polymer, barium sulfate as a radiopacifier, and di-benzoyl peroxide as an initiator. This liquid contains methylmethacrylate monomer, N, N dimethyl-p-toluidine as a promoter and hydroquinone as a stabilizer. The powder and liquid components are mixed, in the provided liquid-to-powder proportions, into a homogenous paste, to initiate the polymerization reaction of monomer into polymer.

Medtronic HV-RTM Fenestrated Screw Cement is self-curing PMMA based (high viscosity, radiopaque) bone cement. Medtronic HV-RTM Fenestrated Screw Cement is provided sterile in two components: 20 grams of powder and nine grams of liquid. The powder contains methylmethacrylate-styrene co-polymer. barium sulfate as a radiopacifier, and di-benzoyl peroxide as an initiator. This liquid contains methylmethacrylate monomer, N, N dimethyl-p-toluidine as a promoter and hydroquinone as a stabilizer. The powder and liquid components are mixed, in the provided liquid-to-powder proportions, into a homogenous paste, to initiate the polymerization reaction of monomer into polymer.

The CD HORIZON™ Fenestrated Screw Set consists of a variety of cannulated multi-axial screws (MAS) with fenestrations offered in diameters ranging from 4.5mm to 10.5mm, with lengths ranging from 30-100mm based on CD HORIZON™ LEGACY™ and CD HORIZON™ SOLERA™ implants contained in the CD HORIZON™ Spinal System. The CD HORIZON™ Fenestrated Screws are specifically designed to connect to 4.75mm, 5.5mm, and 6.0mm diameter rods and associated connecting components contained within the CD HORIZON™ Spinal System. The screws contain six fenestrations near the distal tip of the screw which provides a controlled means to deliver a small amount of polymethylmethacrylate (PMMA) bone cement into a targeted vertebral body. These implants may also serve as traditional pedicle screws when used without bone cement. These screws are provided non-sterile.

The provided text describes specific medical devices (KYPHON™ Xpede™ Bone Cement, CD HORIZON™ Fenestrated Screw Set) and their regulatory clearance (K171938). The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than describing a study with acceptance criteria to prove device performance in a clinical setting in the way an AI/ML device would be evaluated for diagnostic accuracy.

Therefore, the requested information (acceptance criteria, study details for proving device meets criteria, sample sizes, expert involvement, MRMC study, standalone performance, ground truth types and establishment methods) is not applicable to this document.

This document refers to biocompatibility and mechanical testing for physical devices (bone cement and screws), which are evaluated against industry standards and by comparison to predicate devices, not through performance metrics like sensitivity, specificity, or AUC as one would expect for an AI/ML device.

Here's how the requested points relate to the provided text:

1. A table of acceptance criteria and the reported device performance: This document doesn't present acceptance criteria and device performance in the context of diagnostic accuracy or clinical outcomes for an AI/ML device. Instead, it describes:

   • Biocompatibility: The materials of the CD HORIZON™ Fenestrated Screws (titanium alloy, titanium, cobalt-chromium-molybdenum alloy) have a long clinical history of safe and effective use, so no additional biocompatibility testing was required. The Xpede™ Bone Cement is identical to the predicate and uses equivalent implant materials, sterilization methods, and bacterial endotoxin testing (20 EU/ml pyrogen limit).
   • Mechanical Testing:
     • Axial Pull Out Testing (ASTM F543-07): CD HORIZON™ Fenestrated Screws augmented with the subject Kyphon Xepede™ Bone Cement were compared to those augmented with Medtronic HV-R™ Fenestrated Screw Cement. Result: Pull-out strength of the screws was equivalent.
     • Flow Rate Analysis: Compared Kyphon Xpede™ Bone Cement to Medtronic HV-R™ Fenestrated Screw Cement regarding injection and flow characteristics using fluoroscopic imaging. Result: Flow rates of the subject and predicate cements were substantially equivalent.

2. Sample sizes used for the test set and the data provenance: Not applicable. The testing described (biocompatibility, mechanical testing) refers to material and mechanical properties, not a clinical "test set" for diagnostic performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no diagnostic accuracy study requiring expert adjudication is described.

4. Adjudication method: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.

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: Not applicable. The "ground truth" here relates to established material properties and mechanical performance standards, not clinical diagnoses.

8. The sample size for the training set: Not applicable, as this is not an AI/ML device.

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

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When used without cement, the 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 (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, or lordosis), pseudarthrosis, and/or failed previous fusion.

