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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 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) 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, 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 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, rods, rod/bolt cometions, Variable Angle T-Bolts, set screws and locking screws; DYNALOK® PLUS holts, CD HORIZON® Low Profile MULTI-SPAN® CROSSLINK® Plates, as well as CD® HORIZON rods, screws, setscrews and locking screws.

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 Officet Plates may be used anteriorly as well.

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

The purpose of this 510(k) submission is to add modified connectors and setscrews to the TSRH® Spinal System. Additionally, the package insert was modified to include references to the ability of certain CD HORIZON® Spinal System components to be used with the TSRH® Spinal System.

This document is a 510(k) summary for the TSRH® Spinal System, specifically an amendment to add modified connectors and setscrews. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study for performance against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and performance studies for a device that relies on AI or diagnostic capabilities is not present in this type of submission.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as performance metrics. The core "acceptance criteria" for a 510(k) submission are demonstration of substantial equivalence to predicate devices. This is achieved through analysis of materials, design principles, and intended use as compared to devices already on the market.
• Reported Device Performance: Not reported in terms of quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical test results compared against thresholds). The submission asserts that the modified components are substantially equivalent.

2. Sample sized used for the test set and the data provenance

• Sample Size: Not applicable. This submission doesn't describe a 'test set' in the context of a performance study with human or image data. It pertains to a physical medical device.
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of experts/Qualifications: Not applicable. There is no 'ground truth' established by experts in this type of submission. The evaluation is based on regulatory review of design, materials, and intended use.

4. Adjudication method

• Adjudication Method: 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

• MRMC Study/Effect Size: No. This device is a physical spinal implant system, not an AI-powered diagnostic tool.

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

• Standalone Performance: No. This is a physical medical device.

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

• Type of Ground Truth: Not applicable. For this device, the "truth" being established is that the modified components are safe and effective for their intended use and are substantially equivalent to existing predicate devices. This is assessed through engineering analysis and regulatory review, not by establishing 'ground truth' from clinical data in the traditional sense of a diagnostic device.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. There is no machine learning "training set" for this physical device.

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

• Ground Truth for Training Set: Not applicable.

Summary of available information from the document:

• Device Type: Spinal System (implants for fixation and stabilization of spinal segments).
• Regulatory Mechanism: 510(k) Premarket Notification, seeking to add modified connectors and setscrews to an existing system.
• Primary "Acceptance Criteria" implicitly met: Substantial Equivalence to legally marketed predicate devices.
• Predicate Devices cited: K030285, K011029, K050282, K982290, K041282, K020699, K022778, K022778, K042025, K052054, and K062807.
• Study Proving Acceptance: The document states: "Documentation, including a risk analysis, was provided which demonstrated the subject rods to be substantially equivalent to predicate TSRH® components previously cleared..." This documentation would typically include engineering analyses, material biocompatibility data, and potentially mechanical testing (though specific results for the modified components against defined thresholds are not in this summary). The "study" here is a regulatory comparison and risk analysis, not a clinical trial or performance study against specific, quantitative acceptance criteria for a diagnostic device.

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When intended to promote fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Occipitocervical Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks
The occipitocervical plate rods, plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine.
Occipitocervical construct require bilateral fixation to C2 and below. Note: Segmental fixation is recommended for these constructs.

Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws/Connectors
The use of multi-axial screws is limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.
Titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.
In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.

The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion. See the package inserts of both of those systems for labeling limitations.
The VERTEX® Reconstruction System is fabricated from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium, medical grade titanium alloy, and/or medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and or/cobalt chromium with ataless steel in the same construct. The VERTEX® Reconstruction System includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi) - Thane Memory Alloy is compatible with titanium, titanium alloy, and cobalt chrom. Shippe only. Some multi-axial screws contain elastomeric stakes made of silicore adhesive commonly used in implantable medical devices. Do not use with stainless steel. No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MDT Catalog or price list for further information about warranties and limitations of liability.
To achieve best results, do not use any of the VERTEX® Reconstruction System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another MEDTRONIC document. As with all orthopedia and neurosurgical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.

The provided text is a 510(k) summary for the VERTEX® Reconstruction System, a medical device. It describes the device, its indications for use, and its substantial equivalence to other legally marketed devices.

However, the document does not contain any information regarding acceptance criteria, device performance, sample sizes for test or training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The "V. Substantial Equivalence" section mentions: "The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to or better than the testing performed for the predicate VERTEX® Reconstruction System components." This indicates that some form of testing was done to demonstrate equivalence, likely mechanical strength or fatigue testing, but the specific acceptance criteria and detailed results are not provided in this summary.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or the other detailed information about a study based on the provided text. The document is a regulatory summary, not a detailed study report.

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