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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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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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Medtronic Navigated Reusable Instruments for use with StealthStation™ and IPC™ POWEREASE™ Systems

Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Reusable Instruments are also compatible with the IPC™ POWEREASE™ System.

Medtronic Surgical Instruments for use with MAZOR X Stealth™ Edition

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 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 IPC™ 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 subject CD Horizon™ Spinal System drivers are non-sterile instruments that may be used during placement of various Medtronic screws during spinal surgery. The Medtronic instruments are made from materials commonly used in orthopedic and neurological procedures which meet available national or international standards specifications. The subject CD Horizon™ Spinal System drivers are compatible with POWEREASE, Medtronic NavLock trackers and Medtronic single-use sterile spheres to allow a Medtronic computer-assisted surgery system to track the instruments in the surgical field.

The provided text is a 510(k) Summary for the Medtronic CD Horizon™ Spinal System Instruments. This document is a regulatory submission for a medical device and describes its intended use, comparison to predicate devices, and testing performed to demonstrate substantial equivalence. It does not contain information about the performance of an AI/ML device in detail as it pertains to acceptance criteria and performance metrics typically expected for such technologies.

The device in question is "CD Horizon™ Spinal System Instruments", which are non-sterile instruments for use during spinal surgery with navigation systems (StealthStation, MAZOR X Stealth™ Edition) and power tools (IPC™ POWEREASE™ System, AO* style quick connect drilling motors). These are physical surgical instruments, not an AI/ML software device.

Therefore, many of the requested categories regarding AI/ML device performance, such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, and training set information are not applicable to this submission, as it is for physical surgical instruments.

However, I can extract the relevant information regarding the performance testing for these instruments as described in the document.

Acceptance Criteria and Device Performance for Medtronic CD Horizon™ Spinal System Instruments

The document describes the performance testing undertaken to ensure the functionality and compatibility of the instruments. While specific numerical acceptance criteria (e.g., accuracy thresholds) are not explicitly stated in this summary, the tests confirmed the instruments meet their functional requirements.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable. This submission concerns physical instruments, not data-driven AI/ML models. Testing would have involved the instruments themselves, likely in a lab setting or simulated surgical environment. No specific sample sizes for data or data provenance (country, retrospective/prospective) are mentioned as it's not a data-based study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For physical instruments, "ground truth" typically refers to engineering specifications and functional performance. Clinical experts might be involved in defining "customer needs" for simulated use testing, but specific numbers and qualifications are not mentioned.

4. Adjudication method for the test set: Not applicable. This type of regulatory submission for physical instruments does not typically involve adjudication methods like those used for expert consensus in AI/ML model ground truth generation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. This is not applicable to physical surgical instruments.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a set of physical surgical instruments, which are used by humans and with other integrated navigation systems. There is no "standalone algorithm" performance to assess for these instruments.

7. The type of ground truth used: For these physical instruments, the "ground truth" would be established through engineering specifications, design requirements, and possibly functional performance benchmarks against predicate devices or industry standards. The document states that testing was "completed to ensure the functionality and compatibility with the identified Medtronic products" and that the "test results show that the subject device and the predicate device are equivalent." This implies a comparison to established performance of predicate devices and adherence to design specifications.

8. The sample size for the training set: Not applicable. This device is not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established: Not applicable. This device is not an AI/ML model.

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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, 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 pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis) 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 turnor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric pediative 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.

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

The CD Horizon™ Spinal System consists of a variety of shapes and size of rods, hooks, screws, CROSSLINK(R) Plates, staples, and connecting components, and 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 is to allow the use of the patient specific UNiD Rods cleared as a part of the PASS LP Spinal System with the CD Horizon™ Spinal System to allow additional surgeon options.

The provided text describes a 510(k) premarket notification for a medical device, the CD Horizon™ Spinal System. It does not pertain to an AI/ML-driven medical device, nor does it detail a study involving expert readers or ground truth establishment for diagnostic performance. Instead, it focuses on the substantial equivalence of a physical medical device (spinal fixation system) to previously marketed predicate devices, supported by mechanical performance testing.

Therefore, the requested information regarding acceptance criteria, study design for AI performance, sample sizes for test and training sets, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment (as they relate to AI/ML device validation) cannot be extracted from this document.

The document primarily focuses on mechanical performance testing to ensure structural integrity and equivalence of the new version of the spinal system.

