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When used as a pedicle screw fixation system in 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 degencration of the disc confirmed by patient history and radiographic studies), (2) degencrative 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) 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.

For anterior use only the TSRH® Spinal System has the additional indications of: (1) spinal stenosis and/or, (2) spondylolysis.

The TSRH® Spinal System is intended to help provide immobilization and stabilization 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, and connecting components. In addition, GDLH® rods, DYNALOK® PLUS 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.

The TSRH® Spinal System components are fabricated from stainless steel. Alternatively, they may be fabricated from medical grade titanium alloy or medical grade titanium. The TSRH® Spinal System may be sold sterile or non-sterile.

The purpose of this 510(k) submission is to add modified bone screws to the TSRH® Spina] System.

The provided document is a 510(k) summary for the TSRH® Spinal System, specifically an amendment to add modified bone screws. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a de novo study with acceptance criteria and device performance results.

Therefore, most of the requested information cannot be extracted from this document. Here's what can be inferred or stated as not applicable:

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

• Not Applicable. This document is a 510(k) summary for substantial equivalence, not a clinical study report or a performance validation report against specific acceptance criteria. The device performance is implicitly demonstrated through the substantial equivalence to predicate devices, which are already deemed safe and effective.

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. No test set, clinical data, or patient data (retrospective or prospective) is mentioned for this 510(k) submission. The submission is based on engineering documentation and comparison to predicates.

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 test set requiring ground truth establishment by experts is mentioned.

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

• Not Applicable. No test set or ground truth adjudication method is mentioned.

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 a spinal implant device, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI performance evaluation is relevant or mentioned.

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

• Not Applicable. This is a spinal implant device, not an algorithm.

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

• Not Applicable. No clinical ground truth data is presented. The "ground truth" for a substantial equivalence determination often refers to the predicate device's established safety and effectiveness.

8. The sample size for the training set

• Not Applicable. This document does not describe an AI/ML device that requires a training set.

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

• Not Applicable. As there is no training set mentioned, there is no ground truth establishment for it.

Summary based on the provided document:

The 510(k) summary demonstrates substantial equivalence of the modified bone screws for the TSRH® Spinal System to legally marketed predicate devices. This approach, common for medical devices, means that the new device shares fundamental technological characteristics and indications for use with devices already cleared by the FDA, implying similar safety and effectiveness without requiring new clinical studies to establish acceptance criteria and performance from scratch.

• Acceptance Criteria & Device Performance: Not explicitly stated as this is a substantial equivalence submission. The implicit acceptance criteria is that the modified screws are as safe and effective as the predicate devices (K011067, K020699, K021170, K022778, K041282, K052054, and K062807). Performance is considered equivalent to these predicates based on documentation, including a risk analysis.
• Study Type: Substantial Equivalence Comparison.
• Data Provenance/Sample Size/Experts/Adjudication/MRMC/Standalone Performance/Ground Truth (for test or training sets): Not applicable or not detailed in this 510(k) summary, as the submission focuses on engineering documentation and comparison to predicate devices, rather than a de novo clinical study with these elements.

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