(147 days)
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using bone graft, 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 turnor, 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 using bone graft: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral 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.
When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor, pseudarthritis; and/or failed previous fusion.
For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.
The purpose of this Special 510(k) is to add the subject devices which consist of bone screws, set screws, and connectors to the 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, staples, plates 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 These components include GDLH® rods, GDLH® rod/bolt TSRH® Spinal System. connectors, GDLH® Variable Angle T-Bolts, GDLH® set screws and locking screws, bolts, CD HORIZON® MULTI-SPAN® DYNALOK® PLUSTM Low Profile CROSSLINK® Plates, VANTAGE™ Anterior Fixation System screws, and CD HORIZON® rods, set screws and locking screws.
The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3D® and TSRH-3Dx™ connectors and TSRH-3D® and TSRH-3Dx™ 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 medical grade stainless steel. Alternatively, they may be fabricated from medical grade titanium alloy or medical grade titanium. The subject components will be manufactured from medical grade titanium or titanium alloy described by such standards as ASTM F67 or ASTM F136 or ISO 5832-3 or ISO 5832-2. The TSRH® Spinal System may be sold sterile or non-sterile.
This 510(k) summary for the TSRH® Spinal System describes adding new components (bone screws, set screws, and connectors) to an existing system. The primary method for demonstrating substantial equivalence is through mechanical test results and comparison to predicate devices, rather than a clinical study involving human or algorithmic performance. Therefore, many of the requested categories related to clinical study design and AI performance are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Description from Document |
|---|---|
| Mechanical Performance | Substantially equivalent mechanical test results for bone screws, set screws, and connectors compared to predicate devices. |
| Material Composition | Fabricated from medical grade stainless steel, titanium alloy (ASTM F67 or ASTM F136), or titanium (ISO 5832-3 or ISO 5832-2). |
| Indications for Use | Identical to those cleared in K052054 (bone screws) and K072317 (set screws and connectors). This implies the new components maintain the same intended uses and safety profiles as the predicate devices. |
| Labeling | Identical to that cleared in K052054 (bone screws) and K072317 (set screws and connectors). |
| Sterility | May be sold sterile or non-sterile. |
Reported Device Performance: The document states that "Mechanical test results were provided in support of this submission." The conclusion is that the new components "were demonstrated to be substantially equivalent" to the predicate devices in terms of mechanical performance and other characteristics. Specific quantitative performance metrics (e.g., maximum load, fatigue cycles) are not detailed in this summary but would have been part of the full 510(k) submission.
2. Sample Size Used for the Test Set and Data Provenance
This submission relies on mechanical testing of the device components, not a clinical test set with patient data. Therefore:
- Sample Size for Test Set: Not applicable in the context of clinical data. The sample size would refer to the number of devices or components tested in the mechanical studies. This information is not provided in the summary.
- Data Provenance: Not applicable in the context of clinical data. The data originates from laboratory mechanical testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth in this context would refer to the established mechanical specifications and performance standards for spinal fixation devices, which are defined by regulatory bodies and consensus standards, not by individual clinical experts in a test set.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are relevant for human interpretation of clinical data. This submission is based on mechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study assesses human reader performance (with or without AI assistance) on clinical cases and is not relevant for a device submission focused on mechanical equivalence of new components to an existing spinal system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for this submission is based on established mechanical performance standards and specifications for spinal fixation devices, as demonstrated through laboratory testing and comparison to legally marketed predicate devices. This is a technical/engineering ground truth rather than a clinical ground truth like pathology or expert consensus on patient outcomes.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of a mechanical device submission demonstrating substantial equivalence. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as above.
§ 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.