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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 spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral ioint: (b) who are receiving fusions using autogenous bone graft only; (c) 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) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used as an anterolateral thoracic/lumbar 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) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The purpose of this 510(k) submission is to add the 3D Connector and associated screws to the TSRH® Spinal System.

The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, and connecting components. In addition, GDLH® rods, DYNA-LOK® bolts, CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® Plates, GDLH® rod/bolt connectors, GDLH® Variable Angle T-Bolts, and GDLH® and CD HORIZON™ set screws and locking screws may be used with the TSRH® Spinal System.

The TSRH® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3D™ connectors and TSRH-3D™ 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 either stainless steel conforming to ASTM F-138 or ISO 5832-1 or ISO 5832-9, or titanium alloy conforming to ASTM F-136 or ISO 5832-3. The TSRH Spinal System may sold sterile or non-sterile.

This 510(k) summary (K984522) describes the addition of 3D Connectors and associated screws to the existing TSRH® Spinal System. The submission primarily focuses on establishing "substantial equivalence" to predicate devices rather than providing detailed acceptance criteria and performance study results in the manner common for AI/ML device submissions.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and adjudication methods is not available in this document. This is typical for a 510(k) submission for a physical medical device from this era, where the focus is on demonstrating that the new components are essentially the same as previously cleared components and do not raise new questions of safety or effectiveness.

Here's an attempt to answer the questions based on the provided text, while highlighting what is missing due to the nature of the document:

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

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

Not available/Applicable. This document does not describe a performance study with a test set of data points in the way an AI/ML device would. Instead, substantial equivalence is claimed based on similarities in design, materials, and intended use to existing predicate devices.

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 available/Applicable. No expert-derived ground truth for a test set is described.

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

Not available/Applicable. No test set or adjudication method 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 available/Applicable. This is not an AI-assisted device, and no MRMC study is mentioned.

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

Not available/Applicable. This is not an algorithm-only device.

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

Not available/Applicable. The concept of "ground truth" for a performance study is not relevant here as the submission focuses on substantial equivalence of physical components. The "truth" in this context is that the new components are comparable in design, material, and function to previously cleared devices.

8. The sample size for the training set

Not available/Applicable. No training set for an algorithm is discussed.

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

Not available/Applicable. No training set or ground truth establishment for it is discussed.

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