When used in conjunction with KYPHON HV-R™ Fenestrated Screw Bone Cement, the CD HORIZON™ 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. CD HORIZON™ Fenestrated Screws augmented with KYPHON HV-R™ Fenestrated Screw Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The CD HORIZON™ Fenestrated Screw Set consists of a variety of cannulated multi-axial screws (MAS) with fenestrations offered in diameters ranging from 4.5mm to 10.5mm, with lengths ranging from 30-100mm based on CD HORIZON™ LEGACY™ and CD HORIZON™ SOLERA™ implants contained in the CD HORIZON™ Spinal System. The CD HORIZON™ Fenestrated Screws are specifically designed to connect to 4.75mm, 5.5mm, and 6.0mm diameter rods and associated connecting components contained within the CD HORIZON™ Spinal System. The screws contain six fenestrations near the distal tip of the screw which provides a controlled means to deliver a small amount of polymethylmethacrylate (PMMA) bone cement into a targeted vertebral body. These implants may also serve as traditional pedicle screws when used without bone cement. These screws are provided non-sterile.

This document is a 510(k) premarket notification for a medical device called the "CD HORIZON™ Fenestrated Screw Set." It describes the device's indications for use, its comparison to predicate devices, and provides a summary of the reasons for its substantial equivalence determination.

Based on the provided text, there is no information about a study that proves the device meets specific acceptance criteria in the way one would describe a performance study for an AI/algorithm-driven device. The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is a regulatory pathway for medical devices in the United States.

Therefore, many of the requested points regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be answered from the provided text because the 510(k) submission for this mechanical medical device (spinal screws) does not typically involve such studies as would be performed for a diagnostic or AI-powered device.

Here's a breakdown of what can be inferred from the document regarding "acceptance criteria" in the context of this device, even though it's not a direct answer to the prompt's implied AI/algorithm context:

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

The "acceptance criteria" for this mechanical device are typically based on demonstrating equivalent mechanical and material properties to a legally marketed predicate device. The document does not provide a table with specific numerical acceptance criteria for performance metrics (like sensitivity, specificity, or accuracy) because it's not an AI or diagnostic device.

Instead, the "performance data" mentioned is:

• "Non-Clinical mechanical testing of the subject fenestrated screws demonstrating substantial equivalence to the traditional pedicle screws found in the predicate CD HORIZON® Spinal System was previously provided in K152604."

This implies the "acceptance criteria" were related to achieving mechanical performance (e.g., strength, fatigue life, torsional stability) that was demonstrably comparable to the predicate devices. The reported device performance is that these tests showed "substantial equivalence."

2. Sample 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

These questions are not applicable to the type of device and regulatory submission presented. This is a spinal implant, not an AI or diagnostic tool. The "testing" involved non-clinical mechanical testing, not a clinical study with human readers or ground truth established by experts in a diagnostic sense.

8. The sample size for the training set
9. How the ground truth for the training set was established

These questions are not applicable as there is no "training set" or "ground truth" in the context of an AI/algorithm for this mechanical device.

Summary based on the document's content:

• Device Type: CD HORIZON™ Fenestrated Screw Set, a mechanical spinal implant.
• Regulatory Pathway: 510(k) Premarket Notification based on "substantial equivalence."
• Nature of "Acceptance Criteria" / Performance Demonstrations: Focused on non-clinical mechanical testing to demonstrate substantial equivalence to predicate devices in terms of mechanical properties and material characteristics.
• Study Proving Device Meets Criteria: While the document states "Non-Clinical mechanical testing... was previously provided in K152604," it does not detail the specifics of that testing or its sample size within this document. The "proof" is the demonstration of substantial equivalence through this mechanical testing.
• Applicability of AI/Algorithm-Specific Questions: Not applicable to this type of medical device submission.

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When used in conjunction with the CD HORIZON® Fenestrated Screws, KYPHON HV-R® Fenestrated Screw 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. KYPHON HV-R® Fenestrated Screw Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.

When used in conjunction with KYPHON® HV-R Fenestrated Screw Cement, the CD HORIZON® 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. CD HORIZON® Fenestrated Screws augmented with KYPHON HV-R® Fenestrated Screw Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

1. KYPHON HV-R® Fenestrated Screw Cement is self-curing PMMA based (high viscosity, radiopaque) bone cement. KYPHON HV-R® Fenestrated Screw Cement will be provided sterile in two components: 20 grams of powder and nine grams of liquid. The powder contains methylmethacrylate-styrene co-polymer, barium sulfate as a radiopacifier, and di-benzoyl peroxide as an initiator. This liquid contains methylmethacrylate monomer, N, N dimethyl-p-toluidine as a promoter and hydroquinone as a stabilizer. The powder and liquid components are mixed, in the provided liquid-to-powder proportions, into a homogenous paste, to initiate the polymerization reaction of monomer into polymer.

2. The CD HORIZON® Fenestrated Screw Set consists of a variety of cannulated multi-axial screws (MAS) with fenestrations offered in diameters ranging from 4.5mm to 10.5mm, with lengths ranging from 30-100mm based on CD HORIZON® LEGACY™ and CD HORIZON® SOLERA™ implants contained in the CD HORIZON® Spinal System. The CD HORIZON® Fenestrated Screws are specifically designed to connect to 4.75mm, 5.5mm, and 6.0mm diameter rods and associated connecting components contained within the CD HORIZON® Spinal System. The screws contain six fenestrations near the distal tip of the screw which provides a controlled means to deliver a small amount of polymethylmethacrylate (PMMA) bone cement into a targeted vertebral body. These screws are provided non-sterile.

