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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, kyphosis, 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 pedicle screw fixation in pediatric patients, 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.
To achieve additional levels of fixation, CD HorizonTM Spinal System rods may be connected to the VertexTM Reconstruction System with the VertexTM rod connector. Refer to the VertexTM Reconstruction System package insert for a list of the VertexTM indications of use.

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This document describes a spinal system, not an AI/ML powered device. Therefore, the requested information pertaining to AI/ML device performance, such as acceptance criteria for AI models, human expert adjudication, MRMC studies, standalone algorithm performance, and training/test set details are not applicable.

The provided text focuses on the substantial equivalence of the Medtronic CD Horizon™ Spinal System to predicate devices, supported by mechanical testing and rationales.

Here's an analysis of the provided text based on the request's categories, indicating where information is present and where it is not applicable for this type of device:

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

2. Sample sizes used for the test set and the data provenance

• Sample Size: Not explicitly stated in this summary. Mechanical testing usually involves a specific number of samples per test type (e.g., 5-10 samples per group).
• Data Provenance: Not applicable in the context of "data provenance" for patient data, as this is a mechanical device. The testing was conducted by Medtronic to demonstrate substantial equivalence to existing predicate devices.

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

• Not Applicable: This is a mechanical device, not an AI/ML diagnostic or therapeutic device that relies on expert interpretation for ground truth. Ground truth for mechanical performance is established through standardized testing protocols (ASTM standards) and engineering principles.

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

• Not Applicable: Adjudication methods are relevant for subjective interpretations, typically in clinical studies or AI model evaluations. For mechanical testing, the results are quantitative and directly measured against engineering specifications.

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 mechanical device. MRMC studies are specific to evaluating diagnostic accuracy of imaging systems, often in the context of human reader performance with or without AI assistance.

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

• Not Applicable: This is a mechanical device. "Standalone" performance refers to AI algorithm performance without human intervention.

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

• Engineering Specifications and Standardized Test Methods: The "ground truth" for this device's performance is established by the specified mechanical properties (e.g., strength, durability, fatigue resistance) defined by relevant ASTM (American Society for Testing and Materials) standards (F1717, F1798, F2503). Compliance with these standards indicates the device performs as intended for its mechanical application.

8. The sample size for the training set

• Not Applicable: "Training set" refers to data used to train AI/ML models. This is a mechanical device, not an AI model.

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

• Not Applicable: As no AI training set exists, no ground truth establishment for it is relevant.

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Medtronic Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the Mazor X Stealth™ Edition, which is indicated for medical conditions in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

Medtronic Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the Mazor X Stealth™ Edition Arm Guide. Medtronic surgical drills shall only be used through the Mazor X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPCT™ Powerease™ System or AO* style quick connect drilling motors. An instrument may incorporate a measuring function which has uses as described on the label and the instrument.

The CD HORIZON™ Spinal System surgical instruments are non-sterile or sterile, single, or re-usable instruments that may be used during the preparation and placement of various Medtronic spinal implants during spinal surgery. The subject instruments are made of a variety of materials commonly used in orthopedic and neurological procedures which meet available national or international standards specifications. Single-use Medtronic Surgical instruments should never be reused under any circumstances.

The CD Horizon™ instruments are intended to be used when preparing and placing Medtronic screws during spinal surgery. To enable optical navigation compatibility of the surgical instruments with the MAZOR X Stealth™ Edition System, the proximal ends of the instrument shafts have been designed with a bushing that provides a connection site where the NavLock™ trackers (K171267, S.E. 07/03/2017; K182104, 11/02/2018; K201327, S.E. 06/18/2020) can be attached. To enable trajectory guidance compatibility of the surgical instruments with the Mazor X Stealth™ Edition, the instrument dimensions have been designed to work with the Mazor X arm guides. The subject RG FAS Drivers may also be operated under power when attached to the POWEREASE™ Driver (K111520, S.E. 10/26/2011).

The subject instruments are reusable and will be provided non-sterile.

The provided text is a 510(k) summary for a medical device (Medtronic Surgical Instruments for use with Mazor X Stealth™ Edition) and does not describe acceptance criteria for an AI/ML device or a study proving that an AI/ML device meets such criteria.