Here's what can be extracted about acceptance criteria and performance related to the mechanical testing of the device:

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

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

• Sample Size: Not specified quantitatively in terms of number of devices or test repetitions, but "confirmatory testing" was conducted.
• Data Provenance: The testing was conducted by Medtronic as part of the 510(k) submission to demonstrate substantial equivalence to legally marketed predicate devices. The country of origin for the data is implicitly the USA, where Medtronic is based and submitting to the FDA. The nature of the testing (mechanical property evaluation) means it's not "retrospective" or "prospective" in the clinical study sense; rather, it's laboratory-based engineering validation.

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 information is not applicable to the type of device and testing described. Mechanical performance testing relies on established engineering standards (ASTM F1717, ASTM F1798) and physical measurements, not expert human interpretation or "ground truth" derived from clinical experts in the context of diagnostic performance.

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

• Not applicable. Adjudication methods are used in clinical studies or expert review processes, typically for diagnostic accuracy. Mechanical testing involves repeatable measurements and adherence to testing standards.

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 device is a physical spinal implant, not an AI/ML-driven diagnostic or assistive tool for human readers. Therefore, no MRMC study or AI assistance evaluation was conducted.

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

• Not applicable. This is not an algorithm-based device.

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

• The "ground truth" for this device's performance is adherence to established mechanical performance standards (ASTM) and demonstration of equivalent or superior mechanical properties compared to predicate devices. This is based on physical property measurements rather than clinical ground truth like pathology or outcomes data for diagnostic purposes.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. As this is not an AI/ML device, there is no training set or ground truth in that context.

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

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis) 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 pediatric pedicle screw fixation is limited to a posterior approach.

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

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

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

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.

The provided document is a 510(k) summary for the Medtronic CD Horizon™ Spinal System. It focuses on demonstrating substantial equivalence to existing predicate devices, primarily by showing that the new device has the same intended use, indications, fundamental scientific technology, materials, and sterilization method, with the key difference being that the subject devices are provided sterile.

The document does not describe an AI/ML-driven device or study involving acceptance criteria related to AI/ML performance metrics such as accuracy, sensitivity, specificity, or human reader improvement. The "performance data" section refers to mechanical testing, biocompatibility, and bacterial endotoxin testing, typical for a physical medical implant, not a software or AI/ML device.

Therefore, it's not possible to extract the information requested in your prompt based on the provided text, as it pertains to an entirely different type of medical device (a mechanical spinal implant) and its regulatory submission.

To answer your request, if the provided document were for an AI/ML device, the following would typically be found (but is absent here):

Regarding the study details, based on a hypothetical AI/ML device submission, you would typically look for:

• Sample size for the test set and data provenance: Number of images/cases. Origin (e.g., US, Europe, multi-country), and whether data was collected retrospectively or prospectively.
• Number of experts and qualifications for ground truth: How many clinicians (e.g., radiologists, pathologists) annotated the data. Their specialty, board certification status, years of experience.
• Adjudication method for the test set: How disagreements among experts were resolved (e.g., majority vote, senior expert, consensus read, 2+1 means two initial readers and a third to resolve discrepancies).
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: If conducted, details on the study design (e.g., crossover, paired), the number of readers, the effect size (e.g., how much human readers' performance metrics like AUC, sensitivity, or specificity improved with AI assistance compared to without).
• Standalone performance: Metrics (e.g., sensitivity, specificity, AUC) achieved by the algorithm alone, without human intervention.
• Type of ground truth: How the "truth" was established (e.g., expert consensus, biopsy, surgical confirmation, long-term patient outcomes, follow-up imaging, synthesis of multiple data points).
• Sample size for the training set: Number of images/cases used to train the AI model.
• How ground truth for the training set was established: Similar to the test set, but sometimes less stringent or with programmatic labeling.

In summary, the provided document does not contain any of the information requested because it pertains to a mechanical medical device (spinal implant) and not an AI/ML-driven software 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.

DO NOT IMPLANT THE INSTRUMENTS

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 specifically designed for use in spinal procedures with MAZOR X Stealth™ Edition. The instruments can be navigated or non-navigated manual instruments that may or may not be guided through the MAZOR X Arm Guide. Some instruments (e.g. drills, drivers, taps etc.) are also compatible with Medtronic's IPC™ POWEREASE™ System when connected to the POWEREASE™ Driver, these CD HORIZON™ instruments 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, cannulas, and drill guides. Placing Medtronic single-use sterile spheres on each of the NavLock™ Tracker passive stems allow MAZOR X Stealth™ Edition to track the Medtronic instruments in the surgical field.

The document provided describes the CD HORIZON Spinal System Instruments for use with MAZOR X Stealth™ Edition. This is a medical device subject to FDA approval, specifically a 510(k) premarket notification. The document states that the device is substantially equivalent to a predicate device.

