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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using bone graft, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative disc disease(defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment. (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal turnor, and/or (8) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients using bone graft: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint: (2) who are receiving fusions using autogenous bone graft only: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6)pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion.

When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor, pseudarthritis; and/or failed previous fusion.

For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.

The purpose of this Special 510(k) is to add the subject devices which consist of bone screws, set screws, and connectors to the TSRH® Spinal System.

The TSRH® Spinal System is intended to help provide immobilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.

The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, staples, plates 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.

Certain implant components from other Medtronic spinal systems can be used with the These components include GDLH® rods, GDLH® rod/bolt TSRH® Spinal System. connectors, GDLH® Variable Angle T-Bolts, GDLH® set screws and locking screws, bolts, CD HORIZON® MULTI-SPAN® DYNALOK® PLUSTM Low Profile CROSSLINK® Plates, VANTAGE™ Anterior Fixation System screws, and CD HORIZON® rods, set screws and locking screws.

The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3D® and TSRH-3Dx™ connectors and TSRH-3D® and TSRH-3Dx™ screws are intended for posterior use only. ALL CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used anteriorly as well.

The TSRH® Spinal System components are fabricated from medical grade stainless steel. Alternatively, they may be fabricated from medical grade titanium alloy or medical grade titanium. The subject components will be manufactured from medical grade titanium or titanium alloy described by such standards as ASTM F67 or ASTM F136 or ISO 5832-3 or ISO 5832-2. The TSRH® Spinal System may be sold sterile or non-sterile.

This 510(k) summary for the TSRH® Spinal System describes adding new components (bone screws, set screws, and connectors) to an existing system. The primary method for demonstrating substantial equivalence is through mechanical test results and comparison to predicate devices, rather than a clinical study involving human or algorithmic performance. Therefore, many of the requested categories related to clinical study design and AI performance are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Reported Device Performance: The document states that "Mechanical test results were provided in support of this submission." The conclusion is that the new components "were demonstrated to be substantially equivalent" to the predicate devices in terms of mechanical performance and other characteristics. Specific quantitative performance metrics (e.g., maximum load, fatigue cycles) are not detailed in this summary but would have been part of the full 510(k) submission.

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

This submission relies on mechanical testing of the device components, not a clinical test set with patient data. Therefore:

• Sample Size for Test Set: Not applicable in the context of clinical data. The sample size would refer to the number of devices or components tested in the mechanical studies. This information is not provided in the summary.
• Data Provenance: Not applicable in the context of clinical data. The data originates from laboratory mechanical testing.

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

Not applicable. Ground truth in this context would refer to the established mechanical specifications and performance standards for spinal fixation devices, which are defined by regulatory bodies and consensus standards, not by individual clinical experts in a test set.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are relevant for human interpretation of clinical data. This submission is based on mechanical testing.

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

No, an MRMC comparative effectiveness study was not done. This type of study assesses human reader performance (with or without AI assistance) on clinical cases and is not relevant for a device submission focused on mechanical equivalence of new components to an existing spinal system.

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 device is a physical medical implant, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on established mechanical performance standards and specifications for spinal fixation devices, as demonstrated through laboratory testing and comparison to legally marketed predicate devices. This is a technical/engineering ground truth rather than a clinical ground truth like pathology or expert consensus on patient outcomes.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of a mechanical device submission demonstrating substantial equivalence. Training sets are relevant for machine learning algorithms.

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

Not applicable for the same reasons as above.

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