The document discusses:

• Device Name: CD Horizon™ Spinal System / Medtronic Surgical Instruments for use with Mazor X Stealth™ Edition
• Regulatory Information: 510(k) clearance, product codes, classification, predicate devices.
• Intended Use: Surgical instruments for preparing and placing Medtronic implants during spinal surgery, assisting in precisely locating anatomical structures, compatible with MAZOR X Stealth™ Edition.
• Technological Characteristics: Comparison with predicate devices, stating similar intended use, indications, material, fundamental technology, and sterilization method.
• Performance Data: This section briefly mentions verification/validation activities, but these are for the surgical instruments themselves and their compatibility with the navigation system, not for an AI/ML algorithm's performance. The activities listed are:
  • Design Validation and Anatomical Simulated Use
  • Navigation Simulated Use
  • Navigation Accuracy Analysis

Given this, I cannot provide the requested information about acceptance criteria and the study that proves an AI/ML device meets them because the provided text does not describe an AI/ML device or its evaluation. It focuses on traditional surgical instruments.

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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 pedicle screw fixation in pediatric patients, 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 pediatic 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 (1.2 - 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.

Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medronic 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.

The IPC™ System is indicated for the incision/outting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

The IPC™ Powerease™ System is indicated for drilling, tapping, 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.

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 3.5 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 tailormade for the individual case. Certain components within the CD Horizon™ Spinal System are specifically excluded for use in pediatric patients. These include PEEK rods, Shape Memory Alloy Staples, Spire™ plates, and Dynalok™ bolts. Screws used in pediatric cases are only cleared for use via a posterior approach. Components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium alloy, and medical grade cobalt-chromiummolybdenum 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, and Crosslink™ bar and connectors; Liberty™ rods and screws; Dynalok™ Plus and Dynalok Classic™ bolts along with rod/bolt connectors; and Medtronic multiaxial rods and screws. Note: 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 CD Horizon™ Eclipse™ rods 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 alloy, medical grade cobalt-chromium- molybdenum alloy, or medical grade PEEK Optima-LT1. Certain CD Horizon™ Spinal System components may be coated with hydroxyapatite. No warranties, expressed or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. Never use stainless steel and titanium implant components in the same construct. Medical grade titanium, titanium alloy, and/or medical grade cobaltchromium-molybdenum allov may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromium- molybdenum alloy with stainless steel in the same construct. The CD Horizon™ Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt-chromiummolybdenum alloy. Do not use with stainless steel. These staples are not to be used in pediatric patients. 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. As with all orthopedic and neurosurgical implants, none of the CD Horizon™ Spinal System components should ever be reused under any circumstances.

The Medtronic Reusable Instruments compatible with Medtronic's IPC™ Powerease™ System are spine preparation instruments, manufactured from materials commonly used in orthopedic procedures which meet available national or international standards specifications. Instruments may be connected to the Powerease™ Driver or used manually. These instruments are also compatible with various Medtronic spinal implant systems.

Medtronic Navigated Reusable Instruments are spine preparation instruments made of high-grade stainless steel. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. Placing Medtronic single-use sterile spheres on each of the NavLock™ Tracker passive stems allows a Medtronic computer-assisted surgery system such as the StealthStation™ Image Guidance System to track the instruments in the surgical field. Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems. These instruments are also compatible with Medtronic's IPCTM Powerease™ System when connected to the Powerease™ Driver.

This is a 510(k) summary for the Medtronic CD Horizon™ Spinal System, which includes spinal implants and instruments. This document does not contain information about software with acceptance criteria or a study proving that a device meets acceptance criteria. The performance data section describes mechanical tests performed on the physical spinal system components.

Therefore, I cannot provide the requested information.

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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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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, kyphosis, 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, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted. When used for posterior non-cervical pedicle screw fixation in pediatric patients, 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. Devices are 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, 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 Vertex™ indications.

The IPCTM 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 instruments.

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 IPCTM Powerease™ System. Do not implant the instruments.

Medtronic Navigated Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments can be compatible with various Medtronic spinal implant systems. Navigated surgical 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. An instrument may incorporate a measuring function, which has uses as described on the label and the instruments. Do not implant the instruments.