The provided text does not contain the detailed information requested regarding specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test or training sets, expert qualifications, or adjudication methods. The information pertains to the regulatory approval process and a general summary of performance testing.

Therefore, many parts of your request cannot be answered from the provided document. I can, however, extract the information that is present.

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

The document does not provide specific quantitative acceptance criteria or reported device performance metrics in the format of sensitivity, specificity, or accuracy, which are typical for AI/diagnostic devices. Instead, it lists general performance tests conducted.

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

The document does not specify the sample sizes used for any of the described tests, nor does it detail the provenance of any data (e.g., country of origin, retrospective/prospective nature). The tests are described as "simulated use" and "analysis" rather than clinical trials with patient data.

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)

The document does not mention using experts to establish ground truth for a test set. The nature of the device (surgical instruments for navigation) suggests performance testing would involve engineering and functional verification rather than expert clinical assessment of diagnostic output.

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

The document does not mention any adjudication method, as it doesn't describe expert-based ground truth establishment or a review process for a test set in the context of diagnostic performance.

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

The document does not indicate that an MRMC comparative effectiveness study was done. This device is a set of surgical instruments used with a navigation system (MAZOR X Stealth™ Edition), not typically an AI-powered diagnostic device that assists human readers.

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

This request is not applicable to the device described. The device consists of surgical instruments that are part of a system intended for human use during surgery. It is not an algorithm that can perform standalone diagnostics or analysis.

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

The concept of "ground truth" in the diagnostic sense (e.g., pathology for a diagnosis) is not directly applicable here. The "ground truth" for the performance tests would likely be engineering specifications, physical measurements, and expected functional behavior of the instruments and system. For instance, "Navigation Accuracy Analysis" would involve comparing the navigated position to an objectively measured physical position, which is a form of engineering ground truth.

8. The sample size for the training set

The document does not mention a training set specific to an AI algorithm. This device is a set of physical surgical instruments, not a machine learning model that requires training data.

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

Not applicable, as no training set for an AI algorithm is mentioned or relevant to this device description.

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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 (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 may also be used for the same indications as an adjunct to fusion.

With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the 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® 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: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

The Navigated Disc Preparation Instruments are intended to be used to facilitate a discectomy during spinal surgery. The Navigated Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery.

The Navigated Probe is intended to be used during pedicle and disc preparation during spinal fusion procedures.

Navigated 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.

IPC® System is indicated for the incision/cutting, 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 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.

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 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 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 subject CD HORIZON® Spinal System offers cannulated, multi-axial bone screws that have an opened head (MAS) or closed head (CMAS). The subject screws offer additional angulation for anatomies or trajectories that require a sharper angle than what is typically used when placing a rod into the screw head. The subject MAS and CMAS are provided both sterile and non-sterile.

The subject Medtronic Navigated Reusable probe is specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. The subject probe is used to prepare for placement of the subject bone screws into the bone.

The subject Medtronic Reusable drivers, torque multiplier adapter, and taps are spine preparation instruments made of high grade stainless steel. The subject drivers, torque multiplier adapter, and taps are compatible with Medtronic's IPC® POWEREASE® System may be connected to the IPC® POWEREASE® handpiece. The subject drivers, and taps can be used manually using existing Medtronic Class I Exempt quick connect handles in place of the IPC® POWEREASE® handpiece.

The subject Medtronic Navigated Reusable drivers and taps are spine preparation instruments made of high grade stainless steel. These instruments were specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. The subject drivers and taps are also compatible with Medtronic's IPC® POWEREASE™ System when connected to the POWEREASE™ handpiece or may be used manually with existing Medtronic Class I Exempt quick connect handles in place of the IPC® POWEREASE® handpiece or the NavLock™ tracker.

The document provided is a 510(k) premarket notification from the FDA for several Medtronic spinal system components and instruments. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and study results for a new AI/Software as a Medical Device (SaMD).

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance for an AI/SaMD is not present in this document.

This document pertains to traditional medical devices (spinal implants and surgical instruments), and the evaluation methods described are typical for such devices, involving biocompatibility and mechanical testing against recognized standards (e.g., ASTM F1717, ASTM F1798).

Here's the information that can be extracted, albeit not in the context of AI/SaMD:

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

Missing Information (as it relates to AI/SaMD):

• Specific numerical values or thresholds for the acceptance criteria for mechanical testing are not detailed (e.g., "Pass" is stated, but the exact pass/fail criteria and specific measured values are not provided).
• The document does not describe the types of studies typically conducted for AI/SaMD (e.g., diagnostic accuracy studies).

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

• This information is not present as the studies described are in vitro mechanical and biocompatibility tests of physical devices, not data-driven performance evaluations of an algorithm. There is no "test set" in the context of data for an AI/SaMD.

