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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, 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 tumor, 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: (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) pseudoarthrosis, (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; pseudarthrosis; and/or failed previous fusion.

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

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 TSRH® Spinal System. These components include GDLH® rods, GDLH® rod/bolt connectors, GDLH® Variable Angle T-Bolts, GDLH®set screws and locking screws, DYNALOK® PLUS™ bolts, CD HORIZON® Low Profile MULTI-SPAN® 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 implant components are fabricated from medical grade stainless steel, medical grade titanium or titanium alloy, and/or medical grade cobaltchromium-molybdenum alloy. Medical grade titanium alloy, and/or cobaltchromium-molybdenum alloy may be used together. Certain TSRH® Spinal System components may be coated with hydroxyapatite. Never use titanium, titanium allov, and/or cobalt-chromium-molybdenum alloy with stainless steel in the same construct.

The provided text is a 510(k) summary for the TSRH® Spinal System, specifically focusing on the inclusion of a new 3Dx 90° Offset Connector. It primarily addresses the non-clinical testing performed to demonstrate substantial equivalence to predicate devices, rather than a study proving performance against acceptance criteria in a clinical setting.

Here's an analysis based on the information provided and what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes non-clinical mechanical testing standards, but does not explicitly state specific pass/fail acceptance criteria or quantitative performance results in a table format. Instead, it states that the tests were performed "per ASTM F1798-97" and "per ASTM F1717-04" and that Medtronic "believes that documentation provided demonstrates that the TSRH® 3Dx 90° Offset Connector is substantially equivalent to its predicates."

Therefore, it's not possible to create the requested table with specific numerical acceptance criteria and reported performance from this document. The implicit acceptance criterion is that the new component performs comparably to the predicate devices when tested under the specified ASTM standards.

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

• Sample Size: The document does not specify the number of individual components tested (sample size) for the mechanical tests. It only lists the types of tests performed.
• Data Provenance: The data provenance is from non-clinical mechanical testing, conducted by Medtronic Sofamor Danek USA. It is not human subject data; therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not directly apply in the way they would for clinical studies.

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

This section is not applicable as the document describes non-clinical mechanical testing, not a study involving human subjects or expert assessment of clinical data. The "ground truth" for mechanical testing is established by the test standards (ASTM F1798-97 and ASTM F1717-04).

4. Adjudication Method for the Test Set:

This is not applicable for non-clinical mechanical testing. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is used to assess the impact of a device (like an AI algorithm) on human reader performance, which is not relevant to the mechanical testing of a spinal implant component.

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

No, a standalone study was not done. Again, this concept applies to AI algorithms, not mechanical medical devices. The testing described is "standalone" in the sense that it evaluates the component's mechanical properties independently of human interaction.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical testing is the performance specifications and methodologies defined by the ASTM standards (ASTM F1798-97 and ASTM F1717-04) and the established performance of the predicate devices. The new connector is expected to perform comparably.

8. The Sample Size for the Training Set:

This is not applicable. There is no "training set" in the context of mechanical testing for a spinal implant. Training sets are relevant for machine learning algorithms.

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

This is not applicable for the same reasons as above.

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