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 3.5 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, Shape Memory Alloy Staples, Spire™ plates, and Dynalok™ bolts. Screws used in pediatric cases are only cleared for use via a posterior approach. 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, and Crosslink™ bar and connectors; Liberty™ rods and screws; Dynalok™ Plus and Dynalok Classic™ bolts along with rod/bolt connectors; and Medtronic multi-axial rods and screws. Note: 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 CD Horizon™ Eclipse™ rods 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 alloy, medical grade cobalt-chromium-molybdenum alloy, or medical grade PEEK Optima-LT1. Certain CD Horizon™ Spinal System components may be coated with hydroxyapatite. No warranties, expressed or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. 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. The CD Horizon™ Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol – NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt-chromium-molybdenum alloy. Do not use with stainless steel. These staples are not to be used in pediatric patients. 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. As with all orthopedic and neurosurgical implants, none of the CD Horizon™ Spinal System components should ever be reused under any circumstances.

The Medtronic Reusable Instruments compatible with Medtronic's IPCTM Powerease™ System are spine preparation instruments, manufactured from materials commonly used in orthopedic procedures which meet available national or international standards specifications. Instruments may be connected to the Powerease™ Driver or used manually. These instruments are also compatible with various Medtronic spinal implant systems.

Medtronic Navigated Reusable Instruments are spine preparation instruments made of high-grade stainless steel. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. Placing Medtronic singleuse sterile spheres on each of the NavLock™ Tracker passive stems allows a Medtronic computer-assisted surgery system such as the StealthStation™ Image Guidance System to track the instruments in the surgical field. Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems. These instruments are also compatible with Medtronic's IPCTM Powerease™ System when connected to the Powerease™ Driver.

Medtronic Navigated Reusable Instruments are spine preparation instruments made of high-grade stainless steel. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. Placing Medtronic singleuse sterile spheres on each of the NavLock™ Tracker passive stems allows a Medtronic computer-assisted surgery system such as the StealthStation™ Image Guidance System to track the instruments in the surgical field. Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems. If the device passes the visual and functional inspection as described in the IFU, the instrument can be expected to perform as intended for the perioperative period.

The provided text is a 510(k) summary for the Medtronic CD Horizon™ Spinal System. It describes the device, its indications for use, and a comparison to predicate devices to establish substantial equivalence. However, it does not describe an AI/ML-based device or a study with acceptance criteria and performance metrics typically associated with such devices (e.g., sensitivity, specificity, AUC).

Instead, the "Performance Data" section (VII on page 13) focuses on mechanical testing of the spinal implant system and associated instruments to demonstrate substantial equivalence to predicate devices. The acceptance criteria mentioned are related to these mechanical tests, not to AI/ML performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device because the document describes a mechanical spinal implant system.

Here's what can be extracted regarding the device performance and testing, which is not AI/ML-related:

1. Table of acceptance criteria and reported device performance:

Missing Information (as the device is not AI/ML):

2. Sample size for the test set and data provenance: Not applicable for mechanical testing.
3. Number of experts used to establish ground truth & qualifications: Not applicable for mechanical testing.
4. Adjudication method: Not applicable for mechanical testing.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable for mechanical testing.
6. Standalone (algorithm only) performance: Not applicable for mechanical testing.
7. Type of ground truth used: Not applicable for mechanical testing (ground truth is physical measurement against standards).
8. Sample size for the training set: Not applicable (no AI/ML training).
9. How ground truth for the training set was established: Not applicable (no AI/ML training).

In summary, the provided document is a regulatory submission for a traditional medical device (spinal implant system) and its associated instruments, not an AI/ML device. Therefore, the requested AI/ML-specific performance metrics and study details are not present.

Ask a specific question about this device

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), 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, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediativ indications noted.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, 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™ System is intended to treat pediatic 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 (L2 – S1) in skeletally mature patients. Devices are 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, spondylolisthesis, trauma, and/or tumor.

To achieve additional levels of fixation, CD Horizon™M 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 Vertex™ indications

The PASS LP™ Spinal System is a pedicle screw fixation system intended for 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 (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.