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 information is not present. Ground truth in the context of AI/SaMD refers to expert-validated labels or outcomes. For traditional medical devices and the tests described, ground truth is established by objective measurements against engineering standards.

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

• This information is not present. Adjudication is relevant for resolving discrepancies in expert labeling of data, which is not applicable to the types of tests described in this document.

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

• This information is not present. MRMC studies are specific to evaluating diagnostic devices, particularly those involving human readers and AI assistance. This document describes physical spinal system components and instruments.

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

• This information is not present. There is no standalone algorithm being evaluated in this submission.

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

• For the biocompatibility evaluation, the "ground truth" is defined by established international standards (ISO-10993) and the known safe history of the materials used in medical implants.
• For mechanical testing, the "ground truth" is established by adherence to recognized ASTM standards (e.g., ASTM F1717, ASTM F1798) and pre-determined engineering acceptance criteria.

8. The sample size for the training set

• This information is not present. There is no "training set" as this is not an AI/SaMD submission.

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

• This information is not present. As there is no training set for an AI/SaMD, this question 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 (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 may also be used for the same indications as an adjunct to fusion.

With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System 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® 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: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

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. Similarly 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.

The purpose of this Traditional 510(k) is to modify Medtronic's CD HORIZON® Spinal System to add additional components to the system. The subject devices will include sterile and non-sterile CROSSLINK® plates which have a posterior lower profile by introducing a breakoff setscrew, which would reduce the dorsal profile of the CROSSLINK® once implanted. The subject devices are made of titanium alloy.

The provided document describes a medical device, the CD HORIZON® Spinal System, and its substantial equivalence to previously cleared predicate devices. It does not contain information about an AI/ML powered device, therefore no information about acceptance criteria and the study that proves the device meets the acceptance criteria is described.

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 fosion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion. With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System 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 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® 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: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

IPC® System is indicated for the incision/cutting, 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.

1. 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 subject devices include: Taps Screw Drivers The subject CD HORIZON® Spinal System device will be available in similar sizes as the predicate systems.
2. IPC® POWEREASE® System. The CD HORIZON® reusable instruments (subject taps and screw drivers) are compatible with Medtronic's IPC® POWEREASE® System, and are spine preparation instruments which are manufactured from materials commonly used in orthopedic procedures which meet available national or international standards specifications. The subject taps and drivers may be connected to the POWEREASE® Driver or used manually if desired. These instruments are also compatible with various Medtronic spinal implant systems.

This document does not contain information about the acceptance criteria and a study proving a device meets acceptance criteria in the context of diagnostic or screening performance.

Instead, this document is a 510(k) premarket notification summary for the CD HORIZON® Spinal System and the IPC® POWEREASE® System. It focuses on demonstrating substantial equivalence to predicate devices.

Here's what the document does provide in relation to product validation:

1. Acceptance Criteria and Reported Device Performance:

The document describes performance data related to biocompatibility and mechanical testing for the CD HORIZON® Spinal System devices (taps and drivers) in combination with the IPC® POWEREASE® System.

• Biocompatibility:

  • Acceptance Criteria (implied): The devices must be safe for body contact for up to 24 hours, in accordance with "FDA's Draft Guidance for Industry and FDA Staff 'Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'". They are manufactured from medical grade stainless steel (ASTM F899).
  • Reported Device Performance: "Medical grade stainless steel has a long history of safe and effective use in spinal surgery and biocompatibility testing is not required and no testing was conducted." The material choice is the proof of meeting the (implied) acceptance criteria.

• Mechanical Testing:

  • Acceptance Criteria (implied): The devices must demonstrate substantial equivalence to predicate devices and not represent a "new worst case" as per "Guidance for Industry and FDA Staff -Spinal System 510(k)'s".
  • Reported Device Performance: "It was determined that subject devices do not represent a new worst case. Engineering rationales were used to demonstrate substantial equivalence." No specific quantitative metrics or results from mechanical tests are provided in this summary, only the conclusion that they met the criteria through engineering rationales.

The other points you requested are not applicable or not explicitly detailed in this 510(k) summary because it's not a study evaluating diagnostic or screening performance of an AI/ML device.

Here's why these points are not present:

• 2. Sample sized used for the test set and the data provenance: Not applicable. This is not a study with a 'test set' in the sense of clinical data for diagnostic performance.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. There's no ground truth establishment for diagnostic purposes here.
• 4. Adjudication method: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not a comparative effectiveness study involving human readers or AI assistance.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an instrument used by a human surgeon.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device with a training set.
• 9. How the ground truth for the training set was established: Not applicable.

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