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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 (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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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® 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. 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.

2. MEDTRONIC REUSABLE INSTRUMENTS COMPATIBLE WITH THE IPC® POWEREASE® System
   The Medtronic Reusable drivers and taps that are compatible with Medtronic's IPC® POWEREASE® System 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 is a 510(k) Pre-market Notification for the Medtronic Sofamor Danek CD HORIZON® Spinal System and the IPC® POWEREASE® System. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of an AI/algorithm-driven device.

Therefore, many of the requested sections (acceptance criteria, device performance, sample sizes for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable or not provided in this type of regulatory submission.

The document primarily addresses the safety and effectiveness of the device by comparing its technological characteristics and intended uses to previously cleared devices.

Here's an attempt to answer the questions based on the provided text, indicating when information is not applicable or not found.

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

This document does not present a table of specific acceptance criteria (e.g., performance metrics like sensitivity, specificity, accuracy) or quantitative device performance metrics in the context of an algorithm's classification or prediction capabilities. This submission focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of indications for use, technological characteristics, and material safety.

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

Not applicable. This submission does not describe a clinical study with a test set of patient data to evaluate algorithmic performance. The "performance data" mentioned refers to material biocompatibility and mechanical testing (not detailed in this summary).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment for a test set is described.

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

Not applicable. No adjudication method for a test set is described.

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

Not applicable. This is not an AI/algorithm device that supports human readers; it is a spinal surgical system (implants and instruments).

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

Not applicable. This is not an AI/algorithm device.

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

Not applicable. No ground truth for an algorithmic performance evaluation is described. The "performance data" refers to biocompatibility testing, where the "ground truth" would be established by standard analytical and biological testing methods for materials.

8. The sample size for the training set

Not applicable. This document is not about an AI/algorithm requiring a training set.

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

Not applicable. No training set is involved.

Summary of Relevant Information from the Document:

While the direct questions about "acceptance criteria" for an algorithm's performance are not applicable, the document does contain information about how the substantial equivalence of the device was demonstrated, which is the regulatory "acceptance criterion" for a 510(k) submission.

• Device Description:

  • CD HORIZON® Spinal System: Consists of various shapes and sizes of rods, hooks, screws, CROSSLINK® plates, staples, and connecting components, which can be rigidly locked into various configurations.
  • MEDTRONIC REUSABLE INSTRUMENTS COMPATIBLE WITH THE IPC® POWEREASE® System: Spine preparation instruments (drivers and taps) manufactured from materials commonly used in orthopedic procedures. These can be connected to the POWEREASE® Driver or used manually.

• Predicate Devices (used for comparison to establish substantial equivalence):

  • CD HORIZON® Spinal System (K141605, S.E. 07/14/2014)
  • IPC® POWEREASE® System (K111520, S.E. 10/26/2011)

• Comparison of Technological Characteristics:

  • The subject Medtronic CD HORIZON® Reusable drivers and taps, compatible with the IPC® POWEREASE® System, have the same fundamental technology and stainless steel materials as the predicate devices.
  • Materials: Medical grade stainless steel (ASTM A564, ASTM F899, ASTM A693, Custom 465, Custom 455, 17-4 Stainless Steel).

• Performance Data (Type of data provided, not quantitative results):

  • Biocompatibility: The instruments are classified as external communicating devices with limited body contact (up to 24 hours), according to FDA's Draft Guidance for Industry and FDA Staff: Use of International Standard ISO-10993, Biological Evaluation Method Devices Part 1: Evaluation and Testing. (No specific test results are provided in this summary, but the materials meet standards).

• Conclusion: Based on risk analysis and supporting documentation, the subject CD HORIZON® Spinal System is substantially equivalent to the listed predicates.

In essence, this document demonstrates that the new device is as safe and effective as previously cleared devices by showing similar design, materials, and intended use, rather than demonstrating improved or specific quantitative performance against defined clinical acceptance criteria through a study with a test set of data.

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