Except for rod plates and caps for sacral plates, when non-cervical pedicle screw fixation in pediatric patients, the PASS LP™ Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. The PASS LP™ Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD Horizon Spinal System and PASS LP™ Spinal System (including UNiD™ Patient Specific Rods) consist of a variety of shapes and size of rods, hooks, screws, crosslink, plates, staples and connecting components, as well as implants 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.

The purposes of this submission are to:

• Add the UNiD™ Patient Specific Rods (new diameter 4.75mm) to the previously cleared CD Horizon™ Spinal System (K113174, cleared 11/21/2011) and PASS LP™ Spinal System (K140738, cleared 11/04/2014)
• Change the propriety Trade Name from "PASS LP™ Patient Specific Rods" to "UNiD™ Patient י Specific Rods"

UNiD™ Patient Specific Rods are manufactured in titanium alloy Ti-6AI-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, or in cobalt chrome alloy Co-Cr28Mo6 conforming to ISO 5832-12 specifications and ASTM F1537 specifications.

UNiD™ Patient Specific Rods are differentiated in two subgroups: UNiD™ Patient Specific Standard Rods (UNiD ROD) and UNiD™ Patient Specific Percutaneous Rods (UNiD™ Patient Specific Rods have been designed and manufactured for one specific patient. UNiD™ Patient Specific Rods must be used during surgery for this patient only and must not be reused (single use only). The UNiD™ Patient Specific Rods 4.75 diameter rods are not compatible with the PASS LP system. For a complete guide to the system, it is important to refer to the surgical technique.

Please find the information regarding the acceptance criteria and study for the device below.

The provided text is a 510(k) Summary for the CD Horizon™ Spinal System and PASS LP™ Spinal System, which are pedicle screw fixation systems. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, particularly for UNiD™ Patient Specific Rods. The primary purpose of this submission is to add UNiD™ Patient Specific Rods (new diameter 4.75mm) and to change the proprietary Trade Name from "PASS LP™ Patient Specific Rods" to "UNiD™ Patient Specific Rods."

The testing conducted is for mechanical equivalence, not clinical performance or diagnostic accuracy. Therefore, concepts like sensitivity, specificity, accuracy, and reader studies (MRMC, standalone algorithm performance) are not applicable to this type of device submission. The acceptance criteria and "performance" here refer to mechanical strength and durability.

Here's a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (implantable spinal system), the acceptance criteria are based on mechanical properties as per a recognized standard. The document does not provide specific numerical acceptance criteria (e.g., minimum load values) but rather states that testing was conducted in accordance with a standard and demonstrated mechanical equivalence.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. Mechanical testing typically involves a sufficient number of samples (e.g., typically n=5 or n=6 per test condition for medical device mechanical testing) to provide statistically significant results according to the chosen standard (ASTM F1717-18).
• Data Provenance: The testing was conducted by Medicrea (Medtronic). It's scientific/engineering test data, not patient data, so 'country of origin' of data or 'retrospective/prospective' doesn't apply in the common clinical sense. The manufacturer is based in France.

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

• Number of Experts: Not applicable. Ground truth for mechanical testing is established by recognized engineering standards (ASTM F1717-18) and measured physical properties, not expert consensus.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is mechanical testing data, not human-interpreted data. Results are quantified using laboratory equipment.

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

• MRMC Study Done: No. This type of study is for evaluating the impact of a diagnostic or assistive AI device on human reader performance. This submission is for an implantable medical device, not a diagnostic or AI-driven system.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Standalone Study Done: No. This also refers to AI algorithm performance, which is not relevant to this mechanical device submission.

7. Type of Ground Truth Used

• Type of Ground Truth: Engineering standards and measurements of mechanical properties. The "ground truth" is adherence to established, validated mechanical test methods (ASTM F1717-18) that ensure the device is "substantially equivalent" in performance to predicate devices.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This concept applies to machine learning models. The manufacturing process of UNiD™ Patient Specific Rods involves patient-specific design (i.e., custom bending for one specific patient based on their anatomy), but this is not an AI "training set."

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

• How Ground Truth for Training Set Was Established: Not applicable. No "training set" in the machine learning sense is used here. For the patient-specific rods, the "ground truth" for each rod's design is the specific patient's anatomical requirements, which are determined via medical imaging and planning, not a training set.

