(18 days)
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 purpose of this 510(k) submission is to add modified TSRH® components along with previously cleared ARROWHEAD® Spinal System, CD HORIZON® Spinal System and COLORADO II® Spinal System components to the existing TSRH® Spinal System.
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, 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.
This document pertains to the Medtronic Sofamor Danek TSRH® Spinal System and is a 510(k) summary for regulatory clearance, not a study evaluating device performance against acceptance criteria in the typical sense of a clinical or AI-based study. It focuses on demonstrating substantial equivalence to previously cleared devices through mechanical testing and comparison of indications for use.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable to this type of regulatory submission. However, I can extract the relevant information where possible and indicate when a category is not relevant or not provided in the document.
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to predicate devices, which is largely met through mechanical testing and comparison of indications for use. The document refers to "mechanical test results" as the primary evidence. Specific quantitative acceptance criteria or detailed performance metrics are not given in this summary.
| Acceptance Criterion (Regulatory) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (K050282, K042025, K991091, K032560) | Met: "The subject components were demonstrated to be substantially equivalent..." "Mechanical test results were provided in support of this application." The labeling is also identical to a cleared predicate. |
| Safety and Effectiveness for Stated Indications | Assumed Met: By demonstrating substantial equivalence to devices already cleared for safety and effectiveness for similar indications. |
| Material Compatibility | Met: Fabricated from stainless steel, medical grade titanium alloy, or medical grade titanium, consistent with standards for implants. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not specified in terms of the number of specific test articles or components. The document refers to "mechanical test results" in general.
- Data Provenance: The document does not specify the country of origin for the mechanical test data. Given it's a US FDA submission, it's typically assumed such testing is conducted in a compliant manner, often in the US or in accredited labs elsewhere. The testing is for pre-market notification, so it is, in effect, prospective for the purposes of this submission, though the testing itself would have been conducted prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This concept is not applicable to a mechanical testing submission for substantial equivalence. "Ground truth" in this context refers to the defined engineering specifications, material properties, and mechanical load requirements that the device must meet, which are established by engineering standards and regulatory guidance for spinal implants.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically relevant for human interpretation tasks or clinical outcome assessments, not for mechanical testing of an engineering device.
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 medical device (spinal implant) submission, not an AI or imaging device submission that would involve multi-reader studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a spinal implant, not an algorithm.
7. The Type of Ground Truth Used
For mechanical testing, the "ground truth" implicitly refers to engineering specifications, material standards, and biomechanical performance metrics established for spinal instrumentation. These are often derived from industry standards (e.g., ASTM, ISO) and biomechanical literature for spinal stability and fixation.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of a mechanical device submission. This term applies to machine learning/AI models.
9. How the Ground Truth for the Training Set Was Established
Not applicable (see point 8).
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.