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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.

Device Description

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.

AI/ML Overview

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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K Number

K033352

Device Name

VERTEBRON PSS PEDICLE SCREW SYSTEM

Manufacturer

VERTEBRON, INC.

Date Cleared

2004-02-25

(128 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K970635,K030383,K022778

Intended Use

The Vertebron PSS Pedicle Screw System is intended for non pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (2.0. , fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The Vertebron PSS Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Device Description

The device consists of a system of implantable rods, screw and hooks for the purpose of aiding in spinal fusion. The system also includes various hand tool used to assist in implantation of the rod system. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136-98. The device is supplied non-sterile and is intended for sterilization by hospital personnel.

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the way typically found for AI/ML-based medical devices.

The document K033352 is a 510(k) summary for a non-AI/ML medical device, specifically a Spinal Rod System (Vertebron PSS Pedicle Screw System). This device is a traditional hardware implant for spinal fusion.

Therefore, many of the requested points, such as sample sizes for test/training sets, expert ground truth establishment for AI, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this type of device and are not present in the provided submission.

Here's a breakdown of the information that is available based on the request:

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

Acceptance Criteria: The submission states that the device was tested "in accordance with the requirements prescribed in ASTM F1717." ASTM F1717 is a standard specification for spinal implant constructs in a vertebrectomy model, which outlines mechanical testing protocols (e.g., static and dynamic compression bending, torsion). The specific quantitative acceptance criteria (e.g., maximum deflection, fatigue cycles survived, failure load) are not detailed in this summary.
Reported Device Performance: "The device was found to perform comparably to other spinal rod systems." This is a qualitative statement of performance relative to predicate devices, but specific quantitative results against the ASTM F1717 criteria are not provided in this summary.

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 / Not provided. For a physical implant, testing involves mechanical samples of the device itself, not patient data in the typical sense of an AI/ML ground truth test set. The number of physical units tested is not specified.