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The PASS LP™ Spinal System is a pedicle screw fixation system intended for 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 (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.

Except for rod plates and caps for sacral plates, when used for posterior non-cervical pediative patients, the PASS LP™ Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. The PASS LPTM Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD Horizon™ Spinal System 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), 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, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediativ indications noted.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, 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™ 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 (L2 – S1) in skeletally mature patients. Devices are 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, 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 Vertex™ indications.

The PASS LP" Spinal System is composed of screws, hooks, rods, plates, cross links, connection and locking devices. The range of different sizes and shapes of the implants allows the surgeon to adapt to the pathology and morphology of each of his patients.

The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, with the exception of the rods intended for in situ bending which are manufactured in non-alloyed titanium (CP titanium) conforming to ISO 5832-2 specifications and ASTM F67 specifications.

CoCr rods and implants are manufactured in Cobalt-Chromium Molybdenum alloy Co-Cr28Mo6 conforming to ISO 5832-12 specifications and ASTM F1537 specifications. Under no circumstances are the implants reusable.

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.

The purpose of this submission following:

• introduce new PASS LP™ Spinal System 'Universal Crosslinks' components
• expand use of the previously cleared CD Horizon™ Spinal System rods with the subject PASS LP™ Universal Crosslinks
• expand use of previously cleared CD Horizon™ Spinal System hooks with previously cleared PASS LP™ Spinal System components

The provided text is an FDA 510(k) summary for a spinal system device. It does not describe or contain information about a study that proves a device meets acceptance criteria related to AI/ML device performance, which is what the prompt is asking for when it refers to "acceptance criteria," "sample size for test set," "data provenance," "experts," "adjudication," "MRMC study," "standalone performance," "ground truth," and "training set."

This document describes a spinal fixation system, its components, indications for use, and a comparison to predicate devices, primarily focusing on mechanical testing to demonstrate substantial equivalence for a physical medical device. The "acceptance criteria" mentioned in this document refer to the mechanical performance of the spinal system components (e.g., dynamic compression bending) as per ASTM F1717, to ensure the device is safe and effective when compared to existing devices.

Therefore, it's impossible to extract the requested information (related to AI/ML device performance studies) from the provided text.

The closest relevant information from the text to the prompt's structure is:

1. A table of acceptance criteria and the reported device performance:
* Acceptance Criteria (Mechanical): Mechanical equivalence of the subject PASS LP™ universal crosslinks when used with the CD Horizon™ 5.5/6.0 Spinal System, as demonstrated by testing in accordance with ASTM F1717.
* Reported Device Performance: "The performance testing demonstrates mechanical equivalence of the subject PASS LP™ universal crosslinks when used with the CD Horizon™ 5.5/6.0 Spinal System." and "The mechanical testing (e.g., dynamic compression bending) and an engineering analysis were performed to demonstrate substantial equivalence."
* Note: No specific numerical values for performance are provided in this summary.

The following information cannot be found in the provided text as it pertains to AI/ML device validation, not mechanical device testing:

• Sample sized used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
• Adjudication method for the test set.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc).
• The sample size for the training set.
• How the ground truth for the training set was established.

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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, 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, CD Horizon™ 3.5mm rods and associated components may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediativ indications noted.

When used for posterior non-cervical pedicle screw fixation in pediatric patients. 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, and congenital scoliosis, Additionally, the CD Horizon™ 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 (L2 – S1) in skeletally mature patients. Devices are 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, 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 Vertex™ indications.

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 3.5 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, Shape Memory Alloy Staples, Spire™ plates, and Dynalok™ bolts. Screws used in pediatric cases are only cleared for use via a posterior approach. 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 and Crosslink™ bar and connectors; Liberty™ rods and screws; Dynalok™ Plus and Dynalok Classic™ bolts along with rod/bolt connectors; and Medtronic multi-axial rods and screws. Note: 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 CD Horizon™ Eclipse™ rods 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. No warranties, expressed or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.

Never use stainless steel and titanium implant components in the same construct.

