(317 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 as an adjunct to fusion for one 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 as an adjunct to fusion 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, 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 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, 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 TSRH® Spinal System. These components include GDLH® rods, GDLH® rod/bolt connectors, GDLH® Variable Angle T-Bolts, GDLH® set screws and locking screws, DYNALOK® PLUS™ bolts, CD HORIZON® Low Profile MULTI-SPAN® 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. Within the TSRH® family, the cobalt chromium rods should only be used with TSRH® 3Dx™ Spinal System. 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, medical grade titanium alloy, and/or medical grade cobalt-chromiummolybdenum alloy. Medical grade titanium, titanium alloy, and/or cobalt-chromiummolybdenum alloy may be used together. Certain TSRH® Spinal System components may be coated with hydroxyapatite. The subject components will be manufactured from medical grade titanium alloy described by such standards as ASTM F 136 or ISO 5832-3. The TSRH® Spinal System may be sold sterile or non-sterile.
The purpose of this 510(k) submission is to include hydroxyapatite coated screws into the TSRH® Spinal System.
Here's an analysis of the provided text regarding the acceptance criteria and study for the TSRH® Spinal System, structured according to your request:
Acceptance Criteria and Device Performance Study for TSRH® Spinal System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Non-Clinical Mechanical Tests) | Reported Device Performance |
|---|---|
| Static Tensile Testing per ASTM F1147-05 | Study performed with results supporting substantial equivalence. (Specific numerical performance metrics are not provided in the summary, only that tests were performed and supported equivalence.) |
| Average Coating Thickness Analysis per ASTM F1854-01 | Study performed with results supporting substantial equivalence. (Specific numerical performance metrics are not provided in the summary, only that tests were performed and supported equivalence.) |
| Requirements of FDA guidance document "510(k) Information Needed for Hydroxyapatite Coated Implants" | Existing testing was provided to demonstrate compliance with these requirements. (Specific details of how these requirements were met are not provided in the summary, but it's stated they were addressed.) |
2. Sample Sizes and Data Provenance
This submission is a 510(k) for a medical device (spinal implant system), not an AI/software device. Therefore, the concepts of "test set," "training set," "data provenance," "country of origin," "retrospective or prospective," "number of experts," "adjudication method," and "ground truth" as they relate to clinical studies for AI/software are not applicable here.
The "studies" conducted are non-clinical mechanical tests, not studies involving human subjects or data sets in the way AI/ML models are evaluated.
3. Number of Experts and Qualifications
Not applicable, as this is a mechanical device evaluation, not an AI/software diagnostic or prognostic study.
4. Adjudication Method
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable, as this is a mechanical device evaluation. It doesn't involve human readers assisted by AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Not applicable, as this is a mechanical device. There is no algorithm.
7. Type of Ground Truth Used
The "ground truth" in this context refers to the standards defined by ASTM (American Society for Testing and Materials) for mechanical properties and FDA guidance documents for material and coating characteristics of medical implants. The tests performed are designed to demonstrate that the device meets these established engineering and regulatory 'truths'.
8. Sample Size for the Training Set
Not applicable.
9. How the Ground Truth for the Training Set Was Established
As this is a mechanical device, there is no "training set" in the AI/ML sense. The "ground truth" for the non-clinical tests is established by industry standards (ASTM) and regulatory guidance (FDA). These standards define the acceptable mechanical performance and material characteristics required for such implants.
§ 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.