The provided document is a 510(k) premarket notification for the KYPHON HV-R® Fenestrated Screw Cement and CD HORIZON® Fenestrated Screw Set. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a study with specific metrics like sensitivity, specificity, or reader performance.

Therefore, many of the requested details about acceptance criteria, study design for performance measurement, ground truth, and expert involvement are not available in this type of regulatory document.

However, I can extract information regarding performance data and the overall conclusion.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Not Applicable. The document explicitly states "Clinical data and Non-Clinical testing were provided in support of substantial equivalence of the subject device." This indicates that the performance data was used to demonstrate that the new device is as safe and effective as the predicate devices, rather than meeting predefined acceptance criteria for diagnostic performance metrics (like sensitivity/specificity) for a specific task (e.g., detecting a condition). The performance data cited would likely be mechanical properties, biocompatibility, or other engineering parameters relevant to medical devices, not diagnostic accuracy.

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

• Not Available. The document does not specify test set sample sizes or data provenance. The "clinical data" mentioned would typically be focused on patient outcomes and safety profiles compared to predicate devices, not on a "test set" for an AI algorithm's performance.

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 medical implant and bone cement system, not an AI diagnostic tool. Therefore, there is no "ground truth for a test set" in the context of expert review for diagnostic accuracy as there would be for an AI algorithm. Ground truth, if applicable in a clinical study for an implant, would relate to patient outcomes, imaging results post-procedure, or pathology reports after explantation, which are typically assessed by treating physicians or pathologists, not necessarily a panel of experts specifically for "ground truth establishment" in the way it's described for AI.

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

• Not Applicable. As explained above, this is not an AI diagnostic device and therefore, adjudication methods for a test set based on expert review are not relevant to this document.

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 a medical device (cement and screws), not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described in this document.

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

• Not Applicable. This is not an algorithm or AI system.

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

• Outcomes Data/Substantial Equivalence to Predicates: While not framed as "ground truth" for an AI, the "Performance Data" and "Clinical Data and Non-Clinical testing" would have relied on various forms of data to demonstrate safety and effectiveness. For implants, this typically includes:
  • Mechanical Testing Data: Demonstrating the physical properties (strength, fatigue, etc.) of the cement and screws.
  • Biocompatibility Testing: Ensuring the materials are safe for implantation.
  • Clinical Outcomes Data: Potentially from studies comparing the device to existing treatments, or from safety monitoring, though detailed clinical trial results are not provided in a 510(k) summary. The primary "ground truth" here is often the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not Applicable. This is a medical device, not an AI model requiring a training set.

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

• Not Applicable. This is a medical device, not an AI model.

Summary of Relevant Information from the Document:

While the document doesn't fit the typical "AI performance study" framework, it does describe its substantial equivalence to predicate devices based on presented data.

Device(s) being reviewed:

• KYPHON HV-R® Fenestrated Screw Cement
• CD HORIZON® Fenestrated Screw Set

Predicate Devices:

• KYPHON® HV-R® Bone Cement (K150460)
• CD HORIZON® Spinal System (K042025 and K113174)

Basis of Substantial Equivalence (implied "performance criteria" for a 510(k) device):
The substantial equivalence is based on demonstrating that the new device has the same intended use, similar technological characteristics, and comparable performance to the legally marketed predicate devices. The document explicitly states:

• KYPHON HV-R® Fenestrated Screw Cement: "identical in composition, method of manufacture and sterilization to the primary predicate Kyphon® H-VR® Bone Cement... The only differences between the subject and predicate cement are the method in which the cement is delivered and that the subject cement is limited to patients with advanced stage tumors..."
• CD HORIZON® Fenestrated Screw Set: "have the same or similar indications, intended use, fundamental scientific technology, and are manufactured from similar materials as the pedicle screws found in the following FDA cleared CD HORIZON® Spinal System applications... The primary difference is the subject screws contain fenestrations which allow PMMA cement to flow in a controlled manner through the screw and into the targeted pedicle."

Conclusion:
"Based on the provided performance data, the subject KYPHON® HV-R Fenestrated Screw Cement is substantially equivalent to the KYPHON® HV-R® Bone Cement (K150460, SE 04/28/15) and the CD HORIZON® Fenestrated Screw Set is substantially equivalent to the CD HORIZON® Spinal System (K042025 (SE 08/25/2004) and K113174 (SE 11/21/2011))."

Performance Data Mentioned:
"Clinical data and Non-Clinical testing were provided in support of substantial equivalence of the subject device." (Details of this data are not provided in this summary.)

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