Medical grade titanium, titanium alloy, and/or medical grade cobaltchromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromiummolybdenum alloy with stainless steel in the same construct. The CD Horizon™ Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol – NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobaltchromium-molybdenum alloy. Do not use with stainless steel. These staples are not to be used in pediatric patients.

PEEK Optima-LT1 implants may be used with titanium or cobaltchromium-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. As with all orthopaedic and neurosurgical implants, none of the CD Horizon™ Spinal System components should ever be reused under any circumstances.

The changes/ modifications to the CD Horizon™ Spinal System presented in this submission are:

• . Introduction of Revision Connectors which have modifications to the primary predicate device geometry offering additional options for rod size and screw trajectory connections.
• Cross-compatibility is presented for use of the insertion devices presented in K210637 (S.E. 04/30/2021) for use with implants presented in K201407 (S.E. 09/10/2020).

This document is a 510(k) premarket notification for the Medtronic CD Horizon™ Spinal System, specifically addressing the introduction of "Revision Connectors" and cross-compatibility of insertion devices. The document asserts substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify sample sizes for the mechanical testing (ASTM F1798 and ASTM F1717). These standards typically outline the number of samples required for each test type (e.g., static bending, fatigue).
• Data Provenance: The mechanical testing and risk analysis were performed by Medtronic ("Medtronic performed confirmatory mechanical testing..."). The provenance of the data is therefore internal to the company, conducted as part of their regulatory submission for the U.S. FDA. The data is based on prospective testing of the new and predicate device components.

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

• This information is not applicable to this type of submission. The ground truth for mechanical testing of spinal implants is established by engineering standards (ASTM F1798, ASTM F1717) and material specifications (ASTM F136), not by human expert consensus or clinical evaluations in the context of this 510(k). This is a purely engineering and materials-based assessment for hardware.

4. Adjudication Method for the Test Set

• This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in clinical or image-based expert reviews. For mechanical testing, the "adjudication" is inherent in successfully meeting the specified requirements of the ASTM standards and demonstrating equivalence in the risk analysis.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This document pertains to the mechanical and material aspects of spinal implant components, not to diagnostic algorithms or AI-assisted clinical interpretations that would involve human readers.

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

• No, a standalone algorithm performance study was not done. This submission is for mechanical spinal implants, not for an algorithm or AI device.

7. The Type of Ground Truth Used

• The "ground truth" for this device's acceptance is based on:
  • Engineering Standards: Defined mechanical properties and performance criteria as outlined in ASTM F1798 and ASTM F1717.
  • Material Specifications: Compliance with ASTM F136 for material composition and properties.
  • Predicate Device Performance: The established, legally marketed safety and effectiveness profile of the predicate devices. The new device must perform equivalently or better than the predicates.

8. The Sample Size for the Training Set

• This information is not applicable. This is not an AI/machine learning device that would require a "training set." The development of these mechanical components relies on engineering design principles, material science, and manufacturing processes, not data-driven model training.

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

• This information is not applicable as there is no "training set" for this type of medical device.

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Medtronic Surgical Instruments are intended to be used during the preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the MAZOR X Stealth™ Edition, 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 Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the MAZOR X Arm Guide. Medtronic surgical drills shall only be used through the MAZOR X arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ POWEREASE™ System. An instrument may incorporate a measuring function which has uses as described on the label and the instrument.

The CD HORIZON™ Spinal System surgical instruments are non-sterile, single or re-usable instruments that may be used during the preparation and placement of various Medtronic spinal implants during spinal surgery. The subject instruments are made of a variety of materials commonly used in orthopedic and neurological procedures which meet available national or international standards specifications. Single-use Medtronic Surgical instruments should never be reused under any circumstances.

The CD Horizon™ instruments are intended to be used when preparing and placing Medtronic screws during spinal surgery. To enable optical navigation compatibility of the surgical instruments with the MAZOR X Stealth™ Edition System, the proximal ends of the instrument shafts have been designed with a bushing that provides a connect ion site where the NavLock™ trackers (K171267, S.E. 07/03/2017; K182104, 11/02/2018; K201327, S.E. 06/18/2020) can be attached. To enable trajectory guidance compatibility of the surgical instruments with the MAZOR X Stealth™ Edition System, the instrument dimensions have been designed to work with the MAZOR X arm guides. The subject taps and drivers may also be operated under power when attached to the POWEREASE™ Driver (K111520, S.E. 10/26/2011). The instruments will be provided non-sterile and are reusable.

