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The CD HORIZON® Spinal System without SEXTANT® instrumentation is intended for posterior, non-ecryical fixation as an adjunct to fusion for the following indications: degencrative 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, 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 degeneralive discase, the CD HORIZON® LEGACY™ 3,5mm rods and the CD HORUZON® 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 indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatic patients, the CD HORIZON® Spinal System implants are indicated as an adjunct 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: spondylolishesis 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 tailormade 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 Special 510(k) is the modifications of implants for the CD HORIZON® Spinal System. The modifications to the implants are adding additional sizes of cannulated multi-axial screws (MAS), print updates for a rebaselining of existing closed lateral connectors, and adding additional sizes of SEXTANT® pre-bent rods with different tip geometries and connection types.

This document is a 510(k) Summary for the Medtronic CD HORIZON® Spinal System. It is a premarket notification to the FDA to demonstrate substantial equivalence to previously cleared devices. Therefore, it does not describe a study to prove a device meets acceptance criteria in the typical sense of a clinical trial or performance study for a novel AI/software medical device.

Instead, this document focuses on demonstrating that the modified CD HORIZON® Spinal System is substantially equivalent to existing, legally marketed predicate devices. The "acceptance criteria" here are met by showing that the modified device has the same indications, intended use, fundamental scientific technology, materials, and sterilization method as the predicates, and that design modifications do not introduce new issues of safety or effectiveness.

Here's an analysis based on the provided document, addressing your points where applicable:

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

Since this is a 510(k) for a spinal implant system aiming for substantial equivalence to predicates, the "acceptance criteria" are not performance metrics like sensitivity, specificity, or AUC as one might find for an AI device. Instead, they relate to material properties, design equivalency, and 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 is a 510(k) for an updated spinal implant system, not an AI/software device that requires a test set of data. The "test" consists of analytical methods (risk analysis, engineering rationales, material equivalency) rather than performance on a data set.

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

Not applicable. This document does not describe a study involving expert review for ground truth establishment.

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

Not applicable, as there is no "test set" in the context of an AI/software device performance study.

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 document is for a spinal implant, not an AI-assisted diagnostic or therapeutic device.

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

Not applicable. This document describes an updated spinal implant system, not a standalone algorithm.

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

Not applicable. The "ground truth" for this submission is whether the modified device remains functionally and materially equivalent to its predicates, which is established through engineering analysis and comparison to existing regulatory clearances, rather than clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device requiring a training set.

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

Not applicable. This is not an AI/machine learning device.

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The General Spinal System is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

The spinal system consists of screws, rods, crosslink plates, set screws and hooks.

It is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well known biocompatibility.

The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development. validation, and routine control of a sterilization process for medical devices

The provided text describes a 510(k) submission for a spinal system and focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. It does not contain information about the use of AI, human readers, or clinical study data for device performance as would be relevant for acceptance criteria in the context of an AI-powered diagnostic device.

Therefore, the following information regarding acceptance criteria and a study proving device performance as typically applied to AI devices (especially those involving diagnostic accuracy) cannot be extracted from the given text:

1. A table of acceptance criteria and the reported device performance: Not available. The document refers to "design specifications" being met, but these are not defined in terms of specific performance metrics suitable for a table.
2. Sample size used for the test set and the data provenance: Not applicable, as no test set beyond bench testing materials is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no expert evaluation for ground truth is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: 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: Not applicable. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as clinical ground truth establishment is not mentioned for this type of device. The studies are bench tests.
8. The sample size for the training set: Not applicable, as this is not an AI device.
9. How the ground truth for the training set was established: Not applicable.

However, based on the provided text, here's what can be extracted regarding the device's "acceptance criteria" (in the context of a 510(k) submission for a physical implant) and the study that proves it meets them:

Acceptance Criteria and Device Performance for the General Spinal System (K122994)

Study Details:

• Type of Study: Non-clinical bench tests.
• Sample Size for Test Set: Not explicitly stated, typical for bench testing where a representative number of samples are tested according to defined standards.
• Data Provenance: Not applicable, as these are laboratory bench tests, not clinical data.
• Ground Truth Establishment: For bench tests, the "ground truth" is defined by the specified performance limits and methodologies outlined in the ASTM and ISO standards used. The device's physical properties and performance are verified against these objective criteria.
• Training Set: Not applicable as this is not an AI device.
• Adjudication Method: Not applicable for bench testing against established engineering standards.
• MRMC Comparative Effectiveness Study: Not applicable.
• Standalone Performance: The non-clinical bench tests evaluate the device's standalone physical performance parameters. The "algorithm only" concept does not apply here.

The core of the submission relies on demonstrating that the proposed device, the General Spinal System, performs similarly to a legally marketed predicate device (CD HORIZON® Spinal System, K042790) by meeting the same widely accepted industry standards for spinal implants.

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