The provided document is a 510(k) summary for the Medtronic CD Horizon Spinal System. It does not include information about a study proving the device meets specific acceptance criteria in the way a clinical study would for an AI/algorithm-driven medical device.

This document describes a new version of surgical instruments, designed to be compatible with existing navigation and robotic systems (MAZOR X Stealth™ Edition, IPC™ POWEREASE™ System, and NavLock™ trackers). The "performance data" section refers to engineering verification testing rather than a clinical study evaluating diagnostic or therapeutic accuracy against human performance. The device itself is a set of surgical instruments, not an AI algorithm.

Therefore, I cannot extract the requested information (acceptance criteria, sample size, expert ground truth, MRMC study, standalone performance, etc.) from this document because it is not relevant to the type of device and study requested in the prompt.

The "Performance Data" table provided in the document refers to engineering and functional testing of the instruments, such as:

• Navigation Accuracy Analysis: Confirmed navigated instrument accuracy.
• Anatomical Simulated Use: Confirmed instrument functionality under expected use conditions.
• Navigation Simulated Use: Confirmed navigation system functionality under expected use conditions.
• CAD Model Evaluation: Verified that the CAD models are accurately reflected in the application software.
• Navigation Software Module Instrument Functional Testing: Verified that the instrument attributes are correctly implemented in the navigation software module.

These are design verification and validation activities for a physical instrument, not a study evaluating the performance of an AI algorithm or a diagnostic tool against human ground truth.

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The LigaPASS is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bory fusion and aid in the repart of bone fractures. The include the following applications:

-Spinal trauma, used in sublaminar, or facet wiring techniques

-Spinal reconstruction surgery, incorporated into construction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and kyphosis; -Spinal degenerative surgery, as an adjunct to spinal fusions;

The LigaPASS system may also be used in conjunction with other medical implants made of titanium or cobalt chrome alloy whenever "wiring" may help secure the attachment of other implants.

The CD Horizon™ Spinal System with or without Sextant™ intended for posterior, non-cervical fixation as an adjunct o fusion for the following indications: degenerative disc disease (DDD - defined as back pain with degeneration of the disc confirmed by history and radios). spondylolisthesis, trauma (i.e. fracture or dislocation), soinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis). tumor, pseudarthrosis, and or failed previous fusion. Except for hooks, when used as an anterclateral 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™ 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 pediativ indications noted below.

When used for posterior non-cervical pediation in pediatric patients, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to freat progressive spinal deformities (i.e. scolosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis. Additionally, the CD Horizon™ Spinal System is intended to tred pediativ patients diagnosed with the following conditions: spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and or failed previous fision. These cevices are to be allograft. Pediatic 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 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™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the (TI-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the ing supplemental fixation in the following conditions: DDD (as reviously defined), spondylolisthesis, trauma, and/or tumor.

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

The purpose of this submission is to expand use of the previously cleared LigaPASS® Spinal System with the previously cleared CD Horizon™ 5.5/6.0 Spinal System rods.

LigaPASS® Spinal System: The LigaPASS® MEDICREA® INTERNATIONAL S.A. spinal system is composed of four components: a connector, two set screws and a band. The LigaPASS® system is designed to stabilize a vertebra in the same manner as a hook around the vertebra during development of solid bony fusion. The LigaPASS® system must be implanted via a posterior approach to complete a thoraco-lumbar fixation system as the PASS LP® MEDICREA® INTERNATIONAL S.A. spinal system. The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136, with the exception of the band which is manufactured in polyethylene terephtalate (PET) and titanium T40 conforming to ISO 5832-2 specifications and ASTM F67.

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.

I am sorry, but there is no information about acceptance criteria or a study proving device performance in the provided text. The document is a 510(k) premarket notification clearance letter from the FDA for a spinal system, discussing its substantial equivalence to predicate devices and detailing its indications for use, product description, and a general statement about performance testing. It mentions mechanical testing in accordance with ASTM 1798 but does not provide specific acceptance criteria or study results.

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